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   Table of Contents - Current issue
July-September 2020
Volume 11 | Issue 3
Page Nos. 103-135

Online since Monday, July 6, 2020

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Real-world data in COVID-19 pandemic: An essential unmet health-care need p. 103
Arun Bhatt
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COVID-19 effect on clinical research: Single-site risk management experience p. 106
Fatma Soliman Elsayed Ebeid
Background: The ongoing coronavirus disease 2019 (COVID-19) pandemic is extensively impacting new and ongoing clinical trials of various medical products irrespective of indication. It has the potential to adverse effect not only in terms of recruitment and immediate patient care but is also likely to affect the data collection and analysis in the months to come. Aim: The aim was to illustrate the effect of COVID-19 on the clinical research in one of the research centers in low limited-resource country as Egypt and the management plan performed to decrease this adverse impact. Methodology: Secondary data were collected anonymously about the measures implemented to deal with the challenges of conducting the nine ongoing and new clinical researches during COVID-19 pandemic at Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Center. Results: Out of the 47 enrolled participants, thirty participants required investigational product (IP) dispensation during the remaining study period; 27 of them had their IP dispensed at site, and six participants who were from far away Governorate were not able to come to the center due to the partial lockdown and had their IP deliver through courier to their home. Safety laboratory assessment had performed at the site or local laboratory at their hometown. Virtual visit alternatives to in-person visits for communication and patient evaluation had been performed. Recruitment of new participants and opening new sites were stopped in many trials. In order to reduce the on-site activities, in particular, on-site monitoring, all monitoring visits were performed virtually. Conclusion: The adverse impact of COVID-19 pandemic on clinical trials could be lessening by active management plan.
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Addressing challenges due to the COVID-19 pandemic – A site and investigator perspective p. 111
Priya Ranganathan, Deepa Nair, Nithya Jaideep Gogtay
The coronavirus disease-19 pandemic has affected all aspects of health care including clinical research, as the focus of health-care systems has shifted to maintaining essential care. The impact on clinical research has been profound. In this article, we have enlisted the multiple challenges faced by investigators and sites in carrying out clinical research activities during this crisis and the steps which can be taken by them to reduce the impact of this evolving pandemic on clinical research.
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Challenges and opportunities for sponsors in conducting clinical trials during a pandemic p. 115
Sanish Davis, Seema Pai
The COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges have arisen, from country/ state lockdowns, site closures due to hospitals being taken over / sites being taken over for COVID-19 related care, travel limitations to sites for patients, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-scheduled visits and laboratory/diagnostic testing. This position paper from the perspective of Indian Society for Clinical Research (ISCR) aims to provide guidance to both frontline Clinical Research Professionals and sponsors on measures that can be taken while continuing ongoing clinical trial activities at site as well as resuming site level activities in the post COVID setting. Broad guidance is also given to sites and sponsors on use of Direct to Patient drug shipments, supplies and cold chain management and use of technologies to support enhanced remote functioning during and post COVID.
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Ethics committee meetings – Online or face to face? p. 121
Ravindra Bhaskar Ghooi
Ethics committee meetings are held periodically, with all members being physically present in the meeting room. During the COVID-19 pandemic, and the lockdown, a number of committees have resorted to the use of videoconferencing. Online meetings have significant advantages over physical or face-to-face meetings, though the guidelines and regulations imply that online meetings should not be the norm. Considering the advantages of online meetings in terms of saving time and costs, can the regulations and guidelines be tweaked to allow them even after the lockdown is over?
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Medical affairs post-COVID 19: Are we ready to take the baton? p. 124
Viraj Deodatta Rajadhyaksha
The spread of coronavirus epidemic has resulted in a change in the work schedule for Medical affairs professionals in the pharmaceutical industry. There has been an increase in virtual scientific interactions and prioritization of scientific communication. In the long term, this is likely to affect the structure and responsibilities of Medical affairs teams. New areas such as interactions with patients' groups, leading treatment access in specific channels of health-care delivery and role in specialty care are likely to be an integral part of the Medical Affairs function. Along with that, Medical Affairs teams would take a proactive role in developing platforms for real-world evidence programs and forging cross-industry partnerships. To make this successful, Medical affairs teams will have to build specialized skills such as expertise in healthcare, use of digital technology, patient engagement, and soft skills such as agility and ability to influence. The future of medical affairs is set for a major change.
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Pharmacovigilance and assessment of drug safety reports during COVID 19 p. 128
Mira K Desai
The speed and volume of clinical research to discover effective drug against novel corona virus has been remarkable. To address the unmet medical need, the regulations are made flexible and convenient without any relaxation in drug safety reporting. The pharmacovigilance activities, especially adverse event reporting regardless of clinical trials or clinical practice should continue as usual because patient safety is the priority. The exposure to experimental drugs with limited evidence of risk - benefit makes it more crucial to adapt robust safety monitoring, accuracy in adverse event reporting, and timely assessment. With the current restriction on physical contact, travel and free movements, isolation, quarantine, and huge clinical workload during pandemic, causality assessment will be more challenging. It may not be possible to capture details of all adverse events, thereby affecting completeness and quality of safety reports. A substantial number of COVID 19 patients will receive investigational drugs along with multiple other medications for clinical manifestations and drug therapy for lifestyle diseases. Causality assessment will be a challenge due to overlapping toxicities, multiple confounding, contributory factors, and insufficient data on safety and risk profile of combining drugs. Assessment will be unable to precisely determine the causality as certain or unlikely, although, it will be valuable in categorizing the causal association as “possible” adverse drug reactions and their scientific basis. Several of these detailed reports, when collated, can identify risk factors for possibilities of prevention or avoid harm. In the current situation of pandemic and uncertainty of experimental new and old repurposed drugs, causation needs to be viewed for the study drug with a public health perspective. After all, this is the best time tested approach to generate evidence and drug evaluation to prevent damage to prospective patients.
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Indian regulatory update during the COVID-19 pandemic p. 132
Amita Chandan Bhave
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Prerequisite of doing clinical trial with drugs in COVID-19 patients: Situational experience p. 135
Pugazhenthan Thangaraju, Atul Jindal
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