Updated: Mar 20
Of course, clinical trials can fail or there would be no point in conducting the research, would there? The point is: whether or not the trial succeeds in in proving the safety and efficacy of new drug, as far as the investigator is concerned, the trial is a success if it satisfactorily answers the question, “Is the drug or treatment safe and effective?” and has all the data to back up his claim.
So when then can a clinical trial be considered a failure?
Clinical trials are composed of a large number of activities which have to be closely monitored and documented in which case a single lapse in any one of these activities can make or break the entire operation. This is especially true if the slip-up or omission is not detected at an early stage. With a trial conducted over a long period of time, even years, you can imagine the amount of data, activities, personnel that have to be monitored, not to mention the patients that have to be screened, etc.
Clinical research can be deemed a failure only when it cannot provide an answer to the research question with absolute accuracy or there are too many questions the trial cannot provide answers for. This is likely to happen when the systems for data collection are inadequately put into place; when there are loopholes in the framework.
These loopholes may be due to insufficient tools, facilities, procedures or personnel. More often than not, clinical trials fail because of problems in these areas although, of course, patient enrollment is likewise a cause of concern.
Hence, the importance of good quality clinical trial management which ideally should be in place right from the start. Clinical trial management likewise involves assessments of all systems and processes as the trial progresses to ensure that all possible loopholes are plugged.