Pharma’s Cutting Edge

I’m not going to spend much time on this one, since I actually agree with many of the criticisms leveled at open-label extensions (OLEs) of previously blinded clinical trials as discussed in the article. The principles that should be adhered to when conducting open-label extensions are those of the scientific method and good clinical practice (GCP), not good marketing practice. It is that simple. When we ask subjects to participate in such studies, we should do so with full disclosure of the risks, benefits and treatment alternatives available to them, and we should be forthright in explaining to them the advantages and limitations of the open-label extension design. Any inducements beyond supply of drug and study-related medical care to subjects agreeing to participate should be minimal and non-coercive. That said, we should not throw away the baby with the bath water. Just because pharma has shirked its responsibility to publish OLEs does not mean pharma and the research community should abandon the OLE study. OLEs offer certain advantages over blinded trials, including collection of long-term safety, tolerability and adherence data that might otherwise not be possible. They also serve an important marketing role. However, this role must take a back seat to the welfare of clinical trial participants and to the integrity of the clinical trial process.

Part of the problem is one of continuing insufficient interaction between marketing and R&D personnel within industry. Most companies still pay lip service to this interaction. The two functions work with each other more often and earlier in development than ever before, but little attention is paid to understanding each other’s roles in a truly meaningful way. This must change. It is critically important that these functions cooperate in a meaningful way, in which each continuously informs the other of its practices, motivations and rules of conduct. Fix this interaction, and many of the ills plaguing questionable pharma R&D practices go away.