Craig Lipset

The COVID-19 pandemic has created urgency for clinical trials to modernize and transform.  As the pandemic emerged, research teams scrambled to continue to support patients in need of access to investigational new medicines.  As we emerge from the pandemic, how do we take the best of the change and embed it to become the “new normal”?  How will clinical research in 2021 and beyond be faster and smarted as we get to the other side of the curve?

Craig Lipset pioneered the industry’s first fully in-home clinical trial for an investigational new drug over a decade ago.  Fueled by the urgency of a pandemic and powered by digital with the patient at the center, virtual and remote clinical trials are poised to become the “new normal”.  What will push this future over the finish line, and how will clinical research participation continue to evolve?

The history of clinical trials and medicine development has been defined by researchers and pharmaceutical companies, with patients relegated to the role of ‘subject’ (a term with roots based in “owing obedience” at worst and someone “being discussed” at best).  Patients were required to have patience, waiting for researchers to prioritize their unmet medical needs and invest in research and development for new treatments.

This presentation explores how today’s digitally-empowered and socially-organized patient is able to seize control over medical research and development, no longer needing to wait to be noticed.  From crowdfunding of research and venture philanthropy, to do-it-yourself biohacking online data sharing – today’s patients are positioned to own the research process.  What is the 21^st century role of the patient in medical R&D, and who may be displaced in the journey to this new future?

Clinical trials are essential to bring cutting-edge medical breakthroughs into the hands of physicians and patients.  Yet the tools being used for these trials have seen little evolution, shifting incrementally from “pen and paper” to “manual entry into web forms”.  With the proliferation and accessibility of digital tools – from social media to electronic health records, and mobile phones to wearable tech – clinical trials are on the cusp of a digital revolution.  How is digital shaping medicine development and what lies ahead?

In 1951, a tumor was biopsied from Henrietta Lacks.  Without her knowledge or consent cells from that biopsy were culture and immortalized as the HeLa cell line, and used by well-intentioned researchers to drive new cures albeit without respect and transparent to the patient who serve as the source.

Nearly 70 years later we are now poised to repeat the error of the past in the digital age, as patient data is accessed, shared, and monetized among researchers.  Despite being used by well-intentioned researchers, the patients serving as source for these data have no more awareness or respect than did Henrietta Lacks.  How do we redirect our efforts to ensure patients are included and engaged when their data is being used for good?