Rescuing a Study in Jeopardy with Comprehensive Clinical Adjudication
Contributed Commentary by Judy Narisi, BSN, RN, Clario
June 16, 2023 | Global clinical trial programs are complex, often encompassing dozens of studies for increasingly uncommon indications. Sponsors of these programs are wisely seeking out independent adjudication of clinical events, or endpoints, that occur over the course of the trial to ensure patient safety and the efficacy of drugs and devices. While endpoint adjudication is not required by regulatory bodies, it can deliver valuable insights during a trial and lend strong, unbiased support for approvals down the road.
Trial sponsors have high expectations for expensive trials and seek assurances of high-quality results that can be delivered in a timely fashion. It is no surprise then that "rescue" or transition plans are discussed when an adjudication program falls short. The rescue process entails transitioning all ongoing clinical trial data and adjudication documentation, such as source materials and issued site queries, to a new platform and partner so proper analysis can be carried out. Naturally, sponsors are eager to accelerate this process as much as possible to keep trials on track, but balancing speed with rigor is essential.
Applying diligence to the process
A top priority in any adjudication program rescue is ensuring the availability and traceability of relevant data. It is the responsibility of the program inheritor to create a virtual clone of the original data package, and to do so in a way that is both cost and time efficient for sponsors. This meticulous process ensures that all previously adjudicated events can be substantiated and attributed to the original adjudicator in the new system and that additional data capture is consistent and reliable throughout the entire trial. It is designed to minimize the risk of discrepancies that could compromise study results and ensure sponsors can access both legacy and new event data as needed.
Building a clear and thorough data transfer plan is a critical first step in any rescue and where experience pays dividends. Done right, an adjudication program can be rescued in weeks not months, depending on the size of the program or study, saving sponsors valuable resources and keeping promising therapies on track for timely approval.
Recognizing the need for rescue
Studies requiring rescue are typically plagued by questionable data quality, missed deadlines, and overall mismanagement. It is not uncommon, for example, to discover in the process of a rescue that the necessary source material was not obtained to adjudicate a specific event type (e.g., an ECG report for a myocardial infarction), leading to an onslaught of site queries by frustrated adjudicators. This is typically the result of an adjudication program that was not set up properly at the outset with guidance by an experienced partner and may be a sponsor’s first indication that the program is going awry.
Problems can take many forms, however. In one example of a large pharmaceutical organization, the original event adjudication system caused enough issues that the entire program was jeopardized. Software failures required the team to move to antiquated, paper-based data collection processes and manual spreadsheets that led to compliance concerns and high potential for error. Compliance concerns were exacerbated by privacy concerns since imaging source document files were not properly redacted with consistency, as well as physically transported via courier, opening the door to serious privacy violations that come with hefty costs.
The same pharmaceutical organization also struggled with inadequate and slow-moving support for trial sites and adjudicators. The program was based in the APAC region which required strict adherence to local regulations and thoughtful consideration of geographic diversity. An adjudication partner that doesn’t demonstrate an understanding of cultural practices and related nuances may be another indicator of program vulnerability. Effective partnership requires communication competence, encompassing everything from basic local language support to in-depth expertise that enables all stakeholders to contribute to the program’s success.
These issues, among others, increase costs and delay the process of bringing treatments to market, driving sponsors to seek another vendor to take over management of the adjudication program.
Ensuring a seamless transition
Once the decision to engage a new partner has been made, a precise and thorough chain of events must occur. The first step in a successful rescue is the co-development of a transition plan with all involved parties and the establishment of clear channels of communication. There are many technical aspects of adjudication program transition that only an experienced partner can navigate to reduce the likelihood of missteps and speed time to value for sponsors.
It is critical that the program inheritor dedicates a point of contact to oversee the required data transfer of legacy cases, ensuring that as much historical trial data is captured as possible for accurate replication and future traceability. This includes all adjudicated events, the source documents provided for analysis of each event, the adjudicator’s decision, and the adjudicator’s name(s). Any gaps or missing materials must also be properly documented.
A dedicated point of contact is also needed to configure the new data platform according to the sponsor’s specifications and needs moving forward. This may include thoughtful cloud organization and automated redaction of source documents, as well as real-time visibility into case status. Similarly, web-based workflow tools for adjudicators and on the ground site support are necessary to smoothly operate adjudication programs anywhere in the world.
In the case of the pharmaceutical organization referenced above, a local point of contact was assigned given the unique challenges in that geography. This resource was instrumental to supporting regional regulatory requirements and facilitating consensus reviews for adjudicator meetings, payments to adjudicators, and hospital requirements. This enabled the organization to keep the adjudication effort and the entire study on track.
Further, the implementation of electronic image handling by the program rescuer meant the organization no longer needed to receive event related images via courier. Sensitive information was much more secure and compliant, and adjudicators benefited from digital source document review capabilities that streamlined their workflow.
Proper project management and technology, when combined with global support, drives meaningful improvements across data quality and integrity in global clinical trial adjudication programs.
The importance of trust
A successful rescue requires a relationship based on mutual trust and communication. Through a close working partnership with sponsors, partners can address all expectations and needs, provide tailored guidance, ensure data integrity, and deploy the right people to the right positions for ongoing support. A rescue that embodies this partnership and employs best practices keeps the fast pace for approvals going strong.
When vetting a new partner, it’s important to evaluate their ability to provide a comprehensive solution for the adjudication program and study. This should include their expertise in the field, technological prowess, and dedication to quality assurance. By selecting a partner who meets these criteria, the research team can ensure a successful and effective rescue effort.
Judy Narisi, BSN, RN, leads the project management and operational teams at Clario to ensure that each client benefits from knowledgeable and experienced adjudication team support. Trained as a critical care RN, Judy began her research career in 2004 as a study coordinator, moving into safety event case management and then event adjudication in 2006. She can be reached at Judith.firstname.lastname@example.org.