How to incorporate pragmatic design elements into your clinical studies

There’s been a steady trend in the clinical research industry in recent years to consider more pragmatic approaches to evidence generation – especially in oncology where research is often complex, costly and time-consuming.

While there is varying language to define what ‘pragmatic’ means in the clinical research context, most definitions agree that it’s about embedding research into routine clinical care to scale more practical studies.

In this webinar, speakers will:

Explore the value of running clinical studies with pragmatic design elements
Share examples of where pragmatic designs have already been successfully applied
Provide clear action steps that you can bring back to your research organization

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Tara Marti

Precision Oncology Portfolio Sr Manager, MRD, Exact Sciences

Tara Marti is Precision Oncology Portfolio Sr. Manager, MR, for Exact Sciences where she is a leader in evidence generation and product development strategy. Tara is passionate and a collaborative problem-solver who values the opportunity to think beyond the way things are. Tara developed the protocol for Exact Science's first prospective precision oncology clinical validation study. Before Exact Sciences, Tara was the research supervisor at Decipher overseeing the acquisition and processing of thousands of study samples and data to validate their prostate cancer prognostic signature. Tara is a certified molecular biologist and CAP inspector with a bachelor's degree in microbiology from the University of Wisconsin-La Crosse.

moderator

Lockwood Taylor

Senior Director, Head of Regulatory Strategy, Flatiron Health

Lock Taylor, PhD, MPH is Head of Regulatory Strategy at Flatiron Health, where he leads a team of regulatory experts who advise clients on evidence generation and regulatory considerations to optimize regulatory success. An epidemiologist by background, Dr. Taylor has over 15 years of experience in leading observational studies of medication safety and effectiveness. Lock spent 7 years at the U.S. Food and Drug Administration, most recently as a Deputy Director in CDER's Office of Surveillance and Epidemiology, where he led regulatory-focused research and was involved in RWE guidance development. Additionally, Lock held a position as an epidemiologist within the Office of the U.S. Army Surgeon General, where he led observational studies of medication safety and worked in adverse event signal detection supporting military pharmacovigilance efforts. Immediately prior to Flatiron, Lock spent 5 years at IQVIA leading pharmacoepidemiologic research studies, developing innovative and fit-for-purpose RWE solutions, and providing clients with regulatory strategy in pre- and post-approval settings across a diversity of medical products.

Dr. Taylor received his PhD from the University of Texas School of Public Health and currently holds an adjunct faculty appointment at Georgetown University Medical Center's Department of Biostatistics, Bioinformatics & Biomathematics.

More speakers to be announced soon