Clinical trials are gasping during the ongoing COVID-19 pandemic

Abstract

We read with interest the article by Mathrudev et al. regarding the status of the ongoing clinical trials during the current coronavirus disease 2019 (COVID-19) pandemic.[1] COVID-19 has infected more than 3.4 million people globally and led to almost 2.4 lakh deaths, affecting more than 210 countries.[2] The war is so close to the health-care professionals that thousands have died across the world, 133 have become its victims in India alone (personal communication, Jayadevan R, April 29, 2020), including one prominent frontline COVID fighter, Dr. Breen, who committed suicide.[3] As of May 7, 2020, in the national capital region, there are 399 health-care professionals already infected with COVID-19 (personal communication, Pankaj Goyal on May 7, 2020) [Table 1]. In this case, ignorance is not bliss. it is the kiss of death.Table 1: List of hospitals and health-care facilities in New Delhi (national capital region) with the number of health-care professionals affected by COVID-19, as of May 7, 2020 (personal communication, Pankaj Goyal)It is, therefore, not surprising that there is an unimaginable impact of the pandemic on the ongoing clinical trials as well. There is no doubt that every stage of clinical trials faces clear and present danger with regards to recruitment, medical care of patients, adherence to the study schedule, and regulatory and ethical compliance with reporting (regulatory drug authorities, ethics committees, sponsors, contract research organizations, and institutional review boards). What will be the effect on the robustness of the data that are finally generated is anybody's guess. To a certain extent, it will depend on how quickly the stakeholders "learn on the job," come up with innovative solutions, develop "protocols" to deal with the triage of the doctor's professional time, and juggle tasks amidst the dwindling availability of staff and infrastructure. We have previously reported on our survey among forty oncologists with open clinical trials in India.[4] In the majority of instances, sites had stopped screening or recruitment. About half of the sites were struggling because of the inadequate infrastructure. Not surprisingly, most patients were clearly worried about getting infected by the novel coronavirus. Adherence to the schedule of events for these studies was not possible at almost all the sites. More than half were trying to ensure collection of important trial-related data points using virtual visits, once telemedicine was given the official nod in India on March 25, 2020.[5] It was not surprising that identification, documentation, and reporting of adverse events as well as serious adverse events (SAE) was an uphill task. Regulatory authorities in India as well as other countries have realized this and taken vital steps to ensure that the ongoing clinical trials do not fall victim to the current scenario.[678] Irrespective of how long the COVID-19 pandemic disruption lasts, its consequences on clinical trials will remain long term. We hope that saner minds and saner circumstances will pave the way for disaster management standard operating procedures that will, hopefully, prevent the clinical trials from gasping in intensive care in the future. A PubMed search with "COVID-19" showed 1795 results on March 28, 2020, 3075 on April 8, 2020, and 8319 on May 2, 2020 – a jump of 463% in 36 days. This means that 181 new articles were being published in PubMed-indexed journals every single day. Health-care professionals continue being committed to academics during the COVID-19 pandemic, providing much-needed data and evidence of what we really are dealing with. Undoubtedly, research should be focused on how we can get rid of the mammoth COVID-19 health-care problem, but other ongoing clinical trials cannot be forgotten. Patients enrolled in clinical trials usually have advanced or rare diseases, or they may belong to a subset with unmet needs.[9] Now, they face the additional risk of morbidity and mortality due to COVID-19. This is especially important for oncology patients, as reports emerging from China (subsequently confirmed from Italy, Singapore, and the United States of America) indicate that if infected with COVID-19, patients with cancer do poorly.[1011] Their safety is our first priority. Hence, avoiding in-person visits, additional prophylaxis, mitigation procedures to accelerate recovery, as well as timely discharge from hospitals are some of the steps that are being implemented.[12] Effective communication remains the key to success. Nationwide extended lockdowns are testing disaster preparedness and business continuity plans vigorously. Truth is stranger than fiction. The current situation reminds me of the 2011 triple disaster in Japan.[13] The hope of a brighter future continues to motivate us. Remember, even the darkest clouds have a silver lining. Resilient clinical trial investigators will come up with innovative solutions.[1415] What remains to be seen is how quickly we can "heal" the ongoing clinical trials and report a happy ending to this SAE. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.