Movement Towards Decentralized Clinical Trials
Sponsored by: GlobalData / Egnyte
- Clinical Trials
- Decentralized Trials
Date: 23 June
Days to go: 10
Time: 5pm BST / 9am PST
Challenges and Potential Adjustments for Decentralized Clinical Trials
COVID-19 pandemic has caused a major disruption in clinical trials worldwide. The disruption of clinical trials could be either due to delayed initiation of planned trials, temporary suspension of enrolment or slow recruitment of participants, and may potentially impact regulatory approval of innovative and lifesaving drugs for other diseases.
In the wake of these disruptions, the pharmaceutical industry is moving towards adapting new models to conduct clinical trials, including, but not limited to remote patient monitoring, adapting to virtual or decentralized clinical trials model and direct-to-patients drug delivery. The movement towards decentralized trials has been evident for several years, but COVID-19 has been a catalyst to enhance this movement. Decentralized clinical trials allow the collection of safety and efficacy data from study participants by using a range of digital technologies that require a minimum number of site visits. This can include telemedicine, wearable devices, eConsent, electronic clinical outcome assessments, and electronic health records. However, there are several challenges and changes that are required for successfully conducting decentralized clinical trials. This includes changing procedures, processes, and systems integration, as well as keeping up with the latest regulatory requirements. Moreover, decentralized trial models can be easily implemented only for certain diseases.
Based on B2B surveys and the clinical trials data, increased use of decentralized clinical trials is expected to be one of the emerging trends, not only to combat the disruptive impact of COVID-19 on clinical trials, but also to improve enrollment in clinical trials. However, this will require overcoming challenges and adapting to newer protocols to ensure that trial integrity and patient safety are maintained.
In this webinar Revati Tatake, Global Director at GlobalData, will present an analysis of clinical trial disruption due to COVID-19, how is pharma responding to the disruption of clinical trials and movement towards decentralized trials. Bonnie Bain, Global Head and EVP of Healthcare Operations and Strategy at GlobalData, will moderate a Q&A session following the presentation.
Global Director, Databases and Analytics
Revati Tatake, PhD, is the Global Director of Databases and Analytics at GlobalData in New York City, where she is responsible for the development and continuous enhancement of databases in the company’s Pharma Intelligence Center. Revati has diverse experience, both in academic research and the healthcare industry, where she worked on several research, drug discovery, and competitive intelligence projects across many therapeutic areas. Before joining GlobalData, Revati worked at Citeline, where she was involved in competitive intelligence and analytics of clinical trials and products in the areas of Autoimmune/Inflammation, CNS, and Ophthalmology. Previously she worked at Boehringer Ingelheim Pharmaceuticals for 13 years, where, she led drug discovery projects involving traditional high-throughput screening, as well as innovative approaches for gene and cell therapies. She is a co-inventor on many issued US patents and applications related to projects on cell and gene therapies. Revati holds a PhD in Tumor Immunology from the Tata Cancer Research Institute in Mumbai, India. She was also a postdoctoral fellow at the University of Connecticut Health Center.
Global Head and EVP of Healthcare Operations and Strategy
Bornadata (Bonnie) Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy at GlobalData. Bonnie has almost 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, including Data Monitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.
Key Learning Objectives
- Learn how COVID-19 has impacted clinical trials worldwide.
- Understand how the industry is finding ways to mitigate clinical trial disruption.
- Learn benefits and challenges for adapting to decentralized clinical trials model.
- Learn emerging trends and the outlook for clinical trials beyond the pandemic.
- Clinical Operations
- Clinical Research Organizations (CRO) Competitive Strategy
- Heads of Research and Development
- Suppliers of digital or remote patient monitoring devices
- IT infrastructure
- IT operations
- Data management; Clinical