As clinical trial trials resume from pandemic-related delays and the industry begins to adapt to a new normal, sponsors should remain prepared for new and continued challenges as increases in COVID-19 cases in the United States, and other spikes in cases around the world will affect clinical trials in the coming months.
Many pharmaceutical and biotech companies have reported delays or postponements to clinical trials due to difficulties recruiting and treating participants, which, in turn, is a result of restricted travel and social distancing measures. In fact, a recent analysis by Medidata revealed that the number of new participants entering clinical trials remains 30 percent below where they were before the pandemic. Yet, it’s significantly higher than the approximately 70 percent decline in new participant starts in April.
In addition, most on-site monitoring of clinical trials has been delayed or postponed. Specific challenges facing clinical monitoring processes include tracking processes for visit schedules, protecting patient safety through compliant safety reporting, changing data collection modalities, and administering clinical outcomes assessments (COAs).
Also, many sites still use paper-based methods and have outdated or ageing technology infrastructures. However, incorporating newer innovations at sites and within trials requires protocol changes and site staff training for proper implementation, which can escalate costs. These challenges have been exacerbated by COVID-19, which has led to about a 30 percent increase in site costs due to sites being forced to adopt remote monitoring in response to inabilities to carry out responsibilities on-site.
As procedures typically carried out on-site continue to be managed remotely, sponsors will need to implement a remote clinical trial management strategy to mitigate further roadblocks that may arise and keep clinical trials moving forward.
Virtual from study start to data closeout through SMAs and electronic compliance tools
Incorporating remote monitoring, where on-site visits by a clinical research associate (CRA) are no longer viable, starts with reviewing study progress. Operational teams should review study-specific protocols and consider adopting remote services needed to reduce disruption to trial timelines, while staying compliant with local legislation.
Using a centralised site management associate (SMA) model, for example, can accelerate the adoption of remote and central monitoring. Located in regional hubs around the world, SMAs operate remotely (via phone or online) and serve as a single point of contact from the day a site is recruited until the day the study closes, thereby ensuring that site partners can always reach a knowledgeable study team member fluent in their own language and cultural context.
Through this centralised model, SMAs can remotely qualify and activate community study sites much more quickly than with traditional on-site support models. More importantly, SMAs can work with community sites to ease data submission. Where sites have electronic health records and data capture systems in place, much of the process can be automated, easing site administrative burdens. And finally, because disruptions to monitoring can have serious consequences for data validity, using an SMA model allows for remote source data verification (SDV), enabling sponsors to verify data without sending a CRA to a clinical trial site.
In addition to SMAs, sponsors can adopt automated regulatory intelligence and safety reporting solutions, ensuring compliance in an evolving regulatory environment and enabling visibility into the safety profile of a product throughout its lifecycle. Moreover, implementing remote management solutions can maximise health technology assessment (HTA) and health economics and outcomes research (HEOR) readiness and evidence generation planning. In addition, COA selection, design and validation can all be conducted remotely with the right strategies.
COVID-19 clinical operations
Keeping your clinical trial on track in an evolving environment.
Adapting operations to changing conditions
ICON has adapted its services to support sponsors during this time; offering remote monitoring where on-site visits were not permitted, providing additional support to get IMP to patients and pre-recording investigator meetings because of travel restrictions.
Treatment and vaccine trials for COVID-19
ICON is proud to be supporting clients and government organisations in the search for a treatment or vaccine for COVID-19. Download our whitepaper on Pandemic respiratory vaccine clinical trials.
Remote management in a post-COVID world
The coronavirus pandemic forced the acceleration of digital health technologies, remote monitoring and virtual trial strategies within the clinical trials industry. As this pandemic subsides, the benefits to remote management will continue to grow its adoption into post-covid clinical trial designs and protocols as mitigation strategies, eventually becoming the industry standard. As our world continues to shift to an increasingly virtual reality, adopting remote monitoring solutions into clinical trial designs — whether initiating a new study or restarting a postponed study — will be necessary to keep drug development programmes on track today and tomorrow.
For more information on how ICON’s processes, technologies and experiences can help sponsors shift to a remote monitoring model to avoid COVID-19 related disruptions, contact us.
To learn more about how digital health technologies are accelerating clinical trial transformation, read our latest whitepaper Advancing digital endpoints: an end-to-end approach to managing wearable devices through clinical developmentRead whitepaper