While the challenges of treating Coronavirus are familiar from the perspective of it being a dangerous infectious disease, the speed of its progression and the breadth of those who are affected and at risk pose unique challenges for everyone.
If we’re going to enroll patients in Coronavirus clinical trials quickly, finding participants is going to come down to the behavioral and psychodynamics of identifying affected patients (and healthy subjects) that are most likely to participate. As these are often studies where there really isn’t a specific patient database to draw subjects from, while study protocols have been developed quite quickly, it’s important to take steps to maintain flexibility in your approach.
We call on researchers to make the following considerations to expedite clinical trial participation:
- Simplify the inclusion/exclusion criteria. Enable patients to accurately self-report their eligibility. It will lead to better targeted outreach. If the protocol is too broad and PIs need to make judgement calls, it slows the ability to promote the study properly without overburdening the study coordinators. Patients are likely going to be interested in the study designs, too. Materials should include if they are being given the virus, questions about the history of the medication, and how family or caregivers may need to be involved. Considering research is already behind from a timeline perspective,you can end up ahead if you understand which participants are going to be most at risk and most interested in your specific study design before finalizing protocol and sites.
- Use conversion-based adaptive recruiting. I’m not interested in selling anything here — in fact, all Leapcure Coronavirus efforts are being offered to researchers at cost. However, this tactical tweak we offer is going to be the difference between spending $50k/month in media to get clicks without participants, vs. spending $5k-10k/month in media and filling your study with interested participants. In addition, allow for adaptive recruitment with your IRB submissions. Allow for the screener to adapt so that patients can be pre-screened for the specific criteria for indicators that suggest willingness to participate and communication preferences. Iterate on your outreach based on conversion milestones at each research site. Whether you need our services or not, email us at research@leapcure.com to learn more about this critical component or find out how we can help in managing your campaigns.
- Look at news focused communities/e-newsletters. Look at folks like Bionews Services, partner with IDSA, and pay attention to coronavirus related hashtags for distribution ideas. Additionally, try platforms like Reddit, Twitter, Bing, Craigslist/digital classifieds and others to spread awareness of the clinical trial. You are swimming in crowded waters and a broad approach is going to be needed.
In addition to at cost offerings, free consultations for research coordinators and drug development sponsors are also available. Our time is booking up quickly, but we will find a way to help you. You can email us at research@leapcure.com to set up a time. We can all play a part together to accelerate research outcomes during these uncertain times.