Taking a Risk-Based Strategy Further

There probably isn’t a person on this planet that isn’t closely watching the current coronavirus (COVID-19) pandemic. Like everyone, I am concerned with the health of my family, our employees, our customers, and generally the people of the world impacted by this virus.

But it is in the face of such adversity that we need to ask how we can adapt for whatever uncertainty the future holds. If anything is certain, it is that there will be circumstances that will disrupt business as usual.

Disruption happens. Businesses need to be prepared for these disruptions and many have business continuity strategies currently in place. But, who could have predicted a global pandemic which has impacted every business sector and supply chain? Answer: No one.

Clinical trials are vital for evaluating and advancing medical and patient care. Today’s current situation is impacting how these clinical trials can continue operating safely and efficiently. Functions impacted include – but are not limited to – supply chain, patient safety, data integrity, patient retention, investigational product management, clinical trial monitoring and trial management in general.

All areas in clinical trial management have been impacted but specific to clinical trial monitoring, the current model must be modified to ensure that the clinical trials can continue to operate. Specifically, clinical trial monitoring must be adapted to ensure a risk-based strategy is implemented to manage all study-related risks but also to ensure that patient safety is addressed and that data integrity is maintained.

Here are a few observations in the current clinical trial monitoring model that need to be reconsidered in light of our current situation:

• Clinical trial monitoring is primarily based on physical movement of people. CRAs are moving from site to site. You only need a few flight disruptions and cancellations to cause issues. And now, CRAs are likely not able to perform site visits due the coronavirus restrictions.

• It can be retrospective and reactive. CRAs can only be at one place at a time. As a result, there is no real-time detection of site related issues. It might not be until the next site visit weeks later that potential risks are identified.

• It can separate research staff and critical medical/scientific knowledge. In most instances, the CRAs are the intermediaries between research staff and trial management and medical monitors. This “switchboard” means providing study related answers can take precious time that no one can afford. In the current environment, quick and real-time communication is essential to ensure continuity of care.

• It is dependent on paper. This requires that site staff physically refer to the regulatory binder for protocol-specific information. How will regulatory documents be accessed for verification if CRAs or site staff are not physically located on site? Specifically related to the protocol for quick reference, how will sites be ensured that they are utilizing the most current version available?

In consideration of the current circumstances and to bring us forward in confronting the current monitoring limitations, it is time to rethink the approach to monitoring and bring it into the 21st Century.

We can help. Here are some targeted solutions that I think can realistically improve the effectiveness of monitoring and address the inevitability of disruptions that will happen in the future:

• Rely less on face-to-face interactions. Utilizing a risk-based approach, CRAs will only be on-site to address any critical milestones and will have more time and bandwidth to assess critical to quality endpoints in-house rather than onsite.

• Streamline communication with research sites. CRAs and clinical trial management should have a proactive, simple and streamlined way to provide real-time updates rather than generic or passive means (e.g. in person visits, email, newsletters, etc.). This includes proactive information on study updates as well as answers to time sensitive questions.

• Measure the impact of the communication. Hope isn’t a strategy. When it comes to knowing whether study-related information has been effectively delivered and received and being actioned by the target audience, there is no room for guessing whether the PI or study coordinator got the message.

• Respond quickly to data that shows potential risk to the study. With less physical travel, CRAs can review data remotely in real time and respond to critical data points that are negatively trending and represent a risk to the study. In this model, we can further improve the quality of the trials and better protect patient safety.

• Have immediate access to the current protocol any time. Research staff and CRAs always need access to the right version of the protocol at their fingertips. This isn’t always practical or efficient with paper or PDFs in a portal. But real-time access to the right version at the right time is vital.

Out of any crisis, there is an opportunity to reflect on how we can better prepare for the future. We’ve seen how important it is to continually evaluate new ways of operating in light of this current situation. With the management of clinical trials, there are numerous strategies to be considered. Specific to monitoring clinical trials, it’s time to rethink the current model. Fortunately, with the smart use of technology, it is not out of reach to make changes in how clinical trials are monitored and we are well-positioned to rise up and meet the challenges imposed by COVID-19 and its impact on the management of clinical trials.

Andrea Parish

Quality Assurance Leader

Guest

Andrea is an accomplished leader with 22 years of comprehensive experience in the clinical research industry. A conscientious planner and manager of all aspects of customer expectations, she has a proven ability to lead teams to achieve focused results and creative solutions.