Clinical trials evaluating new ways to prevent, detect, or treat disease are at the heart of all medical advances. However, the traditional ways of conducting these studies are not always the most productive ones. For some research questions, newer types of trials may be more informative. Innovative designs and methodologies may help researchers learn how to optimize an intervention and understand how it works (or doesn’t work) in real world settings.
Clinical trials using innovative study designs to assess complementary health approaches and their integration into health care are one of the top scientific priorities identified in our Center’s 2016 Strategic Plan: Exploring the Science of Complementary and Integrative Health.
We envision that new types of trials—such as pragmatic cluster randomized trials with stepped wedge designs and multiphase optimization strategy designs—will complement standard randomized controlled trials and help us find out which complementary health approaches are the most effective, for whom, and under what conditions. New types of trials may also inform whether integration of effective complementary health approaches into health care delivery is beneficial and guide health policy decisions.
Our objectives for innovative study designs include:
- Using innovative early-phase methods such as Bayesian estimation dose-finding approaches to identify safe and tolerable doses for natural products
- Using Multiphase Optimization Strategy (MOST) designs to refine mind and body interventions
- Conducting pragmatic clinical trials to address questions about integrating complementary health approaches into health care systems or to compare integrative approaches with standard care
- Applying lessons learned from the NIH Health Care Systems Research Collaboratory about how best to study complementary health interventions in health care systems such as those that serve our Nation’s military and veterans
- Using innovative designs such as Sequential Multiple Assignment Randomized Trials (SMART) to develop stepped-care treatment strategies that include complementary approaches.
To find out more about how we propose to strengthen our clinical research by using these and other innovative study designs, please visit our new strategic plan.
We welcome your input on this topic. Please share your ideas and let us know your plans to use innovative study designs!