Capacity

​Madibeng Centre for Research made substantial improvements to the building of a new wing to house a modified Laboratory and Pharmacy with fully equipped consultation and examination rooms and reception area.  The building commenced in May 2016 and saw total completion in 2017.  The building process was delayed due to structural strengthening to carry a second floor for future growth plus the excavation was marred by intense granite rock formations which needed specialised chemical cracking for removal.  The capacity to increase participation in future clinical studies has grown with the extension and completion of a professionally functional clinical section.

Staff

The staff of 54 includes medical doctors, pharmacists, laboratory scientists, nurses, Social Scientist, Data Management, recruiters & retention, counsellors, community liaison and administrative personnel.

All staff is regularly trained on the International Convention on Harmonisation of Good Clinical Practice (ICH-GCP) and has learnt to work according to ethics guidelines as described in ICH-GCP on all their trials. The MCR staff also adheres to ethics guidelines, regulations and laws as described by the Declaration of Helsinki, the South African Good Clinical Practice guidelines, the South African Health Act and the Food and Drug Administration (FDA) requirements. Staff ensures that their studies are conducted ethically and in a manner that safeguards patient confidentiality, safety, and the integrity of data. Staff members have built their capacity in various areas pertaining to the effective conduct of clinical trials including data management, electronic data capturing, internal quality control (QC) of lab procedures, rapid tests, and external QC procedures.

Clinical Studies

Year 2005-2006
Protocol Number 102248 (Rota-037) GSK
Title
A phase III,double-blind, randomized, placebo-controlled, multi-center study to assess the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus(HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants in South Africa.
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Year 2005-2008
Protocol Number 444563/022 (Rota-022) GSK
Title
A phase II, double-blind, randomized, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa
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Year 2006-2007
Protocol Number 102248/037 (Rota-037) Cohort 2 GSK
Title
A phase III, double-blind, randomized, placebo-controlled, multi-center study to assess the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants in South  Africa.
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Year 2006-2007
Protocol Number 104756 GSK
Title
A phase III open, single centre booster vaccination study to assess safety and reactogenicity of a dose of DTPw-HBV/Hib vaccine given at 15-18 months of age and to assess the immunogenicity, safety and reactogenicity of a dose of MencevaxTM ACW vaccine given at 24 to 30 months of age in subjects primed in study 759346/007
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Year 2007-2008
Protocol Number IPM 100
Title
A Cross-Sectional And Prospective, Observational, Cohort Study To Estimate HIV Incidence Among Sexually Active Adult Females
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Year 2007- 2008
Protocol Number 111274/037 (Rota-037) Cohort 2 Year 2 extension
A phase III, double-blind, randomized, placebo-controlled, multi-center study to assess the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants in South  Africa.
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Year 2008
Protocol Number CFAM810A2310 Novartis
Title
A randomised, multicentre, double-blind study to compare the efficacy of single-day treatment (1000mg b.i.d) with Famciclovir compared to that of placebo in patient-initiated  episodic treatment of recurrent genital herpes in immunocompetent Black patients
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Year 2009
Protocol Number CSPA100A2305 Novartis
Title
An 8-week double-blind, multicenter, randomized, multifactorial, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren administered alone and in combination with amlodipine in patients with essential hypertension
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Year 2009-2010
Protocol Number IPM014B
Title
A double-blind, randomized, placebo-controlled phase I/II study to evaluate the safety and acceptability of dapivirine gel 4789, 0.05% 2.5g, a vaginal microbicide, conducted using daily monitored adherence in healthy HIV-negative women
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Year 2010
Protocol Number IPM014A
Title
A double-blind, randomized, placebo-controlled phase I/II study to evaluate the safety and acceptability of dapivirine gel 4759, 0.05% 2.5g, a vaginal microbicide, conducted using daily monitored adherence in healthy HIV-negative women
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Year 2010
Protocol Number IPM015
Title
A double-blind, randomized, placebo-controlled phase I/II study to evaluate the safety of an intravaginal matrix ring with dapivirine in healthy HIV-negative women
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Year 2010
Protocol Number REMoxTB TB Alliance
Title
A randomised placebo – controlled double blind trial comparing two treatment shortening regimens with the standard regimen (two months ethambutol, isoniazid, rifampicin and pyrazinamide followed by four months isoniazid and rifampicin) namely
1) two months moxifloxacin, isoniazid, rifampicin and pyrazinamide followed by two months moxifloxacin, isoniazid and rifampicin and
2) two months ethambutol, moxifloxacin, rifampicin and pyrazinamide followed by two months moxifloxacin and rifampicin for the treatment of adults with pulmonary tuberculosis
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Year 2012
Protocol Number IPM 027
Title
A Multi-centre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-negative Women
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Year 2012
Protocol Number IPM 007
Title
A long-term follow-up cohort study of  HIV infection in participants who seroconvert after enrolment in Dapivirine Vaginal Ring trials
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Year 2014
Protocol Number EXSCEL Parexel
Title
A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with exenatide once weekly in Patients with Type 2 Diabetes Mellitus
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Year 2015
Protocol Number STAND NC(NC-006) TB Alliance
Title
A Phase 3 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin plus PA-824 plus Pyrazinamide after 4 and 6 months of Treatment in Adult Subjects with Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and after 6 months of Treatment in Adult Subjects with Multi-Drug Resistant, Smear-Positive Pulmonary Tuberculosis.
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Year 2016
Protocol Number ECHO
Title
Evidence for Contraceptive Options and HIV Outcomes (ECHO): A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)
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Year 2016
Protocol Number IPM 032
Title
A Follow-on, open-label trial to assess continued safety of and adherence to the Dapivirine (25 mg) vaginal ring-004 in healthy, HIV-negative woman
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