Design, objectives, execution and reporting of published open-label extension studies

Journal of Evaluation in Clinical Practice

Volumn 18, Issue 2, 2012, Pages 209-215

  Megan, Bowers ^a   Pickering, Ruth M ^a   Weatherall, Mark ^b  

^a UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^b UNIVERSITY OF OTAGO WELLINGTON   (New Zealand)

Author keywords

open label extension studies; reporting; retention; validity

Indexed keywords

NEW DRUG;

ARTICLE; DRUG EFFICACY; EMBASE; EVIDENCE BASED MEDICINE; EXPERIMENTAL DESIGN; HUMAN; INFORMATION PROCESSING; INTERNAL BIAS; MEDLINE; OPEN LABEL EXTENSION STUDY; OPEN STUDY; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); VALIDITY;

CHI-SQUARE DISTRIBUTION; CONFIDENCE INTERVALS; DRUG APPROVAL; DRUGS, INVESTIGATIONAL; ETHICS, CLINICAL; ETHICS, RESEARCH; HUMANS; MARKETING OF HEALTH SERVICES; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 84858145867     PISSN: 13561294     EISSN: 13652753     Source Type: Journal    
DOI: 10.1111/j.1365-2753.2010.01553.x     Document Type: Article

References (17)

1. Day, R. O., &, Williams, K. M., (2007) Open-label extension studies: do they provide meaningful information on the safety of new drugs? Drug Safety, 30, 93-105.
2. Wainwright, P., (2002) Consent to open label extension studies: some ethical issues. Journal of Medical Ethics, 28, 373-376.
3. Taylor, G. J., &, Wainwright, P., (2002) Open label extension studies: research or marketing? BMJ, 331, 572-574.
4. Schneider, L. S., (2006) Open label extension studies and misinformation [correspondence]. Archives of Neurology, 63, 1036.
5. Jadad, A. R., Moore, R. A., Carroll, D., Jenkinson, C., Reynolds, D. J. M., Gavaghan, D. J., &, McQuay, H. J., (1996) Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clinical Trials, 17, 1-12.
6. Debruyne, F., Barkin, J., van Erps, P., Reis, M., Tammela, T. L. J., &, Roehrborn, C., (2004) Efficacy and safety of long-term treatment with the dual 5α-reductive inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. European Urology, 46, 488-495.
7. Müller-Lissner, S., Kamm, M. A., Musoglu, A., Earnest, D. L., Dunger-Baldauf, C., &, Shetzine, M. A., (2006) Safety, tolerability and efficacy of tegaserod over 13 months in patients with chronic constipation. American Journal of Gastroenterolgy, 101, 2558-2569.
8. Lyketsos, C. G., Reichman, W. E., Kershaw, P., &, Zhu, Y., (2004) Long-term outcomes of galantamine treatment in patients with Alzheimer disease. American Journal of Geriatric Psychiatry, 12, 473-482.
9. Hauser, R. A., Rascol, O., Korczyn, A. D., Stoessl, A. J., Watts, R. L., Poewe, W., De Deyn, P. P., &, Lang, A. E., (2007) Ten-year follow-up of Parkinson's disease patients randomized to initial therapy with ropinirole or levodopa. Movement Disorders, 22, 2409-2417.
10. Altman, D. G., Machin, D., Bryant, T. N., &, Gardner, M. J., (2000) Statistics with Confidence, 2nd edn. London: BMJ Publishing Group.
11. Schulz, K. F., &, Grimes, D. A., (2002) Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet, 359, 781-785.
12. Schulz, K. F., &, Grimes, D. A., (2002) Blinding in randomised trials: hiding who got what. Lancet, 359, 696-700.
13. Maguire, M. J., Hemming, K., Hutton, J. L., &, Marson, A. G., (2008) Reporting and analysis of open-label extension studies of anti-epileptic drugs. Epilepsy Research, 81, 24-29.
14. Hemming, K., Hutton, J. L., Maguire, M. J., &, Marson, A. G., (2008) Open-label extension studies and patient selection biases. Journal of Evaluation in Clinical Practice, 14, 141-144.
15. Weatherall, M., Burgess, C., &, Taylor, W., (2007) Open-label extension studies: interpretation and statistical issues. International Journal of Pharmaceutical Medicine, 21, 115-120.
16. Taylor, W. J., &, Weatherall, M., (2006) What are open-label extension studies for? Journal of Rheumatology, 33, 642-643.
17. Elm, E. V., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., Vandenbroucke, J. P., for the STROBE Initiative (2007) Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ, 335, 806-808.