Beyond Evidence Generation: How Clinical Research Strengthens Zimbabwe’s Pharmaceutical Ecosystem

Siphosami Musikavanhu, BPharm (Hons), CTGU

Clinical Research Pharmacy Lead, Africa Clinical Research Network, Harare, Zimbabwe

Introduction: Pharmaceutical resilience is more than manufacturing

Discussions about pharmaceutical resilience in Zimbabwe often focus on local manufacturing, regulation, procurement and access to quality-assured medicines. National policy identifies domestic production as a priority.¹ Manufacturers work alongside the Medicines Control Authority of Zimbabwe (MCAZ) and the National Pharmaceutical Company of Zimbabwe (NatPharm), which perform essential regulatory and supply functions.^2,3

However, resilience also depends on evaluating new health technologies, regulating and managing them safely, and monitoring their performance in local populations. It requires skilled professionals, credible institutions, robust quality systems and partnerships connecting Zimbabwe to regional and international product-development programmes.^4–6

Clinical research contributes to these capabilities. Its value extends beyond producing data for a single medicine or vaccine: well-designed trials require regulatory science, research pharmacy, pharmacovigilance, trained teams, reliable laboratories, controlled supply systems and inspection-ready documentation. Retained and integrated into national systems, these capabilities can strengthen the pharmaceutical ecosystem.^7,8

Clinical research is not a substitute for manufacturing, regulation, procurement or medicine financing — it is one contributor among several. Its distinctive contribution is developing the people and systems needed to evaluate, introduce and use innovation responsibly.

Figure 1. Clinical research connects multiple components of Zimbabwe’s pharmaceutical ecosystem.

How clinical research builds pharmaceutical capability

Regulatory science and pharmacovigilance

Before a clinical trial can begin, its protocol, investigational products, safety arrangements and supporting evidence undergo ethical and regulatory review. During implementation, regulators may assess protocol amendments, safety reports, compliance with Good Clinical Practice (GCP) and the adequacy of participant-protection systems.^9–12

These requirements create repeated opportunities to build expertise in reviewing complex products and study designs, and may strengthen institutional familiarity with risk assessment, safety reporting and inspection.

Clinical trial oversight is one contributor to regulatory capability. Broader regulatory maturity also depends on governance, product registration, licensing, laboratory systems, market surveillance and routine pharmacovigilance. Zimbabwe’s regulatory development — including MCAZ’s electronic Clinical Trial Application and Registry system and e-pharmacovigilance system — reflects this larger programme.^2,10,13 Clinical trial regulation is one component of that progress, not its sole cause.

Clinical trial safety monitoring differs from national post-marketing pharmacovigilance. Trial participants are actively followed under a protocol, with adverse events reported under defined investigator, sponsor and regulatory requirements. Post-marketing pharmacovigilance instead covers medicines in routine care, relying on spontaneous reports and other national data sources; reporting timelines and lines of responsibility may differ.

The two systems are not interchangeable. Nevertheless, experience gained through trials can contribute useful competencies to routine medicine-safety systems, including identifying and documenting adverse events, assessing seriousness and causality, meeting reporting timelines and communicating emerging safety concerns.

Pharmacists and other research professionals with these competencies can support a stronger national culture of medicine-safety reporting, provided trial experience is connected to routine services and MCAZ reporting systems.¹³

Research pharmacy and quality systems

The research pharmacy is one of the clearest examples of how trials build pharmaceutical capability. A trial pharmacy must receive investigational products through a documented chain of custody, ensuring products are quarantined, released, stored, dispensed, reconciled and returned or destroyed per protocol. Product accountability must explain the movement and status of every unit.

Storage areas require controlled access, calibrated temperature-monitoring equipment and documented environmental review. When a temperature excursion occurs, the pharmacist must quarantine affected stock, assess or escalate it, and document the decision before use.

Randomisation codes and blinding must be protected, while emergency unblinding remains available when safety requires it. Trials may expose pharmacists to complex product preparation, adherence counselling, medication-error reporting and integrating GCP with GMP principles.

Pharmacy deviations require investigation and corrective and preventive action. Sponsor audits and regulatory inspections demand accurate records, traceable decisions and staff who can explain how the system works in practice.^9,10,14

These are not simply administrative tasks. They build disciplined approaches to inventory control, cold-chain management, deviation management and quality assurance — competencies that can benefit hospital pharmacy, vaccine delivery and other medicine-management settings when trained staff are retained and systems adapted for routine use.

Equipment can be removed, licenses can expire and facilities can become unusable without maintenance and calibration. The research-pharmacy dividend persists only when institutions plan for ownership, continued financing and post-trial use.

Workforce and institutional capability

Clinical trials depend on multidisciplinary teams: investigators, pharmacists, nurses, laboratory scientists, data and quality staff, and community-engagement personnel.

Protocol implementation requires standard operating procedures, role-specific training, source documentation, data review, monitoring and audit readiness, with deviations investigated and addressed through corrective and preventive actions.¹⁴

This work provides practical experience in regulated product management, complex laboratory methods, quality control, informed-consent processes and cross-institutional collaboration. Universities and research centers can convert that experience into postgraduate supervision, publications, mentorship and specialist career pathways.

