Conduct of clinical trials in developing countries: a perspective

被引:25
|
作者
Devasenapathy, Niveditha [1 ]
Singh, Kavita [1 ]
Prabhakaran, Dorairaj [1 ]
机构
[1] CCDC, SDA, New Delhi 110016, India
关键词
clinical trials; developing countries; ethics; INFORMED-CONSENT; ETHICS; INDIA;
D O I
10.1097/HCO.0b013e32832af21b
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Purpose of review To provide a broad perspective of contextual factors involved in the conduct of clinical trials in developing countries. Recent findings The quantity of research in developing countries continues to be inadequate, with clinical trials comprising a small fraction of the total research output. Most trials done in developing countries tend to be designed in developed countries and led by investigators in those nations. The main challenges in the conduct of trials in developing countries stem from the vulnerability of the populations due to illiteracy, poverty, limited research infrastructure, lack of sufficient numbers of experienced investigators and trained support personnel, and fragmented healthcare system. Summary There is a need to formulate and conduct trials to test treatments that are context-specific and socially relevant, With careful planning in advance and shared partnership among sponsors, host-country research practitioners, government agencies and the community, many of the challenges facing clinical trial research can be overcome over the medium to long term. This would enable conformity to contemporary guidelines in both letter and spirit and hopefully develop research questions addressing the needs of developing countries.
引用
收藏
页码:295 / 300
页数:6
相关论文
共 50 条
  • [1] Conduct of clinical trials in developing countries
    Kasper, CK
    HAEMOPHILIA, 2002, 8 (03) : 166 - 169
  • [2] CLINICAL TRIALS IN DEVELOPING COUNTRIES - ETHICAL CONSIDERATIONS
    Pasic, Marija Bosnjak
    Vidrih, Branka
    Sarac, Helena
    Pasic, Hanna
    Vujevic, Luka
    Koruga, Anamarija Soldo
    Rajic, Fabijan
    PSYCHIATRIA DANUBINA, 2018, 30 (03) : 285 - 291
  • [3] Clinical trials in developing countries: A review of the moral issues
    Lackey, DP
    MOUNT SINAI JOURNAL OF MEDICINE, 2001, 68 (01): : 4 - 12
  • [4] Clinical research and trials in developing countries
    Yusuf, S
    STATISTICS IN MEDICINE, 2002, 21 (19) : 2859 - 2867
  • [5] THE INFORMED CONSENT IN INTERNATIONAL CLINICAL TRIALS INCLUDING DEVELOPING COUNTRIES
    Montenegro Suris, Alexander
    Monreal Aguero, Magda Elaine
    CUADERNOS DE BIOETICA, 2008, 19 (65): : 67 - 79
  • [6] Ethical issues in clinical trials in developing countries
    Brody, BA
    STATISTICS IN MEDICINE, 2002, 21 (19) : 2853 - 2858
  • [8] Fast, cheap, and out of control? Speculations and ethical concerns in the conduct of outsourced clinical trials in India
    Kamat, Vinay R.
    SOCIAL SCIENCE & MEDICINE, 2014, 104 : 48 - 55
  • [9] Challenges in the conduct of vaginal microbicide effectiveness trials in the developing world
    Ramjee, G
    Morar, NS
    Alary, M
    Mukenge-Tshibaka, L
    Vuylsteke, B
    Ettiègne-Traoré, V
    Chandeying, V
    Karim, SA
    Van Damme, L
    AIDS, 2000, 14 (16) : 2553 - 2557
  • [10] THE CONDUCT OF CLINICAL-TRIALS AND GOOD CLINICAL PRACTICES - THE SPONSORS PERSPECTIVE
    ROBB, EJ
    DAVIS, DD
    FARRINGTON, DO
    JOURNAL OF ANIMAL SCIENCE, 1995, 73 (02) : 614 - 621