Clinical trials in Ghana: evolution and current landscape

George O. Adjei, Abdul M. Sulley

Abstract

A review of published clinical trials from Ghana shows the earliest trials initiated in the 1970s, were mainly trials of interventions against onchocerciasis and childhood Burkitt’s lymphoma. Subsequent trials in the 1980s and 1990s were more diverse, comprising of preventive as well as therapeutic interventions against major communicable diseases of the period. In more recent times, trials of interventions against malaria have since 2000, been the most dominant and have included some of the most recently developed vaccines. There has, since the early days of clinical trial history in Ghana, been a consistent presence of trials of reproductive health interventions and surgically-related trials. There have been few trials of tuberculosis, or neonatal-related interventions, and trials against major non-communicable diseases such as hypertension, cardiovascular diseases, and mental health disorders have been virtually non-existent. The clinical trial evolution in Ghana has reflected global health initiatives and external funding exigencies and there is an urgent need for trials that are dynamic and directed towards addressing other significant and especially non-communicable disease causes of morbidity and mortality in Ghana.

Keywords

Clinical trial, Disease burden, Communicable diseases, Non-communicable diseases

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References

Pocock SJ. The historical development of clinical trials. In: Pocock SJ, eds. Clinical Trials. Chichester: John Wiley & Sons, 2006: Chapter 2.

Council. MR. Streptomycin treatment of pulmonary tuberculosis. Br Med J. 1948;2:769-82.

Amoah AG. Hypertension in Ghana: a cross-sectional community prevalence study in greater Accra. Ethn Dis. 2003;13(3):310-5.

Amoah AG, Owusu SK, Adjei S. Diabetes in Ghana: a community based prevalence study in Greater Accra. Diabetes Res Clin Pract. 2002;56(3):310-5.

Amoah AG. Undiagnosed diabetes and impaired glucose regulation in adult Ghanaians using the ADA and WHO diagnostic criteria. Acta Diabetol. 2002;39(1):7-13.

Sowa J, Sowa SC. Long-term treatment of onchocerciasis in children with low doses of diethylcarbamazine. Ann Trop Med Parasitol. 1978;72(1):79-85.

Awadzi K. The chemotherapy of onchocerciasis II. Quantitation of the clinical reaction to microfilaricides. Ann Trop Med Parasitol. 1980;74(2):189-97.

Awadzi K, Dadzie KY, Schulz-Key H, Gilles HM, Fulford AJ, Aziz MA. The chemotherapy of onchocerciasis. XI. A double-blind comparative study of ivermectin, diethylcarbamazine and placebo in human onchocerciasis in northern Ghana. Ann Trop Med Parasitol. 1986;80(4):433-42.

Taylor HR, Awadzi K, George T, Schulz-Key H, Murphy RP. Fluorescein angiographic studies of mebendazole treatment for onchocerciasis. Trop Med Parasitol. 1985;36(1):7-11.

Nkrumah FK, Biggar RJ. High dose cycloposphamide in drug resistant and relapsing Burkitt’s lymphoma. Ghana Med J. 1979:64-7.

Nkrumah FK, Perkins IV, Biggar RJ. Combination chemotherapy in abdominal Burkitt’s lymphoma. Cancer. 1977;40(4):1410-6.

Nkrumah FK, Biggar RJ, Neequaye J. Chemotherapy of Burkitt’s lymphoma: Randomised clinical trial of single agent versus combination chemotherapy. West Afr J Med. 1983;2:9-12.

Neequaye JE, Nkrumah FK. Intrathecal chemoprophylaxis in the prevention of central nervous system relapse in Burkitt’s lymphoma. Proceed Twelfth Int Congr Chemother. 1982;11:1524.

Neequaye J, Viza D, Pizza G, Levine PH, De Vinci C, Ablashi DV, et al. Specific transfer factor with activity against Epstein-Barr virus reduces late relapse in endemic Burkitt’s lymphoma. Anticancer Res. 1990;10(5A):1183-7.

Neequaye J, Viza D, Pizza G. Specific transfer factor with activity against Epstein-Barr virus reduces late relapse in endemic Burkitt’s lymphoma. Anticancer Res. 1990;10(5A):1183-7.

Lamptey P, Klufio C, Smith SC, Feldblum PJ. A comparative study of Neo Sampoon, ortho vaginal tablets and Emko vaginal tablets in Accra, Ghana. Contraception. 1985;32(5):445-54.

Egbert PR, Williams AS, Singh K, Dadzie P, Egbert TB. A prospective trial of intraoperative fluorouracil during trabeculectomy in a black population. Am J Ophthalmol. 1993;116(5):612-6.

