Dr Steve Cutler
Chair, Association of Clinical Research Organizations (ACRO)
The global COVID-19 pandemic has created a fundamental shift in the way we run clinical trials, this momentum could help change the future of research.
The rapid outbreak of COVID-19 presented unprecedented global challenges. The eyes of the world were on our industry as we mobilised to help develop new diagnostics, vaccines and treatments in response to the crisis.
We witnessed unparalleled collaboration and speed of response from biopharma, CROs, tech companies, sites, investigators and regulators. As a collective, we pivoted to adapt the ongoing portfolio of clinical trials and initiated trials that would quickly and effectively prove the new vaccines and treatments were safe and effective.
The innovation, agility and resilience in advancing vaccine and treatment programs rapidly provides a blueprint for improving the efficiency and output of clinical development going forward. We now need to maintain the pandemic-inspired momentum and not fall back into old practices.
Adopting decentralised trials
One notable area of opportunity going forward is the accelerated adoption of decentralised clinical trials (DCT) and the use of remote monitoring to support the collection and verification of study data. This approach enables a more patient-centric approach to trials allowing a less burdensome patient experience, using technology which now has the power to objectively measure many key study data points.
Actively progressing decentralised and hybrid trials will enable the democratisation of clinical trials, increasing access to more patients and the inclusion of more diverse populations.
Clinical teams can also review accumulating data remotely online, thereby certifying the validity of the data that helps to affirm the safety and efficacy of the drug or vaccine being tested. Actively progressing decentralised and hybrid trials will enable the democratisation of clinical trials, increasing access to more patients and the inclusion of more diverse populations.
Improving the validity of outcomes
By focusing attention on areas such as DCTs going forward, we can shift clinical development towards a less centralised model that encourages the involvement of patients and fundamentally improves how we conduct clinical trials to ensure better and more valid outcomes.
I am optimistic the pandemic will be a significant turning point in the way clinical trials are understood and embraced by the public and in our ability to build further efficiency into the clinical development process.
We have a great opportunity to apply the experience gained and build on what we have achieved over the last year, helping us deliver on the industry mission to bring treatments and devices to patients faster. Let’s take it!