The coronavirus (COVID-19) pandemic is causing major disruptions to clinical trials, with one third of study sites anticipating closure and nearly 80% reporting at least one ongoing trial has been put on hold, according to a US site survey conducted by Continuum and the ACRP.
Since sites are largely unable to screen new patients, many sponsors have put the enrollment of new patients on hold or delayed the startup for a planned clinical trial. When these COVID-19-related clinical trial holds or delays are lifted, sponsors and sites will be under immense pressure to get enrollment back on track. However, since so many trials will have experienced similar delays, sites will be busier than usual and have an increased volume of competing studies.
If your trial has been put on hold or if you’ve delayed startup for an upcoming trial, you may still be able to meet enrollment milestones—or at least make up for some of the time lost—by implementing a Continuum Clinical Catalyst CampaignTM.
What is a Catalyst Campaign?
A Catalyst Campaign is a focused recruitment campaign that runs before or during a clinical trial; it results in the identification, engagement, and databasing of interested, highly qualified patients. Catalyst Campaigns include additional screening steps (not necessary in traditional patient recruitment campaigns) that ensure referrals are as qualified as possible. Providing reactivated study sites with an immediate source of referrals who can be contacted once enrollment begins or resumes helps ensure sites can randomize patients quickly, easing the burden your study sites will be experiencing as they get back up and running.
Why now?
Sites and studies cannot afford to delay patient recruitment, even if new patient enrollment is on hold or startup is delayed. As patients adjust to spending more time at home, they are spending more time with digital media. Simultaneously, large advertisers (like airlines and hotels) are reducing or eliminating advertising spending, meaning there is less competition for the attention of audiences and keywords. This has created an extremely cost-effective media environment. In short, media can reach a broader audience for less money than ever. Physicians, too, are seeing fewer patients and are more available than ever before to consider clinical trials for their patients, so establishing a physician referral campaign is more efficient than ever.
Waiting until sites reopen to resume recruitment efforts will only increase the burden sites will face once they reopen. Investing in a Catalyst Campaign now will position you as sponsor of choice, helping ensure sites are ready to quickly enroll qualified patients for your study, even as the number of competitive trials grows.
How does it work?
A Catalyst Campaign directs patients to a study-specific website through digital ads and/or a physician referral network. Patients will be presented with qualifying information (or an IRB-approved prescreener, depending on the status of your trial), opt in for study communications, and leave their contact information. Within 48 hours, patients are contacted by phone and further qualified through a secondary screener. Patients that qualify will receive study-specific communications to keep them engaged until enrollment resumes. During this time, patients can also be assisted with proactively transferring their medical records to the study site, further reducing burden on the site. Once sites are ready to receive referrals, patients are contacted a final time to confirm qualifications remain intact. The highly qualified patients are then referred to a study site in their area, where they can be immediately scheduled for their screening visit.
Since sites face different obstacles depending on their geography and staff availability, a Catalyst Campaign can be adjusted over time and tailored to best support sites in specific areas at any given time.
Getting Enrollment Back on Schedule
Catalyst Campaigns prioritize the quality of patient referrals above all else. This ensures that once your sites are reactivated, they are provided with a list of patients who have undergone multiple thorough screenings. This saves sites time and gives your clinical trial an immediate enrollment boost, helping to close the gap created by your screening pause or delay.
Interested in learning more about how a Continuum Clinical Catalyst CampaignTM can help ensure your trial stays on track despite your enrollment pause or delay? Contact us!