T 16: Best Practices for Medical Review Process in Clinical Research
Senior Medical Director
Celldex United States
Medical review on clinical data is a comprehensive reivew of patient data in the database. It is different to data cleaning and source verification by the data managers and site monitors. It involves the sponsor or CRO medical team. The task is critical for data quality and study timelines. However, the complexity is often under-estimated by the study team.
We reviewed our internal processes and external practices from publications and purposed several principles to streamline the processes for better quality and efficiency. We examed a number of studies in the past and summarize the processes and best practices.
Timing: medical review should start as early as possible when data are entered into the database for the first few patients enrolled at each site. The focus should be on eligibilities against CRF data for demographics, baseline disease characteristics, medical history and pre-trial symptoms and medications. Early identification of issues may prompt protocol modification or retraining. Later review should focus on AEs, reason for DC and study endpoint measurements. Tools: To facilitate medical review, relevant CRF data for a patient from different panels should be pooled in an easy format (patient profile) mincing patient chart in practice. Patient profiles are often developed and programed out of J-review with decoded information. A review tool with visual presentation is preferred. Data listings can be effective to target known issues identified during individual case review. However, the patient profile is essential for comprehensive medical review. It is helpful to have access to patients EHR directly by the medical team.
Communication: Issues identified during the medical review should be clarified and resolved with the investigator via data queries. The query flow can be tracked by DM. The process should ensure the query clarity for all parties (DM, Monitors and sites) involved towards query resolution without delay and re-query. For important issues, contacting the investigators (via a local medical monitor) and direct access to the source data is encouraged. For common and generalized issues, additional listings and/or edit checks can be programed for automation and re-training should be considered.
Medical review conducted by the medical group is essential for data quality but the process is largely driven by DM. The timing could be optimized to avoid repetition with focus on key aspects of medical quality. Effective tools such as patient profiles complimented by data listings are required for reviews. Clear communication among all parties is essential for medical query resolution. A feedback system can be built in the process to address identified issues programmatically. Optimal medical review process is needed for medical quality of the data.