Thursday, October 6, 2016

Patients as a partner in Aspirin clinical research

Technology is putting more power into the hands of patients and clinical trial recruitment is no different.

One of the first sessions of Partnerships in Clinical Trials US heard how virtual trials, personalized patient data and the use of electronic health records (EHR) are part of pioneering efforts in patient recruitment. Lisa Berdan, a Director of Duke Clinical Research Institute shared early progress in the ADAPTABLE Aspirin Study, which compares the effectiveness of two daily doses of aspirin to prevent heart attacks and strokes in individuals living with heart disease. The study is the first project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network, to improve the US’s capacity in clinical research.

Delegates heard how patients had been involved at every step of the trial, from design to including patient representatives on the executive and data & safety committees.

“Patients are a partner all the way”

20,000 patients are being enrolled in ADAPTABLE to compare two common doses of aspirin: a regular strength 325mg pill or a low-dose version of 81mg. A network of academic sites is using EHRs to find patients who might be suitable and patients give consent remotely to take part. It’s early days but lessons learned from such a vast enterprise could set the standards for many more virtual trials to come. Melanie Goodwin, Senior Manager of Patient Recruitment Planning at ICON showed how the rapid uptake of technology, including mobile phone use, meant that contract research organizations (CROs) like ICON had powerful new tools to consider.

However, she added a word of caution: “There is a role for technology in clinical trials but let’s keep the patient in mind and make sure it works for them. Technology shouldn’t overburden patients or the trial site.”

Early patient profiling was key in making sure the right choices were made in how best to reach patients, according to ICON. That included a typical patient’s environment, lifestyle and logistics. The site’s experience in the therapeutic area was also important – could the site have a bigger role in the patient’s continuum of care? Finally, Ryan Norris Chief Technology Officer of Be The Partner told of early efforts to give patients their individual data from a clinical trial. Sharing data and the trial results can make a big difference to a patient’s willingness to take part.

In fact, 91% of patients have reported that they would not take part in clinical research unless they received the findings, Ryan said.

Julie Walters is the founder of Raremark, which helps families affected by rare disease. She recently won Best Investment in a High-Growth Women Founder at the UK Business Angels Association. @julieannwalters

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