Patient recruitment is the most challenging aspect of a clinical trial. According to the latest research, it’s also the main reason for delays in 85% of the studies. Planning and predicting recruitment is a major focus of every sponsor company and in turn, of every CRO. But can patient recruitment actually be predicted?
Many experts in the field of clinical trials are convinced that it’s impossible.
Knowing whether patients exist and where they are located, is one thing. Predicting if they will be willing to join a clinical trial is completely different. There is no silver bullet for all clinical trials either.
Yet, I truly believe there are many ways to forecast patient recruitment rates of a clinical trial. I also believe that it’s not about a precise number, but about anticipating challenges and coming up with solutions before falling into “rescue” mode. Below I will list a few methods that the industry is NOT YET using to their full capacity. They could be helpful to consider for your next clinical trial.
- EMRs or EHRs (Electronic Health Record).
I wish we had Electronic Medical Records (EMR) in a standardised format in every country. It seems so easy, yet, we are so far away from achieving this goal. However, some hospitals and/or companies (mainly in the US, and now starting in Europe) are using the records to match EMRs to clinical trials in order to accurately foresee numbers of eligible patients
NB! Knowing how many patients might be eligible, does not necessarily mean that they will participate in your clinical trial.
2. KOLs vs Asking Practitioners
I work closely with country clinical trial managers from top 10 pharma companies (Bayer, Novartis, J&J etc.) and all of them confirm contact to local Key Opinion Leaders (KOL). These are the people that you need to engage with for better adoption of your drug.
However, most KOLs are not the doctors actively engaging with patients face-to-face on a daily basis. Sometimes, no matter their experience, a simple chat with a few practitioners can be eye-opening. It can help you understand the patient’s clinical pathway and experiences – their fears, biggest struggles, preferences.
This information is crucial for your clinical trial success, especially if you already have a protocol in place.
NB! To sum up, of course KOLs are important but don’t forget to talk to General Practitioners to not miss important information about your patients.
3. Standard Of Care
It takes time to research the current standard of care per country. An excellent source of information are KOLs and practitioners. Another approach is reviewing the approved and reimbursed medications in your country of interest.
The better the current standard of care, the less your patients might be interested in joining a clinical trial. This factor can be very powerful in combination with site feasibility or patient estimations from EMRs.
NB! You can request a Standard of Care report on TrialHub and you can also connect to local country advisors in order to understand the patient pathway better.
4. Patient Insights: Social Listening Vs Patients Advocacy Groups
Or why not both?
You should consider and use every opportunity to understand what your patients care about and are looking for. This can improve your engagement and potentially increase the number of participants by 50%.
Misunderstanding your patients can lead to a disaster (e.g. one randomized patient in six months). There are many methods to better understand patients. Two of the most powerful methods are engaging with patient advocacy groups and/or using social listening.
If you engage with a patient advocate willing to support you with insights and protocol development, just make sure that he/she also has the expertise of doing so.
NB! The European Patients Academy – Eupati, is dedicated to educating patient advocates on how to contribute to the healthcare industry. They also organize trainings for the industry on how to receive feedback and to efficiently implement it into the core business, plans and activities.
When it comes to social listening, there are many providers. We are very successfully using this technology to provide Patient Insights and Social Media potential reach. Social Media is a powerful tool to provide you with insights into what patients want/ are looking for, how aware they are of clinical trials as an option, how active they are on which platform, etc. It’s all about asking the right questions.
Patient recruitment cannot be predicted by looking at only one side of the table. Being able to combine multiple perspectives and data will help you navigate estimations, forecasts and see the Big Picture.
This means not underestimating the “patient factor” and trying to understand, among others, if a study is attractive to your target patients. Relying solely on the investigators to inform patients about your study is insufficient in a world full of digital information and clinical trial competition. The patient recruitment champion will be the team, who understands their patients and works in their best interests.