Dr Dan Hartman
Director, Integrated Development, Bill & Melinda Gates Foundation
Dr Thea Norman
Senior Program Officer, Integrated Development, Bill & Melinda Gates Foundation
Clinical studies are always expensive and time-consuming but only sometimes yield insights that improve health and well-being. Implementing best practices in design, analysis and communication can help researchers get the most out of their hard work.
The purpose of clinical research in global health is to generate knowledge that improves and saves lives. However, good intentions aren’t sufficient. It takes a lot of specialised expertise in trial design, data analysis and scientific communication to conduct studies that have an impact.
The paradox of “uninformativeness”
In fact, a significant minority of studies end up “uninformative”; in other words, despite their cost in money and time, they don’t reveal anything that advances the field.
Studies can be uninformative for many reasons, including asking questions that have already been answered, they’re conducted in a geography where the questions they ask cannot be answered, or, most commonly, they don’t enrol enough participants to be statistically significant.
A recent study of thousands of COVID-19 drug trials found that only 5% of study arms were adequately powered.
A significant minority of studies end up “uninformative”; in other words, despite their cost in money and time, they don’t reveal anything that advances the field.
Maximising viability of results
As an organisation, we have funded hundreds of clinical studies over the years. These trials routinely cost $15 million or more, and more than a few have ended without usable results. The opportunity cost of spending $15 million and several years on research that isn’t valuable is unacceptable. Therefore, we recently pored over the academic literature about “uninformativeness” and identified evidence-based best practices in three areas:
- Design: Ask the right questions in the right way so the data can lead to answers.
- Analyze: Plan how to crunch the numbers so that the data does lead to answers.
- Communicate: Tell the people who matter (like policymakers and doctors and nurses) about the answers so that they can respond appropriately.
Based on these best practices, the Design, Analyze, Communicate (DAC) programme was created. Now, in partnership with the Global Health Network, we are making DAC’s resources publicly available at the DAC Trials Hub.
Clinical researchers want to make people’s lives better. These best practices and other tools on the Hub can increase the likelihood that they actually do.