Regional initiatives such as the Trials of Excellence for Southern Africa have sought to connect research delivery with institutional and workforce development.^15,16

Training individuals, however, does not automatically create national capacity. Skills may stay concentrated in a few organisations, and experienced staff may leave research, move abroad or depend on short-term contracts. Sustainable workforce development requires recognised career pathways, local leadership, succession planning and opportunities to apply expertise beyond a single study.

Institutions learn through repeated trial delivery, developing systems for ethics submissions, contracting, data governance, laboratory operations and quality management. This institutional memory eases future studies — but only when procedures and knowledge belong to the institution, not individual projects or staff.

Preparedness and access to innovation

Established research sites support public-health preparedness, since they already have trained personnel, regulatory experience, community relationships and systems for managing data and investigational products.

During an outbreak, these capabilities can support faster, more reliable evaluation of candidate medicines, vaccines or diagnostics — without them, each system would have to be built from scratch.

Participation in international studies can give local investigators and regulators earlier familiarity with emerging technologies, generate locally relevant experience, strengthen professional networks and create opportunities for Zimbabwean scientists to contribute to global product development.

This participation does not guarantee registration, procurement or equitable access — those depend on the regulatory evidence package, sponsor decisions, manufacturing evidence, pricing, financing and implementation planning. Research is one part of the pathway from innovation to access.

Figure 2. The clinical trial lifecycle and the pharmaceutical system capacity it can leave behind.

Illustrative Zimbabwean examples

These mechanisms appear across several parts of Zimbabwe’s clinical research ecosystem, which includes universities, public institutions, established research organisations and newer networks.

Illustrative examples include the University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC), the Biomedical Research and Training Institute (BRTI), CeSHHAR Zimbabwe and the Africa Clinical Research Network (ACRN) — not an exhaustive list.^16–19

UZ-CTRC’s participation in HPTN 084 placed Zimbabwean researchers within a multicountry evaluation of long-acting cabotegravir for HIV prevention.^20,21 This gave local investigators and regulators product experience, forming part of a broader pathway to national registration.

The registration decision depended on the global evidence package, the sponsor’s submission and MCAZ’s independent assessment.²² Trial participation should be viewed as a contribution to product familiarity and regulatory engagement, not as the direct cause of registration.

In July 2025, Zimbabwe administered the first doses of the investigational GRAdHIVNE1 HIV vaccine candidate at the Mutala Trust clinical trial site in Harare, as part of the IAVI C114 Phase I study.²³

Such studies demand particularly careful product management, safety oversight, laboratory capability and participant follow-up. Their significance lies not only in the candidate evaluated, but in the experience Zimbabwean teams gained delivering complex early-phase research.

Institutions such as BRTI and CeSHHAR contribute to research, training and policy engagement.^16,18 MRCZ provides national ethical oversight, while MCAZ regulates trials and investigational products within its mandate.^9–12 Together, these bodies show research depends on an ecosystem, not a single institution.

International partnerships bring funding, specialist knowledge, technology and collaborative networks, but their value should be judged by more than trial or training numbers. Strong partnerships expand local leadership, support fair authorship and data access, strengthen institutional systems and include credible plans for technology transfer and post-trial access.

Making capacity sustainable

Clinical research does not automatically strengthen national systems. Capacity built for a single project may remain unretained, confined to a research unit, or lost when trained staff leave and sponsor-specific systems fragment rather than strengthen national arrangements.

Benefits endure when sustainability is addressed from the start: study agreements should clarify asset ownership, infrastructure maintenance, data governance, publication rights and post-trial use, with resources for calibration, servicing, licensing and staff development after grants end.

Local scientific leadership is equally important: Zimbabwean researchers should participate in agenda-setting, protocol development, analysis and publication, not only trial implementation.

Post-trial access requires early planning among sponsors, regulators, government and implementing partners. Participation in research is not a guarantee of access, but partnerships should consider how successful interventions become affordable and usable within national programmes.

When these conditions are met, research can produce a double dividend: credible evidence for a health technology and lasting capability within Zimbabwe’s pharmaceutical system.

What Zimbabwe should do next

Manufacturing and research capability are mutually reinforcing: local production is stronger when supported by evidence-generation and quality systems, and research has greater national value when it addresses local industrial and public-health needs.

Conclusion

Zimbabwe’s pharmaceutical resilience depends on more than the ability to manufacture and procure medicines — the country must evaluate new technologies, regulate them effectively, deliver them safely and monitor their performance in local populations.

Clinical research contributes to these functions by developing skilled professionals, strengthening research pharmacy and quality systems, and connecting national institutions to product-development programmes.

These benefits are not automatic. They require local leadership, workforce retention, durable infrastructure, fair partnerships and integration with national priorities. When those conditions are met, clinical research becomes more than evidence generation: it becomes a strategic national asset for pharmaceutical resilience.

Declaration of interests

The author is employed by the Africa Clinical Research Network. ACRN is included as one illustrative example within Zimbabwe’s clinical research ecosystem.

About the author

Siphosami Musikavanhu, BPharm (Hons), is the Clinical Research Pharmacy Lead at the Africa Clinical Research Network in Harare, Zimbabwe.

ORCID: https://orcid.org/0009-0004-0910-9683

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