6 key clinical trial trends that we should embrace and build on
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When penicillin was discovered in 1928 by Alexander Fleming, the average clinical trial time was 12 years. In 2021, the average industry trial time is 10 years, an improvement of only 2 years. In almost a century, there have been no advancements that have delivered a substantial change to how clinical trials are conducted.
While the Covid-19 pandemic itself had a devastating impact on trials around the world, the disruption it caused also carries with it the chance for innovation. The urgency and acceleration to adopt new ways of working caused by the pandemic is also an opportunity. By maintaining the innovation mindset that initially came from necessity, the industry can drive durable, sustainable innovation with the potential to transform the clinical development model. Here are 6 key trends that we should embrace and build on moving forward.
The first key trend that should prevail is a mindset of not “just in time,” but “just in case.” By proactively thinking about what might go wrong and building “disruption-proofing” steps into trial protocols from the very start, teams can pivot more quickly, minimizing interruptions for staff, investigators, and most importantly, people participating in the clinical trial.
Secondly, the pandemic forced the industry to quickly move as much of our business to virtual as possible, with teams conducting site visits and investigator engagement remotely. Even as regulations ease, we are seeing that sites, investigators and patients are all embracing virtual as the new norm. Industry should follow suit and continue to include activities such as remote monitoring and digital patient solutions into trials where appropriate.
Embracing virtual solutions will also help support the third key trend – home is the new trial site. With many sites becoming Covid treatment centers, it became both difficult and potentially dangerous for some clinical trial patients to go to the hospital. Implementing tactics around this trend, teams worked to set up solutions such as in-home nursing programs or direct to patient shipments of their study medication. These are options that patients may prefer, regardless of restrictions, and many trial sites have now expanded their capabilities to accommodate these services. Therefore, we need to prioritize building assessment of decentralized clinical trial elements, such as home nursing, direct to patient drug delivery or telemedicine options, into trial protocols.
That commitment to patient preferences leads to the next trend – the rise of the patient as a consumer. During Covid, industry and various teams worked at an almost individual level to ensure every clinical trial patient had access to their treatment. Why should this end? The needs of each patient are unique and it is up to us as researchers to develop flexible trial engagement options that reduce their burden. In fact, based on the changes implemented during the pandemic, patients have the right to expect that trials can be structured to suit them, versus adapting their life to the trial. We believe the solutions, processes and technology that were put in place during the pandemic set a strong foundation of patient-centricity that all can continue to build upon.
The key underlying component that enabled teams to lead in the areas above is technology. Prior to Covid, clinical trials were a largely manual operation, requiring people to visit hospitals and sites. The situation mandated that companies embrace innovative solutions, including technologies that enabled remote monitoring and virtualization. Adopting these new technologies ensured that companies and teams could remain agile and sustain engagement with sites and patients to keep trials progressing while ensuring trial and data integrity. Therefore, the fifth key trend is the evidence that technology enables resilience during disruptions.
As described above, the pace of the pandemic caused pharmaceutical companies to very quickly make decisions and put solutions in place. In fact, as an industry we did not wait for guidance and instead focused on doing what was right for our patients, sites and investigators. By forging ahead and doing what was needed, the practices that we put in place were then followed and formalized by policy. This achievement illustrates the sixth and last key trend: let practice inform policy versus policy dictating practice. Collectively, we demonstrated to policy makers that we can lead and bring forward the right approaches, shifting our role from waiting for policy to shaping policy.
For the first time in almost a century, we have the opportunity to change the clinical development model. While each of these trends has potential on its own, by embracing them together we can create durable and sustainable change. For example, companies conducting trials for Covid saw the time it took for each stage of the trial – start-up, execution and close-out – reduced by as much as 10-fold. This is proof of what can be achieved. It is up to us to seize this moment where, as an industry, we can transform how clinical trials are conducted.