A video consultation can replace a clinic visit. It cannot replace clinical judgment, reliable connectivity, regulatory oversight, or accountable data governance.
That distinction is often blurred in discussions about decentralized clinical trials (DCTs). Remote consent, telemedicine, wearable devices, home visits, direct-to-participant delivery, and electronic patient-reported outcomes are frequently presented as parts of a single innovation. In practice, each introduces different operational demands, risks, and regulatory questions.
The useful question is therefore not whether African clinical trials should become decentralized. It is which trial activities can safely move beyond the research site, for which participants, under what conditions, and with whose oversight.
Decentralization is not a binary choice
A trial does not need to be fully remote to reduce participant burden. It may retain site-based clinical examinations and laboratory procedures while using telephone follow-up, home visits, electronic questionnaires, or community-based services for selected activities.
This hybrid approach is likely to be more relevant across many African settings than the fully remote model often associated with DCTs. It allows trial design to respond to the intervention, participant population, research question, and local infrastructure rather than to a technology category.
Evidence from stakeholders involved in clinical research in sub-Saharan Africa points to genuine opportunities for decentralized methods, including greater convenience for participants and potential improvements in trial efficiency. The same evidence identifies infrastructure, digital literacy, data management, regulation, and implementation capacity as significant constraints (1). These are not minor obstacles to be addressed after a platform has been selected. They determine whether the model is viable in the first place.
Connectivity is an operational chain
Connectivity is often reduced to a measure of internet coverage. For a trial participant, however, successful digital participation may depend on several conditions being met at once: access to a suitable device, electricity for charging, affordable data, adequate network quality, confidence using the application, technical support, and a private place to communicate.
Failure at any point can produce missing data, missed safety contacts, protocol deviations, or participant withdrawal. It can also shift costs from the sponsor to the participant through data purchases, travel to areas with better reception, or reliance on another person’s device.
A responsible trial should therefore assess more than whether an area has mobile coverage. It should establish whether the proposed process works consistently for the intended participants. It should also provide alternatives when it does not.
Offline functionality, low-bandwidth design, voice calls, text messaging, provisioned devices, data reimbursement, and in-person options may be more valuable than a sophisticated application that performs well only under ideal conditions.
The principle is simple: technology should absorb complexity for participants, not transfer complexity to them.
Every remote activity creates a new oversight question
Moving an activity away from the research site does not remove the site’s responsibility. It redistributes the work across investigators, community-based personnel, couriers, laboratories, technology providers, and other third parties.
That distribution can create uncertainty unless responsibilities are defined before recruitment begins. Who confirms participant identity during remote consent? Who assesses capacity and understanding? Who responds when a wearable generates an abnormal reading? How quickly must an adverse event reported through an application reach the investigator? Who verifies that an investigational product delivered to a home was stored correctly and received by the intended participant?
The recently finalized ICH E6(R3) Annex 2 applies Good Clinical Practice principles to trials incorporating decentralized elements and reinforces a proportionate, risk-based approach (2). It does not make decentralized methods automatically acceptable in every jurisdiction. Sponsors and investigators must still demonstrate that each element complies with national regulatory and ethics requirements.
Across Africa, those requirements are not uniform. Regional harmonization initiatives and the operationalization of the African Medicines Agency offer important routes towards greater regulatory convergence, but national authorities remain central to trial authorization and oversight (3, 4). Until expectations are clearer across jurisdictions, early engagement with regulators and research ethics committees is essential, particularly for electronic consent, remote safety monitoring, digital endpoints, home delivery of investigational products, and cross-border data processing.
Data must be mapped before it is collected
A conventional site-based trial already requires strong data governance. A decentralized model may add participant-owned devices, commercial applications, cloud services, wearable manufacturers, telemedicine providers, couriers, and remote monitoring systems.
The result is not simply more data. It is a longer and less visible chain of custody.
Before a study starts, sponsors should be able to show where each data element originates, where it is transmitted and stored, which organisations can access it, how changes are recorded, how long it is retained, and what happens if a provider changes ownership or stops operating.
This is especially important in multi-country studies. African data-protection laws differ in their requirements for consent, processing of sensitive health information, cross-border transfers, breach management, and data-subject rights. A platform’s technical capability to move data across borders does not establish the legal or ethical basis for doing so.
Commercial contracts also deserve scrutiny. Participant data should not acquire undefined secondary uses merely because a vendor’s standard terms permit broad analytics or product development. The protocol, consent materials, vendor agreements, and actual data flows must tell the same story.
