How COVID-19 is impacting clinical trials and what post-COVID trials might look like
Clinical trials are an integral part of the discovery and development of treatment options for various health conditions. Everything from acetaminophen to zolpidem has had to go through a highly regulated clinical research process to be approved. Clinical studies are of pivotal importance to ensure the safety and effectiveness of treatments and also guarantee that medications are approved for the patients who need access to them.
Over the past few years, clinical trials have dealt with several challenges, with the fundamental success and completion of clinical trials continuing to be the number one issue for clinical research today. This is such an issue due to patient access, trial adherence and a lack of real-time monitoring. The following statistics represent the effect of these challenges: on average, 86% of clinical studies fail to meet their recruitment targets; 80% were delayed significantly; and the average dropout rate remains around 33%.
The current situation: clinical trials during COVID-19
On top of already existing challenges, COVID-19 has influenced clinical studies this year by forcing them to pause with no clear timeframe on when these trials will be able to resume. According to a recent Medidata study, there was a 67% enrollment decrease in March 2020 when compared to March 2019 in the US. Pfizer, GlaxoSmithKline, Merck, Bristol-Myers Squibb, and Eli Lilly have all publicly announced a delay or pause in a series of clinical studies due to the pandemic.
The future of clinical trials after COVID-19
In these uncertain times, new ideas on how clinical research might proceed in the future and how they can successfully resume trials are being discussed more widely. An increase in the uptake of technological solutions in clinical trials is one key driver that can potentially determine the path for clinical research in the future. This, combined with regulators and clinical trial sponsors showing significant thoughtfulness and flexibility for innovative, non-traditional approaches, gives us hope that the clinical protocol of the future will emerge triumphantly. How exactly this will play out is hard to tell at this point; however, there are emerging trends that have been identified that will define “the new normal” as Sy Pretorius, EVP, Chief Medical & Scientific Officer at Paraxel described it. Some key drivers can be found that will enable clinical trials to commence, continue and succeed after the pandemic’s long pause effect.
Telemedicine will play a critical role in this innovation as it will allow "virtual-study visits" using new mobile apps from the comfort of the patient’s home. Leveraging smartphone technology to allow for telemedicine check-ins with research sites managing the study will enable patients to stay more engaged, and can reduce drop-outs as well.
In-home support services
Support services such as home nursing to provide injections, administration of essential medication and other clinical protocol requiring sterile procedures will help ensure the safe delivery of treatment options as well as capture essential data in the convenience of a patient's home. In addition, "direct to patient" shipments will allow patients to have treatment options delivered to their homes.
Decentralized clinical trials
These trials will continue to evolve as the clinical trial ecosystem is experiencing a substantial change due to the pandemic. A combination of patient awareness and site acceptance of decentralized solutions will play a pivotal role in the expansion and innovative solutions of clinical trial decentralization.
Patient- centricity will continue to be at the forefront of this new, clinical trial landscape. Patient safety, privacy and preferences will continue to define the rate of innovation of clinical research as the ecosystem moves towards a more virtual experience.
Enhanced patient recruitment and engagement through digital solutions
Digital solutions will continue to transform every stage of clinical research. New and innovative ways to recruit qualified participants, keep participants engaged and compliant throughout the clinical trial lifecycle, and better tools for data collection will result in better clinical trial experiences and higher patient engagement.
Here at Citruslabs, we've created the ideal patient recruitment dashboard to help any researcher improve their current metrics. With over 3 million patients on record, we ensure research sites are connected to a thoroughly educated and engaged pool of participants; so, it is no wonder why we have such high patient confidence! Now, we would say that other models are available - but this would be a lie. In fact, unlike that offered by other patient recruitment companies, our easy-to-use dashboard is the first-of-its-kind for the market; giving researchers a unique insight into their patients’ wants and needs via industry-leading technology. The future of clinical recruitment starts here.
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