Clinical trials should be accessible to the population suffering from the illness. However, with a limited number of research sites conducting the majority of the world’s clinical trials, how can trials really be accessible to all patients?
Clinical trial diversity is a multi-layered problem, and one that fundamentally must start with physicians. More principal investigators on more studies will open clinical trials to populations that otherwise could be left behind. How then do
we make clinical trials simpler for clinical staff so they want to participate and therefore increase accessibility to a broader number of patients?
This session will include introduction thoughts from our speakers as well as a panel discussion. We will also unveil some new research from the Tufts Center for the Study of Drug Development of perceptions of clinical trial protocols.
- Why a changing global population requires more clinical trial diversity for the future of drug development
- Why we need to make it simpler for more physicians to run clinical trials so they will be more apt to participate, making trials more accessible to a broad range of patients
- New protocol perception research and the challenges with today’s clinical trial protocols
- Addressing the challenge – where do we go from here
- Pharma and biotech senior leadership – specifically in clinical operations, digital innovation/mobile health groups, diversity/inclusion, physician engagement
Kenneth Getz, MBA
Deputy Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
Kenneth A. Getz is the Deputy Director and a professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts research focusing on drug development management and operating strategies and tactics; protocol design practices; and global outsourcing, investigative site and patient recruitment practices and policies. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors, including WCG and ORA and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science. Ken received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Ken is the founder of CenterWatch, a leading publisher in the clinical trials industry.
Cassandra Smith, MBA
Director, Diversity and Inclusion in Clinical Trials Lead, Janssen R&D
Cassandra Smith currently serves as the Director, Diversity and Inclusion in Clinical Trials and also is a lead in Investigator & Patient Engagement, within Global Clinical Development Operations at Janssen. In this position, Cassandra leads efforts to optimize the Informed Consent experience for Janssen study participants. She is the business lead for electronic Informed Consent and is leading global expansion efforts of the technology at Janssen. Cassandra holds a BS from Pennsylvania State University and an MBA from Saint Joseph’s University.
Brendan Buckley, MD, DPhil
Brendan Buckley is a medical graduate of University College Cork (UCC) and a doctoral graduate in Biochemistry of Oxford University. He brings more than 40 years of experience in academic clinical practice as a physician in endocrinology, diabetes and clinical pharmacology. Brendan is also a non-executive director of a number of biopharma development and services companies. He chairs the board of the leading Irish research charity, Fighting Blindness, and is a member of the board of Breakthrough Cancer Research. He was a member of the Board of Directors of the Irish Medicines Board (now the Health Products Regulatory Authority), chairing its statutory Advisory Committee for Human Medicines. In the past, he was also a member of the European Medicines Agency Committee for Orphan Medicinal Products (COMP) and of the European Medicines Agency (EMA) Scientific Advisory Committee on diabetes and metabolism. Brendan is an Honorary Clinical Professor at UCC and an Adjunct Professor at University College Dublin in the respective medical faculties. He was Director of the European Collaborative Centre for Clinical Trials in Rare Diseases at UCC. With more than 150 scientific papers published in his career, Brendan also authored the opinion-leading book Re-Engineering Clinical Trials. He has directed a number of very large outcomes trials in metabolic/cardiovascular disease and chairs the independent data and safety monitoring boards for a number of large clinical development programs.
Director, Clinical Operations, Teckro
Cayce brings more than a decade of clinical research experience, working at sponsor companies, CROs, and investigative clinical trial sites. Cayce has worked on numerous Phase I-IV trials across therapeutic areas. She has undergraduate degrees in Biology and Mental Health and holds two Master’s Degrees in Microbiology and Clinical Research.
Teckro clinical trial software optimizes site performance, increases transparency and oversight, and delivers targeted communications with research site staff and monitors. With Teckro, you can transform your clinical trial protocol from a static document into a critical data source for engagement and trial conduct.
Teckro is used globally by more than 14,000 research sites and both pharmaceutical and biotech companies across therapeutic areas. The impacts on clinical trial operations are significant as sites using Teckro recruit 50% more patients and have fewer protocol deviations compared to those sites not on Teckro.