PPD proposes finding patients first, activating sites second

PPD credited the process for completing subject randomization three months early in three phase 3 cardiovascular studies conducted for The Medicines Company. (Pixabay)

PPD unveiled a new patient enrollment model, dubbed PatientAdvantage, which uses big data to identify eligible patients and then connect them with possible study sites, inverting the traditional steps of clinical trial delivery.

“Biopharmaceutical companies typically have used a model that focuses on identifying and starting up sites that are expected to have access to patients with the relevant indication for the trial,” said Roger Smith, senior VP and general manager of PPD’s enrollment solutions.

“Instead of that traditional site-first approach, PatientAdvantage enables us to start by rapidly enrolling community-based patients from our proprietary databases and modeling. Then, after mapping patient locations, we select sites to match patient-rich populations,” Smith said. “This patient-centric solution is highly predictive and yields greater enrollment and budget certainty.”

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PPD cited the use of its model in three phase 3 studies the CRO conducted for The Medicines Company, evaluating inclisiran and its effects on lowering LDL cholesterol. The studies enrolled patients with atherosclerotic cardiovascular disease or equivalent risk as well as homozygous or heterozygous familial hypercholesterolemia.

Subject randomization was completed nearly three months early, PPD said, with tasks between receiving the first protocol and the first site being activated taking 64% less time than the industry standard. Other benchmarks, such as first-to-last site activation, and first-to-last subject randomization, were both completed over 70% faster.

RELATED: PPD to run ‘patient concierge’ trial service

“This achievement is unprecedented and vitally important to the future of cardiovascular drug development,” said Peter Wijngaard, executive VP and chief development officer of The Medicines Company. “There are few places in the clinical trial process where time can be saved and value created.”

PPD and its patient recruitment business unit, Acurian, launched a “patient concierge” service earlier this year in an effort to boost trial enrollment and retention. The program proactively guides participants for the duration of a clinical study and manages their logistics, including appointment and medication reminders, device training, transportation and reimbursement support.