Over the past two years, the COVID-19 pandemic served as a focal point for the clinical trial landscape. However, many studies beyond the scope of coronavirus made major developments in the trial space, from Crohn’s disease to autoimmune diseases and Alzheimer’s. But in order to allow these trials to progress and provide the crucial data needed to make such strides, the industry needs to shift towards increasing patient-centric approaches to clinical trials.

Patient centricity allows the patient voice to be incorporated throughout the clinical trial process. Some initial steps in exploring this method include hosting focus groups, conducting live protocol simulations, working with patient advocacy organizations, and analyzing real-world data. By incorporating the patient perspective into each stage of the process, sponsors would increase enrollment as well as retention in clinical trials.

Clearing the obstacles for clinical trial engagement

Eliminating hurdles patients face while involved in clinical trials begins by considering the patient’s point of view in the earliest steps of the process, including location, eligibility, and accessibility. According to a study by Informa Pharma Intelligence and Rare Patient Voice, a major hindrance towards trial involvement is the distance of the study site, with over two-thirds of respondents having claimed they would be more likely to participate in a clinical trial study if they were able to find one at a nearby location. In addition to mere mileage, sponsors should take into account means of transportation and appointment times, which both play a pivotal role in narrowing the field of accessible trial sites.

The increase in trials across drug classes, most notably mRNA developments sparked by the COVID-19 pandemic, has been paralleled by the need for participants. The responsibility falls to sponsors to ensure there are sufficient pools of potential patients for trials during the site selection process. As the aforementioned study showed, nearly half of the respondents were unable to locate a trial within a suitable distance pertaining to their disease or condition. Feasibility studies can also be utilized in order to confirm not only that there are suitable participants in nearby locations but also that studies won’t be competing for the same target patient pools.

Decentralization is another essential aspect of enrollment to expand inclusion in clinical trials. This can be achieved through multiple channels such as including telehealth visits and measuring patient outcomes via mobile devices and trackers as opposed to during visits on location. By creating opportunities for patients to participate in remote settings, decentralized clinical trials allow patients who are located at a distance from the study site to still take part in the process. This also enables organizers to expand the cohort of participants and drive the inclusion of underrepresented parties in medical research, enhancing the quality of the results and providing a better representation of how the intervention will perform in the real world.

Education is a key component in increasing enrollment

As the world continues to shift towards a digital-first approach, sponsors need to evolve and update websites accordingly, creating sites that are patient-friendly in terms of navigation and content. Information provided on the sites must be easily digestible among diverse populations, including translations to ensure accessibility for visitors who are visually and/or hearing impaired as well as those with other disabilities.

Patients must be provided a resource to seek out enrollment opportunities. According to the previously mentioned Clinical Trial Participants Survey, only 23% of respondents who were included in clinical trials used ClinicalTrials.gov as their source of information.

With internet searches resulting in a clear lack of packaged information around clinical trials, platforms such as Informa Pharma Intelligence’s Citeline Connect provide a meaningful solution for providers to jump-start the enrollment process with a robust search engine function, location services such as map plug-in features, and prescreening surveys to help patients self-screen, minimizing the burden on overworked and understaffed trial sites.

Elevating the patient experience through communication

Maintaining a constant line of communication before, during and after the clinical trial process is crucial in creating a positive patient experience. A key factor in confirming enrollment is following up with patients who show initial interest. Waiting weeks, if not longer, to respond to patients who are willing to commit not only decreases the odds of involvement but damages the patient relationship moving forward, creating a sense of unreliability.

The next step in securing positive patient feedback is providing a speedy and streamlined enrollment process. Citeline Connect is the industry’s only all-in-one clinical trial recruitment platform for clinical trial education, recruitment and enrollment. Allowing for easy connection between sponsors and eligible participants is likely to incite both repeat and recommended participation by previous patients. We see this reflected in the Clinical Trial Participants Survey results where 87% of participants said they were likely to participate in another clinical trial, and 84% said they would recommend participation to others.

As for how often participants should receive progress reports during the study, there is no formula and communication is likely to vary among trials; however, weekly, biweekly, or even monthly intervals would suffice — but communication less than once a month is viewed as insufficient.

Data collection during clinical trials is only possible due to patient participation and, therefore, the patients should be prioritized in receiving study results. Despite the ongoing call for further transparency in clinical trial results, over 60% of respondents from the Clinical Trial Participants Survey did not receive the results from their studies and 64% found this to be of importance. This not only demonstrates the significance of continued communication beyond the trial, but also reveals that many patients have a vested and moral interest in the findings, which can play a role in their future involvement.

Despite an uptick in clinical trial research, there is an evident need for process restructure in order to maintain growing involvement. The incorporation of patient-centric approaches into clinical trials is essential to not only building better patient experiences but also eliminating barriers in the path to participation.

Citeline Connect, developed by Informa Pharma Intelligence, is the all-in-one clinical trial recruitment platform that accelerates trial enrollment via innovative technology and services. To learn more or request a demo, visit here.