The Challenges behind Clinical Trial Transparency

Originally posted here: https://crotraining.co.uk/clinical-trials-transparency-issues-the-other-side-of-the-coin/

Transparency in clinical studies is important. It is said to play a huge role when it comes to enhancing the efficiency of a number of trial procedures. In relation to this, the European Medicines Agency (EMA) has presented a consultation on the integration of transparency rules within the new clinical trial database. The primary function of this database is to collect all of the required information and to distribute it to the public for free use. However, despite the many advantages that have been pointed out, there are certain issues in terms of applying complete clinical trials transparency to the usual practices of every Pharma-oriented company.

Janet Wisely, Chief Executive for HRA argued that; “Transparency in health research is fundamental to medical advancement, improving efficiencies and increasing public confidence. Through greater transparency we can further enable high quality, ethical health research.” In addition to this, transparency allows the audience to read useful information in terms of the start and end-trial date. People who show interest in participating in the study can also find how long the whole procedure will last and what phases it will include. For trial that have been carried out already, people will be given the results as well. But just as anything else in any business or sector, there are two sides to this story as well. Despite the fact that there seem to be plenty of positive aspects, the truth is that negative aspects, in fact, exist too.

• To begin with, because of the free access to documents, descriptions and other trial files, everyone can get information about patients and personnel too. This can turn out to be a huge problem. Why? Because it can put under question the actual protection of participants’ welfare, privacy and rights. As a result, it can prevent the trial process from running in a smooth way.

• Next, there comes the moment when transparency of clinical researches can place one Pharmaceutical, medical or clinical organization in a competitive disadvantage over other organizations.

• Lastly, there is a chance that people might abuse this free access to important data. For instance, some individuals may reach to improper conclusions and independent reanalysis that are incorrect.

It comes as no surprise that there is a variety of positive outcomes of clinical trial transparency. Nevertheless, there are serious clinical trial transparency issues. Such issues include putting confidentiality of trial participants at risk; interrupting patent-procedures and, lastly, reaching to wrong assumptions and unappropriated analysis.