Carroll, C., Kaltenthaler, E., FitzGerald, P., Boland, A. and Dickson, R. (2011) A thematic analysis of the strengths and weaknesses of manufacturers' submissions to the NICE Single Technology Assessment (STA) process. Health Policy, 102 (2-3). pp. 136-144. ISSN 0168-8510Full text available as:
Objectives: The NICE Single Technology Appraisal (STA) process in the UK has been underway for five years. Evidence Review Groups (ERGs) critically appraise submissions from manufacturers on the clinical and cost effectiveness of new technologies. This study analysed the ERGs' assessment of the strengths and weaknesses of 30 manufacturers' submissions to the STA process.
Methods: Thematic analysis was performed on the textual descriptions of the strengths and weakness of manufacturer submissions, as outlined by the ERGs in their reports.
Findings: Various themes emerged from the data. These themes related to the processes applied in the submissions; the content of the submission (e.g. the amount and quality of evidence); the reporting of the submissions' review and analysis processes; the reliability and validity of the submissions' findings; and how far the submission had satisfied the STA process objectives.
Conclusions: STA submissions could be improved if attention were paid to transparency in the reporting, conduct and justification of review and modelling processes and analyses, as well as greater robustness in the choice of data and closer adherence to the scope or decision problem. Where this adherence is not possible, more detailed justification of the choice of evidence or data is required. (C) 2011 Elsevier Ireland Ltd. All rights reserved.
|Copyright, Publisher and Additional Information:||© 2011 Elsevier. This is an author produced version of a paper subsequently published in Health Policy. Uploaded in accordance with the publisher's self-archiving policy.|
|Keywords:||Review; Systematic; Cost effectiveness; Cost benefit analysis; Pharmaceutical industry; Drug approval|
|Institution:||The University of Sheffield|
|Academic Units:||The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield)|
|Depositing User:||Miss Anthea Tucker|
|Date Deposited:||09 Nov 2011 16:02|
|Last Modified:||08 Feb 2013 17:35|
|Published Version:||http://dx.doi.org/10.1016/j.healthpol.2011.06.002 ...|