Turkey recruited 590 patients in EORTC studies between 2000-2007. A total of 42.098 patients were recruited during this period.
Turkey is the second most recruiting non-EU country in Europe.
Clinical Trials Toolkit web site is for help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004.
Clinical Trial Magnifier published a review on Investigator Initiated Trials. An analysis on registered to ClinicalTrials.gov showed that in the last 3 years a total of 24,931 new Phase I-IV study was registered and 13,065 (52.4%) of these studies were non-industry sponsored. 23% of these were Oncology studies.
JAMA Manuscript: Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union..
After the approval of first biological in October 1982, more than 250 biologicals was approved in USA and EU. The article published in JAMA is on the Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union.
The new issue of Clinical Trials Magnifier on-line journal is on "Sponsored Clinical trials in Korea". The previous issue was on sponsored clinical trials in China.
FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals..
Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs.
The European Commission has published two guidelines concerning orphan medicinal products...
The guidelines are about the application of Articles 8(1), (2) and (3) of Regulation (EC) No 141/2000 on orphan medicinal products:
- the possibility for Member States to inform the European Medicines Agency that the criteria on which market exclusivity was granted may no longer be met (potentially resulting in the market exclusivity period for the medicine concerned being shortened); and
- assessment of the similarity of medicinal products, which is a requirement for accepting marketing authorisations when orphan medicinal products have been authorised for similar indications.
FDA Issued an alert for Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
The Food and Drug Administration (FDA) issued two Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. FDA also issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.
A new document is added to our webpage on "Information And Documents To Be Included In The Application File To Be Prepared For The Import Of Drugs To Be Used In Clinical Drug Trials and Information And Documents To Be Included In The Application File To Be Prepared For The Control Of The Centers Performing Bioavailability And Bioequivalence Studies"
New Zealand's department of labour has admitted that a researcher who lost her legs and arms due to meningococcal septicaemia in 2005, probably became infected while working at a government laboratory.
Regulation Regarding the Implementation and Inspection of the Support for Research & Development Activities
Ministry of Industry and Trade released the Regulation Regarding the Implementation and Inspection of the Support for Research & Development Activities. This Regulation shall encompass the procedures and principles on the implementations and inspections of the support and incentives for technology centers (technology center operations), on the Establishment of the Small and Medium Industry Development Directorate as well as the R&D centers, R&D and innovation projects, pre-competition cooperation projects and techno-venture capital.
FDA issued a final regulation that makes early Phase I clinical drug development safe and efficient
FDA issued a final regulation that makes early Phase I clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes.
A new link is added to our webpage that gives information about the web addresses of international and national authorities regulating clinical trials.
Industry clinical testing of new medicinal products requires 95,000 study sites and 1,300,000 subjects..
The annual investment for this research is estimated to be US$38.5 billion; US$9.6 billion for internal costs, US$8.5 billion to investigators and US$19.3 billion to clinical trial service providers.
Harmonisation of GCP inspection in member states of EU..
In order to harmonise the conduct of Good Clinical Practice (GCP) inspections by the competent authorities of the Member States, guidance documents containing the common provisions on the conduct of those inspections are now published in Chapter IV of the Eudralex - Clinical Trials Volume 10.
FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety ..
In the first use of a framework allowing submission of a single application to the two agencies, the FDA and the EMEA worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs.
Engaged in 18.1% of all protocols globally Asia is involved in more sponsored trials than any other emerging region. You can read the details of this article published in the last issue of Clinical Trial Magnifier.
UK's National Institute of Health and Clinical Excellence (NICE) will open its standing advisory committee meetings to public and press...
From June 2008 onwards the UK's National Institute of Health and Clinical Excellence (NICE) will open its standing advisory committee meetings to observers from the public and press.
New Rule to Provide Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding..
The U.S. Food and Drug Administration proposed major revisions to the physician labeling for prescription drugs to provide better information about the effects of medicines used during pregnancy and breast-feeding.
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.
ACRP 2009 Global Congress will be held in Denver, USA between 24-28 April 2009. The ACRP 2009 Global Conference Program Planning Committee is issuing a call for proposals for oral and poster presentations for the 2009 Global Conference.
