What is the critical path?

Within the context of clinical trials, the "critical path" refers to the sequence of activities, tasks, or events that, if delayed or extended, would directly impact the overall timeline for the trial. 

These essential steps and dependencies must be completed in a specific order to ensure the trial stays on schedule. Any delay in the critical path can potentially lead to a delay in the entire trial, affecting its completion date and potentially increasing costs. Identifying and managing the critical path is crucial for efficient trial management and timely delivery of treatments to patients.

For a simpler example, take a look at how Monday.com describes the critical path within the context of building a house. “For example, if you’re building a house, the critical path might include digging the foundations, building the walls, and installing the roof. If any of these critical activities fall behind schedule the whole project gets delayed.”

For a visual example of the critical path, see the image below which shows how an organization cannot switch to a new system prior to sending out the communication and training plan.

eCOAs, the critical path, and Institutional Review Boards (IRBs)

Today’s clinical trials are increasingly relying  on eCOA and ePRO (electronic patient-reported outcomes) to drive precision outcomes and provide further evidence that the therapy is working as intended. 

Like all other aspects of a clinical trial, all COAs must be submitted to an IRB/EC before a trial takes place to ensure the safety, rights and well being of all human participants is maintained and protected.  This includes reviewing and approving all patient facing study materials, including eCOAs. 

For instance, the unavailability of patient-facing eCOA materials in a timely manner can impede ethics submissions, and the enrollment of the first patient at a site hinges on the readiness of the eCOA system to commence data collection. 

The IRB review process for eCOAs typically involves the following steps:

  1. Submission of materials
  2. Initial review
  3. Full board review
  4. Ongoing monitoring

eCOA deployment complexities 

Complexities in eCOA implementation often arise from the necessity to coordinate multiple service providers, each with deliverables dependent on the other. Key elements of eCOA implementation include:

  1. Securing License Agreements
  2. Linguistic Validation and Translation
  3. Platform Development
  4. Copyright Holder Approvals

The problem simplified

As previously mentioned, all COAs and eCOAs must be submitted to an IRB before a trial takes place to ensure the safety of all human participants.  

Because IRBs are charged with ensuring safety, the process of building, translating, and submitting eCOAs for review can often back up or force organizations to restart the path from the beginning. 

Since this process can never be removed from clinical research, Medable has found a way to facilitate this review in an expedited fashion. 

How Medable takes eCOA off the critical path

With Medable's eCOA technology platform solutions, clinical teams can transform eCOA from a potential bottleneck into a strategic advantage, accelerating study timelines and ensuring that eCOA plays a supportive role in the pursuit of improved patient care.

This is done through Medable's library of 300+ reusable, pre-validated instruments, assessments, and diaries that eliminate the need to start from scratch, saving valuable time and resources. For instance, we have taken the ten most used oncology scales and prevalidated them against the IRB requirements in countries where oncology trials are most commonly conducted. 

For our customers’ trials’ benefit, we have prevalidated, pre-translated, and facilitated better review processes, contributing to the overall speed of our operations. All these efforts are not rocket science; rather, we prioritize simplifying processes instead of complicating them. The result is an efficient system that aligns with our commitment to streamlining procedures and optimizing workflows. These standardized templates not only provide a consistent and IRB-compliant data collection method but also enable real-time decision-making, ultimately driving study progress.

Together, let's take eCOA off the critical path and pave the way for a healthier tomorrow.

To learn more about Medable’s eCOA+ capabilities, or to speak with one of our SMEs, click here.