“The Korean pharmaceutical industry has been accelerating investments in open innovation and focusing on R&D for entry into overseas markets,” says Deborah Chee, president, Korean National Enterprise for Clinical Trials.
Having a highly-qualified clinical site participating in a trial can be a blessing to any operations person. Sites interact with patients, help pharma test new therapies, and provide reliable data that leads to regulatory approval. When evaluating sites, how can you tell which ones will over-perform and which will leave you wishing you had passed on them altogether?
This is part two of a three-part series that will look at how the industry is changing its perspective on patient recruitment. Maura Snyder, director of Clinical Insights and Experience at Janssen, shares some of her thoughts on the recruitment challenge and what pharma must do to overcome it.
A clinical trial transformation is currently underway at Eli Lilly and Company. Three years ago, it was taking the company an average of over 10 years to go from first patient dosed to actual product launch, and the time it took to simply enroll patients in trials was averaging four years. The situation had to change.
Thirty years ago, patient recruitment was a challenge for pharma companies. Today the patient participation rate in trials still hovers around five percent and is not expected to improve anytime soon. Mary Rose Keller, VP of Clinical Operations at Heron Therapeutics, shares some of her thoughts on the recruitment challenge and what pharma must do to overcome it.
Many patients who suffer from cardiovascular, renal and metabolic (CVRM) diseases face not one, but several overlapping co-morbidities that can critically impact quality of life and overall health. AstraZeneca is bringing renal into focus, by developing CVRM medicines that attempt to both answer important clinical questions and put patients’ needs first.
In 2015, Vivli was launched as a centralized platform for those willing and able to share data. Vivli gained 501(c)(3) status, formed its executive leadership team, and held its first board meeting in 2017. That is the same year it began constructing a data sharing platform and research environment.
“The key to fully understanding the safety and efficacy of new medical and device therapies is developing clinical trial databases that adequately reflect the diversity of the U.S. population.”
“Being inspection-ready means making sure the TMF is up to speed,” says Brent Sorrells, director of clinical operations for Allakos. “During a preapproval inspection in 2015, we learned quite a few things. The FDA inspector followed the BIMO guidance to a T. One of the primary things I learned is that we were not as organized as we had thought, even though we had done a dry run of an inspection after our NDA filing.”
As the Otsuka VP of Applied Innovation and Process Improvement, Debbie Profit spends a lot of her time thinking about the future of clinical trials. “There are changes occurring in the industry that will force clinical development executives to shift their mindset,” says Profit. “I am trying to understand what clinical trial sites will look like going forward.”
