Links to other groups, resources and standards
- Capacity and consent to research
- CONSORT statement (Consolidated Standards of Reporting Trials)
- The Declaration of Helsinki
- Health Research Authority guidance on consent
- Health Research Authority introduction to Good Clinical Practice
- ICH Efficiency Guidelines, including E6 Good Clinical Practice, E9 Statistical Principles for Clinical Trials and the addendum to E9
- NIHR Clinical Trials Toolkit
- SPIRIT statement (Standard Protocol Items: Recommendations for Interventional Trials)
- Trial Forge
- UK Clinical Research Collaboration Registered Clinical Trials Unit Network
References
- Akl et al. (2015) Reporting missing participant data in randomised trials: systematic survey of the methodological literature and a proposed guide. BMJ Open. 5:e008431. https://doi.org/10.1136/bmjopen-2015-008431
- Brueton et al. (2014). Strategies to improve retention in randomised trials: a Cochrane systematic review and meta analysis. BMJ Open, 4(2), e003821. https://doi.org/10.1136/bmjopen-2013-003821
- Brunsdon et al. (2019). What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study. Trials, 20(1), 593. https://doi.org/10.1186/s13063-019-3687-7
- Cro et al. (2020). A four-step strategy for handling missing outcome data in randomised trials affected by a pandemic. BMC Med Res Methodol 20, 208 https://doi.org/10.1186/s12874-020-01089-6
- Cro et al. (2020) Sensitivity analysis for clinical trials with missing continuous outcome data using controlled multiple imputation: a practical guide. Stat Med. sim.8569. https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.8569
- Cro et al. (2023) Starting a conversation about estimands with public partners involved in clinical trials: a co-developed tool. Trials. 24, 443. https://doi.org/10.1186/s13063-023-07469-9
- Daykin et al. (2018) ‘Recruitment, recruitment, recruitment’ – the need for more focus on retention: a qualitative study of five trials. Trials. 19, 76. https://doi.org/10.1186/s13063-018-2467-0
- Dumville et al. (2006) Reporting attrition in randomised controlled trials. BMJ. 22;332(7547):969-71. https://doi.org/10.1136/bmj.332.7547.969.
- Eborall HC et al. (2011) Accrual and drop out in a primary prevention randomised controlled trial: qualitative study. Trials. 11;12:7. https://doi.org/10.1186/1745-6215-12-7
- Gordon & Prohaska (2006) The Ethics of Withdrawal from Study Participation. Account Res 12(4):285-309. https://doi.org/10.1080/08989620600848645
- Hussain et al. (2022) Development of guidelines to reduce, handle and report missing data in palliative care trials: A multi-stakeholder modified nominal group technique. Palliative Medicine. 2022;36(1):59-70. https://doi.org/10.1177/02692163211065597
- Kahale et al. (2019) A guidance was developed to identify participants with missing outcome data in randomized controlled trials. J Clin Epi. 115, 55-63. https://doi.org/10.1016/j.jclinepi.2019.07.003
- Kang et al. (2022) Incorporating estimands into clinical trial statistical analysis plans. Clin Trials. 19(3):285-291. https://doi.org/10.1177/17407745221080463
- Kearney et al. (2018) Reducing attrition within clinical trials: The communication of retention and withdrawal within patient information leaflets. PLoS ONE. 13(10): e0204886. https://doi.org/10.1371/journal.pone.0204886
- Lynch (2020) The right to withdraw from controlled human infection studies: Justifications and avoidance. J Bioethics. 34(8):833.838. https://doi.org/10.1111/bioe.12704
- Lynggaard et al. (2022) Principles and recommendations for incorporating estimands into clinical study protocol templates. Trials. 23, 685. https://doi.org/10.1186/s13063-022-06515-2
- Mallinckrodt et al (2017) Choosing estimands in clinical trials with missing data. Pharm Stat. 16(1):29–36. https://doi.org/10.1002/pst.1765
- Marie Curie Research: Missing data in palliative and end of life care trials. https://www.mariecurie.org.uk/globalassets/media/documents/research/Missing-Guidance-Report-final-June-2022.pdf
- Ulrich et al. (2021) Experiences of Patients After Withdrawal From Cancer Clinical Trials. JAMA Netw Open. 4(8):e2120052. https://doi.org/10.1001/jamanetworkopen.2021.20052
- Wilson et al. (2005) Enhancing cancer trial management: An intervention study of the impact of providing information, trial results and support to patients in phase I and II anti-cancer drug trials at trial conclusion. Clinical Effectiveness in Nursing. 9(3-4) 119-132. https://doi.org/10.1016/j.cein.2006.06.003
- Wittes (2009) Missing Inaction: Preventing Missing Outcome Data in Randomized Clinical Trials, J Biopharm Stat. 19:6, 957-968. https://doi.org/10.1080/10543400903239825