Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study
Abstract Background An effective drug to treat cryptosporidial diarrhea in HIV-infected individuals is a global health priority. Promising drugs need to be evaluated in endemic areas which may be challenged by both lack of resources and experience to conduct International Committee of Harmonisation-...
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| Format: | Article |
| Language: | English |
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BMC
2020-07-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04620-8 |
| _version_ | 1811286540737839104 |
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| author | Neema Toto Elaine Douglas Markus Gmeiner Lynn K. Barrett Robert Lindblad Lumbani Makhaza Wilfred Nedi Jacob Phulusa Gerald V. Quinnan Leigh A. Sawyer Herbert Thole Wesley C. Van Voorhis Pui-Ying Iroh Tam |
| author_facet | Neema Toto Elaine Douglas Markus Gmeiner Lynn K. Barrett Robert Lindblad Lumbani Makhaza Wilfred Nedi Jacob Phulusa Gerald V. Quinnan Leigh A. Sawyer Herbert Thole Wesley C. Van Voorhis Pui-Ying Iroh Tam |
| author_sort | Neema Toto |
| collection | DOAJ |
| description | Abstract Background An effective drug to treat cryptosporidial diarrhea in HIV-infected individuals is a global health priority. Promising drugs need to be evaluated in endemic areas which may be challenged by both lack of resources and experience to conduct International Committee of Harmonisation-Good Clinical Practice (ICH-GCP)-compliant clinical trials. Methods We present the challenges and lessons learned in implementing a phase 2A, randomized, double-blind, placebo-controlled trial of clofazimine, in treatment of cryptosporidiosis among HIV-infected adults at a single site in Malawi. Results Primary challenges are grouped under study initiation, study population, study implementation, and cultural issues. The lessons learned primarily deal with regulatory system and operational barriers, and recommendations can be applied to other human experimental trials in low- and middle-income countries, specifically in sub-Saharan Africa. Conclusion This study demonstrated that initiating and implementing human experimental trials in sub-Saharan Africa can be challenging. However, solutions exist and successful execution requires careful planning, ongoing evaluation, responsiveness to new developments, and oversight of all trial operations. |
| first_indexed | 2024-04-13T03:01:49Z |
| format | Article |
| id | doaj.art-9a621b4daa5b42cf8cbb95c86626f894 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T03:01:49Z |
| publishDate | 2020-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9a621b4daa5b42cf8cbb95c86626f8942022-12-22T03:05:24ZengBMCTrials1745-62152020-07-012111810.1186/s13063-020-04620-8Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium studyNeema Toto0Elaine Douglas1Markus Gmeiner2Lynn K. Barrett3Robert Lindblad4Lumbani Makhaza5Wilfred Nedi6Jacob Phulusa7Gerald V. Quinnan8Leigh A. Sawyer9Herbert Thole10Wesley C. Van Voorhis11Pui-Ying Iroh Tam12Malawi-Liverpool Wellcome Trust Clinical Research ProgrammeCenter for Emerging and Re-emerging Infectious Diseases (CERID), University of WashingtonMalawi-Liverpool Wellcome Trust Clinical Research ProgrammeCenter for Emerging and Re-emerging Infectious Diseases (CERID), University of WashingtonEmmesMalawi-Liverpool Wellcome Trust Clinical Research ProgrammeMalawi-Liverpool Wellcome Trust Clinical Research ProgrammeMalawi-Liverpool Wellcome Trust Clinical Research ProgrammeEmmesEmmesMalawi-Liverpool Wellcome Trust Clinical Research ProgrammeCenter for Emerging and Re-emerging Infectious Diseases (CERID), University of WashingtonMalawi-Liverpool Wellcome Trust Clinical Research ProgrammeAbstract Background An effective drug to treat cryptosporidial diarrhea in HIV-infected individuals is a global health priority. Promising drugs need to be evaluated in endemic areas which may be challenged by both lack of resources and experience to conduct International Committee of Harmonisation-Good Clinical Practice (ICH-GCP)-compliant clinical trials. Methods We present the challenges and lessons learned in implementing a phase 2A, randomized, double-blind, placebo-controlled trial of clofazimine, in treatment of cryptosporidiosis among HIV-infected adults at a single site in Malawi. Results Primary challenges are grouped under study initiation, study population, study implementation, and cultural issues. The lessons learned primarily deal with regulatory system and operational barriers, and recommendations can be applied to other human experimental trials in low- and middle-income countries, specifically in sub-Saharan Africa. Conclusion This study demonstrated that initiating and implementing human experimental trials in sub-Saharan Africa can be challenging. However, solutions exist and successful execution requires careful planning, ongoing evaluation, responsiveness to new developments, and oversight of all trial operations.http://link.springer.com/article/10.1186/s13063-020-04620-8Clinical trialDeveloping countrySub-Saharan AfricaLow-resource settingCryptosporidiosisDiarrhea |
| spellingShingle | Neema Toto Elaine Douglas Markus Gmeiner Lynn K. Barrett Robert Lindblad Lumbani Makhaza Wilfred Nedi Jacob Phulusa Gerald V. Quinnan Leigh A. Sawyer Herbert Thole Wesley C. Van Voorhis Pui-Ying Iroh Tam Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study Trials Clinical trial Developing country Sub-Saharan Africa Low-resource setting Cryptosporidiosis Diarrhea |
| title | Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study |
| title_full | Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study |
| title_fullStr | Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study |
| title_full_unstemmed | Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study |
| title_short | Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study |
| title_sort | conducting clinical trials in sub saharan africa challenges and lessons learned from the malawi cryptosporidium study |
| topic | Clinical trial Developing country Sub-Saharan Africa Low-resource setting Cryptosporidiosis Diarrhea |
| url | http://link.springer.com/article/10.1186/s13063-020-04620-8 |
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