The interaction between equipoise and logistics in clinical trials: A case study.
Clin Trials
; 14(3): 314-318, 2017 Jun.
Article
em En
| MEDLINE
| ID: mdl-28135804
ABSTRACT
INTRODUCTION:
Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications.BACKGROUND:
Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials. There are also logistical barriers to enrollment in international trials due to prolonged timelines for approvals by government agencies and ethical review boards. CASE STUDY A multinational clinical trial of bridging strategies for treatment of non-adherent HIV-infected youth, experienced differing perceptions of equipoise due to disparities in availability of treatment options by country. Unfortunately, the countries with most demand for the trial were those where the approval process was most delayed, and the study was closed early due to slow accrual.DISCUSSION:
When planning multicenter clinical trials, it is important to take into account heterogeneity among research sites and try to anticipate differences in equipoise and logistical factors between sites, in order to plan to address these issues at the design stage.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Infecções por HIV
/
Ensaios Clínicos como Assunto
/
Seleção de Pacientes
/
Pesquisa Biomédica
/
Equipolência Terapêutica
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Revista:
Clin Trials
Assunto da revista:
MEDICINA
/
TERAPEUTICA
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Estados Unidos