A civil court will hear the case of 70-year-old Dieter Bollmann, who paid more than €11,000 for a stem cell procedure to cure his urinary incontinence in 2005. He claims that doctors at the University Hospital Innsbruck told him that the treatment had a very high success rate, and implied that clinical trials had been completed. The consent form that Bollman signed does not include the word 'experimental'.
Challenges and Barriers to Academic Cancer Research..
This is a presentation by EORTC Board member Tanja Cufer during the meeting titiled "The Burden of Cancer – How Can it be Reduced?" on February 7-8, 2008 in Brdo, Slovenia.
2nd Workshop on Computer Aided Drug Design & Development: Molecular Modeling (WCADD-2)...
Computer Aided Drug Design and Development Society in Turkey ( CADD&D)" is helding the "2nd Workshop on Computer Aided Drug Design & Development: Molecular Modeling (WCADD-2)", on 26-29 June in Ankara, Turkey, which is hosted by Başkent University.
After it was learned that, most of the articles on the Merck & CO drug rofecoxib was written by for-profit companies and the academicians not necessarily involved in the research were presented as original writers, JAMA gave some clues to overcome the problem of ghost writing.
FDA, initiated REMS for 25 drugs and biologic products..
FDA initiated the risk evaluation and mitigation strategy (REMS) under the Food and Drug Administration Amendments Act of 2007 (FDAAA) for 25 drugs. FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug.
A report for EC on National Regulations of Ethics and Research in Turkey..
A report on "National Regulations on Ethics and Research in Turkey" prepared by Gülriz Uygur and Türkan Yalçin Sancar for European Commission can be reached from our web pages.
The results of an telephone survey sponsored by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health is published. According to the survey, half of the adults use at least one prescription drug daily, one-third have skipped filling a prescription because of cost and more than a half say they're at least "somewhat" confident medications are safe.
The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD).
FDA granted priority review for new indications of Peg-Interferon and Bortezomib..
The FDA has recently granted priority review status to two drugs -- Peg-Interferon for the treatment of melanoma, and Botezomib for the treatment of newly diagnosed multiple myeloma.
The U.S. Food and Drug Administration (FDA) today issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.
Pharmaceuticals and Healthcare 2008 Reports..
5 year industry forecast of 16 emerging european markets is published by Business Monitor.
The term "orphan drug" refers to a drug or biologic, such as a vaccine or blood product, that treats a rare disease or condition. A disease is rare if fewer than 200,000 people in the United States have it. FDA is celebrating the 25th year of this succesfull act.
Optimizing Clinical Trials in CEE & CIS Region conference..
The congress will be held in Vienna between 13-14 February. Sule Mene from the Turkish Clinical Research Association and Edibe Taylan from the pharmaceutical sector will be speakers.
FDA reported serious adverse events related to botox..
The reactions may be related to overdosing and there is no evidence that these reactions are related to any defect in the products. The most severe effects were found in spastic children treated with botox. This is not an FDA approved indication.
According to a news in Nature, one of the reviewers of the metanalysis on the effect of Avandia (rosiglitazone) published in New England Journal of Medicine, faxed a copy of the article to GlaxoSmithKline 17 days earier.
The latest analysis from the US National Science Board (see Map) confirms that Israel leads the world in its economic devotion to research and development (R&D). Although US R&D investment was the world's largest — $340 billion — and in 2004, it was more than that of the rest of the G7 nations combined, the report offers some evidence of a slight decline in its standing.
The company stated that the ENHANCE study demonstrated no significant differences between Vytorin which contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet and Zocor on the build up of cholesterol plaque in the carotid (neck) arteries. An IMPROVE IT trial is underway which is designed to evaluate the effect of Vytorin versus Zocor on heart disease and stroke. Until the FDA reviews the data, the agency advises patients to talk with their health care providers if they have questions about the ENHANCE study.
FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age
FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age. FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.
Clnicaltrials.gov is the biggest registry of clinical trials. We will publish the data from Turkiye sent to this site that will be updated quarterly. This data is derived by Nursah Omeroglu from Sanofi-aventis.
Lady sentenced to 33 months after FDA investigation..
The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations today announced that a New Jersey woman has been sentenced to 33 months in prison for falsely claiming that she could cure amyotrophic lateral sclerosis (ALS), commonly called “Lou Gehrig’s Disease.”
The 2008 edition of the International Compilation of Human Subject Protections is now available..
