Clinical Research During COVID: How Enhancing Research Capacity With Technology Accelerates Drug Development
September 25, 2020
I recently had the opportunity to sit down with Sean Walsh to discuss the impact of research capacity challenges within today’s clinical research environment. What is research capacity exactly? In general, clinical research capacity refers to more efficient programs aimed at enhancing the timelines and data reliability of researchers to conduct clinical research.
The need to accelerate development timelines has intensified. Research staff have been burdened by multiple inefficient and difficult-to-use technology platforms. To pre-screen just one patient for a trial, principal Investigators, study coordinators, and ancillary staff must manually sift through multiple interfaces. Unfortunately, despite the best efforts of the industry, there has been little progress made to lessen the overload for critical research site staff resulting in ineffective improvements in enrollment rates.
As clinical researchers, we can only dream of having an instant solution to this very time consuming, but necessary process of finding the right patient for the right trial. While an efficient manual workflow process doesn’t exist for clinical researchers, we do have the power to apply an advanced technological tactic, shifting the inefficiency to a more productive outcome.
Key Barriers to Clinical Research Capacity
The challenge? Study coordinators exhaust valuable time reviewing physician notes to see if patients match the protocol criteria. “On average, a clinical research coordinator spends 30% of their time locating and reviewing patient records to match patients with the most appropriate trial,” says Sean Walsh, Healthcare Executive.
Currently, the EMRs that can search data have low accuracy rates due to searches only covering 30-50% of eligibility criteria. The resulting accuracy is ~10-15% based on industry average patient enrollment conversion rates. Due to the lack of inquiry precision, coordinators can spend up to 4-6 hours manually reviewing a single patient record for a phase II trial. Manual record review further translates into how often an excessive amount of time is spent on ineligible patients, resulting in opportunity costs that cannot be recouped by sites. To address this, the opportunity lies within the ability to impact a key metric in the entire industry — patient enrollment.
In addition to the time spent on pre-screening patients, sites also struggle with the lack of trial standardization and multiple platforms, such as Electronic Medical Record (EMR), Electronic Data Capture (EDC), training systems, Clinical Trial Management Systems (CTMS), eRegulatory, etc. that do not automatically transfer relevant data and trial processes needed for enrollment. This further complicates the research team’s responsibilities and delays patient enrollment due to the variance in communication.
Tactics & Benefits of Automation
Research sites, CRO’s and BioPharma companies can employ a variety of tactics in their pursuit of research capacity optimization. The solution for research sites and coordinators is the access to standardized data, specifically organized unstructured data. If obtained, this solution universally guarantees researchers and institutions a sustainable foundation to conduct clinical trials efficiently. The key is to combine unstructured and structured EMR patient data with workflow and the BEKhealth platform is a forerunner in this capability. BEKhealth has developed an easy-to-use cloud based or within the server environment solution that provides breakthrough clinical advances by increasing efficiency and reducing cost. Providing “real time” rapid trial feasibility analysis with an easy to use graphical interface.
This results in the following advantages for the research site:
- Higher Enrollment – BEKhealth’s EMR ingestion engine can comprehensively screen 100% of patients providing a complete patient trial match list.
- Faster Analysis – Results in seconds not days, supporting faster decision making.
- Accurate Results – Cover > 90% of study criteria, especially the difficult to determine variables such as medication history, lab results, comorbidities conditions and unstructured data.
- Increased Bottom Line – Maximize profits by only taking on trials that have a high probability of succeeding and by making existing research resources more productive.
“When Clinical Research Coordinators and Principal Investigators are supported with standardized data on a single comprehensive platform, like what has been developed at BEKhealth, the burden of administrative tasks will decrease while coordinator time spent on patient care will increase,” says Sean Walsh, Healthcare Executive.
While some clinical research sites and CRO’s are just starting to explore and understand this automation process, these types of technology solutions will continue to advance, putting into place an environment of more efficiently finding the “right patient for the right study” and it will be exciting to review this frequently to see how much progress has been made and who will be the forerunners in setting the best practices and solutions for enhancing research capacity.
About Sean Walsh
Sean Walsh is an experienced leader with a demonstrated history of working in the pharmaceutical and medical industry. Skilled in Clinical Operations, Patient Recruitment, Hospital Administration, and Public Speaking. Strong operational executive with a Master of Business Administration (M.B.A.) focused in Business Administration and Management.
Susan Spencer, Centricia Research Marketing & Media Solutions