Patient education

The best way to secure qualified investigators for a clinical trial is to have an institution-specific point person, or navigator contact them directly about the opportunity.

This was one of the main findings of the Point Person Project, a multi-institute study lead by Dr. Jonathan M. Davis of Tufts Clinical and Translational Science Institute (CTSI) that included child health experts from the Quintiles Pediatric Center of Excellence and other leading institutions. The goal of the Point Person Project was to identify the best strategies to identify and engage the most qualified and interested investigators to participate in pediatric clinical trials.

A good investigator can help overcome many of the obstacles faced on clinical trials, because they understand the complexities of recruiting and retaining patients who are often widely dispersed and may be difficult to enroll. But finding the right investigator for any trial isn’t easy. This is especially true in pediatric studies.

Many pediatric studies need to be completed in Children’s Hospitals, academic medical centers and related institutions. The infrastructure in these institutions is often complex and the communication channels disconnected. These factors, coupled with a lack of harmonized standards for information and data exchange, and the need to use customized solutions for each study make it difficult to match investigator skill sets to relevant trials and patient populations. These challenges are compounded in pediatric clinical trials, where investigators require specific regulatory and medical training to be fully qualified, and recruiting efforts must involve the patient’s entire family to be effective. Because of the relatively low number of opportunities for investigators to be involved in pediatric clinical research in a particular specialty, these experts are often difficult to connect with a sponsor and their associated trial. If we can’t find these investigators efficiently it adds significant time and risk to the trial process.

Navigators bridge the gap

The Point Person Project was designed to address some of these challenges by directly linking clinical-research sponsors with subject-matter experts and relevant patient populations. To achieve these connections, the project team implemented a centralized portal and a network of institutional points of contact, or “navigators,” to facilitate communication. The navigators were a key piece of this solution as they bridged the gap between the two groups by communicating with local investigators about planned trials and determining who had sufficient interest and expertise to respond to selected clinical research opportunities.

The results were promising. In the project, the team designated 84 navigators at 55 institutions to communicate with investigators. During the year-long project, 289 investigators from 40 institutions responded to research opportunities, with 16 sites involved in start-up or enrollment of at least one trial. One research group that formed as a result of the Point Person Project published a manuscript, developed a full clinical trial protocol, and submitted an Investigational New Drug (IND) application for approval by the Food and Drug Administration (FDA).

We also found that the project increased overall awareness of trials among the investigator population; it opened opportunities for investigators to discuss the trial protocol in a blinded fashion with the sponsor or a sponsor’s representative as a part of their decision-making process; and made it easier for information to be disseminated to potential investigators. It also helped the sponsors develop new scientific collaborations and identify design weaknesses before further resource commitment and implementation.

The academic achievement issue

However, the approach was unable to solve all the barriers to engagement faced by potential pediatric clinical trial investigators. Many investigators who expressed initial interest ultimately chose not to participate in the trial. They cited a variety of reasons for their decisions, though the most worrying was a concern that industry-sponsored studies typically don't lead to academic achievement although concerns about patient enrollment and study design were also important. For most academic investigators, participation in industry trials requires a significant time commitment but rarely produces publications or contributes toward promotion or other academic achievements. In addition, they often lack sufficient training in regulatory science and Good Clinical Practice to be comfortable with current regulatory requirements.

Despite this challenge, the Point Person Project clearly demonstrated the value of this engagement step; linking sponsors with experienced and interested investigators. It also suggests that opportunities may exist to leverage this program as a clinical trial–training platform that helps develops the next generation of investigators.

The more we can streamline this communication and engagement process, the more efficiently we can move these trials forward with the confidence that they will be led by the best experts in the field. 

Topics in this blog post: Biopharma, Clinical Trials, R&D, Recruiting