HEL-8018 Introduction to Randomised Control Trials (RCT) - 2 stp

PhD course. This course is available as a singular course.

The course is organised by Clinical Research Department, UNN Tromsø and Graduate School TRAVERS.

• Fundamental principles and practice of RCT
• Guidelines and standards in RCT
• Design of RCT, choice of randomization method
• Protocol writing/documentation requirements
• Approach to data analysis and introduction to statistical methods
• Challenges in planning and conducting RCTs

Registration deadline for PhD students and students at the Medical Student Research Program at Uit - The Arctic University of Norway: September 1st

Application deadline for external applicants: June 1st

Application code 9303

PhD students, masters students at a Medical Student Research Program, or holders of a Norwegian master´s degree of five years or 3+ 2 years (or equivalent) may be admitted. Valid documentation is a statement from your institution that you are a registered PhD student, or master student at a Medical Student Research Program or a Master´s Diploma with Diploma Supplement / English translation of the diploma. PhD students are exempt from semester fee.

For more information regarding PhD courses at the Faculty of Health Sciences go to: http://uit.no/helsefak/forskning/phd/emner

Knowledge:

After finishing the course, participants will

• have knowledge about the fundamental principles of RCT, such as random allocation to experimental groups, blinding, precision, types of bias, ethical issues, dataanalysis etc, as well as practical approach to this type of studies

Skills:

After finishing the course, participants will

• be able to define research question to be answered by RCT
• be able to define comparison groups (inclusion and exclusion criteria)
• be able to choose optimal design and randomization method
• be able to plan, initiate and conduct an RCT (primarily under supervision or in team)
• know the requirements for documentation and registration of clinical trials
• be familiar with statistical analysis methods and challenges of RCT; reporting of RCT results; critical independent appraisal of published RCT reports.

Competence:

Basic competence necessary for planning and conducting RCT. Basis for further development. Basis for further development.

Participation requirements: Mandatory lecture attendance

Exam and evaluation: Home exam (1-3 pages), evaluated with passed/not passed. The assignments may be completed in Norwegian, English, Swedish or Danish.

Re-sit exam will be given. Application deadline for continuation exam is January 15th.

RECOMMENDED READING:

1. Deangelis, C.D., Drazen, J.M., Frizelle, F.A., Haug, C., Hoey, J., Horton, R., Kotzin, S., Laine, C., Marusic, A., Overbeke, A.J., et al. 2005. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. JAMA 293:2927-2929.

2. DeAngelis, C.D., Drazen, J.M., Frizelle, F.A., Haug, C., Hoey, J., Horton, R., Kotzin, S., Laine, C., Marusic, A., Overbeke, A.J., et al. 2004. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 292:1363-1364.

3. Laine, C., Horton, R., DeAngelis, C.D., Drazen, J.M., Frizelle, F.A., Godlee, F., Haug, C., Hebert, P.C., Kotzin, S., Marusic, A., et al. 2007. Clinical trial registration: looking back and moving ahead. Lancet 369:1909-1911.

4. Bretthauer, M., and Haug, C. 2009. [Without registration, no publishing!]. Tidsskr Nor Laegeforen 129:733.

5. Zwarenstein, M., and Treweek, S. 2009. ACP Journal Club. What kind of randomized trials do patients and clinicians need? Ann Intern Med 150:JC5-2, JC5-3.

6. Zarin, D.A., Tse, T., Williams, R.J., Califf, R.M., and Ide, N.C. 2011. The ClinicalTrials.gov results database--update and key issues. N Engl J Med 364:852-860.

7. Cobo, E., Cortes, J., Ribera, J.M., Cardellach, F., Selva-O'Callaghan, A., Kostov, B., Garcia, L., Cirugeda, L., Altman, D.G., Gonzalez, J.A., et al. 2011. Effect of using reporting guidelines during peer review on quality of final manuscripts submitted to a biomedical journal: masked randomised trial. BMJ 343:d6783.

8. Haynes R.B., Sackett D.L., Guyatt G.H., Tugwell P.. 2006. Clinical Epidemiology, How to Do Clinical Practice Research. Lippincott Williams & Wilkins ISBN 0-7 817-4524-1

9. Bassler, D., Briel, M., Montori, V.M., Lane, M., Glasziou, P., Zhou, Q., Heels-Ansdell, D., Walter, S.D., Guyatt, G.H., Flynn, D.N., et al. 2010. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA 303:1180-1187.

10. Pocock, S. J.: Clinical Trials — a practical approach. John Wiley & Sons, 1983, 265 S.

11. Wulff HR, Gøtzsche PC 2006. Rationel klinik: Evidencebaserede diagnostiske beslutninger. København: Munksgaard . 5. utg. ISBN 87-628-0590-8, 304 s

12. Schulz, K.F., Altman, D.G., and Moher, D. 2010. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 152:726-732.

13. Moher, D., Hopewell, S., Schulz, K.F., Montori, V., Gotzsche, P.C., Devereaux, P.J., Elbourne, D., Egger, M., and Altman, D.G. 2010. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 340:c869.

14. Boutron, I., Moher, D., Altman, D.G., Schulz, K.F., and Ravaud, P. 2008. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 148:295-309.

15. Gagnier, J., Boon, H., Rochon, P., Barnes, J., Moher, D., and Bombardier, C. 2006. Improving the quality of reporting of randomized controlled trials evaluating herbal interventions: implementing the CONSORT statement [corrected]. Explore (NY) 2:143-149.

16. Gagnier, J.J., Boon, H., Rochon, P., Moher, D., Barnes, J., and Bombardier, C. 2006. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 144:364-367.

17. Zwarenstein, M., Treweek, S., Gagnier, J.J., Altman, D.G., Tunis, S., Haynes, B., Oxman, A.D., and Moher, D. 2008. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 337:a2390.

18. Piaggio, G., Elbourne, D.R., Altman, D.G., Pocock, S.J., and Evans, S.J. 2006. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 295:1152-1160.