Indian company IPCA is facing trouble..
At the Webpage of the US FDA IPCA products are listed which are impacted by the Import Alert. Two facilities from IPCA have been found to be out of GMP compliance: One in Pithampur (Madhya Pradesh) and one in Piparia (Silvassa). The company IPCA was already known for not meeting the GMP requirements.
FDA approved the first biosimilar in USA..
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
Iphone in Clinical Research..
During yesterdays Apple Keynote event, Apple presented a new project that will help iPhone to be a tool in Clinical research. The name of the open source project is Research Kit..
FDA findings in clinical trials not reflected in peer-reviewed literature...
Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of misconduct. Out of 78 publications only 3 mentioned the objectionable conditions or practices found during the inspection.
Clinical Research Association, Turkey is supporting AllTrials initiative..
Clinical Research Association signed the petition that calls for all past and present clinical trials to be registered and their full methods and summary results reported. AllTrials is an initiative of Bad Science, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS
and Sense About Science and is being led in the US by Dartmouth’s Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice. The AllTrials petition
has been signed by 82836 people
and 542 organisations
Clinical Research performance of Turkey..
According to an analysis based on Clinicaltrials.gov data; Turkey reached to number 31 in the world in 2015, while this number was 36 in 2011. This rank is calculated according to the number of trials conducted in a country.
The first 12 countries share 94.4% of all clinical trials in the world. During this period, China, Korea and Turkey increased their number of clinical trials.
Turkish Clinical Research Association linkedin page
You can now follow us on linkedin
2. Congress on Clinical Research in Turkey (Agenda)..
You can find the Agenda of the 2. Congress on Clinical Research that will be held in Istanbul, 27-28th March.
EMA is getting ready to suspend many drugs..
A number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, says the European Medicines Agency (EMA).
EMA has released a new finalized guideline called Similar Biological Medicinal Products..
The Guideline describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles for establishing biosimilarity.
FDA has established an Office of Pharmaceutical Quality (OPQ) within CDER..
FDA has established an Office of Pharmaceutical Quality (OPQ) within CDER that will manage the process of review, inspection, and research. This super-office will perform non-enforcement-related uniform drug quality oversight across all products – new drugs, generic drugs, and OTC drugs, and across all sites of manufacture, whether domestic or foreign, throughout the whole drug life cycle. Drugs currently being evaluated for approval will remain with their existing review team at the FDA. New applications will be filed with the new office beginning immediately
An important transparency achievement in Turkey..
After the introduction of Clinical Trials Portal by MoH, a new decision came from Association of Research-Based Pharmaceutical Companies (AIFD). AIFD declared that there will be a Public Disclosure of Transfers of Value between the Pharmaceutical Sector and Healthcare Professionals and Healthcare Institutions and Organizations.
FDA drug approval in 2014..
FDA approved 35 new drugs in 2014. 15 of these drugs are approved for rare diseases and 15 of them are first-in-class.
Read the news for details..
EU body recommends approval of first stem-cell therapy..
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) backed approval of Chiesi's Holoclar for the treatment of moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eye in adults. Holoclar is the first advanced therapy medicinal product containing stem cells recommended for clearance in the EU.
Merry Christmas and a happy 2015..
We wish all our readers a Merry Christmas and a happy new year..
BfArM wants to withdraw Marketing Authorisations of Drugs which are based on the studies performed in GVK Biosciences...
BfArM wants to withdraw Marketing Authorisations of Drugs which are based on the studies performed in the Indian Company GVK Biosciences. Inquiries of WDR, NDR and Süddeutschen Zeitung showed that studies of the company were intentional manipulated.
2015 Edition of International Compilation of Human Research Standards Now Available...
The 2015 edition of the International Compilation of Human Research Standards has just been released and is available on-line: www.hhs.gov/ohrp/international/index.html
. The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 113 countries as well as standards issued by a number of international and regional organizations.
Drug trials snapshots from FDA..
The FDA has developed Drug Trials Snapshots to provide information to the public about who participated in the clinical trials for new FDA approved drugs. Drug Trials Snapshot is part of a pilot project to provide information about the sex, age, race and ethnicity of clinical participants for a small group of recently approved drugs.
Clinical Trials web portal is on service now..
The Turkish Clinical Trials web portal is on service now. The portal is prepared by MoH and have sections both for public and for transparency. You can see all the clinical trials approved by MoH on this portal.
Gets injected with Ebola virus, then runs marathon..
A man was deliberately injected with the deadly Ebola virus in order to find a cure but rather than rest up afterwards, he decided to run a marathon.
Patient Safety infograph..
EC released an infograph on Patient Safety. According to this every year adverse events cause 37.000 deaths..
Transperancy in clinical trials: Still a long way to go..
