Clinical trials are the engine room that powers our ability to deliver new treatment options to patients. The rigorous testing and resulting data that help us understand how new treatments work are what propels our industry forward.
But the engine room has flipped a switch. Governments have brought in various measures to reduce the number of COVID-19 infections and to help health systems cope with related pressures. The impact of these measures, compounded by pressures on supply chains, coupled with new recommendations from regulators on managing clinical trials, as well as companies’ own internal reprioritisations, have created a perfect storm in R&D. Nearly 700 trials have been affected at the last count – including delays and disruptions to ongoing trials and cancellations or revisions to planned ones – and more changes are expected.
Furthermore, many healthcare providers have been pulled in to support critical care needs or at-risk patients, leaving less time and resources for clinical trials. With many patients unable to visit clinics, uptake of telemedicine is flourishing, which is a positive step forward but also creates its own set of challenges in data collection. Nonetheless, increased adoption of telemedicine, realworld evidence practices and different types of outcomes could help recalibrate perceptions of acceptable – and approvable – trial results.
But in the meantime, delays to data availability – combined with medical conferences postponing and/or moving to virtual formats – are requiring many companies to rewrite their congress and publication strategies. We need to take new approaches in determining how, when and where to share data with target audiences, while ensuring timely and transparent communications. In addition to changing the playbook of how we communicate with those approving, prescribing or taking medications, we also need to keep advocacy groups, investors and internal colleagues informed of changing plans, particularly as launch timings may be delayed.
In short, it is clear that nimble strategic planning and effective communications will play critical roles in navigating through these choppy waters.
COVID-19 R&D
While research into many conditions and diseases is faltering, one area of R&D has quickly accelerated: more than 300 companies and institutions are now researching COVID-19 related tests, treatments and vaccines – with 1,000 clinical trials of both novel agents and repurposed drugs.
Regulatory authorities are actively supporting trials for the treatment or prevention of COVID-19. The CHMP is calling for large, randomised controlled trials that are powered to draw clear conclusions on the best therapeutic options. European regulators are requesting robust methodology in trial designs and a harmonised approach to data collection to make the best use of potentially limited investigational products.
The US FDA also quickly mobilised by launching its Coronavirus Treatment Acceleration Program (CTAP). The FDA claims it will respond to new clinical trial applicants within a day and provide realtime input into applications, although requests are triaged based on the likelihood the investigational product could play a major role in managing the pandemic.
But even in these uncommon times, our emphasis on scientific rigour and a patientfirst approach must remain steadfast. Demonstrating the efficacy and safety of viable interventions, establishing the ability to scale-up manufacturing and distribution, and ensuring rapid and appropriate access are all key to demonstrating our commitment to patients and the people who care for them.
It is apparent the pandemic will have a far-reaching impact on clinical trials, which will ripple out to all areas of our industry. Our immediate focus should be on protecting the integrity of ongoing trials and ensuring study participants know about changes to trials and how we are protecting their safety. In the medium term, we will have new opportunities to spark greater creativity in communicating results and hopefully new best practices in trial design and regulatory requirements. In the longer term, there will be an R&D pipeline that looks quite different from today’s, and there are steps we can take to prepare now. At every time point, clinical trials will continue to be the engine room that propels medical innovation forward.
AXON Communications and Hanover Communications are part of AVENIR GLOBAL, a powerhouse firm of specialist healthcare communications agencies. They explore the implications of the pandemic on clinical trials for the pharmaceutical and medical device industries on their Ripple Effect site: health.avenir.global.