Kwawukume EY, Ghosh TS. Oral nifedipine therapy in the management of severe preeclampsia. Int J Gynecol Obstet. 1995;49(3):265-9.

Martey JO, Turkson SO, Djan JO, Dunson TR, Amatya R, Krueger S. Clinical evaluation of Norplant in Kumasi, Ghana. East Afr Med J. 1995;72(6):381-5.

Binka FN, Ross DA, Morris SS, Kirkwood BR, Arthur P, Dollimore N, et al. Vitamin A supplementation and childhood malaria in northern Ghana. Am J Clin Nutr. 1995;61(4):853-9.

Filteau SM, Morris SS, Abbott RA, Tomkins AM, Kirkwood BR, Arthur P, et al. Influence of morbidity on serum retinol of children in a community-based study in northern Ghana. Am J Clin Nutr. 1993;58(2):192-7.

Yartey J, Nkrumah F, Hori H, Harrison K, Armar D. Clinical trial of fermented maize-based oral rehydration solution in the management of acute diarrhoea in children. Ann Trop Pediatr. 1995;15(1):61-8.

Mensah P, Ndiokwelu CI, Uwaegbute A, Ablordey A, van Boxtel AM, Brinkman C, et al. Feeding of lactic acid-fermented high nutrient density weaning formula in paediatric settings in Ghana and Nigeria: acceptance by mother and infant and performance during recovery from acute diarrhoea. Int J Food Sci Nutr. 1995;46(4):353-62.

Naaeder SB, Evans DF, Archampong EQ. Effect of chronic dietary fibre supplementation on colonic pH in healthy volunteers. West Afr J Med. 1998;17(3):165-7.

Naaeder SB, Evans DF, Archampong EQ. Effect of acute dietary fibre supplementation on colonic pH in healthy volunteers. West Afr J Med. 1998;17(3):153-6.

Hori H, Afari EA, Akanmori BD, Kamiya Y, Sakatoku H, Nkrumah FK, et al. A randomized controlled trial of two acellular pertussis-diphtheria-tetanus vaccines in primary immunization in Ghana: antibody responses and adverse reactions. Ann Trop Pediatr. 1994;14(2):91-6.

Osei-Kwasi M, Afari EA, Mimura K, Obeng-Ansah I, Ampofo WK, Nkrumah FK. Randomized, controlled trial of trivalent oral poliovirus vaccine (Sabin) starting at birth in Ghana. Bull World Health Organ. 1995;73(1):41-6.

Awadzi K, Schulz-Key H, Edwards G, Breckenridge A, Orme M, Gilles H. The chemotherapy of onchocerciasis. XIV. Studies with mebendazole citrate. Trop Med Parasitol. 1990;41(4):383-6.

Awadzi K, Hero M, Opoku NO, Büttner DW, Coventry PA, Prime MA, et al. The chemotherapy of onchocerciasis XVII. A clinical evaluation of albendazole in patients with onchocerciasis; effects of food and pretreatment with ivermectin on drug response and pharmacokinetics. Trop Med Parasitol. 1994;45(3):203-8.

Awadzi K, Opoku NO, Attah SK, Addy ET, Duke BO, Nyame PK, et al. The safety and efficacy of amocarzine in African onchocerciasis and the influence of ivermectin on the clinical and parasitological response to treatment. Ann Trop Med Parasitol. 1997;91(3):281-96.

Awadzi K, Hero M, Opoku NO, Addy ET, Buttner DW, Ginger CD. The chemotherapy of onchocerciasis XVIII. Aspects of treatment with suramin. Trop Med Parasitol. 1995;46(1):19-26.

Issaka-Tinorgah A, Magnussen P, Bloch P, Yakubu A. Lack of effect of ivermectin on prepatent guinea-worm: a single-blind, placebo-controlled trial. Trans R Soc Trop Med Hyg. 1994;88(3):346-8.

Magnussen P, Yakubu A, Bloch P. The effect of antibiotic- and hydrocortisone-containing ointments in preventing secondary infections in guinea worm disease. Am J Trop Med Hyg. 1994;51(6):797-9.

Fehr H, Egger M, Senn I. Cotrimoxazol in the treatment of Mycobacterium ulcerans infection (Buruli ulcer) in West Africa. Trop Doct. 1994;24(2):61-3.

Binka FN, Kubaje A, Adjuik M, Williams LA, Lengeler C, Maude GH, et al. Impact of permethrin impregnated bednets on child mortality in Kassena-Nankana district, Ghana: a randomized controlled trial. Trop Med Int Health 1996;1(2):147-54.