The 2008 version lists about 900 laws, regulations, and guidelines from 84 countries on human subject protections, including four new countries: Georgia, Kazakhstan, Kuwait, and Turkey.
Clinical Research Association wishes you a healthy and happy new year..
On Behalf of CRA President: Prof. Dr. Murat Akova
Web Coordinator: Prof. Dr. Hamdi Akan
The World Medical Association has initiated a request for comments on Helsinki Declaration..
Comments and suggestions were submitted this summer, collated and reviewed by the Working Group and the Medical Ethics Committee at their October 2007 meetings. The Working Group has prepared a set of suggested amendments to the Declaration
FDA reported a second warning on Fentanyl skin patch..
FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or after people incorrectly used it.
According to a study published in Annals of Internal Medicine drugs routinly used in elderly people have more serious side effects than the drugs accepted as having high risk.
Code of Ethical Promotion Practices for Medicinal Products..
Code of Ethical Promotion Practices for Medicinal Products issued by Association of Research-Based Pharmaceuticel Companies can be reached from our web pages.
FDA reported that neuropsychiatric side effects can be seen in individuals taking the influenza drugs oseltamivir (Tamiflu) and zanamivir (Relenza) ilke delirium, hallucinations and impulsive behavior.
FDA issued a revision on labeling of Avandia (rosiglitazone)..
FDA concluded there is not enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. FDA is allowing Avandia to stay on the market while a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent, is conducted by GSK. The company agreed to add new information to the drug's labeling, warning of the potential for increased risk of heart attacks.
Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
Nature published an editorial on the accountability of the co-investigators in a research..
The editorial states that "there remains a need for a clearer understanding, both within a collaboration and by readers of the eventual papers, of the various contributions made by the authors not only to the research but also to safeguarding its integrity."
FDA has granted approval of IXEMPRA™ (ixabepilone) for breast cancer..
U.S. Food and Drug Administration (FDA) has granted approval of IXEMPRA™ (ixabepilone) as monotherapy for the treatment of patients with metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.
EU published the draft guideline for first-in-man clinical trials..
After the TGN 1412 disaster in 2006, the serious side effects experienced by volunteers Europe took an action to avoid the risk of such dramatic events recurring in a first-in-man trial.
FDA Acts to Ensure Thyroid Drugs Don’t Lose Potency Before Expiration Date..
The action is taken to ensure the drug retains its potency over its entire shelf life. The data revealed a trend toward a loss of potency, with some preparations showing potency approaching 90 percent of labeled potency by the expiration date. Levothyroxine sodium products are used by over 13 million patients.
The first “BASIC GCP COURSE” to be run by ITAPS (International training Academy of Pharmaceutical Sciences) will be held on 1-2 November 2007 at the CROWNE PLAZA HOTEL, İstanbul. The course will be in English.
New England Journal of Medicine published a paper on the role of CRO's in Clinical trials. The paper states that CROs have taken over much of academia's traditional role in drug development by offering greater speed and efficiency, but questions have been raised about their qualifications, ethics, accountability, and degree of independence
To increase the number and variability of generic drugs FDA outlined a progam named GIVE (Generic Initiative for Value and Efficiency). The agency approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year.
According to an article published in Archieves of Internal Medicine , from 1998 through 2005, reported serious adverse drug events increased 2.6-fold, and fatal adverse drug events increased 2.7-fold.
Nature: Turkish physicists face accusations of plagiarism
Almost 70 papers by 15 authors have been removed from the popular preprint server arXiv, where many physicists post their work. The moderators allege that the papers plagiarize the works of others or contain inappropriate levels of overlap with earlier articles.
The Rosiglitazone Story published in New England Journal of Medicine
The chair of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) wrote about the committee discussions on rosiglitazone risk for the treatment of type 2 diabetes.
Journal of the American Medical Association (JAMA) published a two-year evaluation of the registration of clinical trials program required by ICJMA, and new policies are on the way.
The High Court in India, has agreed to uphold India's Patent Act in the face of a challenge by Swiss pharmaceutical company Novartis, in a court case that has been ongoing since January. The Indian Patent Act was designed to promote access to cheaper generic drugs for poor patients. 84% of antiretroviral drugs that MSF uses in clinics globally, for example, are Indian generics.
