Clinical trial design in adult reflux disease: a methodological workshop
Article first published online: 31 MAR 2008
© 2008 The Authors. Journal compilation © 2008 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 28, Issue 1, pages 107–126, July 2008
How to Cite
DENT, J., KAHRILAS, P. J., VAKIL, N., VAN ZANTEN, S. V., BYTZER, P., DELANEY, B., HARUMA, K., HATLEBAKK, J., MCCOLL, E., MOAYYEDI, P., STANGHELLINI, V., TACK, J. and VAEZI, M. (2008), Clinical trial design in adult reflux disease: a methodological workshop. Alimentary Pharmacology & Therapeutics, 28: 107–126. doi: 10.1111/j.1365-2036.2008.03700.x
- Issue published online: 2 JUN 2008
- Article first published online: 31 MAR 2008
- Publication data Submitted 21 January 2008 First decision 20 February 2008 Resubmitted 24 March 2008 Resubmitted 25 March 2008 Accepted 27 March 2008 Epub OnlineAccepted 31 March 2008
Background The development of well-tolerated acid suppressant drugs has stimulated substantial growth in the number of trials assessing therapy options for gastro-oesophageal reflux disease (GERD).
Aim To develop consensus statements to inform clinical trial design in adult patients with GERD.
Methods Draft statements were developed employing a systematic literature review. A modified Delphi process including three rounds of voting was used to reach consensus. Between voting, statements were revised based on feedback from the Working Group and additional literature reviews. The final vote was at a face-to-face meeting that included discussion time. Voting was conducted using a six-point scale.
Results At the last vote, 93% of the final 102 statements achieved consensus (defined a priori as being supported by ≥75% of the votes). The Working Group strongly supported the development of validated patient-reported outcome instruments. Symptom assessments carried out by the investigator were considered unacceptable. There was agreement that exclusion from clinical trials should be minimized to improve generalizability, that prospective evaluation ideally requires electronic timed/dated methods and that endoscopists should be blinded to patient symptom status.
Conclusions Implementation of the consensus statements will improve the quality and comparability of trials, and make them compatible with regulatory requirements.