Neequaye J, Ofori-Adjei E, Ofori-Adjei D, Renner L. Comparative trial of oral versus intramuscular chloroquine in children with cerebral malaria. Trans R Soc Trop Med Hyg. 1991;85(6):718-22.

Dunyo SK, Nkrumah FK, Simonsen PE. A study on the provocative day test effect of ivermectin and albendazole on nocturnal periodic Wuchereria bancrofti microfilaraemia. Trans R Soc Trop Med Hyg. 1999;93(6):608-10.

Dunyo SK, Nkrumah FK, Simonsen PE. Single-dose treatment of Wuchereria bancrofti infections with ivermectin and albendazole alone or in combination: evaluation of the potential for control at 12 months after treatment. Trans R Soc Trop Med Hyg. 2000;94(4):437-43.

Dunyo SK, Nkrumah FK, Simonsen PE. A randomized double-blind placebo-controlled field trial of ivermectin and albendazole alone and in combination for the treatment of lymphatic filariasis in Ghana. Trans R Soc Trop Med Hyg. 2000;94(2):205-11.

Dunyo SK, Simonsen PE. Ivermectin and albendazole alone and in combination for the treatment of lymphatic filariasis in Ghana: follow-up after re-treatment with the combination. Trans R Soc Trop Med Hyg. 2002;96(2):189-92.

Goka BQ, Adabayeri V, Ofori-Adjei E, Quarshie B, Asare-Odei G, Akanmori BD, et al. Comparison of chloroquine with artesunate in the treatment of cerebral malaria in Ghanaian children. J Trop Pediatr 2001;47(3):165-9.

Driessen GJ, van Kerkhoven S, Schouwenberg BJ, Bonsu G, Verhave JP. Sulphadoxine / pyrimethamine: an appropriate first-line alternative for the treatment of uncomplicated falciparum malaria in Ghanaian children under 5 years of age. Trop Med Int Health. 2002;7(7):577-83.

Mockenhaupt FP, Ehrhardt S, Dzisi SY, Teun Bousema J, Wassilew N, Schreiber J, et al. A randomized, placebo-controlled, double-blind trial on sulfadoxine-pyrimethamine alone or combined with artesunate or amodiaquine in uncomplicated malaria. Trop Med Int Health. 2005;10(6):512-20.

Tagbor H, Bruce J, Browne E, Randal A, Greenwood B, Chandramohan D. Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial. Lancet. 2006;368(9544):1349-56.

Adjei GO, Kurtzhals JA, Rodrigues OP, Alifrangis M, Hoegberg LC, Kitcher ED, et al. Amodiaquine-artesunate vs. artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up. Malar J. 2008;7:127.

Koram KA, Abuaku B, Duah N, Quashie N. Comparative efficacy of antimalarial drugs including ACTs in the treatment of uncomplicated malaria among children under 5 years in Ghana. Acta Trop. 2005;95(3):194-203.

Kobbe R, Klein P, Adjei S, Amemasor S, Thompson WN, Heidemann H, et al. A randomized trial on effectiveness of artemether-lumefantrine versus artesunate plus amodiaquine for unsupervised treatment of uncomplicated Plasmodium falciparum malaria in Ghanaian children. Malar J 2008;7:261.

Owusu-Agyei S, Asante KP, Owusu R, Adjuik M, Amenga-Etego S, Dosoo DK, et al. An open label, randomised trial of artesunate+amodiaquine, artesunate+chlorproguanil-dapsone and artemether-lumefantrine for the treatment of uncomplicated malaria. PLoS One. 2008;3(6):e2530.

Chandramohan D, Owusu-Agyei S, Carneiro I, Awine T, Amponsa-Achiano K, Mensah N, et al. Cluster randomised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in Ghana. BMJ. 2005;331(7519):727-33.

Mockenhaupt FP, Reither K, Zanger P, Roepcke F, Danquah I, Saad E, et al. Intermittent preventive treatment in infants as a means of malaria control: a randomized, double-blind, placebo-controlled trial in northern Ghana. Antimicrob Agents Chemother 2007;51(9):3273-81.

Owusu-Agyei S, Ansong D, Asante K, Kwarteng Owusu S, Owusu R, Wireko Brobby NA, et al. Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS One. 2009;4(10):e7302.

Peterson L, Nanda K, Opoku BK, Ampofo WK, Owusu-Amoako M, Boakye AY, et al. SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana. PLoS One. 2007;2(12):e1312.