ACRP is organizing a one day course on SOPs for Investigator Sites
This workshop is intended for Clinical Investigators, Sub-investigators and Clinical Research Coordinators (or anyone actively involved in conducting clinical research in hospitals or other research establishments).
FDA approved restricted use of Tegaserod in Irritable Bowel Syndrome (IBS)..
The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.
New links are added to the web page. You can find the list of insurance and reinsurance companies approved by the state and also the web page addresses of some University Ethical Committees. Please inform us of the data you want to see on our web page.
New set of Frequently Asked Questions and Answers on Informed Consent on DHSS website
The DHHS Office for Human Research Protections (OHRP) announces the availability of a new set of Frequently Asked Questions and Answers on Informed Consent on its website
After the achievements in cooperation on vaccines, oncology, and pharmacogenomics; at a meeting in June 14-15, 2007, it was agreed to expand further the interactions in the areas of pediatrics and medicinal products for rare diseases (“orphan drugs”). Also, a “Principles of Interactions” document that will facilitate the timely exchange of information on scientific and ethical issues for pediatric therapeutics has been finalized.
According to a news on Washington post taken from Associated Press, an advisory panel of experts recommended unanimously yesterday that the Food and Drug Administration reject a new weight-loss drug after hearing testimony that it increases the risk of suicidal behavior.
NEJM published the interim analysis of Rosiglitazone study -RECORD-
After the alert issued by FDA on the adverse cardiovascular risks of Rosiglitazone; interim analysis of RECORD study is published in New England Journal of Medicine. The authors stated that, the interim findings were inconclusive regarding the effect of rosiglitazone on the overall risk of hospitalization or death from cardiovascular causes. There was no evidence of any increase in death from either cardiovascular causes or all causes. Rosiglitazone was associated with an increased risk of heart failure. The data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction.
FDA: safety alert on the use of Avandia (rosiglitazone) in Type II Diabetes Mellitus
FDA issued a safety alert on the use of Avandia (rosiglitazone) in Type II Diabetes Mellitus. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. There will be an article in the next issue of New England Journal of Medicine.
European Commission invites member views on European Research Area (ERA)
In 2000, the EU decided to create the European Research Area (ERA). This means creating a unified area all across Europe. After 7 years, EC invites the members of EU to give their opinion.
Black box warning from FDA on the suicide risk of antidepressant agents..
FDA issued a warning on the increased suicide risk of antidepressant use. According to the warning risk of suicide and suicidal thoughts are increasng in patients between 18-24 years old. This risk decreases in patients between over 65 years old. This warning is followed several objections.
To read the article "Expanding the Black Box — Depression, Antidepressants, and the Risk of Suicide"click
Higher than expected incidence of acute rejection in cardiac transplant patients switched from calcineurin inhibitors in combination with CellCept
(mycophenolate mofetil) to Rapamune (sirolimus) in combination with CellCept at 12 weeks post heart transplantation caused FDA to issue an Important Safety Information
High Prevalence of Physician-Industry Relationships Found in Survey
There is a "high prevalence" of relationships between U.S. physicians and pharmaceutical, medical-device, and other medical industries, a national survey finds.
The study, published in the current New England Journal of Medicine, was based on the responses of some 1700 physicians to a 47-item survey.
MHRA requested Bristol-Myers Squibb to recall a number of batches of Taxol 6 mg/ml..
At the request of the MHRA Bristol-Myers Squibb Pharmaceuticals is recalling a number of batches of Taxol 6 mg/ml Concentrate for Solution for Infusion (Paclitaxel) within expiry as a precautionary measure due to potential lack of sterility assurance. There have been no reports of non-sterile product and no sterility failures have been detected.
FDA's Office of Critical Path Programs and DIA are co-sponsoring a first-of-its-kind workshop on "Protecting Human Subjects Involved in Clinical Investigations: A Continuum from Design to Completion."
FDA panel rejected the approval of a new COX-2 inhibitor..
FDA Panel Recommends Against New COX-2 Inhibitor
A new COX-2 inhibitor Arcoxia (etoricoxib)was rejected by FDA, because the drug was no more effective than naproxen and causes three times as many cases of stroke, heart attack, or death..
Arcoxia is currently available in 63 countries.
