Contributed Commentary by Judy Narisi, BSN, RN, Clario 

September 23, 2022 | Event adjudication is critical to clinical research for developing life-improving therapies. The standardized process entails independent and unbiased experts, often physicians, reviewing clinical events to classify them against predetermined criteria, allowing clinical trial sponsors to better evaluate the safety and clinical efficacy of a drug or device. Implementing a well-managed adjudication program provides sponsors with peace of mind and an unbiased evaluation they may ultimately need to earn regulatory approval. 

However, clinical adjudication program success depends on many factors, such as proper project management and reliable data quality. Common barriers to effective clinical adjudication programs include obtaining timely and supportive documentation for events, de-identification of patients’ protected health information (PHI) in compliance with strict European Union General Data Protection Regulation and 21 Code of Federal Regulations Part 11, and transparency into the process and clinical decision-making. Technology has advanced to address some of these barriers, but the best adjudication programs employ a thoughtful combination of technology and close project management. 

Challenges in Clinical Adjudication 

Adjudication program success hinges on how well event data is managed; unfortunately, there is much room for error. Source documents, which adjudicators rely on to make an informed decision and are an especially common pain point, are often incomplete or poor quality due to sites’ inexperience with adjudication reporting and their limited understanding of the significance of the needed material. These issues lead to site queries by adjudicators that can delay the trial and contribute to increased costs. 

Even when all necessary source material is available, it may not be properly de-identified. Documentation that includes PHI compromises patient privacy and can lead to costly penalties for sponsors for regulatory noncompliance. It’s not uncommon for provided source documentation to be hundreds of pages long, consisting of medical records, autopsy reports, and more. Suppose sites aren’t closely managed or well trained on precisely what information adjudicators need. In that case, they may send far more than is required, creating heaps of documentation that adjudicators must sort through to surface what’s clinically relevant to the event. 

To strike the right balance in providing adjudicators with what they need, trial sponsors must select partners emphasizing strong source documentation management. 

The Growing Role of Technology 

In recent years, technology has advanced to increase efficiencies and reduce costs across various stages of clinical trials, including the adjudication process. Artificial intelligence (AI) is one example that has proved particularly useful in streamlining the arduous but critical task of deidentifying PHI in the source material. Today’s AI can automatically detect PHI in various source document formats, including the digital imaging and communications in medicine standard, videos, photos, PDFs, and ECGs. Furthermore, advanced AI can read and interpret documents—even handwritten clinical notes—to turn them into native text that can be screened for PHI. 

Cloud-based technology platforms are helping manage the AI-powered identification process and making it possible to centralize and organize source documents for adjudicators. Web-based access to these materials is becoming increasingly crucial as trials grow with sites and adjudicators worldwide. 

But technology alone is not sufficient assurance given the high stakes around patient safety. The role of dedicated project managers is critical. Experienced project managers offer everything from guidance and collaboration on charter design to seamless facilitation of global trials at the country level with localized language support. Further, project managers help adjudicators carry out their jobs more efficiently by managing site queries and adjudication committee member worklists and coordinating clinical event committee meetings globally for remote collaboration that ensures timely consensus. As the clinical trial landscape becomes increasingly decentralized, web-based platforms will be essential for ensuring the accuracy, transparency, and compliance sponsors need. Still, project managers' human oversight, commitment, and experience will make the difference. 

The Winning Combination 

Technology offers clinical trial sponsors a means of driving efficiencies that save time and money and allow stakeholders to focus on more strategic priorities. While incredibly valuable, technology is not a replacement for adjudication experience, and the right partner will offer both to ensure a successful event adjudication process. By tackling the intricacies of clinical adjudication programs with the right type of investments—both people and technology—sponsors will be empowered to focus on what matters most: patient outcomes. 

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.narisi@clario.com.