On Industry Efficiency and Effectiveness

A colleague at ACRP forwarded me the following press release from the FDA:

http://www.fda.gov/NewsEvents/Newsroom/
PressAnnouncements/ucm386372.htm

While I’ve never had any responsibility in Pharmacovigilance, what was interesting and exciting to me was the continued interest regulatory bodies have in partnering with other regulatory jurisdictions to improve efficiency and effectiveness in the clinical trial industry, a growing trend we can see in other initiatives as well.

I, for one, am a huge fan of many of the initiatives currently underway because the end goal of all of them is improved clinical trial efficiency, something anyone working in clinical research knows has been difficult to achieve in the past.  Initiatives such as the Clinical Trials Transformation Initiative (CTTI), Multi Regional Clinical Trials Center (MRCT), Transcelerate, Alliance for Clinical Research Excellence and Safety (ACRES), and the Institute of Medicine (IOM) Forum on Drug Discovery, Development, and Translation have brought industry stakeholders together to examine issues such as GCP training, PI turnover, clinical trial site accreditation, and others.

I applaud and support these efforts, and am happy to report that ACRP is participating in and bringing the voice of our membership to many of these initiatives (CTTI, IOM site accreditation collaborative, MRCT, ACRES). However, I do struggle with a sense of duplication in that many of these groups are examining and making recommendations on the same issues.

I believe this, in part, is demonstrative of the level of discontent with the current clinical trial landscape.  Many stakeholder groups have recognized what is broken and have stepped forward to attempt to fix issues they feel they can solve.  I also believe that many groups have formed based on the sheer number of stakeholders involved in the clinical research enterprise.  While I do understand how we’ve gotten to where we are and am a staunch supporter of the many initiatives underway, it is my sincere hope that we can also be efficient and effective in our efforts to improve the clinical trial process.  ACRP will continue to partner with these groups and will do what we can to streamline the efforts of the parties involved, so that we are not duplicating efforts and diluting our ability to impact change.

Until next time,

th