A new report from Gates Ventures and the Schaeffer Center for Health Policy & Economics at the University of Southern California has identified seven key barriers hindering clinical trials in Alzheimer’s disease (AD). Aiming to understand the patient journey to and through a typical AD clinical trial, the report is based on interviews with 60 stakeholders and quantitative survey results from nearly 900 US-based respondents, including patients, caregivers, clinicians and researchers.
Co-authored by the Director of the Schaeffer Center, Gates Ventures and IQVIA, the report shows that Alzheimer’s disease (AD) clinical trials are generally more complex, costly and slower than trials for other conditions. In part, this is due to higher screen failure rates, particularly for trials on prodromal AD (78% failure rate) or preclinical AD (88%): screening procedures for these conditions are time-consuming and costly, making it hard for study sites to recruit eligible participants. Moreover, AD trials often last longer than trials for other conditions, and the tests involved in monitoring participants during these trials can be extremely expensive (e.g $8,000 for a PET scan in the US).
Barriers to AD clinical trial participation identified in the report include personal aspects such as limited awareness of early AD, and fear of an AD diagnosis due to stigma. AD patients in the US healthcare ecosystem find that these systems are often overstretched; that doctors may not diagnose AD until symptoms are more severe; that the lack of treatment options reduces the number of doctors perceiving a benefit from screening for AD; and that mild AD is often diagnosed using a process of elimination, due to the lack of inexpensive diagnostics. For example, an estimated 65% of patients who undergo amyloid imaging tests pay for these tests out of their own pockets. The final barrier identified in the report is limited awareness of AD clinical trials; many healthcare providers lack reliable, accessible information on clinical trials and how to refer their patients to them.
