Cartier Esham, EVP, ECS and SVP, Science and Regulatory at BIO, moderates a discussion on clinical trials during COVID-19, with:
- Jeff Allen, PhD, Executive Director, Friends of Cancer Research
- Ryan Fischer, Senior Vice President, Community Engagement, Parent Project Muscular Dystrophy
- Annie Kennedy, Chief of Policy and Advocacy, Everylife Foundation For Rare Diseases
- Sung Poblete, PhD, RN, Chief Executive Officer, Stand Up to Cancer
The Role of Data and Real-World Evidence (RWE)
“Real-World Evidence is based on the idea that information can be collected outside of a formally run clinical trial that can be informative to how the patients are benefitting or how the treatment is working – using all the data that is available,” explained BIO’s Cartier Esham.
Friends of Cancer Research’s Dr. Jeff Allen has been working with the Reagan-Udall Foundation on the COVID-19 Evidence Accelerator, which brings together different experts and data sources related to the use of RWE.
“The evidence accelerator, itself, is not a traditional clinical trial, but the information generated from this will hopefully inform the clinical trials about things such as treatment patterns and different populations and how they were affected by the first waves of COVID 19 and how treatment modalities have changed over time,” he said.
“In a pandemic, it’s important to catch data as it is coming in, analyze it across the country and across the globe as quickly as possible.”
Parent Project Muscular Dystrophy conducted a survey with the muscular dystrophy community to assess the impact of COVID-19.
“Like many disease communities, we were worried about COVID-19 impact on our patients including access to care, access to clinical trials, and access to newly approved therapies,” said Ryan Fischer.
“We’re almost getting to a true understanding of how we can bring the biotech revolution and merge that with the data technology revolution that has been occurring and start to think about building a paradigm that is more patient centric, more effective, and more informative,” said Esham.
“This is evolving. Some of the lessons remain to be seen. We are going to have to take time to evaluate from the patient’s perspective, from the physician’s perspective, and from industry about what worked and what didn’t,” said Dr. Allen.
“People’s risk tolerance plays a key role here. Not everybody is comfortable with the risks associated with going into a clinic vs. doing telemedicine. We still have a lot of work to do.”
“Our patient communities have learned to navigate technology in a whole new way,” said Everylife Foundation for Rare Diseases’ Annie Kennedy. For example, telehealth has allowed people to participate in clinical trials who otherwise would not have been able to.
Decentralized clinical trials allow “for greater enrollment and increased access for our patients, which addressed one of the biggest barriers to health equity,” said Stand Up to Cancer’s CEO Dr. Sung Poblete.
“We found that patient satisfaction went through the roof and physicians appreciated extra communication with their oncologists and internists.”
“COVID has revealed many of the deficiencies of the healthcare systems and the inequities that remain,” concluded Allen.
“It has also revealed what can be done with some of these unnatural partnerships and collaborations. If nothing else, we’ve learned we’re all in this together and the best way to try and get out of it is to leverage each other’s strengths, mutual interests, and shared capabilities to find data from different sources and motivate each other to accelerate everything that we’ve been doing.”