Clinical trial processes are what we repeatedly do in clinical research, but, unfortunately, the habit of excellence is not as prevalent as it might be. Processes are only as good as the ways in which they are carried out, so this aspect is worth looking at before examining the processes themselves. Excellence means the very best that is achievable in a given situation with the knowledge and resources available, and it is not to be confused with perfection, which is rarely attainable, and trying to achieve it is a waste of time. Although the rational implementation of the various approaches described later can help to make the clinical development process significantly more efficient, this will not in itself achieve excellence. Implementation needs to take place in a cultural, intellectual, and operational environment that lends the necessary support. There are many possible components of such an environment, but one can go far by • instituting some basic behavioral elements; • doing things as well as they can be done all the time; • simplifying processes; • not allowing regulations to develop into liabilities. I have included this section risking that it might be considered unnecessary and patronizing by some. After all, everybody believes that their behavior is impeccable, just as everybody is a perfect driver. It only takes a few people to behave badly to poison an organization (or to injure others). . . . Laws control the lesser man. Right conduct controls the greater one. . . . . . .—Chinese proverb. . . . . .Good behavior is the last refuge of mediocrity.. . . . . . —Henry S. Haskins, stockbroker who was expelled for alleged misconduct and published his aphorisms anonymously. . . Can principles be applied that encourage positive, ethical, complex, and intelligent behavior without retreating into the lowest common denominator of mediocrity? One can argue the extent to which principles can help to achieve these objectives, but what is undeniable is that, in their absence, the results can be extremely damaging. This is exemplified not only by the poor performance metrics but also by the poor reputation of the pharmaceutical industry in the public’s view.
The Evidence REVEAL Study: Exploring the Use of Real‐World Evidence and Complex Clinical Trial Design by the European Pharmaceutical Industry
