CURRENT STATUS OF CLINICAL TRIALS IN ETHIOPIA:HOW MUCH IS DONE?

Biniyam Tefera Deressa, Daniel Rauch, Eugenia Vlaskou Badra, Markus Glatzer, Branislav Jeremic, Kristina Lössl, Nikola Cihoric

Abstract


Introduction: Clinical trials are a cornerstone of modern evidence based medicine. They are an important step in discovering new treatments for certain diseases as well as new ways to detect, diagnose, and reduce the risk of disease. They also highly support the clinical practice by generating local evidence. The aim of this study is to evaluate the status and trend of clinical trials in Ethiopia from international trial registries.

Material and Methods: We have searched WHO International Clinical Trial Registry Platform (WHO ICTRP) for all trials with at least one recruitment center in Ethiopia. The results were exported in XML format and a rational database was formed.

Results: Up to November 15,2016; 145 clinical trials were found to be registered from Ethiopia. Majority of trials were design on infectious disease (n = 87, 60%) and the rest were done on NCD. The five most common infectious disease evaluated were Malaria (n=15; 10%), Tuberculosis (n=13; 9%), trachoma (n=12; 8%), HIV (n=11; 8%) and helminthiasis (n=6; 4%). The most common NCD was malnutrition (n = 19; 13%) and only one trial was on cancer, namely Wilms Tumor (1%). London School of Hygiene and Tropical Medicine was the sponsor with the highest number of registered trials (n=8, 6% of all trials), followed by Columbia, Jimma and Ghent University with 5 (3%) trials each.

Conclusions:The clinical trials done in Ethiopia are very much limited in number and variety. To improve the situation the government, industry, academic institutions, patient advocacy groups, professional societies and other organizations should work together.


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References


Guyatt G, Cairns J, Churchill D, et al. Evidence-based medicine: A new approach to teaching the practice of medicine. JAMA. 1992;268(17):2420-5.

Rare Diseases and Orphan Products: Accelerating Research and Development. In: Field MJ, Boat TF, editors. Rare Diseases and Orphan Products: Accelerating Research and Development. The National Academies Collection: Reports funded by National Institutes of Health. Washington (DC)2010.

Aalen OO, Valberg M, Grotmol T, Tretli S. Understanding variation in disease risk: the elusive concept of frailty. Int J Epidemiol. 2015;44(4):1408-21.

Yasuda SU, Zhang L, Huang SM. The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies. Clin Pharmacol Ther. 2008;84(3):417-23.

Franzen SR, Chandler C, Enquselassie F, Siribaddana S, Atashili J, Angus B, et al. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013;3(11):e003616.

Murphy KM, Topel RH. Measuring the gains from medical research: an economic approach: University of Chicago Press; 2010.

Buxton M, Hanney S, Jones T. Estimating the economic value to societies of the impact of health research: a critical review. Bull World Health Organ. 2004;82(10):733-9.

First F. Exceptional returns: the economic value of America’s investment in medical research. New York. 2000.

Devasenapathy N, Singh K, Prabhakaran D. Conduct of clinical trials in developing countries: a perspective. Curr Opin Cardiol. 2009;24(4):295-300.

Franzen SRP, Chandler C, Atashili J, Angus B, Lang T. Barriers and enablers of locally led clinical trials in Ethiopia and Cameroon: a prospective, qualitative study. The Lancet. 2013;382(Supplement 1):14.

Organization WH. WHO Country cooperation strategy 2008–2011, Ethiopia. Canada; 2009.

Accorsi S, Bilal NK, Farese P, Racalbuto V. Countdown to 2015: comparing progress towards the achievement of the health Millennium Development Goals in Ethiopia and other sub-Saharan African countries. Trans R Soc Trop Med Hyg 2010;104(5):336-42.

Fekadu A, Teferra S, Hailu A, Gebre-Mariam T, Addissie A, Deressa W, et al. International Clinical Trial Day and clinical trials in Ethiopia and Africa. Trials. 2014;15:493.

