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T-24: Should I Stay or Should I go? A Comparison of Primary and Secondary Research on Clinical Trial Retention

Poster Presenter

Christina Cantrell

Senior Patient Insights Leader
Genentech, A Member of the Roche Group
United States

Objectives

The objective of this research was to understand which clinical trial characteristics may be associated with high patient retention or dropout in specific disease areas and generally across clinical trials.

Method

Patient retention literature in oncology and non-oncology disease areas (2003-2017) was reviewed and compared to feedback from patient advisory boards for Advanced Macular Degeneration (AMD), Autism Spectrum Disorder (ASD), and Rheumatoid Arthritis (RA) (2017-2018).

Results

The specific results reported in the reviewed literature and patient advisory boards were grouped based on similarity into the categories. The most frequently reported (three times or more) trial characteristics associated with high retention in the literature were in the categories of Effective and continuous communication (5), Appropriate incentives and support at sites (4), Flexible study visits (4), Perceived benefit to participant (3), and Trust (3). Based on the patient advisory boards, the most frequently reported (three times or more) trial characteristics associated with high retention were in the categories of Effective and continuous communication (5), Appropriate incentives and support at sites (5), Flexible study visits (5), Perceived benefit to other patients (4), Access to progress reports and study results (4), Clear rationale explained for assessments (4), Expressions of appreciation and recognition (3), Trust (3), and 24-hour support (3). Of these most frequently reported categories from patient advisory boards, only Appropriate incentives and support at sites, Flexible study visits, and Expressions of appreciation and recognition were in common for all three therapeutic areas (AMD, ASD, and RA). The most frequently reported (three times or more) trial characteristics associated with dropout or low retention in the literature were in the categories of Complications or side effects (6), Discomfort or inconvenience of study visits (3), and Severe baseline illness or disability (3). Based on the patient advisory boards, the most frequently reported (three times or more) trial characteristics associated with dropout or low retention were in the categories of Discomfort or inconvenience of study visits (4), and Negative experiences with site staff (3). Of these most frequently reported categories from patient advisory boards, only Discomfort or inconvenience of study visits was in common for all three therapeutic areas.

Conclusion

This work is a step in understanding clinical trial retention rates and relationships between published data and primary reports from patients. As clinical development timelines shorten and regulators seek greater patient input into drug development and trial design, it is essential to consider feedback from patients as described in the literature and directly by patients. Findings demonstrate that patient input may improve retention rates and trial success. The most frequently reported characteristics promoting patient retention and the most common reasons for clinical trial dropout in clinical trials are were cited both in literature and by patients. However, important perspectives raised by advisory board participants were not described in prominent literature. Information from patients included the desire for updates on personal and study outcomes and clearly explained assessment rationale, and potential for dropout due to negative staff experiences. There is also a notable absence of caregiver preference in published data regarding patient retention, yet the advisory board reports emphasize the importance of caregiver experience in clinical trial retention. Further research into patient and caregiver preferences is necessary to address gaps in the current literature. In addition, this research highlights the importance of considering different clinical trial design by therapeutic area, patient population, or other specifications of the protocol. For example, negative experiences with site staff was a factor for dropout for both RA and ASD patients, but for RA patients this was specifically related to lack of empathy from staff whereas for ASD patients this was more related to a violation of set expectations. Further clinical trial design research including both patients and caregivers specific to each population is necessary to address gaps in the current literature and ensure clinical trial designs address patient and caregiver needs and preferences.