New paper on the affordances of clinical research participation
A conference blog about the 13th Clinical Trials on Alzheimer’s Disease (CTAD) conference which took online, from 4-7 November 2020, has been published on the AlzForum website. The article mentions EPAD and can be read below:
EPAD had been supported for five years by the Innovative Medicines Initiative (IMI), which is funded jointly by the European Union and the European pharmaceutical industry.
EPAD aimed to recruit, and deeply phenotype, thousands of potential clinical trial participants across Europe, and then to run side-by-side Phase 2 trials with a shared placebo group and a Bayesian adaptive design. By the time the five-year funding period ended, the cohort had more than 2,000 participants, each phenotyped for multiple cognitive measures, genetics, and CSF biomarkers, but, alas, no drug sponsors to run trials. “We had everything but a drug,” said Craig Ritchie of the University of Edinburgh, who headed EPAD.
Why did no would-be trial sponsor take the plunge? Failed Phase 1 trials were one reason, lack of internal funding another, plus companies hesitated to be the first to take a risk on this innovative platform design, Ritchie said. That there was no funding to maintain the trial-ready cohort as trials took off may have also given sponsors cold feet.
After the loss of IMI funding at the end of 2019, EPAD secured some funds from philanthropic sources to wrap up final study visits and to maintain the massive dataset for the cohort. Then COVID-19 hit, and follow-up visits were halted, too.
But all is not lost. The more than 2,000 participants enrolled in EPAD are “desperately keen” to join a clinical trial, Ritchie said. Around 300 of them are cognitively normal but have amyloid, making them perfect subjects for secondary prevention trials. To help them join trials, Ritchie said EPAD is partnering with organizations such as the Global Alzheimer’s Platform Network (GAP-Net), a U.S.-centered network of study sites that aims to boost the efficiency and quality of AD clinical trials. GAP-Net coordinates with TRC-PAD. And of course, participants will be eligible to join trials conducted within their own countries.
While EPAD will not realize its dream of running head-to-head proof-of-concept trials with multiple drugs, Richie hopes that the cohort will nevertheless find its way into clinical trials. Last but not least, the rich EPAD dataset is available to the neurodegenerative disease research community for analysis.
The article can be found here: https://www.alzforum.org/news/conference-coverage/trc-pad-funnel-finally-touches-down
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