The Elusive COVID-19 Patient: Subject Recruitment Remains Challenging Despite Increasing Case Numbers

According to the World Health Organization and clinicaltrials.gov, more than 3,000 studies for COVID-19 were registered globally as of August 17, ranging from observational to randomized controlled trials.
3000+
studies for COVID-19 registered globally
With over 21.5 million confirmed cases worldwide (August 17), it would seem safe to assume that there are enough patients to support all trials.
21.5M+
confirmed COVID-19 cases worldwide
However, FHI Clinical has found that our sponsors and our own teams face a number of challenges to patient recruitment in COVID-19 trials, which include:
  • Overwhelmed hospitals can experience challenges participating in trials while also caring for a large influx of COVID-19 patients
  • Patient location and status can change rapidly
  • Restrictive protocol criteria can limit the potential patient pool
Read on to learn more about these limitations and how FHI Clinical is working with sponsors to develop strategies to address them.
Overwhelmed hospitals
For our COVID-19 trials, we’re working with the sponsors to increase awareness of their trials (with both patients and physicians) when there are multiple competing protocols. Also, during the site selection phase, we’re helping to identify sites that don’t have competing trials or that have implemented systems that could expedite approval as well as patient recruitment.
As hospital beds in hot spots in the United States fill quickly, hospitals and their staff can be overwhelmed by increasing COVID-19 patient numbers. When those hospitals are also functioning as clinical sites conducting COVID-19 research, the hospital staff must balance patient care with research. The situation can become more complex at sites that are executing multiple protocols, each with its own patient inclusion/exclusion criteria. For example, in some of our studies, we are working with sites that are active hospitals and have up to 12 active COVID-19 trials at their location. In these situations, while balancing the demands of ongoing care and treatment of patients, the better-known trials can be top of mind for both physicians and patients, resulting in a greater likelihood that patients will be recruited to those studies.
Some hospitals have taken these competing priorities into consideration and established centralized scientific review committees to evaluate and prioritize incoming trial requests. The decisions may be based on the scientific merit of the studies, how best to utilize existing resources and the logistical challenges of enrolling patients across multiple trials. Another benefit is that a coordinated, centralized effort for patient recruitment effectively transfers the burden from individual clinicians to a study management team that can match patients to the best protocol.
Rapid changes
We also need to take geography into consideration, with some sites currently in hot spots and some in areas that have not yet emerged as a hot spot. To address this issue, FHI Clinical is proactively selecting sites beyond those in current outbreak areas to help ensure a steady source of eligible patients.
Because the situation is rapidly changing, by the time IRB approvals and site training are completed, the disease may be under control at a site that was previously overwhelmed with patients, meaning that patients are no longer available.
Restrictive protocols
FHI Clinical project teams review and make recommendations for a protocol’s inclusion/exclusion criteria and equipment requirements when initiating a contract with a sponsor, because our experience has taught us that early protocol revisions contribute to success by preventing delays for amendments later.

Critical evaluation of the protocol early in the study will also identify if the inclusion criteria are too restrictive, proactively avoiding mid-study protocol amendments. For example, a study seeking hospital in-patients with a high oxygen saturation is unlikely to find them, as the national protocol for treating COVID-19 recommends primary care first and hospitalization only for more severe cases. Some protocols may require equipment that is not available at most sites; then, there should be up-front consideration for supplying that equipment or filling gaps (e.g., lack of cold storage for samples), potentially through third-party vendors.

Even when a study is ongoing, it’s not too late to address site selection and recruitment to ensure the success of a program. Our clinical teams use their experience from other disease outbreaks worldwide to inform the strategies for patient recruitment in ongoing COVID-19 trials. Download our brochure to learn more about our COVID-19 services.

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Lucas Tina, MD, MPH; VIBRI and KEMRI

Dr. Lucas Tina is affiliated with the Victoria Biomedical Research Institute (VIBRI) and Kenya Medical Research Institute (KEMRI) in Kisumu, Kenya. Dr. Tina serves as a Scientific Advisory Expert for FHI Clinical, and VIBRI and KEMRI are listed in FHI Clinical’s database of research sites.

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