Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications.

BACKGROUND: As clinical trial protocol designs become more complex and eligible patient populations narrow, it is becoming increasingly difficult to recruit participants and retain them for the duration of the trial. This study surveyed clinical trial participants to learn about the prevalence and impact of new technologies and other supportive solutions designed to improve patient engagement and retention. Patient perceptions of these convenience-enhancing solutions and how they have changed since our last study in 2017 were examined. METHODS: Based on 12,451 responses to a global online survey collected in 2019, we conducted an analysis of respondents who used convenience-enhancing solutions during their participation in a clinical trial. RESULTS: We found that the prevalence of convenience-enhancing solutions is increasing and that their use correlates with high ratings for clinical trial satisfaction, as well as with high ratings for care and attention received during the trial. CONCLUSIONS: A wide range of strategies and tactics are needed to reduce barriers to participation and improve retention. The use of convenience-enhancing solutions can help reduce these barriers. The solutions are also particularly popular among under-represented populations, revealing further potential opportunities to increase patient engagement specifically among these groups.

Establishing Consensus Understanding of the Barriers to Drug Development in Lupus.

OBJECTIVE: Due to the extreme heterogeneity of lupus and the lack of consensus among stakeholders, pharmaceutical and biotechnology companies have had limited success in developing treatments for lupus. For this reason, the Lupus Foundation of America (LFA), researchers at the Center for the Study of Drug Development at Tufts University School of Medicine (Tufts CSDD) and an advisory committee of 13 international lupus experts collaborated to launch the Addressing Lupus Pillars for Health Advancement (ALPHA) project. METHODS: To inform the ALPHA project, 17 in-depth interviews among lupus experts and a global survey among lupus drug development and clinical care professionals was conducted to identify, characterize, and prioritize fundamental barriers and validate findings. RESULTS: The global survey received 127 responses from experts across 20 countries. Results of the in-depth interviews and the survey findings were consistent. Top barriers to developing new medical treatments for lupus included the lack of a clear definition of the disease with respondents identifying 30 autoimmune conditions that may be lupus-related; lack of predictive biomarkers; flaws in clinical trial designs; and a lack of reliable outcome measures. CONCLUSION: The study findings encourage drug development professionals to validate disease-specific measures and to identify if specific symptoms are caused by lupus. This original research also provides a methodology that can be applied to highly heterogenous diseases where low consensus on diagnosis and treatment exists among drug development and health professionals.