Clinical Researcher—November 2020 (Volume 34, Issue 9)

GOOD MANAGEMENT PRACTICE

Erin L. Pennington

 

Clinical trial management systems (CTMSs) and electronic institutional review board (eIRB) systems have been staples in the information technology (IT) landscape of research organizations and supporting the operations for clinical trials and local IRB offices for more than a decade. Despite the evident overlap of data fields, many organizations lack meaningful integration between the two and still question the potential return on investment (ROI) for pursuing such integration. As electronic regulatory (eRegulatory) systems grow in popularity, even those organizations with some level of IRB and CTMS integration may find themselves reconsidering their approach, especially as funding and resources tighten in response to the COVID-19 pandemic.

It’s important to note that while most of the top commercially available CTMS and IRB systems support at least some level of integration, if your current systems are home-grown, outdated, or highly customized, additional discussions may be needed with your IT professionals and vendors to assess technical capabilities and determine if upgrades or modernization efforts may be required first.

Where to Begin?

Historically, many organizations have abandoned integration plans because the appropriate directional flow of data was unclear. For example, should the CTMS feed the IRB, or should the IRB feed the CTMS?

Many clinical trials will be considered at a site that may never progress beyond the proposal stage. Nevertheless, the trials are entered into CTMS to track the processing of non-disclosure agreements, feasibility/scientific committee reviews, or funding proposals. At the same time, premature submission into the eIRB system can create extraneous records, potentially impacting IRB volume and turnaround metrics.

Furthermore, not all IRB submissions should necessarily result in a CTMS record. Typically, the CTMS will contain only a portion of the research that might pass through an IRB. If one allows for direct entry into the IRB system, it is challenging to enforce entry into the CTMS without risking duplicative submissions.

There can also be financial implications for investigative sites. Many studies are needed in the CTMS for tracking purposes well before a funding source is even identified, and IRB submissions often incur fees. Many CTMS vendors use a tiered maintenance fee structure, so adding CTMS records purely as a conduit for IRB submission can unnecessarily inflate CTMS ownership costs.

Additionally, defining even simple data fields can create unforeseen challenges. For example, consider a principal investigator (PI) change on an industry-sponsored trial. Should the CTMS update the PI when the IRB approves it or when the clinical trial agreement is amended? The answer may change depending on how the CTMS is leveraged for sponsor invoicing and existing or planned integrations with electronic resource planning and grants accounting systems.

There isn’t a clear, one-size-fits-all answer.

 Reasons to Persevere

With all these challenges and the need for a distinct workflow and adherence to detailed procedures related to submission, it’s easy to see how organizations could conclude that pursuing integration is not worth the investment of resources. However, there is much more to the business need beyond the initial submission.

Considering that the average study goes through numerous protocol and administrative amendments, the ongoing maintenance of IRB information into the CTMS creates a significant administrative burden. There is, in fact, much to be gained by leveraging the CTMS for regulatory support:

• Metrics tracking. Turnaround times for regulatory submissions and approval are critical components of monitoring activation times.
• Compliance. CTMS features often allow for the identification of delays in amendment submissions, suspended enrollment status, outdated consent versions, and expired approvals.
• Resource efficiency. A central regulatory team can improve compliance and free up study coordinators to focus on study conduct. The ability to track the receipt, submission, and status of regulatory documents is vital to supporting communication between research and regulatory teams.
• Sponsor invoicing triggers. If the CTMS is used for sponsor invoicing, all those regulatory submissions, continuing reviews, and amendments have associated administrative fees. The CTMS is a convenient way to track this activity and ensure this revenue is captured.
• Document and information transparency. Provide ready access for staff outside the approved IRB research team—investigational pharmacy, clinical research associates, research cores, hospital, and financial and administrative staff.

The cumulative burdens tip the scales in favor of integration. Maintaining two systems in parallel results in considerable and wasteful efforts. Namely, the resource time needed for data entry on every staff change, amendment, continuing review, and reportable new information into both the CTMS and the IRB system becomes excessive, as does the frustrating cycle of downloading documents from one system just to upload them into another (and the quality control mechanisms that must be implemented to ensure this manual process is executed correctly).

Organizations that also have an eRegulatory system experience even greater burdens, including maintaining iterative versions of documents that may be needed in addition to final approvals. Regulatory and research teams must keep all these systems, each with unique needs and purposes, in alignment. Yet, none of those systems, alone, perfectly addresses the challenge of getting information and study documents to the right place, at the right time, for the right people.

Support for Seamless Integration

With the arrival of the global pandemic, research organizations are facing renewed cries to do more with less. Budget constraints and hiring freezes compound the already-significant challenges of managing a remote workforce.

While the cost to implement and maintain a CTMS systems varies widely based on selected vendor and delivery model (e.g., SaaS, hosted, onsite) initial investments upwards of a million dollars are not uncommon. In comparison, the cost of web-based integrations, even fairly extensive ones, can be done for around the average annual salary of a full-time regulatory coordinator. As vendors adopt standardized integration frameworks (e.g., HL-7, IHE) these costs will likely come down.

CTMS and IRB integration can provide much-needed efficiency improvements, reduce work redundancy at investigator sites, and improve recovery of clinical trial revenue. Further integration with eRegulatory systems can facilitate remote monitoring access for sponsors, therefore avoiding potential delays in sponsor reimbursements. Set up correctly, integration between CTMS and IRB, with or without an eRegulatory system, will more than deliver a significant ROI.

Engaging with an experienced organization that knows the logistics and nuances of clinical trial administration and management can help organizations realize this ROI much more quickly. Further, a trusted partner can help ensure each organization is not “reinventing the wheel”—especially in an environment that is so complex and driven by regulatory requirements.

Erin L. Pennington is a Director with the Huron Consulting Group in Houston, Texas, where she specializes in clinical research operations and infrastructure development and CTMS implementation and integrations.