COVID-19: EMA Tackles Trial Data Interpretability
Sponsors Should Assess Likelihood Of Delivering Interpretable Results
Executive Summary
A draft EU guideline explains how companies can ensure that data from ongoing clinical trials remains relevant for regulatory decision-making despite problems posed by the COVID-19 pandemic.
You may also be interested in...
EU Addresses Clinical Trial Integrity Concerns In Face Of COVID-19 Crisis
EU guidance offers high-level recommendations on the steps that clinical trial sponsors should take to assess the impact of COVID-19 on the quality and reliability of data being generated in ongoing studies. Early scientific advice is recommended if changes must be made to existing protocols or data analysis plans.
Parexel Execs On How To Adapt Clinical Studies Amid The Pandemic
Parexel executives tell Scrip about the company’s efforts in tandem with sponsors to navigate the challenging clinical research environment amid COVID-19. A renewed interest for decentralized trials or hybrid approaches and the use of remote monitoring and telehealth visits to keep studies moving are some of the key initiatives.
EU Urges Sponsors To Assess COVID-19 Impact Before Starting New Trials
New EU guidance on managing clinical trials in the context of COVID-19 requires sponsors to critically assess the feasibility of starting a new clinical trial or including new participants in an ongoing trial. A separate survey indicates that patient willingness to participate in new trials has dramatically declined due to the pandemic.