Barriers and facilitators to the recruitment of disabled people to clinical trials: a scoping review Underrepresentation of disabled groups in clinical trials results in an inadequate evidence base for their clinical care, which drives health inequalities. This study aims to review and map the potential barriers and facilitators to the recruitment ...

Shariq et al's scoping review on barriers & facilitators in the recruitment of people with a disability draws on 5 themes
Risk v benefit
Design & management of recruitment protocol
Internal & external validity
Consent & ethics
Systemic factors
#MethodologyMonday
pmc.ncbi.nlm.nih.gov/articles/PMC...

Scientific, ethical, and legal considerations for the inclusion of pregnant people in clinical trials - PubMed Clinical trials to address the COVID-19 public health emergency have broadly excluded pregnant people from participation, illustrating a long-standing trend of clinical trial exclusion that has led to a clear knowledge gap and unmet need in the treatment and prevention of medical conditions experien …

Next up #MethodologyMonday focuses on pregnant women. Sewell et al summarise the scientific, ethical, & legal considerations governing research conducted during pregnancy. They also recommend strategies for overcoming impediments to inclusion and trial conduct.

pubmed.ncbi.nlm.nih.gov/35934117/

It’s the run up to the holidays so there can only be one #MethodologyMonday topic - the scientific way to cut your Christmas cake. Published c1906 in Nature by the statistician Francis Galton 🎂🎄🔪😊 Enjoy!
galton.org/essays/1900-...

Nice to see #MethodologyMonday again!

The stepped wedge design came up in the #CCRDownUnder meeting last week so it seemed a good time to revisit the pros and cons of this design 1/6
#MethodologyMonday #128

The authors analyse the inclusion of women in cardiovascular trials in #MethodologyMonday. Underrepresentation remains a persistent issue & increasingly so for minority women. The current situation has been shown to lead to > side effects & potentially worse outcomes
doi: 10.1016/j.ahjo.2022.100109

A Review of the Evolving Landscape of Inclusive Research and Improved Clinical Trial Access Current clinical research does not reflect the diversity of patient populations, despite continued recommendations to increase enrollment of under-represented racial and ethnic groups. The ramificati...

This #MethodologyMonday by Mohan & Freedman on persistent under-representation of racial & ethnic minorities in clinical trials. They argue that pursuing representative enrollment throughout clinical development is not only a matter of equity but also of scientific rigour.

doi.org/10.1002/cpt....

Using publicly available UK datasets to identify recruitment sites to maximise inclusion of under-served groups: three case studies There is strong evidence that those recruited into studies are not always representative of the population for whom the research is most relevant. Development of the study design and funding decisions are points in the research process where ...

This #MethodologyMonday by Booth et al focuses on case studies from three NIHR-funded trials demonstrating how publicly available UK population datasets can be used to identify under-served communities. They reflect on the challenges and future developments.

pmc.ncbi.nlm.nih.gov/articles/PMC...

The term #estimand is now part of the technical language of trials - but it remains a concept that many find hard to understand. Recent work has aimed to make the term more accessible to researchers, patients & public 1/8
#MethodologyMonday #127

Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent - Trials Background Deferred consent is used to recruit patients in emergency research, when informed consent cannot be obtained prior to enrolment. This model of consent allows studies to recruit larger numbe...

A #MethodologyMonday - Raven-Gregg & Shepherd on how methodology studies on attitudes to deferred consent often poorly represent ethnic minority groups. They argue for more equitable research, we need better reporting & greater diversity in research teams & ethics committees.
doi.org/10.1186/s130...

One of the adaptive designs we are seeing more frequently is the Sequential Multiple Assignment Randomised Trial (or SMART trial) 1/7
#MethodologyMonday #126

Inclusion of under-served groups in trials: an audit at a UK primary care clinical trials unit - Trials Background Clinical trials need to include patients who are representative of the population who may receive the tested interventions in the future. The importance of inclusivity is recognised by ethical and funding bodies and has public support. Appropriate inclusion is required to provide equitable evidence-based healthcare and to comply with ethical principles for research. However, there is little information about the inclusivity of most under-served groups in UK clinical trials. Methods This audit assesses the inclusion of under-served groups in trials run by the Oxford Primary Care Clinical Trials Unit (PC-CTU). We included trials with ethical approval between 2017 and 2023. We checked protocols, patient-facing information and selected data collection tools for information on the under-served groups in the INCLUDE guidance and protected characteristics in the UK Equality Act 2010, to identify explicit exclusions and data collection. Results We included 19 trials. They were in a variety of clinical conditions, testing different types of interventions, both Clinical Trial of an Investigational Medicinal Product (CTIMP) and non-CTIMP. Most were non-commercially funded. We reviewed 21 protocols, 29 Patient Information Sheets/Leaflets and 40 data collection tools. Common exclusions were based on age (19), sex or gender (11), language (8), capacity to consent (14), pregnancy (11), multiple health conditions (10) and severity of illness (17). Trials most often collected data on age (19), sex or gender (15), ethnicity (16), education (11), address (13), mental health conditions (6), who gave consent (19), addiction (6), multiple health conditions (10), severity of illness (17), smoking status (12) and obesity (13). Conclusions Often, exclusions were due to the focusing of the trial for a specific group, such as older people, women, or people being treated for a specific severity of condition. However, many explicit exclusions may not have been essential, may have reduced the inclusivity of the trials and might limit the applicability of the trial’s findings to people to whom the tested interventions might be relevant. These include the exclusion of people aged under 18, people without English language fluency and people without capacity to consent. All trials could have collected more informative data on under-served group status.

