Navigating Change in Clinical Trials with Adaptive, Risk-based Solutions
The need for more digitalized, risk-based approach to clinical trial monitoring is a generally accepted reality in the life sciences and regulated health products industry. But with COVID-19 placing increasing demands on speed to market while simultaneously reducing the efficiency of traditional clinical trials, the transformation takes on a new urgency.
The clinical trial industry, historically methodical, organized and regimented is now scrambling to respond to a rapidly changing environment. The need for a flexible, risk-based approach has never been more apparent.
Suddenly, the life science industry must resource a remote, risk-based monitoring strategy that bridges data management, statistics, medical safety and clinical operations disciplines to gauge protocol risk through analytics. This is in addition to the ongoing obligation to evaluate site compliance, ensure human subjects protection and deliver data accuracy.
If your head is spinning, you’re not alone. The entire trial monitoring workforce must pivot while dealing with the largest global health crisis in living memory.
What follows is a forward-looking, pragmatic view on the transformative impact of emerging trial models, technology innovations and centralized monitoring roles on the clinical research monitoring workforce.
New Approaches Based On Emerging Trial Models
Decentralized and hybrid clinical trials emerged as a leading methodology to address the challenges associated with COVID-19, including the increased demand for patient-centric research.
This trial model relies on various digital platforms such as user-directed health technology (mHealth, wearables, ePROs), electronic clinical outcome assessments (eCOA) and telemedicine to gather data without requiring in-person participation that may put subjects at risk for COVID-19 transmission.
While the benefits of decentralized clinical trials are many, operationalizing the trial and aggregating vast data outputs presents challenges to the current Clinical Research Associate (CRA) workforce. Experience with decentralized methodology is limited, and compliance expectations are still developing. This adds a layer of complexity which require CRAs to adapt swiftly to new monitoring methodologies as well as undefined expectations and requirements.
To remain effective and relevant, the CRA should be adaptive and develop skills that complement the evolving needs of clinical development. They must have regulatory awareness, specifically ICH E6 R2 guidelines as they relate to risk-based clinical trial monitoring. CRAs should also possess basic understanding of the risk management framework as it applies to study procedures and interventions.
CRAs should be able to identify monitoring strategies that adequately assesses compliance in newer areas such as remote consenting, remote enrollment, telemedicine and home health care visits.
Upskilling the CRA workforce to better address all of these considerations is a massive, but necessary, industry-wide undertaking.
New Capabilities Activated By Technology Innovations
Technological developments modernized the monitoring workforce, but also require additional capabilities beyond the typical Electronic Data Capture (EDC) or Clinical Trial Management Software (CTMS) systems. An exponential increase in data sources and volume drives the need for enhanced data aggregation, formatting and analysis.
Risk-based monitoring technology offers organizations a real time, holistic way to view and analyze data. It can detect errors, trends and anomalies in trial data that may significantly impact study integrity. Such platforms offer objective measures of site performance and in return, the CRA should be skilled to interpret metrics and establish a plan of action to improve performance, as necessary.
There are many advantages to implementing this new technology, however the monitoring workforce must gain familiarity with new data sources, understand their limitations/risks, and anticipate the infrastructure required (e.g. participant training, supply management, etc.) for successful site management and monitoring.
As a whole, clinical research professionals will need to adapt and embrace the new visibility gained through enhanced technology and devise appropriate processes to support these functionalities. New Roles To Address Operational Necessity Centralized monitoring is a risk-based strategy that involves remote evaluation of clinical trial data, often by a cross-functional team.
- Mechanical, piping and packaging layout design drawings
- Drafting and design of construction documents, including equipment layout, non-building structural steel, piping systems layout, custom equipment design, equipment research and testing, and vendor drawing checking
- 3D modeling and drawings of equipment and support structures
- 3D modeling of new products and packaging in support of R&D efforts
- Management/coordination of contractors supporting capital projects