A case report form (CRF) is a structured document used to collect essential information about each clinical trial participant: their medical history, and their responses to the investigational treatment or intervention. CRFs are a vital component of clinical research, as the accuracy and completeness of the data collected can impact the validity of study results and participant safety. CRFs are typically developed and finalised during the study protocol development phase and are used throughout the duration of the clinical trial to systematically collect and record data. Data entered on CRFs should be detailed, accurate, and in compliance with the study's protocol and regulatory requirements. A well-designed CRF serves as the backbone of data collection in a clinical trial. This is especially true in specialised and novel fields like cell therapy, where the nature of intervention, outcomes and potential risks can differ significantly from conventional therapies.

During the CRF design phase of a cell therapy study in oncology, the sponsor, a biotechnology company, engaged with ICON’s biostatistics team for guidance. While the sponsor initially considered alternate immune-response criteria, upon consultation with our cell therapy and immune-oncology experts, they pivoted to the iRECIST (Immunotherapy Response Evaluation Criteria in Solid Tumours) approach. By leveraging our standardised iRECIST forms and cell toxicity CRFs, the
team was able to put the sponsor at ease and instil confidence in this approach.

While RECIST v1.1 and iRECIST assessments essentially mirror each other, divergences arise at RECIST v1.1 progressive disease juncture. Challenges exist in recording data for two response criteria while minimising data duplicity. Additionally, the protocol included criteria that allowed for re-treatment with the cell therapy product.

ICON identified that we could use our standard CRFs for two response criteria, RECIST and iRECIST, including target lesions, non-target lesions, new lesions, and disease response assessments. ICON also brought in our cell therapy and immuno-oncology therapeutic area SMEs, who have a depth of knowledge from multiple scenarios and therapy types, to advise on appropriate collection of cell therapy toxicities.

ICON applied its expertise and demonstrated flexibility by bringing multiple  to the table, allowing the sponsor to select the option that worked best within their study requirements, budget and timelines. The sponsor was very interested in re-treating subjects right away, so the team was able to use the existing CRF structure for the investigators to re-treat subjects in the required timeframe, avoiding an even more costly and lengthy database migration.

To date, successful data collection on re-treatment subjects has been achieved, advising the sponsor of alternative approaches to the iRECIST response criteria, cell therapy toxicity scenarios, and the implementation of the same.

ICON continues to maintain several oncology response criteria and cell therapy toxicity CRF templates. As a testimony to this approach, subsequent studies now engage ICON’s cell and gene therapy cross-functional SMEs from the CRF design onset.

Feedback from multiple sponsors confirms the value of ICON’s CRF designs in immuno-oncology. ICON’s team of experts and well-vetted templates help our sponsors meet CRF development timelines and mitigate the risks of important, critical data omissions.