Storey PA, Bugri S, Magnussen P, Polderman AM. The effect of albendazole on Oesophagostomum bifurcum infection and pathology in children from rural northern Ghana. Ann Trop Med Parasitol. 2001;95(1):87-95.

Phillips R, Adjei O, Lucas S, Benjamin N, Wansbrough-Jones M. Pilot randomized double-blind trial of treatment of Mycobacterium ulcerans disease (Buruli ulcer) with topical nitrogen oxides. Antimicrob Agents Chemother. 2004;48(8):2866-70.

Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;376(9741):606-14.

Nafiu OO, Kolawole IK, Salam RA, Elegbe EO. Comparison of caudal ketamine with or without bupivacaine in pediatric subumbilical surgery. J Natl Med Assoc. 2007;99(6):670-3.

Clegg-Lamptey JN, Dakubo JC, Hodasi WM. Comparison of four-day and ten-day post-mastectomy passive drainage in Accra, Ghana. East Afr Med J. 2007;84(12):561-5.

Egbert PR, Fiadoyor S, Budenz DL, Dadzie P, Byrd S. Diode laser transscleral cyclophotocoagulation as a primary surgical treatment for primary open-angle glaucoma. Arch Ophthalmol. 2001;119(3):345-50.

Geels YP, de Gouberville MC, Visser L, van Asten HA. Comparing vaginal and sublingual administration of misoprostol for labour induction in women with intra-uterine fetal death. Trop Doct. 2010;40(2):77-80.

Armah GE, Kapikian AZ, Vesikari T, Cunliffe N, Jacobson RM, Burlington DB, et al. Efficacy, immunogenicity, and safety of two doses of a tetravalent rotavirus vaccine RRV-TV in Ghana with the first dose administered during the neonatal period. J Infect Dis. 2013;208(3):423-31.

Asante KP, Abdulla S, Agnandji S, Lyimo J, Vekemans J, Soulanoudjingar S, et al. Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines: 19 month follow-up of a randomised, open-label, phase 2 trial. Lancet Infect Dis. 2011;11(10):741-9.

Taylor J, Diop A, Blum J, Dolo O, Winikoff B. Oral misoprostol as an alternative to surgical management for incomplete abortion in Ghana. Int J Gynecol Obstet. 2011;112(1):40-4.

Weaver MA, Joanis C, Toroitich-Ruto C, Parker W, Gyamenah NA, Rinaldi A, et al. The effects of condom choice on self-reported condom use among men in Ghana, Kenya and South Africa: a randomized trial. Contraception. 2011;84(3):291-8.

Kirkwood BR, Manu A, Tawiah-Agyemang C, ten Asbroek G, Gyan T, Weobong B, et al. NEWHINTS cluster randomised trial to evaluate the impact on neonatal mortality in rural Ghana of routine home visits to provide a package of essential newborn care interventions in the third trimester of pregnancy and the first week of life: trial protocol. Trials. 2010;11:58.

Kirkwood BR, Manu A, ten Asbroek AH, Soremekun S, Weobong B, Gyan T, et al. Effect of the Newhints home-visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomised controlled trial. Lancet. 2013;381(9884):2184-92.

Adjei GO, Goka BQ, Enweronu-Laryea CC, Rodrigues OP, Renner L, Sulley AM, et al. A randomized trial of artesunate-amodiaquine versus artemether-lumefantrine in Ghanaian paediatric sickle cell and non-sickle cell disease patients with acute uncomplicated malaria. Malar J. 2014;19(13):369.

Stanton CK, Newton S, Mullany LC, Cofie P, Agyemang CT, Adiibokah E, et al. Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject by peripheral health care providers at home births: design of a community-based cluster-randomized trial. BMC Pregnancy Childbirth. 2012;12:42.

Stanton CK, Newton S, Mullany LC, Cofie P, Tawiah Agyemang C, Adiibokah E, et al. Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial. PLoS Med. 2013;10(10):e1001524.

CORONIS Collaborative Group, Abalos E, Addo V, Brocklehurst P, El Sheikh M, Farrell B, et al. Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial. Lancet. 2013;382(9888):234-48.

Vesel L, ten Asbroek AH, Manu A, Soremekun S, Tawiah Agyemang C, Okyere E, et al. Promoting skin-to-skin care for low birthweight babies: findings from the Ghana Newhints cluster-randomised trial. Trop Med Int Health. 2013;18(8):952-61.

Wilson PT, Morris MC, Biagas KV, Otupiri E, Moresky RT. A randomized clinical trial evaluating nasal continuous positive airway pressure for acute respiratory distress in a developing country. J Pediatr. 2013;162(5):988-92.