
Available via
LIVESTREAM
The Need to Accelerate Therapeutic Development — Must Randomized Controlled Trials Give Way?
Wednesday, June 21, 2017 - Thursday, June 22, 2017
The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich St Fl 40, New York, USA
Randomized controlled trials (RCT) are frequently used as part of the clinical trial process, and are generally considered the gold standard for determining the efficacy and safety of an investigational product. As such, they have become a crucial part of the regulatory pathway whereby a new treatment can gain access to the market. While randomized controlled trials are widely considered valuable for their ability to present unbiased and consistent results, ethical concerns have been raised in recent years. For example, questions have surfaced regarding the ethics of placebo usage, especially if there are viable standards of care available; the length of time to complete development programs using traditional RCT paradigms, specifically when the patient population is small or the patient need for a treatment is immediate (e.g. the Ebola outbreak); or the potential of providing a treatment to the experimental group that may prove to be inferior than the standard treatment. In many situations, a case could be made for the need for alternatives to RCTs to speed development and bring treatments to patients in need more rapidly without compromising establishment of appropriate levels of efficacy and safety for registration.
To address these important issues, the NYU School of Medicine and the New York Academy of Sciences will present the two-day colloquium, The Need to Accelerate Therapeutic Development — Must Randomized Controlled Trials Give Way?, which will convene thought leaders who — in a public-facing dialogue — will discuss the ethical, legal, medical, scientific, safety, and economic issues pertaining to the design of clinical trials. Session topics will include the history and future of randomized controlled trials, the role of alternative trials, the ethical and scientific issues associated the randomized controlled trials and alternatives, a case study of a modified randomized controlled trial, and risk and liability associated with accelerated trials. Pitting randomized controlled trials against alternatives will inevitably result in a highly nuanced, ethically ambiguous discussion, and it could have profound effects on public health and the regulation of pharmaceuticals.
Livestream
All panel sessions and keynote lectures will be livestreamed during the two days of the colloquium. Registration is not required to view the livestream, watch it here.
Registration Pricing
This event is free but registration is required.
Registration
Scientific Organizing Committee
Keynote Speakers
Speakers, Moderators & Panelists
Wednesday
June 21, 2017
Registration and Breakfast
Welcoming Remarks
Speakers
Setting the Stage
Speaker
Session I: The History and Contribution of Randomized Controlled Trials to Public Health
Panel Discussion
Speakers
Networking Coffee Break
Session II: Beyond RCTs — Assessing the Need for Alternatives
Panel Discussion
Speakers
Networking Luncheon
Keynote Lecture: Finding the Right Balance in Learning about Therapies
Speaker
Session III: Weighing the Risks of Randomized Controlled Trials and Alternatives
Panel Discussion
Speakers
Networking Coffee Break
Session IV: Ethics and Patient Advocacy in Clinical Trial Design
Panel Discussion
Speakers
Closing Remarks
Networking Reception
Day 1 Adjourns
Thursday
June 22, 2017
Registration and Breakfast
Keynote Lecture: Modern Trends in Clinical Drug Development
Speaker
Session V: Lessons from the Eteplirsen Drug Trial for Duchenne Muscular Dystrophy
Panel Discussion
Speakers
Networking Coffee Break
Session VI: A Way Forward: Shaping Clinical Trial Innovation
Panel Discussion
Speakers
Networking Luncheon
Session VII: Ethics Panel Wrap-up: What is the Future of Accelerated Development and the Randomized Controlled Trial Standards?
Panel Discussion
Speakers