In a recent article published in JAMA, the authors conducted a search in MEDLINE, looking at the clinical trial results (RCTs) that were reanalyzed. Only 37 were found and 84% had overlapping authors from the original report. 35% of the reanalyses produced results that were significantly different from the initial analysis.
A Biosimilar Application Has Been Accepted By The FDA..
Sandoz announced that the U.S. Food and Drug Administration (FDA) has
accepted its application to market a version of filgrastim.
Sandoz, a Novartis Group company, already markets a biosimilar
filgrastim outside the U.S. under the brand name ZARZIO®. The reference
product is Amgen's NEUPOGEN®, a recombinant
human granulocyte colony-stimulating factor (r-metHuG-CSF)
Updated regulation on Clinical Trials (in English)...
The updated name is Regulation on Clinical Trials of Medicinal and Biological Products. This new regulation covers trials on herbal products. Clinical trials will also be conducted in private hospitals. All clinical trials should be submitted and recorded on a national public open database.
FDA Presentation to US House of Representatives on Clinical Research..
FDA President Janet Woodcock presented a statement on clinical trials on 11 July 2014 to Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives. You can reach the full text from our pages..
Report of CT summary results in EudraCT to become mandatory for sponsors..
As of 21 July 2014, it will become mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), of the European Medicines Agency (EMA)
Clinical Trials Turkey..
Clinical Research Association presents the project jointly developed with ClinicalTrials.gov. Clinical Trials Turkey web site focuses on all the studies with a center from Turkey, submitted to the ClinicalTrials.gov. The database can be searched and free to users of our website.
Parexel acquired ATLAS..
Parexel has acquired all of the outstanding equity securities of ATLAS Medical Services (“ATLAS”); an important service provider CRO in Turkey.
Clinical Trials Regulation updated..
The name of the new regulation is ''Regulation on Drug and Biological Products''
All clinical trials on biological products is now going to be regulated by this bylaw,
Coordinator and Administrator is defined,
Now it will be possible to perform clinical trials in private settings,
All clinical trials have to be submitted to an public open web based database,
Documents related to a clinical trial have to be archived for 5 years, this was 14 years before this regulation,
The responsibility of teh Advisory Board is redefined,
All ethical Committee members should have GCP education in the following 9 months.
To read the full text regulation in Turkish, read the news..
Clinical trials with Turkish contribution will be searched from the web page of Clinical Research Association. After the agreement between our Association and clinicaltrials.gov, the database containing clinicals trials with Turkish centres can be accessed and searched from our webpages. The webpage will be active in July..
International Clinical Trials Day 2014..
International Clinical Trials' Day is celebrated around the world each year on or close to 20 May, commemorating the day in 1747 on which James Lind began the first known controlled trial comparing different treatments for scurvy then in common use among sailors in the British Royal Navy.
Bayer HealthCare joins others to access to clinical trial data..
After the startup of www.clinicalstudydatarequest.com site, Bayer joined the other companies in sharing data from its clinical studies. From now on, researchers can access anonymized patient-level data from Bayer HealthCare sponsored clinical studies listed on the website.
Regulation on the Safety of Medicinal Products..
You can find the english version of the latest Regulation on the Safety of Medicinal Products on our webpage..
PhRMA 2014 Biopharmaceutical Research Industry Profile report..
You can read the 2014 Biopharmaceutical Research Industry Profile report created by PhRMA.
EU parliament approves Clinical Trial Regulation..
After Council of Ministers approves the new EU Clinical Trial
Regulation (replacing 2001/20/EC Clinical Trial Directive). The new Directive will be implemented per 2016.
Woman as Authors in Clinical Trials..
A search was conducted on 5011 citations on Cancer clinical trials in PubMed and data was collected on the gender of first or corresponding author.
A review from Turkey on Orphan drugs was published in JCS..
The review ''Orphan Drugs: R&D Challenges with Updates from Turkey and Middle East Countries'' was authored by Hilal Ýlbars, Duygu Koyuncu Irmak and Hamdi Akan.
European Commission has published a proposal for a Clinical Trials Regulation..
European Commission has published a proposal for a Clinical Trials Regulation:
COM(2012) 369 (IDRAC 146705) (Jul-2012). This will repeal
Replacing the Directive with a Regulation will provide a single
regulatory framework and facilitate cooperation between Member States.
New features include:
· Revised authorisation procedure involving:
- a single submission (for regulatory and ethical review) to the intended Member States via an EU Portal
joint assessment between Member States of trials involving more than
one Member State; ethics committees will continue to operate on
a national basis
- one joint decision (regulatory and ethical) from each Member State
Book of Clinical Trials-2014 published..
This 3rd edition covers 55 topics and is 592 pages (In Turkish).
The latest Guidelines in English..
