New ACTG Structure Squeezes Eleven Committees Into Three--But Will Anything Really Be Any Different?
Remaking the 'Iron Lady'
Once again the AIDS Clinical Trials Group (ACTG) has been restructured. This has occurred three times in as many years. Are the deck chairs of the Titanic being rearranged once again? The outcome remains to be seen. Even if this is yet another bureaucratic misadventure, the ACTG Executive Committee (EC) and the Operations Office deserve high marks for the time and effort they have expended in trying to streamline the old Leviathan.
Instead of eleven independent committees working in a vacuum, the ACTG will now consist of a mere three Research Agenda Committees (RACs), which will encompass the eleven former committees. The former committees will remain, but conference calls and core meetings will probably be very different and much less frequent.
The new Research Agenda Committees (RACs) will be organized as follows: HIV Disease, composed of Primary Infection and Virology; Disease Complications, composed of the Opportunistic Infections, Neurology and Oncology committees; and Immunology/Immune-Based Therapy (IBT).
The Research Agenda Committees (RACs) will be the new mechanisms by which protocols are developed. The new protocol development process is very ambitious. Instead of the eighteen to twenty-four months it formally took a concept sheet to be developed into a protocol, the new system envisions a completed protocol to be ready for FDA submission in approximately four months. Much of the unnecessary bureaucratic hurdles have been removed. Instead of crawling from committee to committee for endless monthly reviews, each protocol team will now consist of specialists from each relevant committee. It certainly sounds more efficient. We'll see... Theoretically, any member of the team can stop the development process if the protocol is deemed sub-optimal. But will any courageous individual have the nerve to stand up and say "this concept sheet stinks"? We'll see...
RACs will also be charged with designing a "pathogenesis-driven" scientific agenda from which research goals will be prioritized. In theory, the old Primary Infection Committee, for instance, will no longer be able to gobble up all the resources to the benefit of their own institutions, bloating the ACTG with the "same old, same old" nucleoside analogue protocols. Resources are now to be divided among the three RACs. The scientific agenda will be funded according to what is the best current feasible science. Sounds good! We'll see...
Obviously, the leadership of these three new RACs is of paramount importance. No surprises were expected in electing the chairs and vice-chairs of the RACs. The elections in the HIV Disease Complications and Immunology/IBT RACs went off without a hitch. Drs. Bill Powderly (Washington University, St. Louis), a community favorite, and Mark Jacobson (University of California at San Francisco) were elected chair and vice-chair of the HIV Disease Complications RAC. Drs. Richard Pollard (University of Texas, Galveston) and Michael Lederman (Case Western, Cleveland) were elected chair and vice- chair of the Immunology/Immune-Based Therapies RAC.
The election for the HIV Disease RAC, however, was a bit of a fiasco. Drs. Margaret Fischl (Jackson Memorial, Miami) and Ann Collier (University of Washington, Seattle) had both been nominated for chair. Likewise, Drs. Scott Hammer (New England Deaconess, Boston) and Daniel Kuritzkes (University of Colorado, Denver) had both been nominated for vice chair. And despite the fact that the HIV Disease RAC forwarded Drs. Fischl and Hammer as its preferred slate, the defiant Executive Committee nevertheless proceeded to select Collier and Kuritzkes.
From a community perspective, the two candidates for chair have very different management styles. Dr. Collier is much more flexible, approachable and inclusive. In contrast, while Dr. Fischl was vice chair of the Primary Infection Committee (to Marty Hirsch's, Harvard Medical School, chair), she chaired or vice-chaired almost every tired old protocol that was developed. And her approach has been very rigid. She is not open-minded, nor does she easily accept outside advice. Her obvious logistical abilities and over-achievements notwithstanding, any change from Dr. Fischl's staid, static leadership would be a breath of fresh air.
Dr. Kuritzkes, who was heavily identified with the development of the new HIV Disease RAC's scientific agenda, agreed to serve as that RAC's vice chair. Meanwhile Dr. Collier, fully aware of the political implications of what might be perceived as a dark horse's grab for power, politely declined the appointment, paving the way for one shaken Miami physician to steal into her long coveted primacy. So, despite a clear mandate for change evidenced by an 11-to-2 vote in favor of Dr. Collier, Dr. Fischl will be, by default (some would say 'fiat'), the new chair of the HIV Disease RAC. Does this mean that the last member of the "Gang of Five" will carry its stranglehold on the ACTG into the future? This too remains to be seen.
We hope Dr. Fischl will have the flexibility to institute necessary changes, and to make room for other investigators with fresh new ideas. We hope the scientific agenda of the HIV Disease RAC will be bold, coordinated and statistically sound. We hope all this re-re-structuring will not prove to have been an exercise in futility. Meanwhile, we'll be watching....