As we head full force into the new year, we continue to track some rapidly evolving drivers that are impacting clinical research. Interestingly, many of the drivers of change are not new to the industry; however, there is a new and growing sense of urgency surrounding them.
2020 was a year dramatically shaped by the COVID-19 pandemic. For clinical trials to continue, research teams needed to pivot quickly. In many cases, it required completely restructuring their processes and supporting both remote study management and remote trial participation. 2021 will be no different.
The pandemic required teams to pause, assess, and redefine the way they interacted with each other as well as the ways investigators interacted with trial patients. Local and regional lockdowns continued to wreak havoc on trial sites. Site staff weren’t always allowed to return to clinics, patients were unable or unsure of scheduling physician visits. In many cases, clinical monitors were unable to travel too.
Although remote practices have become more routine since the beginning of the pandemic, greater flexibility and the ability to adapt to new constraints has become increasingly important to clinical trial teams. The demand for flexibility has penetrated every stage of trial conduct. In Top Strategic Technology Trends for 2021, Gartner Research Vice President Brian Burke refers to the demand for ‘organizational plasticity’ as companies implement new operating models and learn to pivot more efficiently. In the clinical research field, this requirement is paramount for success.
Along with flexibility, speed has also taken a priority position in clinical trials, particularly those related to COVID-19 products. Initiatives like the U.S. Government’s Operation Warp Speed were kicked off to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. Other government programs such as the regulatory pathway for Emergency Use Authorization are continuing to illustrate how shifting from serial to parallel processes across clinical programs can save development time in the race for new vaccines and treatments.
Additionally, sponsor partnerships such as the Pfizer-BioNTech and AstraZeneca-Oxford University have emerged and shown significant progress in very short time periods. As the world begins to see highly contagious, mutated strains of SARS-CoV-2, the virus that causes COVID-19, we can expect the need for speed to continue to be a top priority throughout 2021.
The pandemic, new remote work and trial participation models, and the necessity for speed have created a perfect storm that may be the beginning of a sea change in clinical research. At the same time, advances in medical technology and new and increasing numbers of data sources are making clinical study designs increasingly complex. All of these factors have combined to create a different set of expectations about how research is conducted, how trials are managed, how data is collected, and how patients interact with site staff. The new expectations assume a significant ability to pivot and adapt quickly and efficiently.
Expectations and demands on clinical trial teams are probably at an all-time high. To maintain the required degree of flexibility, clinical trial teams must use flexible technology platforms that enable them to maintain or increase speed without sacrificing essential flexibility. All of this must be done without reducing compliance and most importantly, without impacting the safety of trial participants.
In 2021, attention will continue to focus on pharmaceutical, biotechnology, and medical device companies and how quickly and efficiently they can deliver results. The expectations are high and tolerance for failure is low.
As a seasoned clinical technology partner, Mednet understands the complexities of clinical research and the competing requirements of flexibility, speed, and compliance. Though none of us could have predicted the pandemic in 2020, the Mednet team has always and will continue to prioritize flexibility, speed, and compliance in the iMednet product strategy. We are committed to helping our customers continue to innovate in a rapidly changing environment with flexible, scalable solutions that position them for success. To learn more, contact us.