AST COPs – Something’s missing

In 2009, the Board voted to dissolve the Clinical Research Committee. To be truthful, despite the fact that I had served on this committee and was involved on a number of critical projects, I voted in the affirmative of this dissolution.

During my years on the Clinical Research Committee, I had the pleasure of interacting with a number of dynamic individuals with whom I have remained close professionally, including Flavio Vincenti and Bob Gaston, and I benefitted from working with leading industry, federal regulatory and funding agencies. But over time, the Committee floundered due to a lack of productivity and absence of clear vision, eventually leading to the Board prioritizing the staff and funding to other missions.

During our Strategic Planning Board Meeting in the summer of 2011, research again became a leading part of the plan. I have personally been research-focused my entire career, evolving from very basic research to novel clinical trials, and this new focus on research has been heartening and reassuring. But I still feel there is a crucial piece missing.

Clinical research.

Never before has there been a more challenging time in our field – funding is strained, regulation is at an all-time high and research endeavors are more expensive than ever. The immunosuppression we use has excellent short-term outcomes, but long-term toxicities. The development of co-morbidities linked to these agents demand newer, more specific therapies and/or alternatives to current minimization strategies. Problems such as antibody mediated rejection and BK nephropathy still lack safe and efficacious approved therapies.

In spite of tremendous hurdles, I also see tremendous positives:

• ­ There have been incredible technological advances in molecular biology and genomics, as well as new 'omics platforms that can be applied to patients to identify mechanisms and biomarkers
• ­ Organ regeneration is becoming a seeming reality
• ­ More of our members are full-fledged epidemiologists who can provide unique insights into transplant outcomes and the impact of regulations
• ­ Potential therapies exist to manage organ ischemic injury
• ­ There are several large established consortia that have made us realize the strength in numbers and our power as a group rather than individuals

So how can we capitalize on these issues? How can we continue to move our field forward and represent the Society in matters of funding and regulation? Do we not have an obligation and mission to advance care?

I think it's time to formulate a Clinical Research COP.

With so much creative energy in our Society, there is no reason we should not be assisting in research and acting as an expert who can represent the needs of our patients to industry and federal agencies on matters of regulatory policy. And, above all, we have a responsibility to train the next generation of investigators to carry on this mission in the future.

Please let me know your thoughts. As we continue to move forward with this new COP, I'll be calling on volunteers to participate and effect the organization.

Thanks for your consideration.

Roz