Ricardo Eccard da Silva1,2, Angélica Amorim Amato3, Thiago do Rego Sousa4, Marta Rodrigues de Carvalho5, Maria Rita Carvalho Garbi Novaes3,5. 1. Brazilian Health Regulatory Agency (Anvisa), Setor de Indústria Trecho 5, Área Especial 57, Brasília, 71250-050, Brazil. ricardo.eccard@gmail.com. 2. University of Brasilia (UnB), Campus Universitário Darcy Ribeiro, Brasília, 70910-900, Brazil. ricardo.eccard@gmail.com. 3. University of Brasilia (UnB), Campus Universitário Darcy Ribeiro, Brasília, 70910-900, Brazil. 4. Technical University of Munich, Boltzmannstraße 3, 85748, Garching, Germany. 5. Health Sciences Education and Research Foundation (FEPECS), SMHN Quadra 03, Conjunto A, Bloco 1 Edifício FEPECS, Brasília, 70710-907, Brazil.
Abstract
PURPOSE: Participants' rights and safety must be guaranteed not only while a clinical trial is being conducted but also when a clinical trial finishes. The criteria for post-trial access to experimental drugs, however, are unclear in various countries. The objectives of this study were (i) to ascertain if there were regulations or guidelines related to patients' access to drugs after the end of clinical trials in the countries selected in the study and (ii) to analyze trends in post-trial access in countries classified by their level of economic development. METHODS: This study is a retrospective review. The data are from the records of clinical trials from 2014 registered in the World Health Organization's International Clinical Trials Registry Platform (ICTRP) database. RESULTS: Among the countries selected, provision of drugs post-trial is mandatory only in Argentina, Brazil, Chile, Finland, and Peru. The plans for post-trial access tend to be more present in low- and middle-income and upper middle-income countries, in comparison with high-income countries. Studies involving vulnerable populations are 2.53 times more likely to have plans for post-trial access than studies which do not. CONCLUSIONS: The guaranteeing of post-trial access remains mandatory in few countries. Considering that individuals seen as vulnerable have been included in clinical trials without plans for post-trial access, stakeholders must discuss the need to develop regulations mandating the guaranteeing of post-trial access in specified situations.
PURPOSE:Participants' rights and safety must be guaranteed not only while a clinical trial is being conducted but also when a clinical trial finishes. The criteria for post-trial access to experimental drugs, however, are unclear in various countries. The objectives of this study were (i) to ascertain if there were regulations or guidelines related to patients' access to drugs after the end of clinical trials in the countries selected in the study and (ii) to analyze trends in post-trial access in countries classified by their level of economic development. METHODS: This study is a retrospective review. The data are from the records of clinical trials from 2014 registered in the World Health Organization's International Clinical Trials Registry Platform (ICTRP) database. RESULTS: Among the countries selected, provision of drugs post-trial is mandatory only in Argentina, Brazil, Chile, Finland, and Peru. The plans for post-trial access tend to be more present in low- and middle-income and upper middle-income countries, in comparison with high-income countries. Studies involving vulnerable populations are 2.53 times more likely to have plans for post-trial access than studies which do not. CONCLUSIONS: The guaranteeing of post-trial access remains mandatory in few countries. Considering that individuals seen as vulnerable have been included in clinical trials without plans for post-trial access, stakeholders must discuss the need to develop regulations mandating the guaranteeing of post-trial access in specified situations.
Entities:
Keywords:
Access; Clinical trials; Continuity of patient care; Drugs; Ethics
Authors: Angelica P Herrera; Shedra Amy Snipes; Denae W King; Isabel Torres-Vigil; Daniel S Goldberg; Armin D Weinberg Journal: Am J Public Health Date: 2010-02-10 Impact factor: 9.308
Authors: Andrea L Ciaranello; Rochelle P Walensky; Paul E Sax; Yuchiao Chang; Kenneth A Freedberg; Joel S Weissman Journal: HIV Clin Trials Date: 2009 Jan-Feb
Authors: Roberto Iunes; Manuela Villar Uribe; Janet Bonilla Torres; Marina Morgado Garcia; Juliana Alvares-Teodoro; Francisco de Assis Acurcio; Augusto Afonso Guerra Junior Journal: Int J Equity Health Date: 2019-06-03
Authors: Gilles R Dagenais; Leanne Dyal; Jacqueline J Bosch; Darryl P Leong; Victor Aboyans; Scott D Berkowitz; Deepak L Bhatt; Stuart J Connolly; Keith A A Fox; Eva Muehlhofer; Jeffrey L Probstfield; Petr Widimsky; Bernhard R Winkelmann; Salim Yusuf; John W Eikelboom Journal: Heart Date: 2021-05-21 Impact factor: 5.994