Patient recruitment and patient retention are just some of the many major challenges in clinical trials. Getting enough patients to volunteer is a problem and keeping them in the study is another issue. Researchers are finding it harder to attract and retain the requested number of patients in order to complete the studies on time and within budget. But WHY? Here are some reasons why:
Prior to study: (recruitment)
- Participants of a study are turned off by knowing there is a chance they will not be receiving the study drug at all – only a placebo or a drug currently in use (in the market).
- The lengthy and taxing legal paperwork is another deterrence for many patients
- The level of difficulty of recruiting will be determined by the population that a study is trying to recruit. Usually, if recruiting healthy subjects, the recruitment process may be far easier than recruiting subjects that have a specific disease or on a specific medication.
- In some therapy areas, patient recruitment is a challenge due to the smaller population of patients compared to other indications. The doctors participating in the clinical trials face difficulty in recruiting patients as there is poor public awareness about such diseases, resulting in delayed diagnosis
- Investigators of a clinical study often time overestimated their ability to recruit patients. A more realistic assessment of recruitment, and a true forecasting rate can be determined by the historic information associated clinical trial conduct. This issue is beyond the scope of the blog and will not be discussed here.
During study: (retention)
- Participants do not want to deal with the obligation imposed by a clinical trial e.g. keeping a diary, submitting to regular medical testing, visits to test sites
- Commuting to the research site is cumbersome for some patients and/or their respective carers – especially ones are unable to drive or ones that can no longer drive (due to illnesses e.g. Parkinson’s or Alzheimer’s disease)
- Maintaining continuous relationship with patient and clinician
As you can see, these are some of the challenges throughout the recruitment and retention process that happens BEFORE a clinical study progresses with the first phase. In the digital world that we live in today, numerous digital platforms, social media and mobile technology are being used to improve clinical trial recruitment and retention. These technologies allow sponsors to reach patients and caregivers with previously unimaginable speed and precision. Perhaps not all the points listed has a thought through solution from a digital health point of view but I believe points number 2, 6, 7 and 8 are able to address by eConsent, mHealth, remote monitoring and gamification respectively.
When dealing with an illness, it can be such a daunting process joining a clinical trial as well as progressing through the trial. The more user-friendly and easier it is made for a patient, the better it is for everybody involved in a study trial. Digital health can pave a way for this.
What do you think? How can digital health play a solution in this issue? Look out for our next post!