Violeta Georgieva
Manger, Legal Affairs and Healthcare, EuropaBio
The COVID-19 pandemic has been a catalyst for change which has led us to revisit the way we conduct clinical trials. As a result, there is now a greater variety of approaches with proven value for patients.
Traditional clinical research is conducted through the centralisation activities at a clinical trial site such as a physician’s clinic, hospital and laboratories. Patients taking part in clinical studies visit trial sites to meet their treating doctor for progress monitoring and to report any side effects.
With COVID-19, people’s willingness and ability to visit a hospital for non-COVID or emergency reasons diminished. Many patients participating in clinical trials were classified as vulnerable and advised to self-isolate.
Ensuring continuation of trials
Clinical trials needed to carry on to ensure patients’ access to potentially life-saving innovative treatments and collection of valuable data. Patient visits were often replaced by video or telephone consultations, investigations undertaken at local labs, nurses paying home visits for assessments and medication delivered at home. Such trials, delivering procedures and interactions directly to the patient, are often referred to as “decentralised trials” because the physical research site no longer serves as a centralisation of efforts.
Clinical trials needed to carry on to ensure patients’ access to potentially life-saving innovative treatments and collection of valuable data.
The necessary technology was already available before the pandemic, but there was hesitance due to lack of familiarity with use of remote features in clinical research. COVID-19 had a catalysing effect. The breadth and diversity of the experience gained is now vast – different types of trials, investigational drugs, investigators and sites in a relatively short amount of time. The research site maintains the same high level of oversight of the patient, quality of trial conduct, and data quality and security.
Changing future policy
This wealth of experience can inform regulatory policy for the future. Digital and remote technologies have an equalising effect in terms of opportunities for patients to take part in clinical research and access innovative treatments, whether they live close by or further away from specialist hospitals or centres of clinical excellence. Investigators who may have been unable to participate in a trial that required use of a physical site may now be able to engage in research.
We have never been more digitalised and technologically savvy – hence why this is the time to fully embrace technological innovation in the conduct of clinical research.