Innovation in Clinical Research in Times of COVID

One firm is exploring ways to allow mobile trials, providing services that act as a portal for both the patient and the researcher. COVID-19 has put a stop to the conventional model of conducting a clinical trial.

FREMONT, CA: The novelty of the coronavirus has led researchers in the U.S. to learn on the fly. They are all exploring the unknown today. So understanding what the site’s behavior is going to be and what patients will be interested in joining now or later is an adaptive learning process. Patient recruitment firms are also used to deal with this strategy, allowing them a valuable viewpoint on what steps should be taken to ensure that the trials generate patient participation.

As a patient recruitment company, they are used to understand the research sites are more likely to enroll patients and can do so in terms of personnel and resources and to adapt where appropriate. What one sees in some ways is a whole new problem, but it is something they are already grappling with, which is to figure out where they need to find patients to move research forward. Recruiting patients for COVID-19 requires a shift in thought from the industry.

COVID-19 poses a novel scenario in which the industry will continue to implement new approaches at any clinical trial level, from recruitment of patients to selection of samples. It is hard to figure out where creativity is going to happen in this vacuum.

It is unknown whether it is going to be lobbying, patient influencers, or optimizing recruitment? Thus, the industry will enhance creativity, where people work on mobile and virtual testing.

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One firm is exploring ways to allow mobile trials, providing services that act as a portal for both the patient and the researcher. COVID-19 has put a stop to the conventional model of conducting a clinical trial. Overall, there is stress when one has to go to the doctor’s office. Most of the time, because it is an investigational drug that one is not sure of its consequences, the risk of dropping out of the trial is [high]. The explanation for dropouts is twofold. People tend to avoid attending the sites for obvious reasons, and caregivers—often the children of older patients to avoid physical interaction with their parents.

The organization works with patients and researchers on three fronts: patient interaction, home visits, and data collection and analysis. Patients are found on the Internet, by social media and patient advocacy organizations, and they sign electronic informed consent forms and medical record authorization—mainly on-line recruitment and scheduling. They conduct home visits, collect and synthesize medical records and samples, and then send them to the researchers. They also store patient medical records through their trial match portal, allowing them the opportunity to connect patients to additional trials.