How covid-19 shows us the future of clinical trials
Clinical innovation should be brought faster to patients in need
Hello and welcome to Careviser by Marie Loubiere, the weekly newsletter that cuts through the healthcare noise with a single focus: productization of the latest research and tech breakthroughs.
Bringing a new prescription drug to the market takes a decade and costs US$2.5bn (yes you’ve read correctly, we’re talking billions). About half of the time and the expenses are spent on clinical trials. They are notoriously hard to set up. It is an impediment to bringing clinical breakthroughs faster to patients.
Covid-19 has been an exception as shown by the number of vaccines now approved. This week, we’ll focus on one area where clinical trials for covid-19 vaccines and drugs were more efficient than traditional trials: recruitment.
Pragmatic trials with prespecified subgroups: what oncologists can learn from COVID-19 by Rahul Banerjee & Vinay Prasad, Nat Rev Clin Oncol18, 7–8 (2021)
🗝️ Why it matters: Clinical trial recruitment is obviously key to assess the real efficacy of new therapies. That’s something that oncologists struggle with.
Participants in randomized controlled trials (RCTs) of anticancer therapies are often younger and fitter than the average patient with their specific malignancy.
🔎 The study: The RECOVERY trial for patients who suffer from covid-19 can serve as an inspiration to design more inclusive and realistic recruitment processes to enroll patients. It enrolled about 15% of the UK’s eligible population from a large number of hospitals (173 centers).
✅ Current flaws found when recruiting participants in randomized controlled trials:
Restrictive inclusion criteria
Logistics favoring enrolment from academic medical centers as opposed to community-based practices
Referral bias towards healthier patients
The RECOVERY trial addressed these flaws: any covid-19 patient (from any center, of any age or health status) could enroll in the study. Patients could enroll from a simple online form when recruitment from oncology trials sometimes takes up to 20 hours of work from researchers. It didn’t ask for unnecessary data points which are oftentimes common in oncology trials. It used pre-filled information so that patients could be randomized according to available treatments in their medical centers. Patients could be segmented into sub-categories to assess the efficacy of the proposed treatment.
🚀 Opportunities ahead: hiring for clinical trials is a hot health tech space. For both ethical and logistics reasons, some subgroups have been underrepresented in clinical trials (women in general, and pregnant women even more specifically) and there is still an untapped opportunity to find them and enable them to enroll in available trials.
1nHealth was founded in 2019 in Florida as a patient recruitment platform for clinical trials.
🤯 The problem: over 80% of clinical studies fail to recruit enough patients.
🤗 The solution: 1nHealth was started by a team with a strong background in B2C marketing. They built a data solution using methods from the consumer insights field to find patients for clinical studies. They claim that their data edge enables them to find untapped subjects. They also market the clinical study in an attractive way to convert more patients. It’s a very interesting B2C angle that can appeal to sponsors and CROs that lack this expertise.
📈 The traction: in less than two years, they have recruited over 150k participants for more than 20 studies. They raised a US$1m seed round last year.
Patiro is another company active in the same field. Founded in 2014 in Denmark, it has created a health research platform (Health Panel) that people interested in participating in research projects can join. They are notified when there is a research study matching their characteristics. On the B2B side, it offers patient management software that allows sponsors to follow through with the progress of their studies.
That’s a wrap for today! Don’t hesitate to reply to this email with comments, I read and answer all emails :)