Applied Clinical Trials
With the bevy of coronavirus-specific information, databases and trackers, registries, and other tools out there at the moment, the challenge in store is integrating these resources to help in both clinical care response and informing drug intervention in real-time.
There’s been quite an overwhelming amount of industry-specific information regarding COVID-19 the last few weeks. It appears there are a number of patient registries from specific medical associations, as well as others such as the LabCorp/Ciox Health patient data registry. There are companies offering de-identified data to support clinical care or clinical research decisions, including Ancestry and Cerner. There are clinical trials
service providers, including WCG and Bio-Optronics, offering internal benchmarking data on investigative sites, as well as investigative site survey data from Contiuum Clinical and Clinical SCORE. Consortiums have formed such as the COVID-19 Research Database, a secure repository of HIPAA-compliant, de-identified patient-level data sets, and EndPandemic National Data Consortium, with the goal of integrating data from all ongoing and future clinical studies to accelerate analysis on COVID-19 and SARS-CoV-2 research.
This list is not comprehensive.
Further, Jill Wechsler writes in this article, which as an aside lists even more websites that identify and track research on COVID therapies and vaccines-the many competing resources has led the NIH to form a broad public-private partnership to collaborate on prioritizing and coordinating research on COVID-19 drugs and vaccines.
And that’s where we are. When the dust settles we will have a bevy of COVID-19 clinical trials listing trackers, with patient recruitment matching capabilities, with a number of patient registries, and de-identified patient-level health data sets that don’t talk to each other? The industry has that now, it’s just not COVID-specific. On top of that, is the clear need for integrated real-world evidence to help with both clinical care response, as well as informing therapeutic intervention in real-time.
Our Closing Thought op-ed contributors, Ülo Palm, MD, PhD, senior vice president, digital sciences for
Allergan, and Iya Khalil, PhD, co-founder and CCO, GNS Healthcare, urge the use of AI to get to those more informed evidence and therapeutic decisions, not only in COVID, but moving forward as a whole in drug development. Co-founder and CEO Michelle Longmire, MD, of Medable, in our Q&A, envisions a way forward in drug development where decentralization of trials will lead to less expensive studies that can capture more long-term outcomes data, as well as increased participation, to boost innovation in therapies.
Clearly, we need change. Industry experts and observers have been saying that for years and many calling for disruption. Well, this is disruption. Is industry going to go back to its old ways, or will the pandemic result in lasting positive change?