The guidelines are:
Guideline for Observational Studies Conducted on Drugs (2013)
Guidance Relating To Insurance Coverage In Clinical Trials (2013)
Guidance On Ethical Approaches For Clinical Trials Conducted With The Pediatric Population (2013)
Guidance On The Format Of Applications To The Ethics Committee (2013)
Guidance On The Format Of Applications To The Ministry of Health For A Clinical Trial (2013)
Guideline For Developing A Training Program And Evaluation Principles (2013)
Guideline On Site Organization Management Principles In Clinical Trials (2013)
Guideline On Storage And Distribution Of Investigational Products Used In Clinical Trials (2013)
Guideline Regarding Independent Data Monitoring Committees (2013)
Guideline Regarding Collection, Verification, And Submission Of The Reports Of Adverse Events / Reactions Occurring in Clinical Drug Trials (2013)
Guidelines For Archiving In Clinical Trials (2013)
Pharma's biggest R&D budgets...
The R&D budget of the companies during 2013 is revealed. The list is headed by Roche with more than 10 billion USD and followed by Novartis and J&J.
FDA and EMA colloborate on pharmacovigilance..
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration.
From Nature DD: Biosimilar competition: lessons from Europe..
A recent analysis was published in the February 2014 issue of nature Reviews Drug Discovery titled: ''Biosimilar competition: lessons from Europe''..
Top 100 Selling Drugs of 2013..
The top selling three drugs in 2013 were a Levothyroxin - Synthroid, Cresto and Nexium, top prescribed three drugs were an antipsychotic - Abilify, Nexium and Cresor.
From Nature DR: A step closer to European clinical trial reform and US biomedical R&D spending declines...
From Nature Drug Discovery February 2014: A step closer to European clinical trial reform and US biomedical R&D spending declines...
Globalization of Industry-Sponsored Clinical Trials..
According to a report published by a private company under the title of ''Globalization of Industry-Sponsored Clinical Trials: Latest Insight on Shifts in Sites Among Regions'':
- An average of 2,045 Phase II and II trials were initiated annually, representing 54.8 percent of all industry-sponsored trials included in the U.S. trial registry.
- The U.S. contributed 41.2 percent of all sites over the seven-year study period, while the rest of the top 10 countries together contributed 29.9 percent of sites.
- China and New Zealand both climbed 8 places in the rankings of the top 60 countries. However, India fell 10 positions.
- Asia showed a clear trend of increasing growth over the first five years of the study period, then lost 2 percent in the last two years. Eastern Europe, the largest emerging region, also lost 2 percent in the last two years.
- North America is the only location with proportionately more Phase II than Phase III trial sites. 50.4 percent of all Phase II trial sites are located to North America, compared to 42.2 percent of all Phase III trial sites.
- The European country with the largest drop in the number of trial sites, without any clear sign of recovery, is Germany, down from 6.90 percent to 5.14 percent over the seven years of observation.
Variation in the quality of clinical trials in FDA's approvals..
Study results published Tuesday in JAMA suggest there is wide variation
in the quality of clinical trial evidence used by the FDA as the basis
for recent new drug approvals.
Agreement reached on Clinical Trials Regulation in Europe..
Researchers running a clinical trial in Europe have to register the trial before it begins and to publish summary results within a year of its end. The committee of representatives from every EU member state government has agreed with the text of the Clinical Trials Regulation. This agreement now has to be formally ratified by the European Parliament and the Council of Ministers.
FDA's Cybercrime Unit on work..
FDA's Cybercrimes Investigations Unit, was created in March 2013 in the agency's Office of Criminal Investigations (OCI). This unit works with other domestic and international agencies to track down the operators and suppliers of web sites that illegally sell prescription medicines.
Ten problems facing the USA Health system...
A new report identifies the 10 problems facing the USA Health system.
Biotechnology on the rise..
According to a report from Tufts Center for the Study of Drug Development (CSDD) Big Pharma has moved their focus on biotechnology products..
From TED: Body parts on a chip..
An interesting talk from TED: Can we use chips to test new medications?
Patent expirations and market access in 2014..
According to a report, rising market access budgets and fewer patent expirations are expected in 2014
EC awards EU legal status for ECRIN..
The European Commission has awarded the “European Research Infrastructure Consortium status” (ERIC status) for ECRIN (The European Clinical Research Infrastructures Network)
Nobel winner declares boycott of top science journals..
Randy Schekman, a US biologist who won the Nobel prize in physiology or medicine this year said his lab
would no longer send research papers to the top journals, Nature,
Cell and Science.
President Barack Obama signed the Drug Quality and Safety Act...
The system will establish a national track-and-trace system to secure the medicine supply chain. The program will reduce the ways that criminals can infiltrate the legitimate supply chain with counterfeit, adulterated, diverted or contaminated drugs. This law will dramatically improve the safety of compounded drugs and will also establish an unprecedented tracing system that will track prescription drugs from manufacturing to distribution.
