Easing the Clinical Trial Technology Burden on Patients and Sites

Measuring Site and Participant Frustration

While the pandemic drove the rapid adoption of DCT technologies, there is sparse evidence measuring the impact of these technologies on clinical research participants. It might be presumed that the lack of data standards and the plethora of disparate DCT technologies at the site level affect participant recruitment, retention, and compliance. The increase in DCT technology technologies has fundamentally affected how participants experience clinical trials.

Survey Recruitment

Clinical professionals we surveyed were mostly female (75%) and had an average of 14.8 years’ experience. They were diverse in age and clinic size. They worked directly for sites or CROs to support studies in cardiology, immunology, oncology, rheumatology, and women’s health.

How Participants Find a Study

CRCs were asked how participants ⁽¹⁾ find a trial, ⁽²⁾ why they enroll, and ⁽³⁾ why they drop out. They were unanimous on the first question, stating that all participants found their trial by physician referral. Some mentioned in-clinic advertisements and external promotions. One described how oncology participants had registered on the NCI or NIH websites.When asked why their participants enroll, 75% stated that participants enroll to seek the newest treatment; 50% claimed patient altruism. The reasons patients dropped out of a trial: 50% cited Adverse Events (AE) and 28% said when participants do not randomize to the new therapy.

Frustration Scoring

Each clinical professional ranked the clinical processes of interest on a scale of 1-5 in terms of experienced or perceived frustration, where 1 represented the least frustrating and 5 indicated the most frustrating.

Recommended Methods to Ease the Patient Burden

While conveying their frustration levels, CRCs also proposed numerous mechanisms for mitigating these burdens.

In the screening and scheduling function, they suggested that technologies might enable participants to gain a better understanding of the protocol, the study drug, and study logistics. Augmenting manual screening and scheduling technologies with visual aids such as a study portal displaying relevant information may help participants consume study activity information more easily. CRCs also noted that information from very long consent documents is especially difficult for participants to consume. They recommended supplementary learning materials that give participants summarized, smaller amounts of information ahead of consenting so they are better prepared to absorb information once the formal consenting process begins.

Interviewees suggested that eConsent also could likely mitigate participant frustration. In some instances, CRCs said an adaptive approach that seamlessly enables both paper and electronic consent based on participant preference would be ideal.

In the travel logistics for appointments function, respondents recommended having the study (or study technology platform) schedule/provide transportation for participants to diminish frustration.

Recommended Methods to Relieve the Site Burden

Regarding scheduling and labs, CRCs suggested organizational templates to manage study logistics and expectations. They reported difficulty managing participant-specific activities, lab requirements, and timing across multiple studies, especially when left to the site to interpret from the protocol. Materials that explicitly and sufficiently detail activities at given time points, anchored to pertinent dates, would help reduce errors caused when interpreting unclear protocol descriptions. It was also recommended to share patient-friendly versions of organizational and informational materials to help communicate timelines, expectations, and what would occur during lab visits. CRCs saw the potential for educational material to minimize fatigue-driven disengagement they observed in participants overloaded with information.

In the return-visits function, several CRCs communicated they have anecdotally observed that the recent increased use of home health visits has led to a decreased burden on patients and lab staff. They recommended expanded use for visits that only include lab/vital collection.

It was also suggested that study technologies be streamlined into one platform experience instead of disparate DCT technologies at the site, requiring multiple logins that result in a cumbersome experience. Ideally, the platform would enable efficient data editing without starting over.

Multiple respondents reported frustration with having no formal mechanism to provide feedback to sponsors regarding the feasibility of study activities. CRCs saw this burdensome logistical requirement across studies. CRCs expect if sponsors/CROs adopted feedback from CRCs, research nurses, and general site staff, it would ultimately ease trial burdens for sites and patients.

Notably, CRCs consistently commented that early initial investment on the part of the site staff had meaningful impacts on participant frustration in later study activities. CRCs noted they spent a considerable portion of their overall study time preparing for labs, initial appointment logistics, and first visits with the ultimate intention of decreasing the time and complexity during participants’ early study activities (see Figure 3).

Effort investment during this time, as well as learned process familiarity during repeated activities (e.g., reconsents and follow-up visits) anecdotally led to participants appearing less frustrated and visits going more smoothly. We recommend that the industry support site staff and participants alike by generating novel solutions that ⁽¹⁾ ease the burden of site staff during these complex early processes and ⁽²⁾ provide concise, intuitive, and supplementary educational aids to help participants understand clinical trial expectations earlier in their participation, without requiring experience to comprehend study activities fully.

Conclusions

Based on our research, the most constructive recommendation captured for mitigating frustration among site staff and patients is for all parties is to streamline study technologies into one adaptive platform experience instead of using disparate DCT technologies at the site.

Allison Barnard, Product Owner, ClinOne abarnard@clinone.com; along with Brian Ongioni, VP of Product Development, ClinOne, bongioni@clinone.com; Chris Hall, President of Chris Hall & Associates, hallmarketing2018@gmail.com; David Swanger, Adjunct Professor, Daniels College of Business at the University of Denver, david.swanger@du.edu