How to Overcome the Disruption of Clinical Trials 

The pandemic’s most obvious impact on clinical trials has been the suspension of enrollment during periods of high-contagion risk

Sponsors and clinical research organizations (CROs) are continuing to deal with entirely new processes and a world with ever-evolving travel restrictions, fearful patients, and data collection. There are also a unique set of challenges that have come along with hospitals at capacity, for example, the cutbacks in elective surgeries and other hospital services have affected the tumor banks that store cancer samples for use in additional research.  

While some concerns have waned over time, there is a consensus that the COVID-19 virus is here to stay, and disruptions to clinical trial processes are still possible for the long term. However, despite these possible disruptions, the industry must continue innovating to improve patient outcomes by adapting when faced with challenges. 

Here are tips for clinical trial professionals to mitigate and overcome continued disruptions.  

Understand and evolve with the situation 

Uncertainty is our new reality, and adaptability is the name of the game. A key component to dealing with disruption is to fully understand the situation and keep clinical teams updated on changes.  

Instead of taking a reactive approach and waiting for new regulations or restrictions to drop, flip your tactics to be more proactive. Work with industry partners, experts, or third-party vendors to keep you updated while you continue to focus on other critical clinical operations and meeting the needs of patients.  

Patients also play a critical role in the evolving situation. Keep lines of communication open to help them understand what kind or participation is expected.  

For example, is the trial moving to a hybrid or decentralized format? Have timelines been adjusted? Anything that impacts patients should have a high level of transparency.  

One area that can help maintain a proactive and transparent approach is the use of innovative technologies.  

Shift to virtualization and the cloud 

According to our recent survey, only one-third of organizations ranked themselves on the high side of the technology adoption scale, characterized by respondents as clinical tech innovators or early adopters. The reality is: the clinical space is traditionally risk averse, which means that new technologies can be perceived as too risky.  

However, adopting cloud technologies and automation is crucial to the future of R&D, safety, and efficacy of clinical trials. To accelerate the adoption of clinical trial technology, contract research organizations (CROs) should focus on three key steps: 

  1. Define operational success metrics that show how automation accelerates time-to-market and reduces costs.  
  1. Upgrade in-house technology and analytics expertise.  
  1. Ensure that a technology pilot program is in place and includes funding for full implementation.  

Often, clinical trial technologies are implemented but then abandoned due to a lack of buy-in and training. However, these innovations help to reduce friction in the entire drug development process.  

For example, modern platforms use artificial intelligence and automation to manage the end-to-end R&D process in a single cloud platform. This platform unifies data and documents, streamlines collaboration, and stays current on the latest regulatory compliance standards to future-proof the entire system.  

Maintain quality  

The final key way to overcome the disruption of clinical trials is to maintain quality. High quality processes, people, and outcomes will lead to success.  

Adopting more advanced tech, properly training your staff, removing friction in R&D processes, and keeping a level of transparency all goes into a quality experience and breeds quality outcomes.  

Producing high-quality drugs and treatments quickly and keeping them on the market doesn’t end when a pandemic starts.  There’s a massive opportunity to leverage automation to improve compliance and quality and ultimately save more lives. Who wouldn’t want to be a part of that?  

Clinical executives can’t circumvent disruption, so they shouldn’t shy away from technology. It’s time to lean on the innovation and proactive processes that lead to success.  

About the Author 

Art Brown is the Director of Product Marketing, LifeSphere Clinical at ArisGlobal. Art has 17 years of marketing experience, primarily serving in health IT solutions, PBM/pharmacy services, care delivery models at companies such as CVS Health MinuteClinic, and now life sciences. He applies his experience to help life sciences organizations understand the true value SaaS-based clinical solutions can bring to their organizations and ultimately, the patients they serve. 

Featured image: ©Paulista