Starting four years after enactment of the law, manufacturers, followed by repackagers, will be required to affix a unique product identifier to each drug package that contains the drug’s national drug code (NDC), serial number, lot number, and expiration date.
Raw drug data to be released..
European Medicines Agency (EMA) intends to open up access to all new clinical-trial data sets it receives from industry for product registration. The first company to make its raw data available to other scientists with "legitimate" requests was GSK.
The seventh edition of Health at a Glance released..
The 7. OECD report ''Health at a Glance'' is available in full text.
The 2014 edition of the International Compilation of Human Research Standards is now available...
This year’s edition features the laws, regulations, and guidelines on human subject protections in 107 countries. Three new countries are included in the 2014 update: Cameroon, Mozambique, and Zambia. In addition, major changes to the human research standards were made in these countries: Brazil, France, Switzerland, Taiwan, and Turkey.
Academic Drug Discovery Consortium (ADDC) in USA..
5 nonprofit academic drug discovery centers formed the Academic Drug Discovery Consortium (ADDC)
center. The consortium now has 91 centers and programs registered. MIT, Harvard, Duke, John Hopkins are among the centres involved.
Non-publication of large randomised clinical trials..
According to a study published in British Medical Journal 29% of the large randomized clinical trials in clinicaltrials.gov are not published.
New version of Helsinki Declaration..
After the 64. meeting of WMA in Fortaleza, Brazil, the new version of Helsinki Declaration was announced. The new version will be valid after Jan 1, 2014.
FDA's Clinical Investigator Training Course...
FDA's Clinical Investigator Training Course will be held on November 12-14, 2013, Maryland, USA
FDA warns: 70% of the dietary supplements violate cGMP rules..
About 50% of the US population takes vitamins, herbal remedies, protein
powders, weight loss pills and many other products that are defined as
FDA response for questions raised during Post office trips in the MENA region...
FDA prepared a document to answer many questions related to drug approval process or bioequivalence (BE) studies from regulatory agencies and industry in the MENA region.
An article on Turkey From Journal for Clinical Studies...
The manuscript written by Þule Mene et. al. emphasis on the fact that the time to study initiation period shortens after the new regulation.
NIH cancels 40 ongoing clinical trials in India..
The National Institutes of Health (NIH), part of the US department of health and human services, has sighted 'unstable regulatory environment as the main reason for cancelling almost 40 ongoing clinical trials in India In the last six months.
Turkey data on Clinicaltrials.gov (updated)...
Latest data on clinical trials in Turkey from clinicaltrials.gov (July 2013).
EMA approved the first biosimilar antibody..
The EMA has recommended granting of marketing authorisations for the first two monoclonal antibody biosimilars: Remsima of Celltrion Healthcare Hungary Kft and Inflectra of Hospira UK Limited. They both contain the same known active substance, infliximab. They are similar to the biological medicine Remicade, a monoclonal antibody that has
been authorised in the European Union since 1999. Remsima and Inflectra
are recommended for authorisation in the same indications as Remicade,
covering a range of autoimmune diseases such as rheumatoid arthritis,
Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic
arthritis and and psoriasis.
Coursera: A source for international free courses..
Coursera is an education company that partners with the top universities
and organizations in the world to offer courses online for anyone to
take, for free.
Turkey Clinical Research Infrastructure Network on the way..
An agreement is reached between Ministry of Health and Turkey Clinical Research Infrastructure Network (TUCRIN) to develop a database that will carry the information on clinical researchers, clinical research centers and clinical research infrastructure in Turkey. The agreement was signed between the head of Directorate of Pharmacy and Pharmaceuticals; Dr. Saim Kerman and Dokuz Eylul University president, Prof. Dr. Mehmet Füzün. TUCRIN is situated in Dokuz Eylül University-Izmir.
Optimizing the use of CROs by academia and small companies: from Nature Reviews Drug Discovery..
Contract research organizations (CROs) have a key role in drug discovery
and development, but processes for evaluating, engaging and managing
CRO contracts may not be well established in academic institutions or
small companies. In this article, the authors recommend an approach to optimize the
execution of drug discovery programs in such environments.
Universal health coverage in Turkey: enhancement of equity..
A review is published in Lancet on the Health Politics of Turkey in the recent years..
An app for Clinical Research
Cleveland Clinics developed an application for Iphone, IPad and Android for cancer patients to reach 130 clinical trials in Cleveland Clinics..
An important step..
An agreement protocol will be signed on July, 3rd, between MoH and TUCRIN to develop the Clinical Research Network of Turkey.
On behalf of Clinical Research Association, we congratulate everyone who had enormous dedication to this project.
Digital consent: Clinical trials to require patient nod on camera in India..
safeguard the interests of patients participating in clinical trials,
their informed consent will soon have to be audio-visually recorded in India.
