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[ News Archive ] 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.
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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.
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Off-label prescriptions..
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.
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Updated list of CRO's in Turkey..
You can find the updated list of CRO's in Turkey on our webpages..
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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.
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List of MoH Approved Bioequivalance/Bioavailability Centers..
You can find the list of MoH approved Bioequivalance/Bioavailability Centers in Turkey and abroad.
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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.
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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 İlbars from MoH.
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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.
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5th Annual CEE & CIS Clinical trials Forum..
The meeting will be held on 18-19 April 2012 in Vienna by Fleming Europe.
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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.
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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.
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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.
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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.
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Open Source Cancer Research..
A mind opening talk from TED Talks. Jay Bradner is talking about open-source cancer research..
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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.
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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.
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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.
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2011 Regulation of clinical trials (revised translation)..
The revised English Version of the new regulation on Clinical trials is on our webpages.
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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.
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New EU pharmacovigilance (PV) legislation..
The EU recently adopted new pharmacovigilance (PV) legislation, that will be in effect by July 2012.
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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.
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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.
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New Link..
A new link titled "data management companies" is available now..
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Implementation of Medical Research in Clinical Practice..
A report from the The European Science Foundation (ESF) on Implementation of Medical Research in Clinical Practice.
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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.
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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.
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The first-ever randomized “virtual” clinical trial..
Pfizer Conducts First "Virtual" Clinical Trial.
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First Balkan Clinical Trials Congresss..
First Balkan Clinical Trials Congresss will be held in Sofia between 3-5 November 2011..
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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.
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FDA Webinar on Foreign Inspections..
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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.
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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..
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New Law on Clinical Trials is accepted..
The new law describes the role of Ministry of Health in Clinical Trials..
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Clinicaltrials.gov on NEJM..
New England Journal of Medicine published an analysis on Clinicaltrials.gov.
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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.
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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.
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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.
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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.
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Happy New Year..
We wish a happy new year to all our readers..
Turkish Clinical Research Association.
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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.
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CTM last Issue..
Last issue of Clinical trials Magnifier analyses WHO Trials Registry Database..
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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.
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NEJM: The Paradoxical Problem with Multiple-IRB Review..
The article discusses the multiple IRB review of multicentric trials and explains the problems..
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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.
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New pharmacovigilance law was accepted by the EU parliament...
EU parliament clears new pharmacovigilance law.
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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
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CTM Congress..
Clinical Trial Magnifier 2010 Congress will be held in Malaysia..
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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.Ş. GSK Vaccine Clinical Research Center will facilitate participation to international clinical studies from Turkey, as well as realization of national research projects.
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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.
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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.
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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.
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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
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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..
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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.
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MoH announcement about audits to CROs in Turkey
According to the recent announcement from Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals through their web site the Contract Research Organizations have to be audited by Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals in order to conduct clinical research activities in Turkey.
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MoH- E-applications to Clinical Research Department started
According to the announcement from Turkish Ministry of Health (MoH) General Directorate of Pharmaceuticals through their web site ; starting from April 15th, 2010 all applications should be made both by paper format and electronic format. All documents in the applications dossier will be uploaded to IEGM2007 system by Ministry of Health (MoH) General Directorate of Pharmaceuticals.
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Danish case handling times for clinical trials in 2010
Danish Medicines Agency must handle applications for authorisation of clinical trials within 30 working days. The chart shows the case handling times for applications received by the Danish Medicines Agency during each month of 2010.
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The new regulation that revised the Clinical Trials Regulation (2009) can be reached from our webpages...
The new regulation that revised the Clinical Trials Regulation (2009) can be reached from our webpages.
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EMEA is establishing a project is for candidate countries..
The aim of the project is to build contacts and relationships between the EMEA and the Candidate and Potential Candidate Countries, for future collaboration in the EMEA’s activities and its relationships with Member States.
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Thalidomide apology from England after 50 years..
Mr O'Brien, the MP for North Warwickshire said that ¨The Government wishes to express its sincere regret and deep sympathy for the injury and suffering endured by all those affected when expectant mothers took the drug thalidomide between 1958 and 1961.¨ About 2,000 babies were born with deformities as a result of the drug.
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UK response to European Commission review of the Clinical Trials Directive..
The views of MHRA have now been incorporated into the UK’s overall response to the EU's revision process of Clinical Trials Directive 2001/20/EC, and published on the website.
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CTM December: Medical Publication Trends by Geographic Region..
In the December issue of CTM, medical publications were analysed depending on Index Medicus (PubMed) database. There is a considerable increase in the number of publications from Asia and Emerging countries. Performance of Turkey is outstanding in both total number of publications, number of articles published in high ranked journals and number of evidence based articles. Go to the news to reach the full-text article.
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New web addresses..
You can now reach our webpages from these addresses: www.cresearchtr.org or www.researchtr.org Please bookmark.
Last issues of CTM..
The 10-11th issues of CTM are devoted to the CTM congress.
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International Compilation of Human Research Protections..
The International Compilation of Human Research Protections is the standard reference for researchers, regulators, and IRBs/ethics committee members involved in human subjects research around the world.
The Compilation lists the laws, regulations, and guidelines for human subjects research in 94 countries, and from a number of international and regional organizations. The standards are organized into 6 categories:
General
Drugs
Privacy/Data Protection
Human Biological Materials
Genetic
Embryos, Stem Cells, and Cloning
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"Towards A Better Future for Pharmacovigilance in Clinical Trials” by EORTC and ECRIN..
EORTC and ECRIN is organizing a Multidisciplinary Workshop on "Towards A Better Future for Pharmacovigilance in Clinical Trials” on behalf of the Road Map Initiative for Clinical Research in Europe.
