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How the pandemic is helping biopharma break bad habits
In its current form, the pharmaceutical industry is doomed by its own bad habits, leading to spiralling costs and lengthy delays in bringing products to market.
But Covid-19 is forcing the industry to reexamine long-held beliefs and find new solutions to lower costs and speed up drug development.
In Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic, a timely new book edited by Dr Peter Schueler, Senior VP Drug Development Services, Neurosciences, at ICON plc, authors explore how, by learning the right lessons, the industry and wider society could be entering a golden age of drug development.
Presenting a selection of completely updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials, Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic is a concise, necessary investigation on best practices, alternative study concepts, the design of “virtualized” protocols, and moving from data to decisions. Pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design will all find this an essential resource.
As author Dr. Wolfgang Renz writes in his chapter, “The current approach to bring a drug to market includes 6–9 years of clinical development and additional costs related to increased regulatory requirements, cost-effectiveness studies, high recruitment costs, and accounting for subpopulation needs in study design. The evolution of technology in domestic and international settings requires diversity, necessity, and technology innovation. To deliver true, sustainable innovation to clinical trials, these three elements should be assessed across the field of burgeoning products and processes.
With the convergence of mobile and electronic health, social media, and big data, the current model for developing novel medicines sees important changes: adjacencies, such as point-of-care devices, telemedicine, and portable and wearable technologies enable manufacturers to accelerate the development of innovative medicines. The phase II and III randomized control trials must be contextualized in the framework of real-world medication outcomes and thus must leverage from existing investments in health technologies, including social media, health informatics, telemedicine, biomedical innovations, mobile applications, and wearable monitors.”
To read more about exciting ways to conduct clinical trials now an in the future, visit the Elsevier website at https://www.elsevier.com/books/innovation-in-clinical-trial-methodologies/schueler/978-0-12-824490-6 or the ICON website at https://www.iconplc.com/insights/transforming-trials/innovation-in-clinical-trial-methodologies/index.xml
As well as working at ICON, Peter is board certified in Neurology and in Pharmaceutical Medicine (Swiss Medical Association) and lectures Drug Development Methodologies at the Universities Duisburg-Essen, Germany and Basel, Switzerland.
Biomedicine & Biochemistry
The disciplines of biomedicine and biochemistry impact the lives of millions of people every day. Research in these areas has led to practical applications in cardiology, cancer treatment, respiratory medicine, drug development, and more. Interdisciplinary fields of study, including neuroscience, chemical engineering, nanotechnology, and psychology come together in this research to yield significant new discoveries. Elsevier’s biomedicine and biochemistry content spans a wide range of subject matter in various forms, including journals, books, eBooks, and online information services, enabling students, researchers, and clinicians to advance these fields. Learn more about our Biomedical and Biochemistry books here.