Planning patient engagement prior to starting a clinical trial becomes more and more of a priority. The focus used to be on Key Opinion Leaders (KOL) only. And of course, their opinion is still crucial, and not only to facilitate market access. Yet, the patient-centricity movement is growing, and knowing if the target patients will be interested in the trial is the focus.
So, the question is – How do we measure patients’ interest?
One way often used by sponsors and Clinical Research Organisations (CROs) is to collaborate with national or international patient organizations (POs). The idea is to be close to the organizations or patient advocates and understand the following:
· What do patients think of our study?
· Would they be interested in participating?
· Would the PO support us to reach more patients?
The second option is the traditional site feasibility. Reaching out to the medical sites and investigators to understand how likely and many patients would participate in your study. This feedback is still very valuable and still inevitable. However, our experience with patient recruitment support has disclosed that there are worthwhile factors to consider when predicting patient recruitment and would complement your decision-making process.
The formula is simple but powerful:
POA + CTA – QRD = PICT
POA: Patients’ Online Activity (condition-specific)
CTA: Clinical Trial Awareness (country-specific)
QRD: Quality of Reimbursed/Approved Drugs (condition-specific)
PICT: Patients’ Interest in Clinical Trials (country- and condition-specific)
POA: Patients’ Online Activity (condition-specific)
Monitoring the online activity of a target population is nothing new in the marketing world. The tools and analyses used by the advertising sector can also be utilized in the pharmaceutical field to determine topics and challenges discussed online by the patients. Another important factor is the actual online activity and the search for novel treatments in a specific condition. If you are looking for concrete numbers, you can check out Google Search activities, Facebook groups, Twitter, and other popular social media channels and blogs.
For example, on TrialHub you can see clinical trial searches by country as well as channels where advertisement is allowed. This can help you determine whether digital patient recruitment would be a good option based on the number of condition-specific online searches the country’s advertisement policy.
CTA: Clinical Trial Awareness (country-specific)
The assessment of CTA is not as straightforward. In some countries, you can find institutions dedicated to educating patients about clinical trials, one example being the Clinical Trials Gateway in the UK. Another way to measure people’s activity is by checking out the number of online searches about information/ options for clinical trials.
QRD: Quality of Reimbursed/Approved Drugs (condition-specific)
This is the so-called Standard Of Care in a country. The more good treatment options patients have, the less they would be interested in participating in clinical research projects. Sponsors and CROs should be aware of the superiority and the USP (unique selling point) of their new product in development compared to others on the market from the patients’ perspective.
Besides counting and comparing the number of approved and reimbursed drugs in a country, you can discuss the value of Standard Of Care in a country with the investigators, KOLs, and/or patient advocates, who can provide you with profound insights. If you want a hassle-free way to get their insights, TrialHub can connect you to country advisors in a matter of days (up to 5).
In short
Although the formula seems simple, gathering all the required information is not straightforward and requires a lot of time and resources. However, the result will bring you closer to a realistic estimation of the Average Recruitment Rate and Average Dropout Rate (not only based on historical data about completed clinical trials but also based on current real-life insights about your target patient population). The work is not complete yet, patient engagement and involvement is an area that we still need to further research, assess, measure, and improve.