Woldeamanuel YW, Girma B, Teklu AM. Cancer in Ethiopia. Lancet Oncol. 2013;14(4):289-90.

Organization WH. WHO International Clinical Trials Registry Platform (ICTRP) Internet: World Health Organization; 2017 [cited 2017 15.09.2017]. The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base.]. Available from: http://www.who.int/ictrp/en/.

Viergever RF, Li K. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013. BMJ Open. 2015;5(9):e008932.

Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA. 2012;307(17):1838-47.

Franzen SRP, Chandler C, Siribaddana S, Atashili J, Angus B, Lang T. Strategies for developing sustainable health research capacity in low and middle-income countries: a prospective, qualitative study investigating the barriers and enablers to locally led clinical trial conduct in Ethiopia, Cameroon and Sri Lanka. BMJ Open. 2017;7(10):e017246.

Fekadu A, Hailu A, Makonnen E, Belete A, Yimer G. Short-term impact of celebrating the international clinical trial day: experience from Ethiopia. Trials. 2017;18(1):332.

Organisation WH. Ethiopia: Analytical summary - Health Status and Trends [Internet]. Internet: World Health Organisation; 2017 [cited 2017 20.08.2017]. Available from: http://www.aho.afro.who.int/profiles_information/index.php/Ethiopia:Analytical_summary_-_Health_Status_and_Trends.

(IHME) TIfHMaE. The Institute for Health Metrics and Evaluation (IHME) - Ethiopia. Internet: The Institute for Health Metrics and Evaluation (IHME), University of Washington., 2017.

Centers for Disease Control and Prevention US. Centers for Disease Control and Prevention - Global Health - Ethiopia [Internet]. Internet: Centers for Disease Control and Prevention, United States; 2017 [cited 2017 20.09.2017]. The CDC office in Ethiopia was established in 2001 and works closely with the Ministry of Health and other partners to maintain strong programs in training, treatment, counseling and testing, and laboratory capacity building.]. Available from: https://www.cdc.gov/globalhealth/countries/ethiopia/.

Participants in the Conference on Ethical Aspects of Research in Developing C. Ethics. Fair benefits for research in developing countries. Science. 2002;298(5601):2133-4.

Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004;189(5):930-7.

Gaym A. Health research in Ethiopia--past, present and suggestions on the way forward. Ethiop Med J. 2008;46(3):287-308.

Weijer C, Emanuel EJ. Ethics. Protecting communities in biomedical research. Science. 2000;289(5482):1142-4.

Lexchin J. Sponsorship bias in clinical research. Int J Risk Saf Med. 2012;24(4):233-42.

Cihoric N, Tsikkinis A, Minniti G, Lagerwaard FJ, Herrlinger U, Mathier E, et al. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov. Radiat Oncol. 2017;12(1):1.

Tsikkinis A, Cihoric N, Giannarini G, Hinz S, Briganti A, Wust P, et al. Clinical perspectives from randomized phase 3 trials on prostate cancer: an analysis of the ClinicalTrials. gov database. European Urology Focus. 2015;1(2):173-84.

Puppalwar G, Mourya M, Kadhe G, Mane A. Conducting clinical trials in emerging markets of sub-Saharan Africa: review of guidelines and resources for foreign sponsors. Open Access J Clin Trials. 2015;7:23-34.

Alvarenga LS, Martins EN. Biopharmaceutical industry-sponsored global clinical trials in emerging countries. Rev Assoc Med Bras (1992). 2010;56(4):428-33.

Selvarajan S, George M, Kumar SS, Dkhar SA. Clinical trials in India: Where do we stand globally? Perspect Clin Res. 2013;4(3):160-4.

Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2017;2:MR000033.

Reis LL. [Pharmaceutical companies as sponsors of clinical trials--advantages and limitations]. Rev Port Cardiol 1992;11(4):333-8.


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