Provision of investigational drug after clinical research - Review of literature, national and international guidelines

Imagem de Miniatura
Arquivos
art_DAINESI_Provision_of_investigational_drug_after_clinical_research_Review_2011.PDF (2.17 MB)
Citações na Scopus
Tipo de produção
article
Data de publicação
2011
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
ASSOC MEDICA BRASILEIRA
Autores
Citação
REVISTA DA ASSOCIACAO MEDICA BRASILEIRA, v.57, n.6, p.710-716, 2011
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Provision of investigational drug after clinical research - Review of literature, national and international guidelines The post-trial access to investigational drugs has been the object of discussion since the late 1980s at least, initially linked to trials carried out in acquired immunodeficiency syndrome and, particularly, in developing countries, where the concern with patient vulnerability is more important. National and international guidelines do mention the subject; however, the complexity of the issue is not easily addressed and usually requires additional and specific discussions. The decision on providing the investigational drug after the trial shall rest on at least two dimensions: efficacy and safety assessments, as the new drug is still on the experimental phase. Each clinical trial shall have its own assessment, taking into account the disease being studied, as well as the study population and their specific needs. Therefore, the nature of post-trial obligations cannot be considered the same in all situations and contexts; nevertheless, it should be assured that the relationship developed between investigators and patients during the study must be always terminated with respect and responsibility.
Palavras-chave
Continuity of patient care, drugs, investigational, clinical research, bioethics, ethics committees, research, vulnerability
URI
https://observatorio.fm.usp.br/handle/OPI/23370
Referências
  1. Pace C, 2006, AIDS RES HUM RETROV, V22, P837, DOI 10.1089/aid.2006.22.837
  2. Falit BP, 2008, JAMA-J AM MED ASSOC, V300, P2793, DOI 10.1001/jama.2008.828
  3. Zong ZY, 2008, J MED ETHICS, V34, P188, DOI 10.1136/jme.2006.018754
  4. Hamilton EP, 2010, J CLIN ONCOL, V28, P5067, DOI 10.1200/JCO.2010.28.6567
  5. Barsdorf N, 2010, DEV WORLD BIOETH, V10, P78, DOI 10.1111/j.1471-8847.2009.00265.x
  6. Cabral MML, 2006, REV SAUDE PUBL, V40, P521, DOI [10.1590/S0034-89102006000300022, 10.1590/s0034-89102006000300022]
  7. Ciaranello AL, 2009, HIV CLIN TRIALS, V10, P13, DOI [10.1310/hct1001-013, 10.1310/hct1001-13]
  8. *CNS, REL REUN AMPL CONEP
  9. Cohen E. R. M., 2008, DEV WORLD BIOETH, V9, P74
  10. Council for International Organizations of Medical Sciences (CIOMS), 2002, INT ETH GUID BIOM RE
  11. DAINESI SM, 2011, THESIS U SAO PAULO
  12. Dainesi SM, 2009, REV ASSOC MED BRAS, V55, P237, DOI 10.1590/S0104-42302009000300006
  13. DEUCHER KLA, 2009, THESIS U SAO PAULO
  14. Goldim JR, 2008, REV PANAM SALUD PUBL, V23, P198, DOI 10.1590/S1020-49892008000300007
  15. GRADY C, 2006, ETHICS J AM MED ASS, V8, P235
  16. *IND LIAIS FOR, 20022003 IND LIAIS F
  17. KAAS N, 2001, ETHICAL POLICY ISSUE, V2
  18. Lacativa PGS, 2008, CIENCIA SAUDE COLETI, V13, P611
  19. National Bioethics Advisory Commission, 2001, ETH POL ISS RES INV
  20. *NIH, NIH GUID ADDR PROV A
  21. *NUFF COUNC BIOETH, 2002, WHAT HAPP ONC RES IS
  22. Organizacao das Nacoes Unidas para a Educacao a Ciencia e a Cultura (Unesco), 2005, DECL UN BIOET DIR HU
  23. Schlemper-Junior BR, 2007, REV BIOETICA, V15, P248
  24. Schroeder D, 2008, RECIIS REV ELETR S1, V2, pS66
  25. Shaffer DN, 2006, J MED ETHICS, V32, P55, DOI 10.1136/jme.2004.011106
  26. Shah S, 2009, AM J PUBLIC HEALTH, V99, P1556, DOI 10.2105/AJPH.2008.157982
  27. Sofaer N, 2009, J MED ETHICS, V35, P183, DOI 10.1136/jme.2008.024711
  28. World Medical Association (WMA), DECL HELS

Coleções
Artigos e Materiais de Revistas Científicas - FM/MPR
Artigos e Materiais de Revistas Científicas - LIM/39