Expert panel identifies critical challenges in recruiting study participants

Expert panel identifies critical challenges in recruiting study participants

Unless a cure is found, Alzheimer's dementia is expected to affect nearly 13 million Americans by 2050 - placing an overwhelming burden on families, caregivers and our health care system. However, only one new therapeutic agent, aducanumab, has come to market in the last 20 years, and therapeutic progress is hampered for several reasons: recruiting subjects for clinical trials in Alzheimer's is more difficult than in other disease areas, the trials are longer and they are more expensive. The success of Alzheimer's disease clinical trials will require a significant increase in the number of qualified volunteers from diverse backgrounds in the coming years.

To develop solutions to overcome some of the biggest hurdles in recruiting, the USC Schaeffer Center for Health Policy & Economics and the Alzheimer's Therapeutic Research Institute (ATRI) partnered with Gates Ventures to bring together more than 35 experts from the private and public sectors. The advisory board was chaired by Julie Zissimopoulos, Paul Aisen and Jessica Langbaum. A paper published in Alzheimer's & Dementia identifies actionable and integrative solutions to accelerate the development of novel therapies for Alzheimer's disease that emerged from the panel.

The biggest barriers to more efficient Alzheimer’s clinical trials are those that discourage potential volunteers from participating in the first place.”

Julie Zissimopoulos, Co-Director, Program on Aging and Cognition, Schaeffer Center for Health Policy & Economics, University of Southern California

“Reducing these barriers to support progress in Alzheimer’s treatments – even modest progress – would have a profound impact on the communities affected by this disease.”

Barriers limit access

“There is no answer,” says Aisen, who leads ATRI and oversees many clinical trials. "These issues need to be addressed from multiple angles. However, recruitment is the biggest bottleneck."

Current models prevent approximately 99% of eligible volunteers from being referred to a study or considering study enrollment. Black and Latino people are particularly underrepresented, despite being at higher risk of Alzheimer's disease than white Americans.

Even if a patient is referred to a clinical trial and is considering participation, additional barriers exist. Most participants do not meet screening criteria, resulting in screen failure rates of up to 88%. In addition, some of these exclusion criteria - such as: B. chronic illnesses such as cardiovascular disease – lead to different population groups being disproportionately screened out.

“We need to increase enrollment of diverse populations in Alzheimer’s clinical research,” says Langbaum, co-director of the Alzheimer’s Prevention Initiative led by the Banner Alzheimer’s Institute. "These communities are disproportionately affected by the disease, and we can learn more about the disease and how best to detect, treat and prevent it by having diverse representation in trials. But to do so we must address the unique logistical, financial and trust barriers that prevent diverse populations from participating in Alzheimer's research."

Overall strategies

The expert panel met over the course of a year to identify the critical challenges and potential solutions that are scalable and most likely to turn the tide.

“By bringing together a large, diverse group of thought leaders and stakeholders from research, industry, policy and philanthropy, we fostered conversations that would normally occur in silos, resulting in a range of unique and impactful ideas that address bottlenecks in Alzheimer's studies,” says Desi Peneva, the research director at the Schaeffer Center who led the project Advisory board chaired.

The panel's suggestions include:

• Ausweitung der kognitiven Screening- und Früherkennungsbemühungen sowohl bei asymptomatischen Erwachsenen als auch bei solchen, die frühe Symptome der Alzheimer-Krankheit zeigen.
• Entwicklung besserer Instrumente für Primärversorger zur Identifizierung von Risikogruppen unter Berücksichtigung der Tatsache, dass die Krankheit Jahrzehnte vor dem Auftreten von Symptomen beginnt.
• Änderung der Zahlungsmodelle, z. B. Ausweitung der Medicare-Erstattung, um frühere Diagnosen und Überweisungen zu klinischen Studien zu fördern.
• Ausweitung der Verwendung von blutbasierten Biomarkern für die Alzheimer-Erkennung.
• Sensibilisierung der Öffentlichkeit und Reichweite mit maßgeschneiderten Botschaften, um verschiedene Gemeinschaften einzubeziehen.
• Skalieren der klinischen Studienarchitektur, um Alzheimer-Studien in verschiedene Gemeinschaften zu bringen, indem die Satellitenstandorte der Gesundheitssysteme, mobile Einheiten für klinische Studien oder lokale Netzwerke von Diagnosekliniken genutzt werden.
• Verwenden von digitalem Engagement und einem Screen-Fail-Register, um die Informationen der Teilnehmer über mehrere Studien hinweg auszutauschen, da ein potenzieller Teilnehmer, der das Screening für eine Studie nicht besteht, für andere Studien gut geeignet sein könnte.
• Durchführung virtueller klinischer Studien gegebenenfalls um die Reise- und Zeitbelastung für die Studienteilnehmer zu verringern; obwohl einigen Patienten ein Internetzugang zur Verfügung gestellt werden müsste, um einen gerechten Zugang zu gewährleisten.

Implementation of some of these strategies is already underway. The Schaeffer Center and ATRI are leading the new Clinical Trial Recruitment Lab, which opened earlier this year and aims to test and evaluate innovative solutions that have the potential to increase access to clinical trials and reduce disparities.

Source:

University of Southern California

.