The White House Office of Science & Technology Policy (OSTP) convened a listening session January 11. This webinar focused on the need for a coordinated clinical trials enterprise, one that can quickly characterize emerging viral threats and evaluate the effectiveness of vaccines, therapeutics, and other countermeasures across a diversity of trial participants.
Curebase’s mission is to bring quality medical innovations to patients faster and improve human well-being through more efficient clinical studies. The company is proving that clinical research can be radically accelerated if physicians are empowered everywhere to enroll patients in the communities where they live. By applying cutting-edge clinical software and remote study management techniques to the problem, Curebase is reinventing clinical trials and research from the ground up.
Pharma Mirror Interviewed Jane Myles —
From your perspective, what were the most important takeaways from the White House listening session?
The opportunity to listen to leaders in this space and be viewed as an entity working to optimize data capture for clinical trials and make these studies accessible to more people and clinicians – no matter where they are located – was awesome.
It also is significant that these challenges are being discussed at such a high level. Coordination and collaboration with stakeholders across the healthcare ecosystem is critical if we are to make progress, so this type of dialogue is essential. Still, while these types of high-profile summits are a great way to highlight important issues, they should be seen as only a first step; the real work of optimizing data capture and expanding clinical trials is ongoing.
You participated in the “aggregating and analyzing clinical trial data” portion of the webinar. How can we get participants to share data?
Before we can get clinical trial participants to share their data, we must ensure that they are willing to share their data, either from their health records or through their physicians who are participating in a clinical trial.
First, it’s crucial to design with the end in mind so we reduce friction during the data collection process. We need to keep protocols and data collection platforms as simple and intuitive as possible.
Even before that, though, we need to address transparency and make sure what we’re doing isn’t transactional. It’s time for us to establish a new understanding across the public domain of how clinical trials can enable the public health future we want together. If we work only on the technology side and ignore the human element, I don’t think we’ll reach our end goal.
By simplifying the process and increasing transparency, we can gain access to more data, allowing us to expand clinical protocols. Further, this will enable us to push data back to patients. To access more data and expand clinical protocols, however, we need to have standards in place and know the data is going to meet our criteria.
What measures can be taken to put patients at the center of clinical trials?
Putting patients at the center of clinical trials can’t be done with technology alone. We need general public education and awareness of the role science plays in public health and how clinical trials enable a different public health outcome. This will help give us a willing pool of participants who trust the process and who can benefit from being part of it, as can society.
We also need to find ways of involving physicians at the community level in research. That’s a huge challenge, and one in which decentralized clinical trials can play a major role. But again, if we don’t work on the human side while we’re addressing the tech interoperability challenges, we’re not going to succeed in putting patients at the center of these studies.
What public health advantages result from a successful clinical trial continuum?
Expanding access to clinical trials and streamlining the process for patients, practices, and sponsors would go a long way toward increasing health equity because they would allow traditionally underserved populations to participate in research. Health equity is the underlying goal of the entire Office of the National Coordinator for Health Information Technology (ONC) mission. Access and equity are built into all the work they are doing.
An improved and more inclusive clinical trial continuum also would enable us to respond more rapidly to public health crises such as pandemics because we would have in place an infrastructure for testing vaccines and other treatments on a broader population.
Finally, a more efficient and equitable clinical trial infrastructure will help get safe and effective treatments to individuals and populations faster. That alone should improve patient and population outcomes while helping to reduce healthcare costs.