"In addition to endorsing clinical trial registration, member journals of the ICMJE made prospective registration compulsory for all clinical trials that commenced participant recruitment after 1 July 2005 (de Angelis et al., 2004). Many other journals also endorsed clinical trial registration and the number of registered trials increased rapidly (Laine et al., 2007). Since then, many organisations have added their support for clinical trial registration. "
[Show abstract][Hide abstract] ABSTRACT: The loss of public trust in the clinical research community, particularly in the pharmaceutical industry, came after a series of allegations focusing on selective reporting of clinical trial data by the pharmaceutical industry (2,3). Of particu- lar concern were instances in which sponsors disclosed positive results from clinical trials while leaving out the negative ones. This contributes to publication bias and can seriously impact the interpretation of data, both at the indi- vidual study level and for large data sets in meta-analyses on published studies (4-9). In an effort to address the situ- ation, the stakeholders, including the governmental agen- cies, trade associations, journal editors, the WHO, ICH, and Cochrane collaboration (Fig. 1), became proactive regarding the increased transparency of the data on clinical trials—however without always coordinating or fully anticipating consequences of their efforts. Unluckily for those affected in the clinical research community, some of the proposed or implemented actions by the stakeholders were conflicting, making compliance towards increased transparency difficult. Clinical trial registration and transparency of clinical trials has been the subject of previous articles in TWS (10,11). Here we follow up on those reports and summarize some of the latest developments on this fast-changing topic and the way these developments potentially affect all patients, pharmaceutical companies, clinical research organizations, universities or government institutes, and other individuals involved in testing of and reporting on investigational products 1 in humans. We also share some of our own expe- riences gathered while setting up the processes associated with 'Clinical Trial Disclosure' at an internationally ope- rating pharmaceutical company.
[Show abstract][Hide abstract] ABSTRACT: Registering clinical trials is considered an ethical and moral imperative. The launch of the Clinical Trials Registry-India provides opportunities to all in India to fulfil this imperative. The CTRI requires prospective registration, disclosure of all 20 items in the WHO Trial Registration Data Set and proof of ethics and regulatory clearances. Registration in the CTRI is voluntary. However, institutional research ethics committees have obligations. This article reviews these obligations and provides an example of how this can be achieved.
Indian Journal of Medical Ethics 10/2007; 4(4):168-9. · 1.07 Impact Factor
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