A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study
Open accessAbstract
Background: To assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline. Methods: We had access to RCT study protocols that received ethical approval in the UK in 2012 (n=103) and 2016 (n=108). From those, we assessed the adherence to the 33 SPIRIT items (i.e. a total of 64 components of the 33 SPIRIT items). We descriptively analysed the adherence to SPIRIT guidelines as proportion of adequately reported items (median and interquartile range [IQR]) and stratified the results by year of approval and sponsor. Results: The proportion of reported SPIRIT items increased from a median of 64.9% (IQR, 57.6–69.2%) in 2012 to a median of 72.5% (IQR, 65.3–78.3%) in 2016. Industry-sponsored RCTs reported more SPIRIT items in 2012 (median 67.4%; IQR, 64.1–69.4%) compared to non-industry-sponsored trials (median 59.8%; IQR, 46.5–67.7%). This gap between industry- and non-industry-sponsored trials increased in 2016 (industry-sponsored: median 75.6%; IQR, 71.2–79.0% vs non-industry-sponsored: median 65.3%; IQR, 51.6–76.3%). Conclusions: The adherence to SPIRIT guidelines has improved in the UK from 2012 to 2016 but remains on a modest level, especially for non-industry-sponsored RCTs.
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Trial protocols vary in their completeness and often do not adequately describe important elements including primary outcomes, treatment allocation methods, blinding, adverse event measurement, sample size calculations, data analysis methods, dissemination policies, and roles of sponsors and investigators.
“However, trial protocols vary in their completeness and often do not address key elements of design and conduct.”
From SPIRIT 2025 statement: updated guideline for protocols of randomised trials (2025) · cites this paper as [11]
The reporting of protocols for randomised trials has improved somewhat since 2013 but remains far from adequate.
“Although the reporting of protocols for randomised trials has improved somewhat since 2013 it remains far from adequate.9 10 11 12”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 57% and 78%, respectively, reported the name and contact details of the sponsor.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 57% and 78%, respectively, reported the name and contact details of the sponsor.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 unpublished trial protocols from 2016 found that 11% and 17%, respectively, reported the names of protocol contributors or authors.
“Reviews of two samples of 108 and 292 unpublished trial protocols from 2016 found that 11% and 17%, respectively, reported the names of protocol contributors or authors.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
In two samples of 108 and 292 trial protocols from 2016, 98% and 92% respectively reported steering committee membership and roles.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 98% and 92%, respectively, reported the steering committee membership and roles.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
The naming of authors and a description of their roles are standard for protocols published in journals such as Trials and BMJ Open, but they are less common for unpublished protocols.
“The naming of authors and a description of their roles are standard for protocols published in journals such as Trials and BMJ Open, but they are less common for unpublished protocols.”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 61% and 39%, respectively, reported the role of the sponsor and funder.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 61% and 39%, respectively, reported the role of the sponsor and funder.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
In two samples of 108 and 292 trial protocols from 2016, 91% and 83% respectively described funding sources.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 91% and 83%, respectively, described funding sources.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
In two samples of 108 and 292 trial protocols from 2016, 65% and 62% respectively reported declarations of interests.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 65% and 62%, respectively, reported declarations of interests.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
In two samples of 108 and 292 trial protocols from 2016, 23% and 32% respectively reported plans for who would have access to the full dataset.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 23% and 32%, respectively, reported plans for who would have access to the full dataset.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
In two samples of 108 and 292 trial protocols from 2016, 44% and 26% respectively justified the research question.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 44% and 26%, respectively, justified the research question.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
In two other samples of 108 and 292 protocols from 2016, plans to disseminate trial results were described in 56% and 71% respectively.
