The Pandemic Push: Driving Disruption and Lasting Transformation in Clinical Trial Management
Mednet and MedTrials recently partnered on a webinar panel to discuss how the COVID-19 pandemic forced and accelerated innovative change in the clinical research industry. You can access the recorded webinar here. The panel, comprised of Rob Robertson, CEO and Jody Mehl, Solutions Director of Mednet, along with Lynn Van Dermark, CEO and Bridget Browder, Learning and Development Manager, of MedTrials, discussed the significant impact the pandemic is having on the industry and how it is challenging organizations to think and operate differently. Months of unplanned disruption are yielding collaboration and innovation that otherwise might not have happened or would have taken years to emerge. Research organizations and teams are being compelled to question longstanding practices throughout the planning, conduct, analysis and reporting of clinical trials.
Pausing for a moment to look back on the last couple of months, the group offered several recommendations on how teams can move forward and leverage learnings from the pandemic.
Challenge Linear Thinking
Step-by-step sequential approaches and linear thinking can help to identify the shortest distance between two points, but it can also restrict how teams identify and assess new options. The pandemic demanded that teams restructure, reform and redefine goals and realign responsibilities. Change can be very difficult for anyone, particularly risk-averse trial management professionals. However, it can also lead to enhanced creativity, increasing the quantity of options and opportunities. As the industry more broadly takes an adaptive approach to trial design, we must also consider a more adaptive and flexible approach to clinical trial management operations.
Targeted Source Data Verification (TSDV), parallel workflows, and remote monitoring all offer additional efficiencies; yet each also requires additional education. Monitoring plans can be amended to allow alternative methods but monitoring teams must be trained on supporting technologies and new approaches. The opportunity to access real-time data using enabling technology is significant. However, CRAs must challenge assumptions, break down processes, redefine how to manage sites in a more holistic fashion.
Make Technology Work for Us
Now is the time to optimize technology resources and take advantage of automation. The industry does not need electronic processes that mimic paper processes; it needs new digital processes to reflect new goals and encourage broader communication and collaboration. CRAs, CRCs and Investigators should be able to access dashboards and data and use reporting features that promote collaboration. All team members need to be trained on the technologies and how to get the most out of them. Meaningful dashboards and real-time reports can trigger guided discussions and provide more timely decision support.
Collaboration is Essential
The COVID-19 pandemic showed how quickly public/private partnerships can have an impact. Regulators devised new guidance to encourage innovative approaches and new approaches for novel medicines to be assessed more quickly, while continuing to prioritize prioritizing safety. We also saw how industry and health authority collaboration sped up standardization initiatives, such as when volunteers came together to create the CDISC Interim User Guide – COVID-19.
MedTrials and Mednet also collaborated on a product feature for iMednet that more fully supports remote monitoring. The combined teams identified and detailed the requirements for the modification of the source document upload field. It was quickly implemented to simplify the ability for site personnel to share key documents for remote review. We also discovered that adding a redacting capability would make it much easier to use so we are introducing that capability in an upcoming release.
As research organizations and teams look to increase collaboration, it is important to seek broad stakeholder input as well as offer more effective methods of learning. Talent development and adult learning will continue to be important foundational components of disruptive innovation and collaboration. The pandemic is providing the industry a glimpse of the possible. We now know that we can come together to rally around new goals, reshape, and rebuild new processes and encourage scientific innovation. We can see how flexible technologies can be used in more meaningful ways to automate and simplify complex processes. We embrace this opportunity and confirm our commitment to providing flexible technology solutions that address the challenges of today while positioning research teams to take on the unpredictable challenges of tomorrow.