Emerging Clinical Research Centers in Uganda

May 19, 2019 | Africa, Blog, Clinical Research, Uganda

Uganda is a place to not only visit but ultimately one to look out for as it and neighbors in central and eastern Africa emerge into the world’s trading ecosystem in the decades to come. With some of the warmest and friendliest people on the planet, incredible wildlife and beautiful mountains (not to mention large spectacular lakes); or one of the last spots in the world where mountain gorillas live, the powerful source of the Nile represents a core landlocked pumping heart of an Africa. Although afflicted with troubled past as well as serious current socio-economic challenges, Uganda portends a lively, thriving and free spirited future.

Uganda takes its name from a Kingdom called Buganda. Once part of a great ancient empire known as Kitara, it (like much of Africa) was divided up and colonized. It secured its independence from the British Empire in 1963, but independance didn’t stop its’ social and political troubles. With a steadily growing population headed toward 45.5 million, the country possesses material natural resources and it is purported that its agricultural land could feed big swathes of Africa. Its economy represents potential and possibly could be poised for growth.

The country has faced chronic political instability and erratic fiscal and economic management since implementation of self-rule introduced significant challenges to governance and economic oversight. There is a large informal predominantly female economy who face exploitation on a regular basis.

Since the 1990s the economy has grown at an average of 6.7% annually according to the World Bank. Their economic underpinning transformations starting in 1990 through the present as agriculture value added declined from 56% in 1990 to 24% in 2015 while the share of industry grew from 11% to 20% during the same period (manufacturing doesn’t grow as fast as services). Uganda is the 31st wealthiest economy in Africa—out of a total of 54 nations.

Healthcare

There were 8 physicians per 100,000 persons in the early 2000s. Uganda instituted a fee health care access program which was a key factor in supporting its achievement of its Millennium Development Goals. The challenges with poverty however, and underdeveloped healthcare infrastructure persists. Poor hospital communication, less than stellar healthcare service, distance to health service providers undermine the provision of quality health care for Ugandans.  The poor and elderly are hit especially hard as with most under-developed economies.

Health crisis are not uncommon. An Ebola outbreak in the Kibaale District occurred during October 2012. By 2013 at least three had died from Congo Crimean Hemorrhagic Fever.  Uganda has been successful in driving down infection rates from 30% in the 1980s to 6.8% by the end of 2008. Spikes have occurred in recent years reminding all that troubles never far away. Female reproductive health still represents a relatively dire situation. Research has evidenced the further Ugandans live from care, the more difficult it becomes to remain in steady care.

Pharmaceutical Activity

The Ugandan market for pharmaceuticals is approaching $500 million. Its pharmaceutical market represents pros and cons.  Cons include shortages of pharmacies and hospitals, endemic poverty however pros include an intensive government interest in developing the pharmaceutical sector not to mention growing economic options for greater prosperity. Their Minister recently emphasized the government’s keen interest in more investment in local pharmaceutical manufacturing. In 2018, the director general of external security organization in Uganda announced that an Indian venture would invest US$10 million toward a pharmaceutical manufacturing facility there. There were reports of Ebola near the Ugandan border in 2018. Also in 2018, a Chinese donated hospital supplies and medicines worth nearly $100,00 to the Ugandan Ministry of Health, following the success of previous Chinese donations to the China-Uganda Friendship Hospital.

According to one report, nine local companies manufacture generic pharmaceuticals.

Health System

Uganda maintains an organized national health system comprising both private and public sector actors. Private health, contributing about 50% of health care delivery, includes private not for profit, private health practitioners and traditional contemporary medicine practitioners.

The public sectors include government health facilities; health services departments of different ministries with considerable activity delegated to national autonomous institutions such as NDA. Ugandan’s health services are delivered via a decentralized system including national, and health-specific sub districts. At the village level includes “VHTs” or volunteers in villages facilitating health promotion, service delivery, community participation and empowerment.

At the district level includes tiers such as “health center II” and “health center III.” Up the health hierarchy sits the general hospitals which offer health center III- broad services such as surgeries and blood transfusions. These institutions also maintain research and training/education operations.

Clinical Regulatory Framework in Uganda

TrialSite News often utilizes the The NIH’s NIAID ClinRegs for a compelling clinical trials regulatory framework on a country by country basis.  According to ClinRegs, Uganda’s National Drug Authority (NDA) directs regulatory authority for clinical trial approval and inspections. In Uganda, the NDA grants permission for clinical trials to be conducted there in accordance with the provisions of the National Drug Policy and Authority Act (NDPA). The NDA regulates the safety, quality, efficacy and handling and use of drugs or drug related products and devices in research.