“In two other samples of 108 and 292 protocols from 2016, plans to disseminate trial results were described in 56% and 71%, respectively.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 76% and 83%, respectively, explained the choice of comparator.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 76% and 83%, respectively, explained the choice of comparator.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 91% and 94%, respectively, described the specific objectives of the trial.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 91% and 94%, respectively, described the specific objectives of the trial.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that strategies to improve adherence were addressed in 86% to 90%, respectively.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that strategies to improve adherence were addressed in 86% to 90%, respectively.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 69% and 81%, respectively, reported the concomitant care that was permitted.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 69% and 81%, respectively, reported the concomitant care that was permitted.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that key elements of drug treatments (generic name, dose, and schedule of intervention) were reported in more than 90% of protocols.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that key elements of drug treatments (ie, generic name, dose, and schedule of intervention) were reported in more than 90% of protocols.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 40% and 44% reported the location of participant recruitment.
“40% and 44% reported the location of participant recruitment,”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 76% and 82%, respectively, reported criteria for modification of interventions.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 76% and 82%, respectively, reported criteria for modification of interventions.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 90% and 91% described the setting of intervention delivery.
“and 90% and 91% described the setting of intervention delivery.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that the specific measurement variable was reported in 89% to 97%, respectively, whereas fewer specified the analysis metric (83% to 90%) and time point of main interest (82% to 94%).
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that the specific measurement variable was reported in 89% to 97%, respectively, whereas fewer specified the analysis metric (83% to 90%) and time point of main interest (82% to 94%).9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that patient eligibility criteria were reported in 100% of protocols.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that patient eligibility criteria were reported in 100% of protocols.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Eligibility criteria for care providers and centres in protocols for non-drug trials are often poorly reported.
“Eligibility criteria for care providers and centres in protocols for non-drug trials are often poorly reported.”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that eligibility criteria for centres (and criteria for those performing the intervention) were reported in 30% and 38% of protocols, respectively.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that eligibility criteria for centres (and criteria for those performing the intervention) were reported in 30% and 38% of protocols, respectively.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 42% and 56%, respectively, listed the countries where data were to be collected.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 42% and 56%, respectively, listed the countries where data were to be collected,”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 75% and 61%, respectively, described the method of sequence generation.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 75% and 61%, respectively, described the method of sequence generation.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Although most trials will use strategies to promote enrolment of participants, this information is often incompletely reported in trial protocols.
“Although most trials will use strategies to promote enrolment of participants, this information is often incompletely reported in trial protocols.9 10 317”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 99% reported the estimated sample size but only 57% to 78%, respectively, reported the assumed outcome values involved.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 99% reported the estimated sample size but only 57% to 78%, respectively, reported the assumed outcome values involved.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that less than 44% of protocols reported the location of recruitment, individuals to be recruited, or expected recruitment rate.
“For example, reviews of two samples of 108 and 292 trial protocols from 2016 found that less than 44% of protocols reported the location of recruitment, individuals to be recruited, or expected recruitment rate.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 83% addressed the mechanism of allocation concealment.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 83% addressed the mechanism of allocation concealment.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Among protocols for randomised trials approved in 2016, 87% detailed the main analysis plan for the primary outcome.
“Among protocols for randomised trials approved in 2016, 87% detailed the main analysis plan for the primary outcome.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 reported that 69% and 74%, respectively, specified the analysis population.
“Reviews of two samples of 108 and 292 trial protocols from 2016 reported that 69% and 74%, respectively, specified the analysis population.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Despite the high prevalence and important effect of missing data, only 69% and 74% of two samples of trial protocols approved in 2016 considered statistical methods to handle missing data (and the analysis population relating to protocol non-adherence).
“Despite the high prevalence and important effect of missing data, only 69% and 74% of two samples of trial protocols approved in 2016 considered statistical methods to handle missing data (and the analysis population relating to protocol non-adherence).9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 58% reported whether a data monitoring committee would or would not be planned.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 58% reported whether a data monitoring committee would or would not be planned.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Trial monitoring was addressed in 13% to 76% of protocols approved in 2016 or published in 2019-20.