World Clinical Trials Day...
20th of May is celebrated as the World Clinical Trials Day. May 20 is the day the first clinical trial was initiated by Dr. James Lind in May 20, 1747.
Biosimilar consensus report form EC..
European Commission revealed the Biosimilar Consensus report. The report seems to be a reference document for the future in Europe on biosimilars.
Clinical Research Association celebrates Mother's Day..
A man loves his sweetheart the most, his wife the best, but his mother the longest (Irish Proverb)
English version of the new bylaw on Clinical Research..
English version of the new bylaw on Clinical Research is available now.
2023 Strategy Report of Association of Research Based Pharmaceutical Companies (AIFD)..
AIFD released ''Turkey's Pharmaceutical Sector Vision 2013 Report''
British Medical Journal initiated Pharmacovigilance education..
In collaboration with UK Medicines and Healthcare products Regulatory Agency (MHRA), BMJ started a learning module titled ''Pharmacovigilance – identifying and reporting adverse drug reactions''.
New amendment of the Clinical Research Bylaw is effective..
Major changes are:
- Simultaneous application to both Ethical Committee and MoH
- Submission to and approval of any ethical committee regardless of the Principal Investigator institution.
Clinical research in private hospitals is still not allowed.
Unreported Side Effects of Drugs Are Found Using Internet Search Data...
Using data drawn from queries entered into Google, Microsoft and Yahoo search engines, scientists at Microsoft, Stanford and Columbia University have for the first time been able to detect evidence of unreported prescription drug side effects before they were found by the Food and Drug Administration’s warning system.
Time required to publication of clinical trials..
According to an article from JAMA, it takes 2 years for a clinical trial to be published in a journal. 25-50% of the clinical trials never get the chance to be published.
Turkey will not participate in DIA Amsterdam 2013...
After the decision of Istanbul being the venue of DIA Europe 2014, DIA Board changed their mind and moved the location to Vienna.
In reaction to that, MoH Turkey declined to participate in DIA 2013 Amsterdam, and this decision involves all the speakers and attendants from MoH Turkey.
You can find the letter sent to DIA form our Society that supports the decision of MOH.
FDA Publishes the new edition of Orange Book..
The FDA has published its 33rd edition of the Orange Book. The book is widely used in the regulatory community for identifying which drug products are substitutable for one another. The book contains all drug products that are approved or have not been withdrawn for reasons of safety or efficacy with the exception of products marketed before 1938
Top 5 drugs in 2012 Q4..
Top 5 drugs in Q4 2012 according to Drugs.com.
FDA Drug approvals in 2012..
FDA approved 39 new drugs last year, the highest in the last 15 years according to Nature Drug Discovery..
The Harvard Medical School Global Clinical Scholars Research Training Program (GCSRT)...
The Harvard Medical School initiated Global Clinical Scholars Research Training Program (GCSRT)..
VSCR closes down its business...
Vienna School of Research stopped all operations as of January 11th, 2013 due to lack of financial support.
Four members of the Cabinet revised...
4 members of the cabinet changed including the Ministry of Health; Dr. Recep Akdað..
EC Releases New Good Manufacturing Practices Guidelines...
Following chapters have been revised:
Premises and Equipment,
Complaints , Quality Defects and Product Recalls
New EMA guideline on the investigation of drug interactions..
This guideline outlines a comprehensive, systematic and mechanistic approach to the evaluation of the interaction potential of a drug during its development and offers guidance to ensure that the prescriber receives clear information on the interaction potential as well as practical recommendations on how the interactions should be managed during clinical use.
FDA offices in India
FDA now has 2 offices in New Delhi and Mumbai. India is the second largest drug exporter and the seventh largest food exporter to the U.S.
FDA issues Three Critical Medical Device Guidance Documents...
The guidelines are:
eCopy Program for Medical Device Submissions
Refuse to Accept Policy for 510(k)s
Acceptance and Filing Review for Premarket Approval Applications (PMAs)
Clinical Trials vs Clinical Practice..
As clinical trials are performed under specific conditions, there is always a debate on whether the results of a clinical trial reflects daily practice. A modest reply to that question comes from an article published in JAMA.
Happy New Year..
Wish you a happy new year and merry Xmas..
Clinical Research Association..
Partnerships in Clinical Trials Russia-CIS & MENA-Turkey...
''Partnerships in Clinical Trials Russia-CIS & MENA-Turkey'' meeting will be held in Renaissance Polat Istanbul Hotel, Istanbul on 22-23 May 2013. There will be additional benefits for our website members.
Smoking and Clinical Research..
FDA required the manufacturer of the smoking cessation drug varenicline to conduct the meta-analysis to further evaluate the cardiovascular safety of the drug, and is informing the public about the results of a meta-analysis that compared patients who received the smoking cessation drug varenicline to patients who received a placebo.
