How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis.
Adaptive design
Cost-effectiveness
Health economics
Recommendations
Value of information
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
06 Mar 2020
06 Mar 2020
Historique:
received:
04
08
2019
accepted:
04
02
2020
entrez:
8
3
2020
pubmed:
8
3
2020
medline:
29
12
2020
Statut:
epublish
Résumé
Adaptive designs offer a flexible approach, allowing changes to a trial based on examinations of the data as it progresses. Adaptive clinical trials are becoming a popular choice, as the prudent use of finite research budgets and accurate decision-making are priorities for healthcare providers around the world. The methods of health economics, which aim to maximise the health gained for money spent, could be incorporated into the design and analysis of adaptive clinical trials to make them more efficient. We aimed to understand the perspectives of stakeholders in health technology assessments to inform recommendations for the use of health economics in adaptive clinical trials. A qualitative study explored the attitudes of key stakeholders-including researchers, decision-makers and members of the public-towards the use of health economics in the design and analysis of adaptive clinical trials. Data were collected using interviews and focus groups (29 participants). A framework analysis was used to identify themes in the transcripts. It was considered that answering the clinical research question should be the priority in a clinical trial, notwithstanding the importance of cost-effectiveness for decision-making. Concerns raised by participants included handling the volatile nature of cost data at interim analyses; implementing this approach in global trials; resourcing adaptive trials which are designed and adapted based on health economic outcomes; and training stakeholders in these methods so that they can be implemented and appropriately interpreted. The use of health economics in the design and analysis of adaptive clinical trials has the potential to increase the efficiency of health technology assessments worldwide. Recommendations are made concerning the development of methods allowing the use of health economics in adaptive clinical trials, and suggestions are given to facilitate their implementation in practice.
Identifiants
pubmed: 32143728
doi: 10.1186/s13063-020-4137-2
pii: 10.1186/s13063-020-4137-2
pmc: PMC7060544
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
252Subventions
Organisme : Department of Health
ID : DRF-2015-08-013
Pays : United Kingdom
Organisme : Research Trainees Coordinating Centre
ID : DRF-2015-08-013
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