Craig Lipset

Patient voice in clinical trial programs in industry. In: Girman CJ, Ritchey ME, editors. Pragmatic randomized clinical trials: using primary data collection and electronic health records. Academic Press, Elsevier; 2021.Chapter 5, p. 47-70.

Data silos are proliferating while research and development activity explode following genetic and immunological advances for many clinically described disorders with previously unknown etiologies. The latter event has inspired optimism in the patient, clinical, and research communities that disease-specific treatments are on the way. However, we fear the tendency of various stakeholders to balkanize databases in proprietary formats, driven by current economic and academic incentives, will… Show more

Data silos are proliferating while research and development activity explode following genetic and immunological advances for many clinically described disorders with previously unknown etiologies. The latter event has inspired optimism in the patient, clinical, and research communities that disease-specific treatments are on the way. However, we fear the tendency of various stakeholders to balkanize databases in proprietary formats, driven by current economic and academic incentives, will inevitably fragment the expanding knowledge base and undermine current and future research efforts to develop much-needed treatments. The proliferation of proprietary databases, compounded by a paucity of meaningful outcome measures and/or good natural history data, slows our ability to generate scalable solutions to benefit chronically underserved patient populations in ways that would translate to more common diseases. The current research and development landscape sets too many projects up for unnecessary failure, particularly in the rare disease sphere, and does a grave disservice to highly vulnerable patients. This system also encourages the collection of redundant data in uncoordinated parallel studies and registries to ultimately delay or deny potential treatments for ostensibly tractable diseases; it also promotes the waste of precious time, energy, and resources. Groups at the National Institutes of Health and Food and Drug Administration have started programs to address these issues. However, we and many others feel there should be significantly more discussion of how to coordinate and scale registry efforts. Such discourse aims to reduce needless complexity and duplication of efforts, as well as promote a pre-competitive knowledge ecosystem for rare disease drug development that cultivates and accelerates innovation. Show less

Scrolling is a perceived barrier in the use of bring your own device (BYOD) to capture electronic patient reported outcomes (ePROs). This study explored the impact of scrolling on the measurement equivalence of electronic patient-reported outcome measures (ePROMs) in the presence and absence of scrolling.

Presentation by Craig Lipset at the Columbia Business School / HITlab executive education course on Digital Health Strategy on May 11 2019 in NYC.
This presentation shares implications for digital in medicine development including those that will be incremental, those that are disruptive and those that will displace incumbents.

Presentation by Craig Lipset at the NIH / NSF "Digital Clinical Trials Workshop" on April 2 2019 in Bethesda MD.
https://www.nhlbi.nih.gov/events/2019/digital-clinical-trials-workshop-creating-vision-future
This presentation details two key themes for digital in medicine development as well as a range of incremental areas where digital is impacting clinical trials today.

The first completely virtual trial conducted under an IND.