Despite the many advantages to participants of clinical trials, webMD have commented that it can be very difficult for researchers to recruit the desired number of people to their cohort. Adaptive phase 1 studies may be the first stumbling block for recruitment of healthy volunteers, and it is interesting to explore some of the potential reasons or barriers for failure to recruit enough subjects.
Medical criteria for selection of people to a trial may be strict and therefore it may be difficult to actually find the people who fulfil all of the desired criteria. Researchers may advertise for patients but in some cases in particular where a disease or condition is less common this still may prove difficult to reach desired numbers for adequate assessment of a medication. Social media may be the latest platform for improving advertisement for clinical trials.
Some potential participants may be put off by the possibility of receiving a placebo as this means they would not be receiving the possible benefits of the new treatment under investigation. The placebo group are, however, a completely essential part of the trial where used as they provide the benchmark against which a new treatment is measured and with this essential comparison comes the robust information about how effective the new drug could be. The bigger picture needs to be considered, that with the addition of the information from the placebo group, the new drug can be accepted and approved for widespread use more quickly and be available to all who can benefit from it.
Risks of unknown side effects could be a factor in some patients not signing up and this is a fair concern, however it is worth emphasising that in the UK any potential clinical trial must have passed through rigorous ethical review prior to allowing recruitment of human volunteers and the early phases of the clinical trial are performed with low doses of drugs and very close monitoring to assess for safety of the new drug.
Failure to recruit needs to be addressed as it can cause failure of a potentially very important clinical trial and ultimately new and possibly superior treatments can be delayed for the patients who could really benefit from them. The emphasis on safety of these trials can be demonstrated by visiting www.richmondpharmacology.com/specialist-services/adaptive-phase-i-studies and it can be seen that the design of studies is a very expert field with dedicated individuals ensuring they follow strict guidance to minimise the risks and maximise the benefits of such work.
No patient would ever be recruited without their knowledge and every participant would have been provided with a lot of information about exactly how the study would work.