Ebola Crisis Challenges Global Resources


Applied Clinical Trials

The rush is on to develop new therapies and preventives to combat the lethal Ebola outbreak.

On Tuesday, President Obama announced the US plan to extend troops and resources to aid in the ongoing fight to contain the Ebola epidemic. In addition to the pledge to send 3,000 troops, Reuters describes how the plan “calls for building 17 treatment centers with 100 beds each; placing US Public Health Service personnel in new field hospitals in Liberia; training thousands of healthcare workers for six months or longer; and creating an "air bridge" to get health workers and medical supplies into West Africa more quickly.” It is expected that the US will also extend more funding to the cause, on top of the $175 million already pledged.

Obama’s plan comes at the same time as the World Bank’s approval of a $105 million grant to be used in the delivery of emergency supplies and support.

A focus on research

Meanwhile, the rush is on to develop new therapies and preventives to combat the lethal Ebola outbreak, a process that has been stymied by difficulties in testing compounds for deadly diseases and the reluctance of both public and private entities to invest heavily in a field with uncertain demand. Treatments for Ebola have been low on the priority lists for international and national health agencies, as efforts to combat malaria, tuberculosis and other widespread diseases have absorbed more attention and resources.

That has changed as Ebola has sickened and killed thousands. The World Health Organization (WHO) and public and private research programs have shifted funds to preclinical and clinical trials of promising Ebola treatments and vaccines, encouraged by WHO’s decision in August that it is ethical to use unproven therapies to help contain the spreading outbreak. WHO further addressed research priorities at a “consultation” with public health officials and leaders of the biomedical research community in Geneva last month. Executives from large vaccine makers and small biotech firms joined with leaders of the infectious disease research community to consider the challenges in conducting clinical trials and collecting data from ill patients.

Some 200 experts agreed to support Phase I safety studies despite limited preclinical data. The group noted the need for flexibility in requiring ethics committee reviews and in assessing risks and benefits. Harmonized data requirements are important for results from expanded access programs to be compared to support eventual registration.

A stated goal is to minimize bias in evaluating the effect of an intervention without randomized placebo controlled trials; alternative protocols may involve randomizing patients to two different experimental therapies or to offer “usual care” to individuals not willing to be randomized, who could then provide a control group. Meeting participants also agreed that a safety monitoring board should be established to evaluate data from all interventions and that protocols should address informed consent and community concerns.

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