2012 Performance Analysis of the Global Medical Technology Industry: Ernst & Young Report..
In this report, medical technology (medtech) companies are defined as companies that primarily design and manufacture medical technology equipment and supplies and are headquartered within the United States or Europe. For the purposes of this report, we have placed Israel’s data and analysis within the European market, and any grouping of the US and Europe has been referred to as “global.”
FDA Draft Guidance on IRBs.....
A new draft guidance published by the US Food and Drug Administration (FDA) aims to clarify the responsibilities of institutional review boards (IRBs) in the oversight of investigators, research sites and investigational authority of sponsors.
The International Compilation of Human Research Standards avaialable..
The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations. Many of the listings embed hyperlinks to the source document.
Nine Italian cardiologists arrested for fraud and misconduct...
Nine Italian cardiologists have been arrested as part of a broad investigation into serious medical misconduct at Modena Hospital, according to multiple reports in the Italian media. The investigation encompasses at least 67 other individuals and a dozen medical equipment companies, including 6 foreign companies. The charges include conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinical trials. Several news reports mentioned that stents and angioplasty balloons were involved.
The latest analysis of clinicaltrials.gov..
Clinical trials in Turkey according to clinicaltrials.gov..
New information on the regulation of clinicaltrials.gov...
Our previous news titled "FDA now in Charge of clinicaltrials.gov" was inaccurate. Read the details..
FDA now in Charge of clinicaltrials.gov...
Previously regulated by DHHS; clinicaltrials.gov is now in the hands of FDA..
New EU GMP Chapter 1 published...
The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called "Pharmaceutical Quality System".
FDA announced Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications.
Gaining income from research in Universities?
In USA, Universities Report $1.8-Billion in Earnings on Inventions in 2011.
ABPI has updated its guidelines on Phase I clinical trials...
The Association of the British Pharmaceutical Industry (ABPI) has updated its guidelines on Phase I clinical trials.
Digital Health Summit Turkey..
Digital Health Summit Turkey will be held in Istanbul on 11-12 September.
Medical Device Manufacturing Turkey..
Medical Device Manufacturing Turkey meeting will be held in Istanbul on 3-4 October 2012.
FDA Adopts ICH Guidance on Pharmaceutical Quality..
The US Food and Drug Administration released new guidance on 25 July for industry regarding three quality documents released by the International Conference on Harmonization (ICH) related to how manufacturers and sponsors can best prepare these documents for inspection by regulators in the US, EU and Japan.
1. National Clinical Research Congress..
1. National Clinical Research Congress will be held in Istanbul by Clinical Research Society. The meeting will take place in Military Museum on 2-4 May 2013.
European Medicines Agency released all good pharmacovigilance practice modules...
The European Medicines Agency has released all modules on
good pharmacovigilance practices (GVP) for public consultation until 18
EMA finalises first set of guidelines on good pharmacovigilance practices...
European Medicines Agency finalises first set of guidelines on good pharmacovigilance practices.
European Medicines Agency boosts EU transparency with online publication of suspected side effect reports..
The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website:www.adrreports.eu.
ESHLSG Guidelines on transparency in clinical research.
The Ethical Standards in Health and Life Sciences Group (ESHLSG) published the principles of transparency in clinical research in a guideline. This is a joint effort of health care professionals and pharmaceutical industry.
From JAMA: Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010
In an article published in the last issue of JAMA, Clinical Trials Registered in ClinicalTrials.gov between 2007-2010 were analyzed.
From FDA: Guidance for IRBs, Clinical Investigators, and Sponsors IRB Continuing Review after Clinical Investigation Approval..
This guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of human subjects enrolled in clinical investigations.
An article in Archieves of Internal Medicine is describing the off-label drug use in Canada. According to the article, the prevalence of off-label use was 11.0%; of the off-label prescriptions, 79.0% lacked strong scientific evidence.
Updated list of CRO's in Turkey..
You can find the updated list of CRO's in Turkey on our webpages..
The EFGCP Report on Research Projects in Europe; Turkish paragraph....
The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe; Turkish paragraph is finalized (English). You can find the answers to most of your questions in this document.
List of MoH Approved Bioequivalance/Bioavailability Centers..
You can find the list of MoH approved Bioequivalance/Bioavailability Centers in Turkey and abroad.
EMA GVP modules are available for public consultation..
New legislation for pharmacovigilance will apply in the European Union as of July 2012, and the first 7 modules of the guidelines for the conduct of pharmacovigilance in the EU are now available for public consultation.
Clinical Trials in Turkey: 1997-2011..
Basic statistics of Clinical trials in Turkey can be found in the attached document. The figures are from the manuscript published in Turkish GCP Journal (www.iku-dergisi.com
) by Hilal Ýlbars from MoH.
