Enhancing efficiency in clinical trial toxicity data collection: Insights from bladder and prostate cancer radiotherapy studies
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Embargo End Date
2025-06-03
ICR Authors
Authors
Philipps, L
Document Type
Thesis or Dissertation
Date
2024-12-03
Date Accepted
Abstract
Background: Collection of long-term toxicity data in radiotherapy trials is important as side effects can occur years after treatment. It is however time consuming, impacting patients, healthcare staff and clinical trials units. Methods: Using trials of prostate and bladder cancer radiotherapy four approaches for improving the efficiency of toxicity data collection were explored:• Use of either patient or clinician reported outcome (PRO, CRO) collection as a single modality for accurate toxicity follow up (retrospective, exploratory analysis).• Reducing the number of CRO assessments (retrospective, exploratory analysis).• Electronic collection of PRO (prospective clinical study (SPRUCE))• Validity of using routinely collected data for long-term follow up (prospective data linkage study)Results: Patients report toxicities more frequently than clinicians with poor concordance between the two measures on an individual level. Patients report almost all severe side effects reported by clinicians. There is a correlation between acute and late genitourinary and gastrointestinal grade 2+ toxicity, but no distinct pattern to the time to appearance of toxicity when examining individual patients. It was not possible to conclude non-inferiority of response rate with electronic PRO in comparison to paper in the interim analysis of SPRUCE, but electronic PRO use had high levels of questionnaire compliance and completeness of data. Routine healthcare data picked up more late adverse events than trial case report forms and is valid when specific endpoints with accurate disease or procedure codes are used. Conclusions: It is not possible to make specific recommendations about streamlining CRO assessment points universally but the use of both PRO and CRO over the duration of follow-up is inefficient. To complete assessments, paper PRO data collection options should be maintained for patients who have reduced internet access or capabilities. Finally, routinely collected healthcare data can be used to identify late side effects for specific and carefully considered trial endpoints.
Citation
2024
DOI
Source Title
Publisher
Institute of Cancer Research (University Of London)
ISSN
eISSN
Collections
Research Team
Clin Trials & Stats Unit