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dc.contributor.authorHague, Den_US
dc.contributor.authorTownsend, Sen_US
dc.contributor.authorMasters, Len_US
dc.contributor.authorRauchenberger, Men_US
dc.contributor.authorVan Looy, Nen_US
dc.contributor.authorDiaz-Montana, Cen_US
dc.contributor.authorGannon, Men_US
dc.contributor.authorJames, Nen_US
dc.contributor.authorMaughan, Ten_US
dc.contributor.authorParmar, MKBen_US
dc.contributor.authorBrown, Len_US
dc.contributor.authorSydes, MRen_US
dc.contributor.authorSTAMPEDE and FOCUS4 investigatorsen_US
dc.identifier.citationTrials, 2019, 20 (1), pp. 294 - ?en_US
dc.description.abstractBACKGROUND:There is limited research and literature on the data management challenges encountered in multi-arm, multi-stage platform and umbrella protocols. These trial designs allow both (1) seamless addition of new research comparisons and (2) early stopping of accrual to individual comparisons that do not show sufficient activity. FOCUS4 (colorectal cancer) and STAMPEDE (prostate cancer), run from the Medical Research Council Clinical Trials Unit (CTU) at UCL, are two leading UK examples of clinical trials implementing adaptive platform protocol designs. To date, STAMPEDE has added five new research comparisons, closed two research comparisons following pre-planned interim analysis (lack of benefit), adapted the control arm following results from STAMPEDE and other relevant trials, and completed recruitment to six research comparisons. FOCUS4 has closed one research comparison following pre-planned interim analysis (lack of benefit) and added one new research comparison, with a number of further comparisons in the pipeline. We share our experiences from the operational aspects of running these adaptive trials, focusing on data management. METHODS:We held discussion groups with STAMPEDE and FOCUS4 CTU data management staff to identify data management challenges specific to adaptive platform protocols. We collated data on a number of case report form (CRF) changes, database amendments and database growth since each trial began. DISCUSSION:We found similar adaptive protocol-specific challenges in both trials. Adding comparisons to and removing them from open trials provides extra layers of complexity to CRF and database development. At the start of an adaptive trial, CRFs and databases must be designed to be flexible and scalable in order to cope with the continuous changes, ensuring future data requirements are considered where possible. When adding or stopping a comparison, the challenge is to incorporate new data requirements while ensuring data collection within ongoing comparisons is unaffected. Some changes may apply to all comparisons; others may be comparison-specific or applicable only to patients recruited during a specific time period. We discuss the advantages and disadvantages of the different approaches to CRF and database design we implemented in these trials, particularly in relation to use and maintenance of generic versus comparison-specific CRFs and databases. The work required to add or remove a comparison, including the development and testing of changes, updating of documentation, and training of sites, must be undertaken alongside data management of ongoing comparisons. Adequate resource is required for these competing data management tasks, especially in trials with long follow-up. A plan is needed for regular and pre-analysis data cleaning for multiple comparisons that could recruit at different rates and periods of time. Data-cleaning activities may need to be split and prioritised, especially if analyses for different comparisons overlap in time. CONCLUSIONS:Adaptive trials offer an efficient model to run randomised controlled trials, but setting up and conducting the data management activities in these trials can be operationally challenging. Trialists and funders must plan for scalability in data collection and the resource required to cope with additional competing data management tasks.en_US
dc.format.extent294 - ?en_US
dc.subjectSTAMPEDE and FOCUS4 investigatorsen_US
dc.subjectColorectal Neoplasmsen_US
dc.subjectProstatic Neoplasmsen_US
dc.subjectRandom Allocationen_US
dc.subjectResearch Designen_US
dc.subjectClinical Trials as Topicen_US
dc.subjectData Managementen_US
dc.titleChanging platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons.en_US
dc.typeJournal Article
rioxxterms.typeJournal Article/Reviewen_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Prostate and Bladder Cancer Research
pubs.embargo.termsNot knownen_US
icr.researchteamProstate and Bladder Cancer Researchen_US
dc.contributor.icrauthorJames, Nicholasen_US

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