FDA is preparing a guidance on biosimilar drugs..
The guidance is prepared in order to promote biosimilar drug development and enhance competition. As outlined in the draft guidance, FDA recommends a stepwise approach in the development of biosimilar products.
5th Annual CEE & CIS Clinical trials Forum..
The meeting will be held on 18-19 April 2012 in Vienna by Fleming Europe.
The off-shoring of clinical trials outside the USA and Europe is reaching a plateau...
The increase of clinical trials outside USA and Europe seems to be reaching a plateau.
FDA expands user fee programs..
The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients.
Global ClinicalTrials: MENA Region
This is a report comparing and analyzing the countries in the Middle East and North America Region. You can find some data on Turkey separately.
Emergency Hospitalizations for Adverse Drug Events in Older Americans..
A study published in New England Journal of Medicine showed that emergency hospitalization for Adverse Drug Events in Older Americans mainly resulted from commonly used antitrombotic or anti diabetic drugs. Improved management of antithrombotic and antidiabetic drugs has the potential to reduce hospitalizations for adverse drug events in older adults.
Open Source Cancer Research..
A mind opening talk from TED Talks. Jay Bradner is talking about open-source cancer research..
All guidelines related to Clinical Research are now in English..
The guidelines that are active at this moment are translated to English by Association of Research-Based Pharmaceutical Companies (AIFD) and Association of Contract Research Organization Companies (SAKDER). You can reach the guidelines from our English webpage
from the Documents menu on the left, following the Guidelines
link. Read the news to see the list of the Guidelines.
Google Maps of Human Disease..
Google is planning to create a massive data network that would combine cutting-edge genomic and molecular data on patients' diseases with their routine medical records.
Patients’ Motivation about Clinical Trials: A Local Perspective from Turkey..
The article ''Patients’ Motivation about Clinical Trials: A Local Perspective from Turkey'' prepared by Prof.Dr. Atilla Karaalp et al. was published in Marmara Medical Journal.
2011 Regulation of clinical trials (revised translation)..
The revised English Version of the new regulation on Clinical trials is on our webpages.
11th Annual Meeting of the International Society of Pharmacovigilance...
11th Annual Meeting of the International Society of Pharmacovigilance (ISoP 2011) will be held in Istanbul, Turkey from 26th to 28th October 2011.
New EU pharmacovigilance (PV) legislation..
The EU recently adopted new pharmacovigilance (PV) legislation, that will be in effect by July 2012.
The English Version of the GCP Regulation is on our web page..
You can find the complete guideline under Documentation - Regulations/Bylaw link on the main page.
New Bylaw on Clinical Research issued..
The new Bylaw on Clinical Research was published in the last issue of Official Newspaper. The bylaw will be valid after today.
NIH dropped the Conflict Disclosure Plan for universities..
The plan would require universities and medical schools to publicly disclose online any financial arrangements that they believe could unduly influence the work of their NIH-funded researchers by using a web page.
A new link titled "data management companies" is available now..
Implementation of Medical Research in Clinical Practice..
A report from the The European Science Foundation (ESF) on Implementation of Medical Research in Clinical Practice.
New FDA Regulation to Improve Safety Reporting in Clinical Trials from NEJM..
The new regulation published by FDA covers the aspects of safety reporting. You can read about it in an article on New England Journal of Medicine.
PharmaVoice, June 2011, article related to Turkey...
According to the article, Local R&D activity is gaining higher priority and resulting in a higher volume of clinical trials conducts in Turkey. Local and multinational companies are opening more R&D centers and engaging in scientific research partnerships. But the article also states that there are some obstacles to overcome.
The first-ever randomized “virtual” clinical trial..
Pfizer Conducts First "Virtual" Clinical Trial.
First Balkan Clinical Trials Congresss..
First Balkan Clinical Trials Congresss will be held in Sofia between 3-5 November 2011..
11th ISoP Annual Meeting..
The 11th International Society of Pharmacovigilance Annual Meeting entitled "Next stop: Istanbul – bridging the continents!' will be held from 25th to 28th October, 2011 in Istanbul, Turkey.
FDA Webinar on Foreign Inspections..
On Tuesday May 17, 2011, the US Food and Drug Administration (FDA) will host a webinar that answers questions about the agency's foreign inspection program.
New Law on Clinical Trials (2011)
The English version of the New Law that regulates Clinical Trials on Human Subjects is on the web page now..
New Law on Clinical Trials is accepted..
The new law describes the role of Ministry of Health in Clinical Trials..
Clinicaltrials.gov on NEJM..
New England Journal of Medicine published an analysis on Clinicaltrials.gov.
Phase III trial failures..
