The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias
Open accessAbstract
BACKGROUND: Interim analysis of accumulating trial data is important to protect participant safety during randomized controlled trials (RCTs). Data Monitoring Committees (DMCs) often undertake such analyses, but their widening role may lead to extended use of interim analysis or recommendations that could potentially bias trial results. METHODS: Systematic search of eight major publications: Annals of Internal Medicine, BMJ, Circulation, CID, JAMA, JCO, Lancet and NEJM, including all randomised controlled trials (RCTs) between June 2000 and May 2005 to identify RCTs that reported use of interim analysis, with or without DMC involvement. Recommendations made by the DMC or based on interim analysis were identified and potential sources of bias assessed. Independent double data extraction was performed on all included trials. RESULTS: We identified 1772 RCTs, of which 470 (27%; 470/1772) reported the use of a DMC and a further 116 (7%; 116/1772) trials reported some form of interim analysis without explicit mention of a DMC. There were 28 trials (24 with a formal DMC), randomizing a total of 79396 participants, identified as recommending changes to the trial that may have lead to biased results. In most of these, some form of sample size re-estimation was recommended with four trials also reporting changes to trial endpoints. The review relied on information reported in the primary publications and methods papers relating to the trials, higher rates of use may have occurred but not been reported. CONCLUSION: The reported use of interim analysis and DMCs in clinical trials has been increasing in recent years. It is reassuring that in most cases recommendations were made in the interest of participant safety. However, in practice, recommendations that may lead to potentially biased trial results are being made.
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The STAMPEDE trial was a multicenter, multigroup, multistage platform trial evaluating the efficacy and safety of multiple novel systemic therapies compared with standard care for hormone-sensitive prostate cancer.
“The STAMPEDE trial was a multicenter, multigroup, multistage platform trial evaluating the efficacy and safety of multiple novel systemic therapies compared with standard care for hormone-sensitive prostate cancer.”
The James et al investigators' mitigating strategies included new exclusion criteria for patients with contraindications to celecoxib use, changes in the intervention duration, and revisions to the consent materials.
“The investigators' mitigating strategies included new exclusion criteria for patients with contraindications to celecoxib use (SPIRIT item 10; CONSORT item 4), changes in the intervention duration (SPIRIT item 11; CONSORT item 5), and revisions to the consent materials (SPIRIT item 26).”
In a trial by James et al involving celecoxib for hormone-sensitive prostate cancer, investigators were unable to implement the intended intervention because of unanticipated regulatory changes concerning the use of celecoxib in trials.
“In a trial by James et al 23 involving celecoxib for hormone-sensitive prostate cancer, investigators were unable to implement the intended intervention because of unanticipated regulatory changes concerning the use of celecoxib in trials (Table).”
The STAMPEDE investigators could not recruit to the celecoxib group and had to reassess the risk-benefit balance of the intervention.
“The STAMPEDE investigators could not recruit to the celecoxib group and had to reassess the risk-benefit balance of the intervention.”
Prior to beginning recruitment in 2004, rofecoxib was withdrawn from the market by the manufacturer for safety concerns about cardiovascular toxicity, and regulatory agencies stopped all trials involving cyclooxygenase 2 inhibitors.
“Prior to beginning recruitment in 2004, rofecoxib was withdrawn from the market by the manufacturer for safety concerns about cardiovascular toxicity, and regulatory agencies stopped all trials involving cyclooxygenase 2 inhibitors.”
A planned comparison was celecoxib plus hormone therapy vs hormone therapy alone.
“A planned comparison was celecoxib plus hormone therapy vs hormone therapy alone.”
They modified the eligibility criteria to exclude any potential participants who had substantial cardiovascular disease, and the start of recruitment to the celecoxib group was delayed by 1 year.
“They modified the eligibility criteria to exclude any potential participants who had substantial cardiovascular disease, and the start of recruitment to the celecoxib group was delayed by 1 year.”
The intervention duration was also reduced, and cardiovascular risks were added to the consent materials.
“The intervention duration was also reduced, and cardiovascular risks were added to the consent materials.”
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Monitoring committee in clinical trials
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- Authors
- Tharmanathan, P., Calvert, M., Hampton, J., & Freemantle, N.
- Affiliations
- University of Birmingham (GB)
- Queen's Medical Centre (GB)
- Corresponding author
- Freemantle, Nick
- Venue
- BMC Medical Research Methodology
- Published
- 2008-03-20
- Volume
- 8
- Issue
- 1
- Pages
- 12-12
- ISSN
- 1471-2288 (ISSN-L)
- PMC
- PMC2279143
- OpenAlex
- W1975476357
- Cited by
- 42
- References
- 39
- Citations by year
- 2026: 2 · 2025: 1 · 2023: 6 · 2022: 1 · 2021: 4 · 2020: 1 · 2019: 2 · 2017: 1 · 2016: 1 · 2015: 3 · 2014: 4 · 2013: 5 · 2012: 2
- FWCI
- 0.43
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Medical Research Methodology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- interim analysis, data monitoring committees, randomized controlled trials, trial reporting, sample size re-estimation, participant safety
- MeSH terms
- Data Interpretation, Statistical, Research Design, Bias, Randomized Controlled Trials as Topic, Sample Size, Clinical Trials Data Monitoring Committees
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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