Clinical Trial Participation Part 3: The third of an ongoing series of articles examining critical issues concerning clinical trial participation


Using Diversity as a Study Metric in CTMS

In part three (click here for Part 1 and Part 2) of this ongoing series, we examine how Clinical Trial Management Systems (CTMS) can assist in helping to monitor diversity in clinical trials.

In earlier articles in our series, we’ve highlighted one of the critical issues facing clinical trials: lack of diversity. While in some cases lack of diversity can be defined as the lack of a particular race or ethnic group such as African Americans, Asian Americans or Hispanics, it also can represent lack of elderly patients or even the lack of women. If not enough patients of a certain demographic are enrolled into a study, it could have unintended consequences.

A major problem that may arise during the conduct of a clinical trial, is the difficulty in being able to evaluate in real-time the breakdown on certain ethnic or racial lines. Or, it is difficult to evaluate the real-time average age or gender breakdown of the clinical trial participants.

Although this type of information is often captured in the demographics portion of electronic data collection (EDC) during a study, it’s not often looked to as a study metric. In some clinical trials, where a medication is being studied in a condition that highly affects a certain race, ethnicity, or even age group, it is important to make sure that the designated demographic is well-represented in the trial in order to analyze properly the safety and effectiveness of the medication.

One solution to this problem is to use a Clinical Trial Management System (CTMS) rather than electronic data collection (EDC) alone to capture this important demographic information as a study metric. Gathering this information can assist project managers in evaluating clinical trial sites to better understand if they are reaching the diverse population that is wanted.

While this information can be reported directly from external systems like an electronic data collection (EDC) tool, it is often better to use a Clinical Trial Management System (CTMS) such as our proprietary system, ClinPlus® CTMS. Utilizing CTMS to manage diversity has two advantages: 1) You can avoid any potential delay in information entered in the EDC system, and 2) Utilizing ClinPlus® CTMS you can categorize and summarize the data depending on the study or company needs. Using CTMS, this information can be entered directly from an enrollment log which is usually more current than the EDC system. Utilizing the built-in functionality of our CTMS, the information can then be displayed and reported as is, or it can be categorized and summarized into custom fields (e.g. all subjects over 65 = “Elderly”). Study metrics can be displayed in the “overview” screen and reports can be run across multiple studies if need be.

When evaluating a Clinical Trial Management System (CTMS) to manage study activities, one area that should be investigated is how hard or easy it is to configure as not all systems are alike. ClinPlus® CTMS is one system that was designed specifically to easily create custom fields to help manage study specific challenges.

Please provide your thoughts, comments, or feedback on this topic so that we can begin a healthy exchange.