In this Wonkcast, originally posted on July 2010, Tom Bollyky explains the problems that motivated him in establishing CGD’s Clinical Trials and Regulatory Pathways Working Group. The group’s final report, Safer, Faster, Cheaper: Improving Clinical Trials and Regulatory Pathways to Fight Neglected Diseases, will be released on Monday, October 31, with keynote remarks by Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration. Listen to the Wonkcast to understand the problems and get a sneak preview on the proposed solutions. RSVP here to attend the event.
Fueled by charitable giving, more and more medical research is focusing on treating and curing thus-far neglected diseases. Is the regulatory framework ready? My guest this week is Tom Bollyky, a visiting fellow here at the Center for Global Development. Tom is a lawyer by training, and is currently working on the important legal and regulatory issues surrounding clinical trials for medicines to treat neglected diseases.
For those unfamiliar with the scale of the problem, Tom gives a quick introduction to what neglected diseases are. Common diseases like malaria and tuberculosis and less common diseases like dengue fever and hookworm together afflict more than one billion people worldwide. Yet, because they’re not big problems in high income countries, very little research has gone towards finding cures for them.
The Gates Foundation has led the way by putting billions of dollars into new biomedical research, which is starting to pay off. But as Tom explains, new treatments coming down the pipeline must undergo rigorous clinical trials, often in countries that lack the capacity to properly carry out and monitor those trials. Weak regulatory capacity can endanger test subjects, says Tom, and also decreases the value of the trials that do take place. “A clinical trial is just a scientific experiment. But if it’s not appropriately regulated and monitored,” Tom says, “the validity of that experiment comes into question and the investment is useless.”
Beyond basic safety, the clinical trials infrastructure struggles to handle the sorts of complex, multi-drug treatments that show the most promise to treat certain diseases. And, Tom says, trying to navigate the current system can be a headache. One ongoing trial for a malaria vaccine had to clear 40 independent review boards—many reviewing the exact same procedures against different standards.
Tom is leading a working group that will issue recommendations for how the clinical trials process could be improved and streamlined. For a deeper look at the issues the working group will be addressing, you can read Tom’s working paper on the clinical trials process or watch video of his recent testimony before Congress.
Have something to add to our discussion? Ideas for future interviews? Post a comment below, or send me an email. If you use iTunes, you can subscribe to get new episodes delivered straight to your computer every week.
My thanks to Wren Elhai for his very able production assistance on the Wonkcast recording and for a draft version of this blog post.