Independent academic clinical research, indispensable for driving and advancing standards of care, accelerating access to treatment, and improve the use of healthcare resources, faces an increasing tension between the goals of embracing innovative research and escalating bureaucracy inherent with involvement in these studies.

The Best of Intentions & Bad Consequences?

A recent bmj option highlights the impact of European Directive 2001/20/EC triggered many of these tensions in Europe as the rules were established to ensure patient protection and unbiased oversight. The authors argue that although these rules were promulgated with the best of intentions, they are, in fact, now “stifling academic research and hindering patients’ access to innovative treatment options.” The authors believe clinical research in Europe itself is now at risk.

Feeding the Beast

Now academic clinical research expends enormous amounts of time, money, and energy on the collection of what the authors believe is “irrelevant data and exhaustive documentation.” Therefore, investigator-initiative research is now a full-time job necessitating a complex and comprehensive division of labor few have the wherewithal to deal with on an ongoing basis. From funding and dealing with the workflow and process of Ethics Committees to endless regulatory review cycles and clinical trial agreement negotiations, it all becomes too much, especially when factoring in many of these investigators have full-time positions as physicians or professors.

Change in the Air?

A new Clinical Trials Regulation EU 536/2014 represents a movement to reform the Clinical Trials Directive 2001/20/EC with an aim to streamline applications and homogenize and simply authorization procedures with what the author’s report is a “strengthened transparency on the data.”

However, the authors believe that contemplated changes to Directive 2001/20/EC require far more than just a “harmonization of rules on how to conduct clinical trials.” Still, a fundamental rethinking and simplification of the entire endeavor are in order—think how important clinical research is for the future of humanity. Nothing short of complete transformation is required—think about what Uber did to the standard Taxi business, Airbnb for hotel stays, how about how 23andMe is transforming how drug discovery can occur. Clinical research must become incredibly simple on the front end—meaning that complexity of the rules ensuring patient safety and data quality must somehow be pushed to the back end—always there and present but not stifling research.

Source: the bmj opinion

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