CLINICAL DEVELOPMENT TEAM
The compound's clinical development should be closely managed by a dedicated team comprised of experts in these essential areas:
- clinical: A senior clinician usually has a key leadership role on the team due to a familiarity with the therapeutic focus of the development program as well as with the mechanics of clinical trials.
- basic sciences: Especially early in the development of a compound, the basic science representative provides a vital perspective as to what can realistically be pursued as a clinical target. He or she can also facilitate additional laboratory studies to support the emerging clinical program.
- toxicology: All too often the rate-limiting step in advancing the clinical trial program is adequate tox coverage. The toxicology expert must monitor planned trials and ensure that supporting toxicology data are available in time to avoid delays.
- manufacturing/formulation: Just as with toxicology, another potentially rate-limiting step is the availability of appropriate clinical trial material, i.e. drug product. Especially when drug manufacturing is contracted out, lead times may be very long. Not only must the specific formulation for each clinical trial be manufactured, but stability studies must be done to ensure that the synthesized material will meet FDA stability requirements for as long as the trial is anticipated to run.
- statistics/data management: The project statistician will analyze data from each clinical trial and will synthesize information from individual trials into critical sections of the NDA, (e.g. the Integrated Summary of Efficacy and the Integrated Summary of Safety). For example, he or she must ensure that the primary endpoints of all key studies are compatible. The data management representative is responsible for preparing a database appropriate to the design of each proposed trial.
- commercial/marketing: Not all approved drugs generate profits, often because their profile was not tailored for commercially viability during development. For example, a twice-daily antibiotic may have a hard time competing against equivalent or even slightly worse once-daily drugs. The marketing representative on the team must help direct development so that the drug is positioned to sell well following approval.
- regulatory: A regulatory review of all clinical studies is essential to ensure that their design and conduct will be acceptable to the FDA. Close contact with the FDA must be maintained by someone experienced in dealing with the agency. The end of Phase II meeting is a particularly important opportunity for the company to present its proposed Phase III program and gain valuable feedback before such plans are finalized.
- project management: A project manager must coordinate the various efforts described above, track progress, and quickly identify and resolve problems.
What if a CRO is running the clinical development? It is rare for even the most committed CRO to have the same passion for a project as does the sponsoring company. Therefore, the company should maintain close contact with and supervise the CRO. In addition to having a lead contact person, it is useful to have an in-house 'shadow' clinical development team to monitor progress; company employees with expertise in all the relevant areas should regularly liaise with their CRO counterparts. If the full panoply of expertise is not available within the company, it should consider hiring consultants in such areas to advocate for the company in dealing with the CRO.