Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Decentralized trials - A survey of the regulatory and ethical environment when studies no longer take place in a traditional way

Elizabeth Abari (Abschlußjahr: 2020)

Summary
Language: English
When clinical trials take no longer place traditionally with a visit to the doctor and data approval by the investigator, but data collection and communication between doctor and patient take place virtually. Then the restructuring of the ethical and, above all, the regulatory environment is needed.
Clinical trials are a cornerstone of drug development; they generate data and also provide scientific evidence on the safety and efficacy of the drug, medical devise or process being tested. Unfortunately, they are slow, expensive, and inefficient at the same time.
Decentralized clinical trials are not new, but late progress in communication, data capture and transmission technologies have created opportunities to conduct decentralized trials better, as has local health care providers’ value in performing trial-related functions.
According to European law DIR 2001/20/EC, remote trials are not prohibited, but they are also not clearly regulated. There is an obligation to apply existing regulations to a new clinical research environment. Those regulatory considerations may vary, depending on the disease area, the type of investigations drug, and the types of trial activities that are decentralized. New roles and responsibilities for all stakeholders have arisen, and the regulations say little about these new and wider definitions.
Progress in remote or decentralized clinical trials has been hindered by a lack of guidance from regulators such as EMA or FDA. Moreover, a reluctance to invest in the technology needed to run such trials and to truly exploit the potential of telemedicine as a primary means of a health care plan.
The thesis aims to give a summary of the ethical and regulatory environment of current decentralized clinical trials and how the pandemic has accelerated this trend towards increasing digital and remote technology as a way to test new treatments. Furthermore, the exceptional level of regulator engagement and responsiveness has shown the art of possible for regulatory bodies and the industry if they work together to achieve common goals. The pandemic has reset the expectations that will framework the traditional clinical trial environment post-COVID-19.
Pages: 56
Annexes: 0