New ideas on conducting Ebola treatment trials in Africa
Admittedly, I am biased about how I think clinical trials should be conducted. I believe they necessitate the very finest care of patients, meticulous ethical conduct, and collection of the most complete data possible. Most importantly, data obtained from human subjects, who have taken on some risk to advance medical knowledge, should imho never be considered solely the property of the trial sponsor: it cannot be hidden or secretly massaged for proprietary considerations. I am proud to be a long-term board member of the Alliance for Human Research Protection in NYC.
A WHO expert committee on Ebola testing just noted (Nov 13) that conditions are such in Africa that consistently good standard of care is hard to achieve and only minimal data can be collected during drug trials.
... Noting that the standard of care in Ebola affected countries varies between different treatment centres and even in the same centres over time while standard of care is being established, it was agreed that clinical trials should only be conducted in facilities able to provide consistently good standard of care. The number of such sites in West Africa, capable of providing such care and with suitable infrastructure to conduct clinical trials, is limited… Collecting clinical data under the biosafety conditions required when treating Ebola necessitates careful consideration of the minimum data that should be collected…
Here’s the thing. Any company whose drug is approved will make an enormous profit on an Ebola therapeutic. Normally those companies would spend hundreds of millions of dollars on clinical trials to get their drug to market. If they want their drug tested, they should pony up now and help create the improved clinical centers in Africa that are capable of conducting reliable clinical trials. Deciding that only minimal data can be collected is like making a decision, early on, to impair the usefulness of such trials. Perhaps this is how Ebola clinical trials must start, but we should be developing better methods simultaneously. Let’s re-envision the model for care. For example:
What we need is speedy drug testing, and for clinical testing to move quickly, the maximal amount of information needs to be obtained. I submit that patients receiving experimental Ebola drugs must all be given the best care available in Africa. This would include iv fluids, electrolytes, antibiotics and antimalarials when appropriate, iv alimentation when needed, and daily lab tests to guide therapy (particularly iv fluid/electrolyte administration, given the massive amounts required and potential for iatrogenic mistakes). Oxygen concentrators could supply additional oxygen. This would be a minimum standard in the US, available in every hospital.
Most of the direct caregivers would be recovered Ebola patients.
Patients would be placed on the other side of large glass windows, allowing physicians to monitor their visual appearance, outside the limited periods they can assess patients while wearing PPE, and physicians and nurses could communicate with caregivers through or above the window to obtain additional information. Automatic blood pressure cuffs could take blood pressures frequently without need to touch patients. Cardiac monitors to check cardiac rhythms should be available. Central venous lines in the sickest patients could be used to monitor CVP for fluid administration and allow blood to be drawn without repeated needlesticks.
This type of setting would lend itself to the trialing of experimental drugs, yield bountiful clinical data, and greatly enhance clinical care. It would vastly improve patient monitoring., allowing doctors and nurses to be much more effective. It doesn’t cost a fortune, although everything, including generators, would need to be brought in. This effort is worth it to finally stop Ebola.