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MEDR5180M
Clinical Trials Reading List

Clinical Trials Research, 2021/22, Semester 1
Sue Bell, Michelle Collinson
s.e.bell@leeds.ac.uk, m.collinson@leeds.ac.uk
Tutor information is taken from the Module Catalogue

Core reading

  1. Clinical trials tool kit: Planning and Design. http://www.ct-toolkit.ac.uk/routemap/trial-planning-and-design  
  2. CONSORT statement and extensions. http://www.consort-statement.org/  
  3. The Changing Face of Clinical Trials. New England Journal of Medicine. Series of monthly papers from June 2012 https://www.nejm.org/clinical-trials-series  
  4. Clinical Trials Guide. NIHR. https://www.nihr.ac.uk/documents/clinical-trials-guide/20595  
  5. MRC Methodology Hub. Guidance pack https://www.methodologyhubs.mrc.ac.uk/advice/network-guidance/  

Further reading

  1. Crombie, I. K., & Davies, H. T. O. 1996. Research in health care : design, conduct and interpretation of health services research ISBN: 0471962597. Chichester: Wiley.
  2. Pocock, S. J. 1983. Clinical trials : a practical approach ISBN: 0471901555. Chichester; New York: Wiley.
  3. Fundamentals of clinical trials. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets. Springer; 4th ed. 2010
  4. Clinical Trials: A practical guide to design, analysis and reporting. Wang D, Bakhai A. Remedica; 1st ed. 2006
  5. Smajdor, A., Sydes, M. R., Gelling, L., & Wilkinson, M. (2009). Applying for Ethical Approval for Research in the United Kingdom. British medical journal. ISSN: 0959-8138; 1468-5833; 0959-8146; 0959-8154; 0959-535X; 1756-1833; 339:b4013
  6. Study Support Service. https://www.nihr.ac.uk/explore-nihr/support/study-support-service.htm
  7. Good clinical practice for clinical trials. How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection. Published 18 December 2014. Last updated 31 July 2020. Medicines and Healthcare products Regulatory Agency. https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials
  8. Beyond Scientific Publication: Strategies for Disseminating Research Findings. CARE: Community Alliance for Research and Engagement. Yale Centre for Clinical Investigation http://www.idaea.csic.es/sites/default/files/CARE-Beyond-Scientific-Publication-Strategies-for-Disseminating-Research-Findings.pdf
  9. Attributing the costs of health & social care Research & Development (AcoRD) https://www.gov.uk/government/news/attributing-the-costs-of-health-social-care-research-development-acord
  10. Information for participants at the end of a study: Guidance for Researchers/Sponsors/ Chief Investigators/Principal Investigators https://www.hra.nhs.uk/planning-and-improving-research/best-practice/publication-and-dissemination-research-findings/
  11. Developing and evaluating complex interventions. MRC https://mrc.ukri.org/documents/pdf/complex-interventions-guidance/.
  12. Process evaluation of complex interventions. MRC guidance. https://www.bmj.com/content/350/bmj.h1258
  13. Trial Forge: A systematic way to making trials more efficient. https://www.trialforge.org/ Twitter @Trial_Forge
  14. Chan, A. W., Tetzlaff, J.M., etal. 2013. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trialshttps://www.bmj.com/content/346/bmj.e7586
  15. 15. Park, J. J. H., Siden, E., Zoratti, M. J., etal. 2019. Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3664-1

Background reading

  1. Clinical trials and medical research: Definitions. NHS Choices http://www.nhs.uk/Conditions/Clinical-trials/Pages/Definition.aspx
  2. Leeds institute of Clinical Trials Research website: https://medicinehealth.leeds.ac.uk/leeds-institute-clinical-trials-research

 

This list was last updated on 06/08/2021