ArticleTrials2018
Promoting public access to clinical trial protocols: challenges and recommendations.
Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- A systematic review of trials currently investigating therapeutic modalities for post-acute COVID-19 syndrome and registered on WHO International Clinical Trials Platform.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023Pooled it
- Are orthodontic randomised controlled trials justified with a citation of an appropriate systematic review?Progress in orthodontics · 2021Pooled it
- A systematic review of trial registry entries for randomized clinical trials investigating COVID-19 medical prevention and treatment.PloS one · 2020Pooled it
- Outcome switching in cohort studies of interventions: meta-epidemiological study.BMJ (Clinical research ed.) · 2026Article
- Introducing the need for a consensus-based framework for protocol modifications to improve trial trustworthiness.BMC medicine · 2026Review
- Laying the groundwork and designing for trust: why research protocols matter.Advances in simulation (London, England) · 2026Article
- Assessing the assessment: a scoping review of the mode of patient-reported outcome assessment in solid cancer clinical trials.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- Reporting quality and risk of bias in randomized controlled trials of rotavirus vaccines.Clinical and experimental vaccine research · 2026Article
- SPIRIT 2025 statement: updated guideline for protocols of randomized trials.Nature medicine · 2025Review
- [Interpretation and Examples: Key Updates in SPIRIT 2025 Statement].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2025Article
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.BMJ (Clinical research ed.) · 2025Article
- SPIRIT 2025 statement: updated guideline for protocols of randomised trials.BMJ (Clinical research ed.) · 2025Article
- CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials.BMJ (Clinical research ed.) · 2025Article
- Describing the landscape of nutrition- and diet-related randomized controlled trials: metaresearch study of protocols published between 2012 and 2022.The American journal of clinical nutrition · 2025Article
- SPIRIT 2025 statement: Updated guideline for protocols of randomised trials.PLoS medicine · 2025Article
- Secondary Endpoint Utilization and Publication Rate among Phase III Oncology Trials.Cancer research communications · 2024Article
- Volunteering for Infection: Participant Perspectives on a Hepatitis C Virus Controlled Human Infection Model.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers.Clinical trials (London, England) · 2023Article
- Changes to design and analysis elements of research plans during randomised controlled trials in Australia.The Medical journal of Australia · 2022Article
- Assessment of clinical trial protocols for pathology content using the SPIRIT-Path guidelines highlights areas for improvement.The journal of pathology. Clinical research · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRecognizing the value of promoting public access to clinical trial protocols, Trials pioneered the way for their publication over a decade ago. However, despite major advances in the public accessibility of information about trial methods and results, protocol sharing remains relatively rare. MAIN BODY: Protocol sharing facilitates the critical appraisal of clinical trials and helps to identify and deter the selective reporting of outcomes and analyses. Challenges to the routine availability of high quality trial protocols include the gaps in incentives and adherence mechanisms, limited venues for sharing the original and final protocol versions, and the need for mechanisms to ensure transparent and complete protocol content.
conclusionsWe propose recommendations for addressing key challenges to protocol sharing in order to promote routine public access to protocols for the benefit of patients and other users of evidence from clinical trials.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.