An audit at a UK primary care CTU assessed the inclusion of underserved groups in trials in this #MethodologyMonday.
The authors conclude that many explicit exclusions may not be strictly necessary & call for more inclusive eligibility criteria & standardised data collection
doi.org/10.1186/s130...

Who is in your trial? Improving the reporting of participant characteristics in trial protocols and results - Trials Advertisement

Oct #MethodologyMonday focuses on a recent editorial: the usefulness of trial data depends crucially on transparent, consistent reporting of who was actually enrolled, not could have been. Trials will introduce a requirement to address this (01/2026).
trialsjournal.biomedcentral.com/articles/10....

The last September #MethodologyMonday includes input from the consortium on improving the inclusion of those with impaired capacity with the dedicated INCLUDE framework. This article outlines the development of this dedicated framework.

trialsjournal.biomedcentral.com/articles/10....

Great #MethodologyMonday post on assessing acceptability in a pilot trial. Highlights the MRC complex intervention framework that AIMS Periop has used in its frailty research.

LinkedIn This link will take you to a page that’s not on LinkedIn

In the mixed-methods systematic review carried out by Stokes et al, not only were barriers identified, but also facilitators for the implementation of capacity legislation in care homes.

#MethodologyMonday
pubmed.ncbi.nlm.nih.gov/40370080/

One of the key things to address when undertaking a feasibility study ahead of a trial is the acceptability of different aspects of the proposed trial (intervention, trial processes, proposed outcomes etc) to all relevant parties 1/7
#MethodologyMonday #125

Gréaux et al identified barriers across the health system (cost, training, coordinated service) and wider contributing factors (social stigma or health literacy). Moreover, the solutions proposed dont necessarily address these needs
#MethodologyMonday
equityhealthj.biomedcentral.com/articles/10....

The inclusion of adults with intellectual disabilities in health research – challenges, barriers and opportunities: a mixed‐method study among stakeholders in England Background The study aims to understand system barriers to research participation for people with intellectual disabilities. Methods A mixed-methods approach examined the inclusivity of people wit...

Bishop et al discuss inclusion of adults with intellectual disabilities in #MethodologyMonday.

Findings: non-accessible research design, lack of confidence with capacity & consent, limited resources, & the need for training.

onlinelibrary.wiley.com/doi/10.1111/...

I seem to have been discussing pilot and feasibility studies a lot this week. One question often asked is how big should my pilot/feasibility study be? 1/6
#MethodologyMonday #124

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September #MethodologyMonday will focus on the inclusion of persons with disabilities. First, a call to action from Anderson and colleagues for disability inclusion in health research.

(not open access)
www.nature.com/articles/s41...

There has been a lot of debate recently about the promise of real world data - the routine (observational) data collected on patients eg  treatments received, clinical outcomes etc – for estimating treatment effects. But can they deliver? 1/9
#MethodologyMonday #123

Participation of Lower and Upper Middle–Income Countries in Oncology Clinical Trials This cross-sectional study examines the inclusion of patients with cancer from lower and upper middle–income countries in randomized clinical trials conducted by high-income countries.

In this week's #MethodologyMonday post, Rubagumya et al explore the impact of enrolling patients from lower middle-income countries on the bibliometric output. While many trials include such publics it is not reflected in their bibliometric output.

jamanetwork.com/journals/jam...

We often now hear the term “Bayesian borrowing” in trials. But what is Bayesian borrowing and what are the pros and cons around its use? 1/6
#MethodologyMonday #122

The Digital Cancer Research and Vocal co-developed this week’s #MethodologyMonday guidance with patients. They came up with 5 principles for the development of technology clinical trials and an accompanying checklist.

christie.openrepository.com/bitstream/ha...

Over recent weeks I have heard about some trials struggling with the phenomenon known as “Lasagne’s Law.” I’ve flagged this issue before, but always good to revisit it and discuss what can be done to minimise it 1/7
#MethodologyMonday #121

#MethodologyMonday
How the Rare Disease community is leading the way in Trial Design -

At #RareResearch25, Prof Jeffrey Krischer shares how innovative clinical trial designs are opening up new options for rare disease research.

▶️ Watch his keynote: www.youtube.com/watc...

Representation matters: a call for inclusivity and equity in heart failure clinical trials Abstract. The burden of heart failure remains substantial worldwide, and heart failure with reduced ejection fraction (HFrEF) affects approximately half of

#MethodologyMonday: a call to action from Reza and colleagues for the inclusion of all populations impacted by heart failure with reduced ejection fraction in clinical trials. They also catalogue barriers & propose strategies to ⬆️ inclusivity in future trials.

academic.oup.com/eurheartjsup...

Exploring Barriers to Inclusivity: Systematic Analysis of Exclusion Criteria and Potential Bias in Clinical Cancer Trials for Psychiatric and Neurological Conditions in European Protocols Background Cancer clinical trials often employ exclusion criteria that can impact vulnerable populations, particularly individuals with psychological, psychiatric, or neurological conditions. Aims...

Daho et al demonstrate through a systematic review of European cancer trials, that a large majority exclude populations with psychiatric & neurological disorders. Often citing compliance concerns & understanding of informed consent.
#MethodologyMonday
onlinelibrary.wiley.com/doi/full/10....

Clinical Trial Exclusion Criteria Affect Trial Inclusivity by Race and Sex | Journal of the American Heart Association

For #MethodologyMonday, we revisit the impact of exclusion criteria on sex and race. Stanton et al investigated the potential impact that common exclusion criteria by race and sex have on trial eligibility of patients with ischemic stroke.

www.ahajournals.org/doi/full/10....