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Research Consortium Expands Clinical Trial Access, Participation

Six regional health systems have founded a nonprofit research consortium to increase clinical trial access and participation.

Research consortium expands clinical trial access and participation

Source: Thinkstock

By Jessica Kent

- Geisinger is one of six regional health systems announcing the founding of Partners in Innovation, Education, and Research (PIER Consortium), a streamlined clinical trial system that will expand clinical trial access and participation for individuals in New Jersey and Pennsylvania.

Geisinger joins Atlantic Health System, Drexel University, Einstein Healthcare Network, Main Line Health, and Thomas Jefferson University as founding members.

“The concept for creating a world-class, collaborative, clinical research network of regional health institutions began in 2013,” said David Whellan, MD, PIER COO and Senior Associate Provost for Clinical Research at Jefferson University.

“Our vision is to advance patient care in the moment and improve quality of life and outcomes in the future.”

Clinical trials have traditionally taken place at academic medical centers and through affiliated hospitals to ensure patients receive the highest standard of care.

However, this often means that patients must travel long distances to take part in clinical trials and receive novel treatment, a factor that can severely deter patients from participating.

Failing to recruit enough participants can also slow the clinical trial process, making it more difficult to verify that a new treatment will benefit patients.

“It can take decades to prove a medication or other treatment is safe and effective for a particular disease, which can be too late for many patients seeking treatment,” said Whellan.

The PIER Consortium aims to bring clinical trial sites to larger numbers of patients, while also bringing new treatments to market faster.

The consortium’s broad network of physicians and researchers will accelerate the clinical trial process and deliver effective therapies to patients sooner. Having contracts in place and physicians identified will allow trials to both start and reach participant capacity more quickly.

Members of the PIER Consortium will share their expertise across clinical trial sites, enabling researchers to enroll more patients and streamline the clinical trial process across institutions. This will create a more effective method for patients, trial sponsors, and researchers.

The PIER Consortium is one of many efforts aiming to increase patient engagement and participation in regulatory processes.

In January 2018, the FDA sought members for its Patient Engagement Collaborative (PEC), who would discuss how to improve patient engagement in medical product development, clinical trials, and precision medicine.

By incorporating the perspectives of patients, caregivers, and representatives from patient groups, the FDA would better understand how to enhance patient participation in processes that will ultimately improve health outcomes.

The PEC is a joint endeavor between the FDA and the Clinical Trials Transformation Initiative (CTTI), an organization committed to increasing the quality and efficiency of clinical trials.

“The FDA is committed to collaborating with patients, caregivers, and advocates, as well as incorporating the various perspectives from these groups into the FDA’s regulatory decision-making processes,” wrote FDA officials Nina L. Hunter, PhD, and Rachel E. Sherman, MD, MPH, in an FDA blog post at the time.

The PIER Consortium will work to accomplish similar goals in engaging patients and researchers in clinical trials and increasing patient participation.

“Geisinger is pleased to participate in this consortium to expand our research network and the opportunities for clinical trial participation for our patients,” said James Brazeal, Geisinger Chief Administrative Research Officer.

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