“Trial monitoring was addressed in 13% to 76% of protocols approved in 2016 or published in 2019-20.9 10 11 467”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
In a sample of trial protocols approved in 2016, 66% to 77% reported how amendments would be handled.
“In a sample of trial protocols approved in 2016, 66% to 77% reported how amendments would be handled.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols approved in 2016 found that 76% and 88%, respectively, considered confidentiality of data.
“Reviews of two samples of 108 and 292 trial protocols approved in 2016 found that 76% and 88%, respectively, considered confidentiality of data.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 56% and 32%, respectively, addressed ancillary and post-trial care.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 56% and 32%, respectively, addressed ancillary and post-trial care.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
Reviews of two samples of 108 and 292 trial protocols from 2016 found that 15% to 18% of trial protocols approved in 2016 did not describe the process of obtaining informed consent.
“Reviews of two samples of 108 and 292 trial protocols from 2016 found that 15% to 18% of trials protocols approved in 2016 did not describe the process of obtaining informed consent.9 10”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [10]
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Self-citationFawzy, M. M., Khan, K. S., CHIEN, P. F. W., Bueno‐Cavanillas, A., Martín‐Díaz, M., Zamora, J., Ruano‐Raviña, A., Pacey, A. A., Zhang, J. J., Khalaf, Y., et al. (2025) · International Journal of Gynecology & Obstetrics · doi:10.1002/ijgo.70374 · Cited by 3 · see citing works
Kounatidou, N. E., Tzavara, C. K., & Palioura, S. (2023) · International Ophthalmology · doi:10.1007/s10792-023-02687-1 · Cited by 3 · see citing works
Ethics and consent in randomized clinical trial integrity: A scoping systematic review
Elsuity, M. A., Butt, F., Khan, K. S., Fawzy, M. M., Martín‐Díaz, M., CHIEN, P. F. W., de Rojas, J. P., Núñez‐Núñez, M., Rashwan, M., & Bueno‐Cavanillas, A. (2025) · Medicina de Familia SEMERGEN · doi:10.1016/j.semerg.2025.102579 · Cited by 2 · see citing works
Baba, A., Smith, M., Potter, B. K., Chan, A., Moher, D., Toulany, A., Doherty-Kirby, A., Nafría, B., Stratton, C., Gale, C. P., et al. (2026) · The Lancet Child & Adolescent Health · doi:10.1016/s2352-4642(26)00005-2 · Cited by 1 · see citing works
Ramirez, H. W., Chiaborelli, M., Schönenberger, C., Mellor, K., Griessbach, A., Dhiman, P., Gandhi, P., Lohner, S., Agarwal, A., Odutayo, A., et al. (2025) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2025.111818 · Cited by 1 · see citing works
Self-citationWriting, Reviewing, and Reading Standard and Pragmatic Clinical Trial Protocol Papers
Munroe, E. S., Patel, B. K., & Peltan, I. D. (2026) · CHEST Critical Care · doi:10.1016/j.chstcc.2026.100311
- Authors
- Speich, B., Odutayo, A., Peckham, N., Ooms, A., Stokes, J. R., Saccilotto, R., Gryaznov, D., von Niederhäusern, B., Copsey, B., Altman, D. G., Briel, M., & Hopewell, S.
- Affiliations
- University of Basel (CH)
- St. Michael's Hospital (CA)
- University of Oxford (GB)
- Corresponding author
- Speich, Benjamin
- ORCID
- Venue
- Trials
- Published
- 2022-07-27
- Volume
- 23
- Issue
- 1
- Pages
- 601-601
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC9327179
- OpenAlex
- W4288724240
- Cited by
- 21
- References
- 24
- Citations by year
- 2026: 4 · 2025: 11 · 2024: 3 · 2023: 3
- FWCI
- 2.56
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (P4P4PM_194496, P300PB_177933)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- research ethics committee approval, industry-sponsored trials
- MeSH terms
- Clinical Trial Protocols as Topic, United Kingdom, Humans, Guideline Adherence, Ethics Committees, Research
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