With the outbreak of the COVID-19 pandemic in India and elsewhere in the world, efforts to bring out a slew of drugs and vaccines have gained momentum which in turn has given the much needed fresh impetus to kick-start clinical trials for the clinical research organisations (CROs), said Dr Arun Bhatt, consultant, clinical research & drug development.
When the COVID-19 started spreading in the country, there have been impediments in patient recruitment and retention to complete the studies. CROs were concerned about the suspension of current trials and the delay in achieving key milestones which have also resulted in loss of revenues. Now, COVID-19 drug or vaccine trials are a short term boost for the CROs which can quickly organize human studies, he added.
There is also a paradigm shift in clinical trials. The field is moving from physical to digital approach which requires investments, training, and adaptation, Dr Bhatt told Pharmabiz.
The impact of the pandemic on clinical trials is volatile, uncertain, complex and ambiguous (VUCA). The risk of second wave, continuing growth of the coronavirus disease in developing countries, high risk of complications and mortality, persistence of COVID-19 symptoms, absence of effective treatment and ambiguity of universal availability of vaccine are some factors which make the socio-economic-medical pattern VUCA, said Dr Bhatt.
The reality is that the focus has shifted from clinical research to patient care across hospitals as the coronavirus infected patients throng across facilities. In the current scenario, clinical trial participants are unwilling to visit hospitals. There is reluctance at the investigator sites where safety of staff is a prime concern and the need to screen participants prior to enrollment are a concern. Even the Ethics Committees are looking at protection of participants as the fear protocol deviations and adverse events, said Dr Bhatt.
Quoting a Clinical Accelerator report, that indicated between February and May this year, at least 1,118 trials which were sponsored by the industry were stopped due to COVID-19, Dr Bhat said not able to conduct these studies is detrimental to the access of new drugs. The indications for which drugs are under trial in India and globally are same as before as it covered cancer, cardiovascular, neurology, diabetes and infections.
However, there is a need to prioritize trials based on patients’ needs, safety, and disease severity. There is also a need to look at potential patients and site burdens besides availability and allocation of programme resources, said Dr Bhatt at a recent webinar organised by Karnataka Registered Pharmacists Association (KRPA).
Although India is on par with global regulations for clinical trials, it still needs to put in place a new drug registration process. There is need for animal toxicity and testing. Its R&D ecosystem needs the required infrastructure for capacity building, he said.
In pandemic situation, based on Ebola experience, there is a global consensus to expedite vaccine development. However, all regulatory authorities require demonstration of safety and efficacy in large number of participants, before they give approval for marketing. Even repurposed drug studies on humans is the easiest option for generating clinical trial evidence rapidly as the risk: benefit, and safety profile are well-established and thoroughly reviewed by regulatory authorities, said Dr Bhatt.
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