ClinRegs reports that per the NDPA clinical trials regulations, an applicant must also secure approval in the form of a research permit from the Uganda National Council for Science and Technology (UNCST), or from an institution authorized by the UNCST.  According to Uganda’s National Guidelines for Research involving Humans as Research Participants (NGHRP), UNCST can be a one-stop point for registering and clearing all research within Uganda.  However ClinRegs reports that per the Additional Resource (A), the UNCST approves all clinical trials and issues research permits.

Consequently, the UNCST is a powerful institutions within Uganda. It was established in 1990 by the UNCST Act, as a self-autonomous government agency operating under the Ministry of Finance, Planning and Economic Development.  The UNCST collaborates with Uganda National Health Research Organization (UNHRO) to register and renew new research protocols and coordinate health research, as well as liaises with the Research Secretariat in the Office of the President of Uganda to register and clear all research intended to be carried out in the country.  Uganda UC-GCPs and the G-UNCSTreg declare that clinical research applicants must registered their research proposals, obtain approval, and be issued a research permit from the UNCST prior to initiating a study.

For more on A) regulatory authority B) ethics committee requirements C) clinical trial lifecycle (includes submission process, content, trial initiation, etc.) see ClinRegs Uganda.

Research Institutes

Under Uganda’s Ministry of Health sits strategically situated research institutes including:

Uganda Clinical Services

Uganda Cancer institute

Ministry of Health Programs (note these includes HIV/AIDS and Malaria Control programs)

Uganda Heart Institute

Clinical Trials

TrialSite News research staff surveyed existing clinical trials via Clinicaltrials.gov, online literature reviews including government-sponsored information. A total of 415 clinical trials registered with the United States government have had at least some participation in the country of Uganda.

Presently a total of 138 active trials cut across industry, government and non-profit sector (including other government agencies from Europe and North America or Asia).  A total of 24 industry-specific clinical trials are currently active while a total of 69 originate from non-governmental agencies, universities and foundations; a total of 45 studies have some U.S. agency involvement.

Clinical Research Centers

Universities and Institutes contribute tremendously to Uganda’s research growth. TrialSite News provides an example of some of the academic medical centers and research institutes operating in the country.

Uganda Cancer Institute (UCI)

A public, specialized, tertiary care medical facility owned by the Uganda Ministry of Health. The main facility is located in the Kawempe Division of Kampala.  A cancer treatment, research and teaching center, it is affiliated with Makerere University School of Medicine and with the Mulago National Referral Hospital, the teaching hospital for the medical school.  UCI maintains an inpatient facility with a capacity of 80 beds. It sees on average 200 patients per day. In 2011, UCI started development for the UCI/Hutchinson Center Cancer Alliance, a collaboration between Fred Hutchinson Cancer Research Center in Seattle, WA; the facility opened up for patients in 2015. University of Makerere and affiliates such as its Institute for Infectious Diseases (ISI). A prestigious Ugandan institution, Pfizer contributed $11 million during its inception over a decade ago. The ISI is an advanced, forward thinking academic enterprise with a number of programs including:

  • Prevention, Care and Treatment
  • Research
  • Outreach
  • Training
  • Laboratory Services
  • Global Health Security

IDI’s Research represents a comprehensive group with a wide array of programs, including Research Units, Longitudinal Cohort Units, Translational Research Diagnostic Laboratory, Database Collections and Health Economics and Outcomes Research Group.

Moreover, IDI organizes a range of impressive platforms, programs and various initiatives nationwide.

MRC/Uganda Virus Research & LSHTM Uganda Research Unit

Internationally recognized as a center of excellence for HIV and related diseases research, the institute as been active in contributing to understanding the epidemic as well as searching for innovative treatment options.  The Unit was established under an agreement between the Ugandan and British Governments to collaborate in the research of HIV.  The Unit is based at the UVIR Entebbe campus with established outposts in Kalungu, Masaka, Wakiso and Kamapla Districts.

Mbarara University of Science and Technology/Mbarara Regional  Referral Hospital

Known as Mbarara University, it is a public university and is one of eight public universities and degree-awarding institutions in the country.

Its Office of Research Administration supports research with grants and funding options.  Its partners include a broad and diverse range of institution and government.  It includes a central Ethics’ Committee as well as its Pharma-Bio Technology and Traditional Medicine Centre: its’ goal to be a leading African centre of excellence for training and research in traditional medicine and pharma-biotechnology.

