The COVID-19 pandemic is having a huge impact on families, businesses and healthcare systems worldwide. Large healthcare companies such as Lilly, Novartis and Roche to name a few, are in the process of investigating existing approved therapies for the treatment of hospitalised COVID-19 infected patients suffering from very severe and life-threatening symptoms.
As the race to identify an effective treatment for COVID-19 continues, Global regulators are assessing how data generated in the real world could complement clinical trials in order to improve efficiency of the assessment process.
To increase the efficiency of the regulatory process in order to make an effective treatment available in a timely manner, the EMA are reviewing a number of processes and providing guidance to healthcare companies to support robust data generation. A workshop recently facilitated by the EMA with participants representing 28 medicines regulatory authorities globally, and the World Health Organisation, discussed the importance of observational studies as one of the key tools in evidence generation for COVID-19 therapies. Observational studies can be utilised to monitor real-world efficacy of medications and vaccines and address important knowledge gaps that cannot be filled by clinical trials.
Healthcare companies implementing clinical trials to assess efficacy and safety of their asset for COVID-19 should consider observational studies as part of their armamentarium. A real world data set would support development of a robust evidence package in order to facilitate an efficient regulatory review and ensure that a treatment with demonstrated safety and efficacy is available to those that need it as quickly as possible.
A link to the EMA press release entitled “Global regulators discuss observational studies of real world data for COVID-19 medicines” can be found here.