Adjudicating pre-determined adverse medical events that occur throughout a clinical trial is incredibly valuable to the clinical trial process. Performed by an objective team of clinicians with expertise in a specific therapeutic area, the adjudication process ensures the accuracy and consistency of the clinical truth of a given event. This clinical team, known as a clinical endpoint committee (CEC), must review the provided clinical event information and base their assessment on that data without bias or partiality. This rigorous process allows for a truly independent evaluation of the clinical efficacy of a drug or device.

If left to the principal investigators, it can add bias to the equation, contribute to cost, and possibly do more harm than good to participants who are intended to benefit from new therapies. While not a requirement of the clinical trial process, almost 90% of recent survey¹ respondents, the majority of whom are biopharma executives who use clinical adjudication, agree it provides value.

Clinical adjudication offers important safeguards for patients. Consider an example from Mount Sinai Hospital in New York, which recently reported² that more than 15% of patients treated with the T-DXd anti-body drug in clinical trials for advanced cancers developed interstitial lung disease. Prompt adjudication, in this case, resulted in a critical change of protocol.

Unbiased oversight is key in adjudication

Through clinical adjudication, blinded CECs ensure the validity and integrity of trial results, which can lend compelling support for drug or device approvals down the road. Regulatory authorities look favorably on adjudication as a best practice. They may recommend CEC involvement for specific safety events during a study, prompting sponsors to seek partners to execute these programs effectively and efficiently.

Experienced project managers are especially important to a successful clinical adjudication program, capable of operating the process from beginning to end. They support everything from charter development and clear clinical event definition to timely case reviews and milestone data transfers. They also oversee site training and help usher in completing the adjudication dossier.

Further, global programs with a regional project manager eliminate language and cultural barriers that may otherwise hamper effective communication throughout the trial process. In addition to providing valuable expertise to sponsors, direct management of adjudication activity by project managers is an important aspect of maintaining the independence of the process.

While often overlooked, another valued position on an experienced adjudication team is the clinical nurse reviewer. Having a nurse knowledgeable of the protocol, the adjudication charter, and the events provides an added layer of collaboration. In addition, nurse reviewers ensure that all cases are medically supported, that there is no discrepant information, and that all accompanying documents are in order. This supporting role helps reduce the amount of adjudication queries to the site and mitigates the risk of process delays that can cost sponsors.

Technology benefits for stakeholders

Technology has a critical role in adjudication, supporting a range of stakeholders who may also be dispersed worldwide as clinical trials become increasingly decentralized.

Collecting patient data in the form of images, scans, electrocardiograms, video, PDFs, electronic medical records, and DICOM files from multiple sources can now be streamlined using easy digital upload tools and cloud-based repositories centralize and organize key source documents for smooth review by adjudicators. Previously, hundreds or thousands of these source documents from multiple sites were gathered and accessed manually, which was daunting, slow, and prone to error.

Cloud technology is also helping ensure trials meet project objectives to stay on schedule. For example, some systems can alert adjudicators and trial sponsors when a consensus has not been reached among clinical stakeholders and facilitate remote collaboration for further review. This transparency into case status is valued by study sponsors and helps reduce the time needed to complete thorough medical event reviews.

Embedded artificial intelligence also can help safeguard patients by accurately deidentifying protected health information in source materials that third-party adjudicators use to assess a clinical event. This AI-enabled process is key to ensuring compliance with strict EU GDPR and 21 CFR Part 11 regulations that carry hefty fines for any oversights.

Conclusion

While there are many layers to an effective and efficient clinical adjudication program, success is largely achieved through dedicated project management and proven technology for thorough data collection and stakeholder collaboration. When executed properly, trial sponsors and participants benefit from timely, diligent oversight of safety data, assurance that all deadlines are met, and transparency in the process.

1. Clinical Adjudication Survey Results Revealed, Judith Narisi, BSN, RN and Janine Jones, MBA, Clario, 11/11/21
2. Prompt recognition and treatment found effective for lung disease in patients who received new drug for advanced cancer, American Association for the Advancement of Science, The Mount Sinai Hospital/Mount Sinai School of Medicine, 8/11/22

Judith Narisi, BSN, RN, is a senior director of adjudication services and specialty solutions at Clario, leading the project management and operational teams 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. Since then, she has successfully managed a team that has been effective in rescuing several large programs and contributed to the approval of several pharmaceutical drugs supported by the adjudication of thousands of events. Judy received her nursing degree from Gwynedd Mercy University in Pennsylvania.

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Filed Under: clinical trials, Drug Discovery

 

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