Rakai Health Sciences Program

Established as a collaboration between investigators at Makerere, Columbia and Johns Hopkins Universities, the Division of Intramural Research at the National Institutes of Allergy & Infectious diseases and the International Centre for Excellence Research (ICER) formed in 1987. It was the result of the first identification of clinical AIDS in Rakai district Uganda in 1982. The initiation of the program led to a series of clinical studies characterizing the disease and its epidemiology.

Joint Clinical Research Centre (JCRC)

JCRC has led in the treatment for HIV/AIDS and infections in Uganda and Africa at large being the first center to provide Anti-Retroviral drugs as well as expand treatment to the entire country under the PEPFAR (TREAT program) which resulted in the opening of 75 treatment sites in Uganda which were eventually transitioned to MOH. Besides the HIV/AIDS research and care, JCRC runs a private clinic for medical care offering services at a cost recovery basis.

It was founded in 1990 as a collaborative effort by three Ugandan ministries (Health, Defense and Education) address the challenges posed by HIV/AIDS and related infections. The institution collaborates with Makerere University College of Health Sciences

Recent News

Human and Animal Vaccine Phase I Study

Just recently the Uganda Virus Research Institute (UVRI) initiated a phase I clinical trial of the Rift Valley Fever (RVF) human vaccine. The trials will start in June 2019. The team will use an improved version of ChAdOx1-GnGc-a vaccine currently only used by animals to treat RVF in humans. The funding originates from the UK Vaccine Research and Development Network. Director of the UVRI, Professor Potiano Kaleebu, noted that the trail aims at developing one vaccine that can be used by both animals and humans to treat the deadly disease.  The vaccine will be Masaka as it is in the cattle corridor reports The Independent. Professor Kaleebu reports 40 healthy participants will be recruited.

New Malaria Drug Developed in Uganda

Kampala-based researchers have developed a new anti-malaria drug to address malaria reported allafrica. The industry sponsor is actually a Korean biopharma called Shin Poong Pharma; the treatment known as Pyramax, stays in the body for a long time thus protecting the patient for an extended period of time. The Ugandan clinical research has been instrumental reported Bob Peter Okello, Uganda Country Manager for Shin Poong Pharma.  Over 9,000 have been tested in Uganda!

Clinic Distance Impedes Success of PrEP Program Success in Uganda

Recent research in Uganda has revealed that those living in rural areas far away from clinics have a harder time keeping up care.

Gilead Sponsors Clinical Research and Partners with Joint Clinical Research Centre

Gilead and the Joint Clinical Research Centre of Uganda are conducting a Phase II clinical trial there to evaluate the efficacy of GS-9131 Functional Monotherapy in HIV-1 Infected Adults Failing a Nucleos(t) Ide Reverse Transcriptase Inhibitor-Containing Regimen with Nucleos(t) Ide Reverse Transcriptase Inhibitor Resistant Virus. 68 participants will be enrolled for this study.

DolPHIN1 Trial: A pilot Study for Pregnant HIV Mothers and Their Neonates

University of Liverpool and Makerere University Clinical Trial

Makerere University and the University of Liverpool’s aim is to evaluate dolutegravir (DTG) pharmacokinetics in pregnant HIV infected women.  In many developing countries such as Uganda, many women present with a new HIV diagnosis in late pregnancy, and are at high risk for transmitting infection during delivery to their child.  Here DTG is likely to be more effective in reducing mother to child transmission of HIV than NNRTI-based regimens.

Fraudster Exploits Ugandans by Distributing Toxic “Cure”

Uganda is known to host waves of evangelists and apparently in one case, hucksters. In the case of Pastor Robert Baldwin, the story is particularly troubling.  Apparently backed by a former British clairvoyant as the part were part of a scheme to distribute a toxic, bleach-based “cure” for HIV/AIDS. The UK’s Guardian interviewed Baldwin on the phone in New Jersey asking him for an explanation of the Uganda work and he noted “We use natural healing therapies to help people—that’s something Christians do.”

Conclusion

Uganda is a struggling, under-developed African country like many of its neighbors from a colonial past with a troubled liberation-politic thereafter. It was the location of the “Empire of Light”—an ancient Kitara civilization. A dynamic and diverse part of the world, it represents a hungry and upcoming African world.  It does have a long way to go. But it is the originating source of the Nile itself; a core strength embodies the country’s research institutions. Uganda is sophisticated and poised to not only expand their capabilities and reach within the country, but to also expand into neighboring countries. The country’s government, academic and research community seek progress and we suspect they will in fact progress.

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