CoChat
Sign Up
Cited by 907Ethics in Clinical ResearchStatistical Methods in Clinical TrialsHealth Policy Implementation Science

Barriers to Participation in Randomised Controlled Trials

Ross, Sue, Grant, Adrian, Counsell, Carl, Gillespie, William, Russell, Ian, Prescott, Robin·1999·Journal of Clinical Epidemiology
DOI 10.1016/s0895-4356(99)00141-9
Open this paper in CoChat — free account

Abstract

Method A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials.Results Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent.Conclusions To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.

Integrity signals

Registry

Crossref · 10.1016/s0895-4356(99)00141-9

Cites

91 of 91 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Participants are often concerned about being randomized to a less effective treatment.

    “Participants are often concerned about being randomized to a less effective treatment [141, 142], but here the 2 treatment arms will be in true clinical equipoise [143].”

    From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [142]

  • Factors such as participant burden and feasibility can affect the decision of potential investigators and participants to join the trial.

    “These factors can also affect the decision of potential investigators and participants to join the trial (item 20).286”

    From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [286]

  • A systematic review of barriers for conducting clinical trials by clinicians in developed countries identified several major barriers: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting.

    “A systematic review of barriers for conducting clinical trials by clinicians in developed countries identified several major barriers. These include time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently”

    From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [24]

  • A systematic review of physician barriers in RCTs for cancer and other illnesses in the developed world identified lack of time as a major barrier.

    “By contrast, a systematic review related to physician barriers in RCTs for cancer and other illnesses in the developed world identified lack of time as a major barrier [24].”

    From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [24]

  • A systematic review regarding barriers for participation of doctors in clinical trials in developed countries identified lack of time as a major barrier.

    “For example, one systematic review regarding barriers for participation of doctors in clinical trials in developed countries identified lack of time as a major barrier [24].”

    From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [24]

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
Ross, S., Grant, A., Counsell, C., Gillespie, W., Russell, I., & Prescott, R.
Affiliations
  • University of Aberdeen (GB)
  • Western General Hospital (GB)
  • University of Edinburgh (GB)
  • University of York (GB)
Corresponding author
Ross, Sue
ORCID
Venue
Journal of Clinical Epidemiology
Publisher
Elsevier BV
Published
1999-12
Volume
52
Issue
12
Pages
1143-1156
ISSN
0895-4356 (ISSN-L)
DOI
10.1016/s0895-4356(99)00141-9
OpenAlex
W181033957
Cited by
907
References
91
Citations by year
2026: 15 · 2025: 20 · 2024: 13 · 2023: 36 · 2022: 35 · 2021: 35 · 2020: 66 · 2019: 44 · 2018: 46 · 2017: 49 · 2016: 43 · 2015: 48 · 2014: 47 · 2013: 47 · 2012: 50
FWCI
2.49
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of Clinical Epidemiology (publishedVersion)
  • PubMed (publishedVersion)
  • DigitalGeorgetown (Georgetown University Library) (submittedVersion)
Funders
Wellcome Trust
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Keywords
barriers to clinical trial participation, randomized controlled trials, clinician recruitment, patient recruitment, clinical trial participation, physician-patient relationship, informed consent, professional autonomy, trial protocol design
MeSH terms
Data Collection, Humans, Patient Compliance, Patient Participation, Retrospective Studies, Randomized Controlled Trials as Topic, Databases, Factual, Patient Selection

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 ›

Are you an author, or do you see a problem with this page? Request a review