Digital endpoints require evidence, not enthusiasm
Wearable devices can collect frequent or continuous measurements outside the clinic, but volume is not the same as validity.
A device proposed for a trial endpoint must be fit for the specific population, setting, measurement, and intended use. Sponsors need evidence on accuracy, calibration, missingness, participant adherence, software changes, time synchronization, data transfer, and replacement procedures. They must also determine whether the endpoint is acceptable to regulators and clinically meaningful.
Optical devices require particular care. Research has documented differences in pulse-oximetry performance associated with skin pigmentation, while evidence on consumer wearables varies by device and measurement (5, 6). This does not mean such technologies should be rejected. It means validation cannot be assumed from studies conducted in populations that do not reflect those being enrolled.
Operational details matter just as much. A wearable that is accurate in a laboratory may still fail as a trial tool if participants cannot charge it reliably, synchronize it, replace it when damaged, or obtain timely support.
Start with the burden, not the platform
The strongest case for decentralization is not that it modernizes a trial. It is that a specific change makes participation safer, easier, or more practical without weakening data quality or investigator oversight.
In one study, telephone follow-up may be sufficient. In another, a trained mobile team could conduct home visits or collect samples closer to participants. Electronic patient-reported outcomes may work where participants have appropriate access and support, while paper, voice, or assisted options remain necessary elsewhere. Laboratory monitoring and investigational product administration may still require a clinical site or qualified local facility.
This leads to a more disciplined design process. For every proposed decentralized element, trial teams should ask:
- What participant or operational burden are we trying to reduce?
- Is the activity clinically and regulatorily suitable to move away from the site?
- What infrastructure does it require in the participant’s actual setting?
- Who remains accountable when the activity is performed remotely?
- What happens when the technology, network, device, courier, or provider fails?
- Does the model create a new barrier for people who could otherwise participate?
If these questions do not have credible answers, the trial is not ready to decentralize that activity.
What African research networks can build
Africa does not need to reproduce a fully remote trial model developed for different health systems and consumer markets. It can build hybrid models around existing research sites, community health infrastructure, local laboratories, pharmacies, mobile teams, and communication methods that participants already use.
That requires investment beyond purchasing technology. Research institutions need procedures for remote identity verification, technology support, vendor oversight, home visits, safety escalation, data reconciliation, device management, and continuity during power or network disruption. Regulators and ethics committees need practical evidence from well-governed pilots. Sponsors need procurement processes that examine interoperability, data rights, offline performance, and exit arrangements rather than accepting vendor claims at face value.
ACRN’s role is to help institutions examine these models across different settings, generate implementation evidence, and support dialogue among sites, sponsors, regulators, ethics committees, technology providers, and communities. The objective is not to advocate for decentralization as an end in itself. It is to identify when carefully selected decentralized elements can improve participation and trial delivery without compromising safety, quality, or trust.
The future of African clinical trials will almost certainly include more activity beyond the traditional research site. Whether that produces better research will depend less on the number of digital tools adopted than on the quality of the decisions behind them.
Decentralization succeeds when it makes a trial work better for participants while preserving accountable oversight. When it merely moves risk, cost, and complexity away from the site, it is not innovation. It is displacement.
References
- Nebie EI, Sawadogo HN, van Eeuwijk P, Signorell A, Reus E, Utzinger J, et al. Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study. BMJ Open. 2023;13(9):e075903.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3) Annex 2. Geneva, Switzerland: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; 2026. Report No.: E6(R3) Annex 2.
- Arik M, Bamenyekanye E, Fimbo A, Kabatende J, Kijo A, Simai B, et al. Optimizing the East African Community’s Medicines Regulatory Harmonization initiative in 2020–2022: A Roadmap for the Future. PLOS Medicine. 2020;17:e1003129.
- World Health Organization (WHO). WHO and African Medicines Agency launch landmark framework to strengthen access to quality-assured health products in Africa: World Health Organization; Available from:https://www.who.int/news/item/21-05-2026-who-and-african-medicines-agency-launch-landmark-framework-to-strengthen-access-to-quality-assured-health-products-in-africa
- Sjoding Michael W, Dickson Robert P, Iwashyna Theodore J, Gay Steven E, Valley Thomas S. Racial Bias in Pulse Oximetry Measurement. New England Journal of Medicine. 2020;383(25):2477–8.
- Singh S, Bennett MR, Chen C, Shin S, Ghanbari H, Nelson BW. Impact of Skin Pigmentation on Pulse Oximetry Blood Oxygenation and Wearable Pulse Rate Accuracy: Systematic Review and Meta-Analysis. J Med Internet Res. 2024;26:e62769.