Low Patient Enrollment: A Threat to Clinical Trials and Drug Companies
The field of clinical research starts and ends with patient volunteer. Unfortunately, there is a paucity of research volunteers for participation in clinical trials. According to estimates, about or over 80% of clinical trials are delayed because of insufficient or low enrollment. And with low enrollment, pharmaceutical companies cannot submit NDAs to the FDA or other foreign regulatory agencies for review and market authorization. Consequently, those companies will lose millions of dollars for not being able to bring their drugs to market soon enough, and also with intellectual property (patents, trademarks) expiration and generic competition. To say the least, effective recruitment strategies is the key to ensuring adequate enrollment. Inasmuch as the internet is revolutionizing clinical trials, many factors can be blamed for the extreme lack of patient enrollment.
Factors Contributing to Low Patient Enrollment in Clinical Trials
There are many barriers to timely recruitment of study volunteers, some of which are listed below.
- similar subjects competing for the same patient pool in the same location or area
- lack of staff and training
- doctor-patient relationship concerns (ethics???)
- rigorous inclusion/exclusion criteria
- difficulty with the consent procedure
- misunderstanding or negative and ill-advised perception of clinical trials (the media is a big factor)
- past isolated incidents and tragedies in clinical trials (fear of participation)
- the "guinea pigs" idea
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