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FDA Issues Final Guidance on Investigator Responsibilities
FDA has issued final guidance on "Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects."
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Drug ads are troubling search engines..
Major USA search engines are pressed to stop advertisings from overseas.
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CTM new issue..
The August issue deals with Oncology trials. Oncology accounts for 20.8% of all industry sponsored trials and 20.9% of all sites. Non-industry sponsored oncology trials account for 40.1%. Another manuscript shows that there are 4 Ethical Committes in Turkey approved by USA Office of Human Research Protections.
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FDA Expands Access to Investigational Drugs..
FDA has had rules in 1987 that have allowed patients to have access to investigational drugs. On August 12, 2009, FDA announced changes to the rules to make them broader and clearer for the patient and the treating physician.
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The European Medicines Agency and the FDA have agreed to launch a joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities..
The initiative comes under the scope of the confidentiality arrangements between the European Commission, the European Medicines Agency and the US FDA. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes and the conduct of collaborative inspections.
This initiative is an important contribution to ensuring the protection of clinical-trial subjects in the context of the increasing globalisation of clinical research. The European Medicines Agency and the FDA will start their new initiative with an 18-month pilot phase on 1 September 2009.
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Researchers demand more harmonization of European rules for approving clinical studies (from Nature)..
Despite efforts to harmonize the way European countries approve clinical trials, a researcher may see their proposed study rejected in one nation but approved in another. The article in Nature underlines this topic.
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New issue of Clinical Trial Magnifier..
This Issue contains "Industry Trials in BRIC Countries - Brasil, Russia, India and China".
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Clinical trials in Turkiye..
The analysis of clinical tirals conducted in Turkey according to clinicaltrials.gov is updated..
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USA priorities in Comparative-Effectiveness Research
Directed by Congress to develop a list of priorities for the Department of Health and Human Services (DHHS) ended up in a list of priorities of comparative-effectiveness research (CER).
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New documents are on our webpage..
Guidance On The Application Format And Documentation To Be Submitted In An Application For An Ethics Committee Opinion On a Clinical Trial
Manufacture Of Investigational Product(s)
Agreement For Transfer Of Biological Material To Be Used In Clinical Researches
Clinical Trial Budget Form
Ethics Committee Evaluation Form Of A Clinical Trial Application
Standard Operating Procedure Of Ethics Committees
Guidance On Insuring Subjects In A Clinical Trial
Guidance On Observational Studies Performed With Drugs
Guideline On The Compassionate Use Program 01.02.2009
Application Form To Import Investigational Products For Clinical Trial Use
Guideline For Good Clinical Practices -2009
Clinical Trial Application Form
Guidance On The Collection, Verification And Presentation Of Adverse Reaction Reports Occurring During Clinical Trials
Annual Notification Form To The Ministry And Ethics Committee For A Clinical Trial
Notification Form Of The End Of A Clinical Trial To The Ministry And The Ethics Committee
Headings For Aspects Of A Clinical Trial That Might Require A Substantial Amendment
Notification Form To Obtain Ministry Approval and Opinion of The Ethics Committee For a Substantial Amendment To a Clinical Trial
Application Form Of A Clinical Trial For Specialty Thesis and/or Academic Purposes
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ICREL (Impact on Clinical Research of European Legislation) report has been submitted to the European Commission...
ICREL was a one-year project financed by the European 7th Framework Programme. Under EFGCP’s coordination, ECRIN, EORTC, as well as the Hospital Clínic of Barcelona and the Ethics Committee of the Medical University of Vienna collaborated in this project.
Its aim was to measure and analyse the direct and indirect impact of the Clinical Trials Directive2001/20/EC and related legislations in the EU on all categories of clinical research.
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Clinical Research Discussion Forum..
You can start using the Clinical Research Discussion forum from our webpage...
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Scientific fraud disclosed..
A leading anesthesiology researcher has been accused of falsifying data and other fraud in potentially dozens of published studies.
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FDA inspections from the last issue of Clinical Trials Magnifier..
The title of the manuscript is "US FDA Site Inspection Findings, 1997-2008, Fail to Justify Globalization Concerns"
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MoH initiated the accreditation of CRO's..
After the new GCP regulation came into effect, Ministry of Health begin accreditation of CRO's. MENE RESEARCH is the first CRO who gets an accreditation.
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A survey on investigator-initiated studies
A survey on investigator-initiated studies is being conducted by Clinical Trials Magnifier Journal. To respond to the survey, please go to the news.
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New ethical committees..
The cities where the new ethical committees will be organized according to the new GCP regulation is listed.
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New issue of Clinical Trial Magnifier..
This issue includes articles on Validity of Clinical Trials in emerging countries, a survey on Phase I trials and US FDA New Drug Approval Trends, 1999-2008.
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FDA warned against Ranbaxy laboratories..
FDA reported that India based Ranbaxy laboratories has provided falsified data for the approval of drugs.
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Updated web site of General Directory of Pharmacy and Pharmaceuticals is online..
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The new interface deserves attention for the functional design and easy access to documents. The English version will be available soon.
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Turkish Clinical Research Organization Association..
Turkish Clinical Research Organization Association is founded in January. The Society aims to collobrate between its members, represent them in various platforms, and improve the efficiency and quality in Clinical Research. Education is also a main priority of the organization.
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FDA issued a warning for Metoclopramide..
A commonly used drug, metoclopramide requires a box warning for tardive dyskinesa.
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FDA approvals won't save companies..
The US Supreme Court ruled that drug makers can be held liable for harm caused by their medicines, even if the drugs already carry federally approved warning labels.
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