According to a survey conducted by ERT, one of the primary issues that will impact trials over the next 6-12 months is patient recruitment and clinical trial enrollment. Therefore, it is vital that both trial sites and sponsors develop strategies that enhance patient engagement and interest.
To understand patient perspectives on clinical trial participation, especially during the COVID era, Covance fielded a survey from March 31, 2020 to April 2, 2020, with over 1500 participants across the United States and the United Kingdom. Prior to the pandemic, most participants were concerned about the potential adverse effects of taking study medications. Now, with the COVID crisis, participants are significantly more aware of or concerned about their overall health and well-being. This means that there is greater concern about exposure to coronavirus and visiting trial sites for visits. Results also showed that 74% of US respondents would likely participate in a virtual or hybrid trial, meaning travel and in-person interaction are significantly reduced, if not completely eliminated.
SubjectWell, a patient recruitment company, has also been surveying sites and patients throughout the pandemic and has conducted a total of three to date.
Across all three surveys, telehealth remained the top choice to increase the likelihood of participation in the coming months. Participants also indicated that they would be more likely to participate if studies had home visits that are conducted by qualified medical staff, used electronic diaries to collect data, had fewer office visits over the course of a trial and allowed them to collect and send lab samples from home.
Although the number of participants who said they are considering clinical research has continued to increase from mid-March to mid-May, it is important to remember that interest does not necessarily translate to participation.
With that in mind:
1) To Boost Patient Recruitment, Sponsors should…
- Modify study designs to include electronic/remote assessments so patients can complete more from the comfort of their own homes.
- Consider decreasing the number of on-site visits and rely more on virtual visits.
- Identify which study procedures are essential to each clinical trial and make others optional to participants.
2) To Boost Patient Recruitment, Research Sites should…
- Clearly communicate to patients what measures have been put into place to minimize their risk of exposure and prioritize their safety (i.e., COVID screening, temperature checks, increased sanitation, available PPE, waiting room restrictions, alternative methods for study visits).
- Explain to patients how site staff is being monitored for potential exposure/risk of COVID.
- Provide enhanced education to potential participants and current participants about the ongoing pandemic.
- Take advantage of high phone contact rates to grow your patient database and generate waiting lists.
- Continue identifying procedures and assessments that can be performed remotely, virtually, or by the patient themselves.
- Attempt to capture patient insights through follow-up calls or short surveys. By understanding patient thoughts and perspectives, sites can modify their operations accordingly and relay concerns to sponsors/monitors.