Six Tools for Decreasing Clinical Trial Delays

Aug 29, 2012

The logistics involved in running a global image-intensive clinical trial are exceptionally complex. Just one submission error can cost up to seven weeks of trial delay, millions of sponsor dollars, and the potential loss of patient data.

Why do we wait until an image reaches its final destination before we inspect it, reject it, send it back for correction or, worse, deem it “unevaluable”?

Conducting an imaging trial is expensive, time-sensitive and risky. Providing investigator sites with the right tools to assemble and submit their clinical trial data, and ensuring that the quality and completeness of their work is automatically checked prior to submission greatly enhances the efficiency of the downstream process of converting this input into usable trial data by the imaging core labs (ICLs).

The following tips show how, by advocating the use of the proper tools and a validated delivery platform for the submission of imaging data by the sites, a trial sponsor can mitigate the risk of error and ensure the highest level of quality for its data at the source.

Improve workflow automation
Investigators and site study coordinators participate in multiple trials from different sponsors requiring different types of submissions to various ICLs. This is akin to workingin a flexible manufacturing environment in which workers assemble one part today, and another tomorrow. As the requirements for the assemblies vary, the workflow to complete each assembly must vary as well. Workflow automation should guide study coordinators through the necessary steps for each particular trial submission, providing different tools that reflect the protocol-specific requirements of each.

The user interface should only present the tools required, in order, so that study coordinators follow every step properly.

Ensure consistent ease of use
The user interface must be consistent across all tools to reduce training requirements.

Instate quality checks
The tools for each operation must have embedded in them quality control functionality which is constantly in the background checking for errors in data acquisition and data entry. If errors or inconsistencies within or across steps are detected, the tool should alert and guide the user to make the proper input.

Minimize manual data entry
The right tools, presented in the most efficient order will help the study coordinator:
• Enter the correct values in the deidentification process.
• Replace without human intervention those tags for which constants for the site or trial can be used.
• Pre-populate transmittal forms to ensure consistency.
• Facilitate the inclusion of additional files or information to the submission.
• Perform automated checks, on-site, of protocol compliance. These may include anatomical completeness, contrast perfusion and proper series sequencing as required on a trial-by-trial basis.
• Identify if any data is outside protocol parameters to enable corrections for future submissions.

Integrate downstream
The submission of medical image time points should be fully integrated with the rest of the trial information support systems so study coordinators don’t have to enter information about one subject twice. All submissions and their data should automatically update the systems at the ICL, CRO, and sponsor in real time.

Establish efficient delivery
User-entered data should not be subjected to manual re-entry at the core lab/CRO. Since quality checks have occurred during the assembly of the submission, re-entry can introduce errors, data quality degradation, and loss of tracking ability back to the source.

The key to lessening clinical trial delays is an environment where sites can be trusted to do the right thing, recognizing that although participating in clinical trials is an important part of their mission, their priority is caring for patients.

This requires supplying them with proper tools that take into account a number of critical elements about “life at the site”—not just those that help get data to their ICLs faster. These require the least amount of training and help whoever is piecing the data together to complete their task as effortlessly as possible, while checking at every step that their final product is properly assembled.

Give site coordinators the right tools, and trust that query rates will be drastically reduced.

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