Clinical Operations Issues Emerge for Ebola Vaccine Trials
Issues being discussed with the Ebola vaccine sound like issues discussed with clinical trials in general. What can we learn?
This Washington Post article on Ebola vaccine trials asks, "How can vaccines be safely transported and kept at the cold temperatures required in areas without reliable electricity?" Followed by, “How do you recruit and track volunteers during the middle of an epidemic, in countries with shattered health-care systems?" And in regard to trial design, “The intent would be collecting and analyzing the data in as close to real time as possible.”
If you were to read these questions—minus the epidemic and countries with shattered health-care systems—they would almost sound like any other clinical trial operations issues that we cover regularly in Applied Clinical Trials.
I wonder if any of the CROs and service providers have answers for how they would handle these complex clinical trials. Supply chain. Patient recruitment. Quality data. The WHO wants the Ebola vaccine trials to start as early as January. So basically a two-month study start up.
Being overly fascinated with the whole Ebola-as-it-unfolded-in-the-United-States, I was talking about it non-stop. Our community manager told me about an app game called Plague that she plays. Here is a description from CNET: “Plague is a strategy game that challenges you to create a disease that can kill all of the people in the world before a cure is discovered. In order to do this, you have to tweak your disease's characteristics to make it as hard to cure and as easy to spread as possible.” And apparently, it offers “realistic scenarios” players have to address that “would actually occur if there was a fear of a pandemic sweeping from country to country. For instance, the governments of various countries can shut down their airports to prevent infected individuals from entering.”
As the goal of the game is to kill all of the people in the world before a cure is discovered, I would assume there is no challenge to design an effective clinical trial. That is unless part of the game is to confound researchers trying to develop a vaccine. Then, the fact that the GSK vaccine discussed in the article needs to be stored at a constant -80 degree Celsius would be a major barrier. Then the patients for these trials who are living in extremely poor conditions, with a close-to-non-existent healthcare system, in countries that are just coming out of 10-year long civil wars. Factor in what was discussed earlier about Ebola and West African’s initial (and maybe ongoing) distrust of what their governments say, what doctors say and cultural norms, would they agree to or understand what a clinical trial is? No one discussed informed consent in the Washington Post article, but surely it will come up.
With all the clinical trial operations brainpower we have in the United States and Europe, surely there would be a way to put it to use in a public health crisis? Like any executive or manager in clinical trials, what keeps Ripley Ballou, MD, VP, and head of GSK’s Ebola unit awake at night? Says the Washington Post, “My biggest fear is we’ll have a good vaccine, a great plan, and we just won’t be able to do it because it’s not feasible.”
Related links:
New Research Models Spur Third-World Efforts
Ebola Research Requires Flexibility by Sponsors, Regulators
Debate Intensifies on Trial Design for Ebola Treatments
