Healthcare staff facing Covid burnout?
With an anticipated third wave, HCWS urgently need mental health support, say doctors
MUMBAI: A 27-year-old resident doctor from BYL Nair Hospital, Mumbai Central always carries a strip of antianxiety pills in her pockets. At night, she breaks into a sweat when images of the overcrowded Covid-19 wards flash in her sleep. In May, she had a mental breakdown and had sought psychiatric help from a private doctor.
“I have been taking care of Covid-19 patients since the outbreak of the pandemic in March 2020. The first wave was exhausting and frightening as we didn’t know much about the virus. But by the time the second wave hit us, we were already mentally and physically burnt out, and I couldn’t take it anymore,” she said.
Nair hospital was the first civic-run hospital that was converted into a dedicated Covid-19 hospital. Since the start of the pandemic, the hospital has treated over 18,000 Covid-19 patients and hundreds of resident doctors like her have been the backbone of the hospital. Although the pandemic curve has flattened and the daily Covid cases have come down to below 400 on an average compared to 10,000 cases recorded in April this year, it has left a long-lasting impact on the mental health of the healthcare workers (HCWS) including doctors, nurses, radiographers, lab technicians and anaesthetists, Class 4 employees among others. With an anticipated third wave, they urgently need mental health support, claim doctors. thoughts after the pandemic onset, and having a history of receiving mental health interventions,” reads the study—mental health issues among health care workers during the Covid-19 pandemic.
It would be easy to say we could have done better but we must look at the Covid-19 trials against the backdrop of the entire clinical trial environment in the country. In 2019, the New Drugs and Clinical Trials Rules were announced in India, a development that created a more robust regulatory framework for the conduct of clinical trials in the country. Prior to that, clinical trials in India faced very challenging times with activism, misinformation and regulatory uncertainty, resulting in a significant drop in clinical trials done in the country. Clinical trials were beginning to pick up but the pandemic hit and it temporarily halted this progress. The focus turned more towards Covid-19 trials and rightly so. In 2019, we were doing around 4% of global clinical trials in India and that number has since dropped to less than 2% overall (industry-sponsored Covid and non-covid research). India has the second-highest population and the highest disease burden; so, the percentage of clinical trials in India is nowhere near what we should be doing. However, we must also take pride in the research and development being done in India in the fight against Covid-19 which resulted in the discovery and development of drugs and indigenous vaccines.
What are the shortfalls or areas of concern in the Indian clinical research environment?
More than shortfalls, we see opportunities. The pandemic helped us look at clinical trials in a new paradigm and highlighted the importance of two major aspects — how digital adoption can advance and hasten the clinical trial process without compromising on quality, safety or patient centricity, and how collaboration across stakeholders will aid safe, secure and conducive ecosystem of trials. Institutions should be sensitised about importance of doing research in the midst of regular patient care. There is also a need to reach out to a vast swathe of population to help them understand the importance of clinical trials.
A recent opinion piece in the British Medical Journal highlighted fake trials or zombie trials. What is the extent of such fraudulent trials in India?
In most cases, fake or zombie trials can be traced to independent trials. However, the number of such trials is almost negligible. Like any other service industry, you will have players operating at both ends of the spectrum and it is important to note that fake or zombie trials are clearly an exception rather than the norm. There are two
Most countries have a debarment list that features researchers or organisations that have indulged in fraudulent practices. Isn’t it important for India to have such a list?
Undoubtedly, a blacklist or a debarment list is important and required. In the US, a debarment list is maintained by US Food and Drug Administration. This list is accessible to pharmaceutical companies and contact research organisations to verify if an investigator they want to work with is on the list. In India, the National Medical Commission (erstwhile Medical Council of India) for academic studies and CDSCO for regulated trials should maintain a debarment list. CDSCO does regulatory inspections at sites and hence they are well placed to constitute, review and update the list. This will increase the confidence in the clinical research ecosystem in India and will also ensure an additional layer of checks and balances for all stakeholders of clinical research.
What has been ISCR’S contribution to encourage and promote good quality research during pandemic?
The pandemic has played a catalytic role in driving more digital adoption. We have collaborated not just with the regulators but also with all stakeholders to embrace these new changes through workshops, direct discussions and training sessions. The opportunity to do things virtually has also led to an increase in the number of training sessions and webinars.