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Post-covid: ethical practice for clinical trials

Late last month, a coronavirus vaccine developed by Bharat Biotech became the first of its kind to be approved for human trials in India. Though, in recent days, the Indian Council of Medical Research has established its want to launch this same vaccine for public health use by August 15th 2020. This announcement, understandably, has been questioned by independent experts due to the short time-scale set by the council. Among this criticism, the editor of the Indian Journal of Medical Ethics has publicly stated their disapproval.

“I don’t think anywhere in the world has anyone ever given a date in advance for the release of a new vaccine before a clinical trial has even begun… that is not how science works.”

- Amar Jesani, editor of the Indian Journal of Medical Ethics

What research sites can take away from this is a prevalent need for transparent, ethical practice despite the confusion of the pandemic. Today, we take a look at some of the most notable developments in clinical research and consider the ethical issues that may arise in our vast-changing industry. Check out our breakdown below.

Cancer research

Yesterday (7th July 2020), leading biotech, Hubei Soundny, released their findings on the company’s latest project. Concerned with a treatment for cholangiocarcinoma, a form of bile duct cancer, their drug-loaded tumor therapy has been approved for clinical use due to its efficacy in its phase 1 clinical trial. Director at Nankai Hospital and co-author of the report, Zhang Hui, stated that since surgery is almost always preferred as the mode of clinical protocol, treatment is only really available in the later stages of the disease. Hubei Soundny’s drug, he claims, should offer a solution to the majority of patients not eligible for radical surgery.

While the results were positive, with 30% of the patients tested entering a partial remission, it is also important to remember that this data was collected from only 20 enrolled candidates, all in their final stages of the disease with low time-frames of survival. Yes, this is not atypical of early phase trials; however, the restrictions these conditions impose on the trial’s overall success must be noted. According to an article from the Journal of Microbiology, too many trials today are failing to collect adequate preclinical data that, in some cases, is leading to a lack of detailed information on protective correlates of immunity. In short, studies are failing to fully detail signs of immunity in healthy patients that, in turn, contribute to product failure in clinical trials and an easing of ethical conduct.

Alzheimer’s studies

Axsome Therapeutics has been given the all-clear by the FDA for further investigation of their novel, oral treatment, AXS-05. The compound looks to tackle the psychological agitation connected to Alzheimer’s disease - and, with no other treatment currently available, Axsome’s chances of bringing this to market look promising. As part of their phase 2 clinical trial, ADVANCE-1, 336 patients were treated under double-blinded, randomised conditions.The result: the study successfully showed treatment with AXS-05 resulted in a rapid, substantial, and statistically significant improvement in agitation when compared to a placebo.

Again, though this news is definitely optimistic, we must also remind ourselves of the industry-wide issues facing this sort of clinical research. Findings published on the UK government website reports a staggering 99.6% chance of failure for Alzheimer’s drug treatments in the development stages. As no real solutions have, as a result, been brought to market successfully, therein lies an abundance of ethical concerns. Finding drugs to treat the condition is particularly difficult as the brain is relatively inaccessible and harder to test and deliver compounds to, explains Simon Lovestone, a professor of translational neuroscience at the University of Oxford, UK. Thus, it is not merely a question of resolving ethical issues in this area - but of establishing workable, clinical protocol as we continue to learn more about the disease and the brain.

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