FDA has published a draft guidance entitled ‘‘Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting-Improving Human Subject Protection.’’
This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the Institutional Review Board.
Second Education Meeting of the Clinical Research Associaton..
The evaluation of the Budget and Insurance in clinical trials will be the main topic of the meeting that will be held on 11 May 2007 in Ankara. Speakers and participants from Universities, State Hospitals, Social Security System, Pharmaceutical companies, CRO's, govermental bodies and Insurance system will take part during the meeting.
For details click..
Disclosure of payments do not provide easy access to payment information for the public
According to an article in JAMA, in USA disclosure of payments made to physicians by pharmaceutical companies do not provide easy access to payment information for the public. In Vermont, 61% of payments were not released to the public because pharmaceutical companies designated them as trade secrets and 75% of publicly disclosed payments were missing information necessary to identify the recipient. In Minnesota, 25% of companies reported in each of the 3 years
FDA Proposes new, tougher procedures for membership on advisory committees..
The U.S. Food and Drug Administration (FDA) today announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation. FDA is accepting public comments on the proposal for the next 60 days.
JAMA Article: Eligibility Criteria of Randomized Controlled Trials Published in High-Impact General Medical Journals
The authors selected 283 out of 4872 trials published in major medical journals to determine the nature and extent of exclusion criteria among RCTs and the contribution of exclusion criteria to the representation of certain patient populations. They stated that women, children, the elderly, and those with common medical conditions are frequently excluded from RCTs. Such extensive exclusions may impair the generalizability of RCT results.
The bill about the establishment and the administrative functions of Turkish Drug and Medical Device Administration
The Turkish Drug Administration’s bill that is prepared by the Ministry of Health of Turkish Republic and Pharmaceutical General Directorate has been published with the name of “ the bill about the establishment and the administrative functions of Turkish Drug and Medical Device Administration.” You can reach whole text and read reviews from the news.
The first meeting of Clinical Research Association
The first meeting of Clinical Research Association was performed in Ankara at the date of 22 June 2006. The committee of management was elected and Prof. Dr. Murat Akova was elected new president. And Prof. Dr. Meral Tuncer was elected honorary president of our association
ClinArt-ACRP GCP Course in United Arab Emirates..
ClinArt and ACRP approved trainers will train Middle-east healthcare professionals in clinical research in United Arab Emirates between March 4-7, 2009. Details >>
ECCO-AACR-ASCO Workshop..
ECCO-AACR-ASCO Workshop on "Methods in Clinical Cancer Research" will be held in Flims, Switzerland, between 20 - 26 June 2009. Details >>
Clinical Trial Registries and Results Databases..
The meeting on "Clinical Data Transparency and Disclosure Techniques for Compliance in an Evolving Regulatory Framework" will be held in London, UK between 3-4 February, 2009. Details >>
ACRP 2009 Global Congress..
ACRP 2009 Global Congress will be held in Denver, USA between 24-29 April 2009. Details >>
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The latest analysis from the US National Science Board (see Map) confirms that Israel leads the world in its economic devotion to research and development (R&D). Although US R&D investment was the world's largest — $340 billion — and in 2004, it was more than that of the rest of the G7 nations combined, the report offers some evidence of a slight decline in its standing.
Presentations of the speakers participated in Audit & Inspections In Clinical Trials meeting can be found here..
Pfizer withdraws inhale insulin (Exubera) from the market. The decision was made based on low sales.
New England Journal of Medicine published a paper on the role of CRO's in Clinical trials. The paper states that CROs have taken over much of academia's traditional role in drug development by offering greater speed and efficiency, but questions have been raised about their qualifications, ethics, accountability, and degree of independence
Almost 70 papers by 15 authors have been removed from the popular preprint server arXiv, where many physicists post their work. The moderators allege that the papers plagiarize the works of others or contain inappropriate levels of overlap with earlier articles..jpg)
The last issue (No.16, 2007) is published with 2 main topics "CRO's in Turkey" and "Clinical research in different disciplines"
At the request of the MHRA Bristol-Myers Squibb Pharmaceuticals is recalling a number of batches of Taxol 6 mg/ml Concentrate for Solution for Infusion (Paclitaxel) within expiry as a precautionary measure due to potential lack of sterility assurance. There have been no reports of non-sterile product and no sterility failures have been detected.
