So far, investigational Ebola drugs have generally been used in the few patients that received experimental intervention treatment in the United States or Europe. Since the first recognized outbreak, until the current epidemic began in West Africa, researcher have had few opportunities to test novel Ebola treatments. Among the candidates drug are TKM-Ebola, and RNA inhibitor of the virus packaged in lipid nanoparticle, and ZMapp, a laboratory-made cocktail of three Ebola antibodies, the frontrunners. Given the accelerated development of Ebola drugs (which involves, for example, proceeding on the basis of only limited phase 1 data and little or no traditional phase 2 data) and preliminary data suggesting potential for adverse effects, such drugs need to be evaluated in RCTs with an appropriate control group so that any harm can be detected.
Ebola transmission rates remain very high, especially in Sierra Leone. Disease spreads rapidly in Sierra Leone as those infected are left to writhe, with many receiving no medicine or other help. Treatment and isolation capacity continues to be a critical component of the international response. It is important that other countries too contribute to the international effort and support the development of safe, effective and affordable vaccines and treatments. I welcome recent Ebola Treatment Centre in Sierra Leone managed by Australia and New Zealand clinical personnel following the completion of construction by the United Kingdom. This joint commitment demonstrates ones again the importance of international response to the Ebola outbreak
Ebola treatments carried out in makeshift emergency hospitals by researcher in the middle of a deadly epidemic, will be some of the most unusual drug trials ever done. And they also raise major ethical and practical questions, some of which were intensely debated at a World Health Organization (WHO) meeting in Geneva, Switzerland, on 11 and 12 November. Do the treatments of Ebola work? Researcher will soon begin trials in West Africa to find a solid answer to the question. There’s been a pretty fierce debate in public health circles over the pressing question, when testing drugs to treat Ebola virus or vaccines that might prevent infection. Perhaps the most important question: a disease as deadly as Ebola: Is it right to do randomized controlled trials in which some people don´t get the novel intervention?
From the epistemic point of view, the idea behind the RCT is that of the counterfactual analysis. When a new treatment is administered to a patient and an improvement in her condition is observed. “Otherwise, the possibility of drawing a conclusion from the fact is hindered by the absence of a counterfactual: possibly the patient would have recovered anyways if left untreated, or maybe a different treatment would have been more effective”.
Research involving human subjects has anything but a glorious legacy. Over the past decades, randomized controlled trials (RCTs) have prevailed over clinical judgement, case reports, and observational studies and became the gold evidential standard in medicine. Furthermore, during the same time frame, RCTs became a crucial part of the regulatory process whereby a new therapeutic can gain access to the drug market. Because of its scientific credentials, the RCT methodology is currently considered the gold standard in treatment evaluation. Over the past several decades, RCTs prevailed over clinical judgement, case report, and observational studies as evidential standards in medicine, largely due the effort of the movement known as evidence-based medicine. Properly designed RCTs that give reliable answers are critical to identifying urgently needed treatments for responding to the ongoing and widespread transmission of Ebola and any future outbreaks.
In an RCT, participants are divided into two groups, one that receives the experimental treatment and another that acts like a control, providing the answer to the ‘what if’ counterfactual question. RCTs is the sole means of obtaining knowledge about efficient treatments — The Case for RCTs – The argument is made in the New England Journal of Medicine article by three FDA officials: Edward Cox, M.D., M.P.H., Luciana Borio, M.D., and Robert Temple, M.D. Evaluating Ebola Therapies. Randomized, placebo-controlled trials are necessary, they write, and, in fact, the speediest way of actually getting vaccines that might control the outbreak and treatments that might save patients’ lives into broad use.