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The Clinical Trials Transparency Dilemma

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Published - 27.Jan.2015

The progress of clinical trials and the major advances in the Pharma industry would be hard to achieve without volunteers who decide to take part in a number of medical studies. Yet, one of the most debated topics in this sphere is the one related to the clinical trials transparency. In other words, the question is whether or not there should be a much richer and informative scope of data revealed to the public in order to clarify and contribute to the understanding of people about clinical researches.

Similarly, in order to point out the importance of clinical trials transparency, NIH Director Francis S. Collins, M.D., Ph.D. argues that; “Medical advances would not be possible without participants in clinical trials.” He, then, continues and says; “We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld.”

Respectively, above all, clinical trials transparency is in the best interest of those who participate in a variety of clinical research studies. Giving specifications about the effectiveness and/or ineffectiveness of a clinical project will result in not only letting participants know about the progress of the research program but will also form trust with them. In addition to this, the publicly disclosed facts will give them a chance to find out more about all of the phases, authorization, conduct, as well as the results and the start and the end date of a specific trial. This can be implemented by creating a new trial portal and database that will contain and present enough information to the public eye. An example of such external resource is clinicaltrials.gov which offers useful explanatory details about different clinical studies (public and private), carried out around the world. For the time being, the website includes facts and statistics about 178,000 clinical trials and contains summary results for more than 15,000.

Clinical trials transparency is beneficial for other researchers as well. The free and easy access to enlightening registries will prevent them from conducting the same medical studies and unnecessary duplication of trials will be avoided.

Nevertheless, there are exceptions when such publicly available information should be restricted. According to Clinical Trial Regulation, this should be the case when trial participants ask for absolute anonymity and want their personal data to be protected, or when protection of the supervision of clinical trials by Member States is requested as well.

So the moral dilemma of total clinical trials transparency has always been a part of the industry and despite of the risk that full clarity might reduce the number of volunteers for clinical trials, it looks like it has taken a turn in the direction that allows participants to be aware of exactly what they are volunteering for and be well informed before making their decision.

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