The COVID 19 pandemic came with tremendous uncertainly but radically changed the world for life sciences companies to do their best to move quickly and safely. The companies undertaking clinical trials had to quickly adjust to support alternative ways to conduct trials also ensuring monitoring and caring for clinical trial participants for which physical access was not an option.
After a brief stagnation, caused by pandemic that disrupted clinical research globally, sharing and collaboration became the main themes of operation during clinical trials/studies. A wide variety of alternative approaches in clinical trials have been implemented which include remote monitoring, video visits, phone visits, e-Consent, and electronic health records (EHR). Regulatory agencies improved the flexibility, in how the trials operated, by adopting measures such as centralized monitoring, telemedicine visits, and remote source data verification (rSDV) for various trials. While many of these approaches have been around for several years, the COVID-19 pandemic served as a catalyst for adoption.
These newly adopted methods are influencing the evolution of clinical trials in a post-pandemic world. A few of them include:
1. The transition to decentralized trials: Earlier, majority of clinical trials were conducted in a centralized/localized manner – at a hospital site or a clinical facility or a large institute. The decentralized clinical trials allowed CROs to decrease implementation and recruitment times, thereby resulting in decreased cost of studies and enhanced retention of study participants. This occurred while balancing the rising concerns regarding data quality and regulatory compliance. Global pharmaceutical players successfully ran several trials for the COVID-19 vaccines, mainly decentralized. This led to development of vaccine, subsequent tests and release in record time despite restricted resources with the coordination and efforts of the researchers, government, and the medical community. These efforts clearly indicates that trials can be conducted faster, safer, and cheaper.
2. Communication and coordination among stakeholders: Clinical Research sites learned the importance of effective communication and coordination. Due to shortage of staff, many sites were shifted to another site. This load shifting was only possible through the investigator maintaining clear communication between the sites and sponsors. During such volatile situations, where the regulations kept altering, the investigator and regulatory medical writers had to prevent confusion in deciphering it. This dire need to improve communication encouraged intra-site coordination to expedite future clinical trials through agility in working and quick problem-solving.
3. Increasing virtual trials through partnerships and M&A: Post pandemic, FDA and other regulatory bodies across the globe began promoting the adoption of virtual clinical trials, providing flexibility to the clinical investigators in framing appropriate protocols that would support remote care. The pandemic influenced an increase in partnerships and M&As. This change is occurring with the primary objective of providing support for the virtual trials in the new post-pandemic world.
4. Improved patient/participant recruitment: Recruitment of trial participant has become more distributed and decentralized across various geographies to mitigate scarcity. This widespread participation has been enabled through methods that will soon become an industry norm, such as electronic consent, virtual consultation, and remote monitoring. This pandemic led to increased consumer devices to be used for test data collection securely and safely.
5. Use of Real World Data and Real World Evidence: The adoption of new ways resulted in evolution of advance analytics, which uncover new real-world evidence (new data relationships and patterns) from real-world data, and influence patient treatment planning. Real-world data analytics output can influence changes in clinical trial design – how medical affairs experts may identify specific treatment approaches, and how commercial organizations evaluate the effectiveness of patient services programs.
We are at a critical juncture for clinical trials. The newly adopted approaches had a positive impact on clinical trials, which include more timely data, improved flexibility for patients, and increased speed. Among other notable impact were: high quality data, increased protocol compliance, improved retention, robust data, improved patient engagement, increased visibility into the clinical trial, and improved recruitment.
Current paradigms must be continuously challenged by emerging technology and by all stakeholders (the new generations of scientists, physicians, the pharma industry, regulatory authorities and, most importantly, patients). Today, we have an opportunity to observe how routine clinical care and clinical trials can work synergistically for the betterment of humanity.
Profile of Dr. Kiran Marthak, Medical Affairs, Phase I & Regulatory Affairs, Veeda Clinical Research
In the Indian Clinical Research industry, Dr. Kiran Marthak is one of pioneering leaders with a fabulous list of accomplishments and a rich experience of more than four decades.
Dr. Kiran Marthak has conducted numerous Phase 1 studies including First in Human studies, and complex clinical trials and has held senior positions in several Indian and Global pharmaceutical companies such as Ciba – Geigy (Novartis), GSK, Pfizer and Ranbaxy. He has very rich experience in conducting clinical trials across several geographies including USA, UK, Europe, China, Japan and South Africa. Dr. Marthak is highly respected amongst regulatory authorities for his knowledge of international clinical research guidelines. He is one of the accredited members for GCP training by Clinical Development Services Agency (CDSA), India and contributed to the New Clinical Trial Rules implemented in March 2019.
Dr. Marthak is a qualified M.D. in Internal Medicine from Grant Medical College, one of the oldest premier and pioneer medical institution run having 175 years of existence in the country. Additionally, Dr. Marthak is a Fellow of American College of Clinical Pharmacology, Fellow of Royal Society of Medicine, U.K. and Fellow of Faculty of Pharmacology, University of London. He has been awarded with ‘Vishist Chikitsa Medal’ in 1994, by the Association of College of Chest Physicians, India, (“ACCP”) in recognition of his services and was accepted as the honorary life member of the ACCP.
Dr. Kiran Marthak, a veteran in the Indian Clinical Research industry has more than four decades of experience in conducting clinical studies. Has held senior posts in Ciba-Geigy(now Novartis), GSK, Pfizer and Ranbaxy.
He has very rich experience in conducting clinical trials across several geographies including USA, UK, Europe, China, Japan and South Africa. Dr. Marthak is highly respected amongst regulatory authorities for his knowledge of international clinical research guidelines. He is one of the accredited members for GCP training by Clinical Development Services Agency (CDSA), India and contributed to the New Clinical Trial Rules implemented in March 2019.
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