The Centre for Medicines Research International has noted that the average for the combined success rate at Phase III and submission has fallen to ~50% in recent years. There were 83 Phase III and submission failures between 2007 and 2010.
FDA's drug approvals in 2010..
The US Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) approved 15 new molecular entities and 6 new biologics in 2010. The total of 21 new products falls below the 25 approved in 2009 and the 24 in 2008.
Scientific Fraud in Denmark..
A neuroscientist in Denmark who had published over 100 peer-reviewed articles has resigned after facing allegations that she committed research misconduct and misspent grant money. The University of Copenhagen has also recently paid back more than 2 million Danish kroner of the IMK General Fund grant that the foundation awarded to Penkowa. She left her position in the University after the accusations.
A new website for FDA-Industry communication..
The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) to help companies and others save time and resources in their interactions with the agency.
Happy New Year..
We wish a happy new year to all our readers..
Turkish Clinical Research Association.
The 2011 Edition of the International Compilation of Human Subject Protections has been posted..
The 2011 Edition features a listing of over 1,000 laws, regulations, and guidelines on human subject protections in 101 countries. New countries added this year are Belarus, Grenada, Pakistan, Rwanda, and Tunisia.
This year’s Compilation also features the standards regarding device research, which were located in 44 countries.
CTM last Issue..
Last issue of Clinical trials Magnifier analyses WHO Trials Registry Database..
EMA report on trial participation and site inspections between 2005-2009..
61% of the patients who took part in the pivotal clinical trials used to support marketing authorisation applications submitted to the EMA between 2005 and 2009 came from third countries. Since 1997, GCP inspections have been requested for only 228 of the 44,034 investigator sites counted as part of the pivotal trials.
NEJM: The Paradoxical Problem with Multiple-IRB Review..
The article discusses the multiple IRB review of multicentric trials and explains the problems..
Hillary Clinton apologized for human research conducted in Guatemala..
The experiment, carried out in the 1940′s, was the act of inoculating prisoners, soldiers and mental patients with syphilis, without their knowledge or permission. Also Bill Clinton apologized for the Tuskegee study when he was the president of the USA. Tuskegee study was performed on African Americans with syphilis.
New pharmacovigilance law was accepted by the EU parliament...
EU parliament clears new pharmacovigilance law.
MedicReS International Conference on Good Medical Research..
"GOOD MEDICAL RESEARCH" titled International Conference of MedicReS is to take place in March 25-27, 2011 in Istanbul. Medical Researchers: AUTHORS, EDITORS, REVIEWERS from Turkey and abroad are to attend to the congress.
The aim of the congress is to discuss ETHICAL, HISTORICAL, BIOSTATISTICAL, METHODOLOGICAL, ECONOMICAL and LEGAL approaches to medical research with regard to the international standards in "GOOD PLANNING-GOOD ANALYZING-GOOD REPORTING-GOOD REVIEWING" main titles
Clinical Trial Magnifier 2010 Congress will be held in Malaysia..
GSK Opens Vaccine Clinical Research Center in Hacettepe Teknokent
GlaxoSmithKline (GSK) has opened Turkey’s first Vaccine Clinical Research Center in cooperation with Hacettepe University Teknokent A.Þ. GSK Vaccine Clinical Research Center will facilitate participation to international clinical studies from Turkey, as well as realization of national research projects.
New FDA safety website for drugs with no problems..
The US FDA opened a new website on 15 June that provides the public updated information on drug safety with a major difference: unlike other FDA safety notification systems, this one spotlights not only reasons for caution, but also the far more frequent instances when a new drug has been found to have no unexpected safety concerns. The site is designed to be accessed by the general public as well as healthcare professionals.
EC proposal on new clinical trial rules not expected until late 2011 ..
The European Commission says that the consultation exercise on the review of the EU clinical trials directive has yielded some useful information on the shortcomings of the legislation and that it is now looking at the various policy options for tackling them.
Transparency at the FDA..
FDA started a new initiative to maintain a high level of transparency related to his regulatory affairs, inspections and other details.
5 new guidelines..
The following guidelines are on now our webpages in English:
Guideline on Independent Data Monitoring Committees
Guidance on Observational Studies with Drugs
Guidance for the Preparation of Good Clinical Practice Inspection Reports
Guidance on the Format of Applications to the Ministry for a Clinical Trial
Guidance on Ethical Considerations for Clinical Trials on Medicinal Products with the Pediatric Population
The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe - Turkey
The European Forum for Good Clinical Practice (EFGCP) Report on Turkey can be found as an attached file..
Know-how transfer from Turkey to UAE in clinical research
AkademiKA® as a continuous GCP training program that has reached 800 health personnel in Turkey since 2003, has accepted its first foreigner investigators to the programme in 2008 in Istanbul. In 2009, the success that AkademiKA® achieved abroad, turned into a special training demand from United Arab Emirates.