Decentralized Clinical Trials: Should Kenya’s Regulators Get Ahead of the Trend?

Decentralized clinical trials, where telehealth visits, local healthcare providers, and remote monitoring replace some or all of a traditional single trial site, are now the subject of finalised guidance from the FDA and a formal recommendation paper from EU regulators. Kenya’s Pharmacy and Poisons Board has neither. That is not necessarily a criticism. It is a genuine choice point: wait for global practice to settle before writing rules, or start building the framework now, while Kenya’s clinical trials sector is still a relatively attractive destination for sponsors weighing where to run their next study.

Where the Global Guidance Stands

The FDA finalised its guidance, “Conducting Clinical Trials With Decentralized Elements,” on 18 September 2024, closing out a draft version circulated in May 2023. It addresses trial design and oversight, remote visit procedures, use of digital health technology, informed consent, and investigational product handling, while stating plainly that FDA’s regulatory requirements are the same whether or not a trial includes decentralized elements. On the European side, the EMA, the Heads of Medicines Agencies, and the European Commission jointly published a Recommendation Paper on Decentralised Elements in Clinical Trials, version 1, dated 14 December 2022, covering similar ground for the EU regulatory network. Both documents treat decentralization as an operational model layered onto existing GCP obligations, not a separate regulatory category. Neither is binding on Kenya, but both are the reference points any sponsor running a multi-country trial will expect a Kenyan site to be measured against.

Kenya’s Current Framework Has No Equivalent

Kenya regulates clinical trials through the Pharmacy and Poisons Act, the Pharmacy and Poisons (Conduct of Clinical Trials) Rules, 2022, and the Guidelines for the Conduct of Clinical Trials in Kenya, now in their fifth revision, effective 2 January 2026. The Pharmacy and Poisons Board’s Expert Committee on Clinical Trials authorises and oversees trials, ethics review runs through a NACOSTI-accredited Institutional Ethics Review Committee with at least seven members and mandatory balanced representation, and the applicable clinical practice standard is ICH-GCP E6(R2). Ethics approval must precede PPB approval, and NACOSTI research licensing must be in place before a study starts. None of this framework, on its face, contemplates remote visits, decentralized data collection, or a local healthcare provider standing in for a site investigator. The PPB’s own clinical trial registry and public guidance make no mention of decentralized or telemedicine-based trial models. That silence is the gap this article is about, not a defect in what currently exists for conventional, site-based trials.

Two Regulatory Regimes a DCT Would Actually Touch

A decentralized trial in Kenya would not just need PPB sign-off. It would generate substantial remote patient data, collected through apps, wearables, or local clinics, and that data sits squarely inside the Data Protection Act 2019. Sections 48 to 50 govern cross-border transfer of personal data, requiring either proof of adequate safeguards in the receiving jurisdiction or explicit consent for sensitive categories, which is directly relevant where a foreign sponsor’s data infrastructure sits outside Kenya. Separately, Kenya’s Digital Health Act, No. 15 of 2023, together with its 2025 subsidiary regulations on data exchange and health information management, is the closest thing Kenya has to a legal foundation for the telehealth and remote-monitoring components a DCT would rely on. A sponsor planning a decentralized element in Kenya today is really assembling permissions from three separate regimes, clinical trials, data protection, and digital health, none of which was drafted with the others in mind.

The Case for Getting Ahead of It

Kenya is not unusual in lacking DCT-specific rules; most regulators globally are still working from general clinical trial frameworks rather than a dedicated decentralized-trial regime. But the absence of guidance functions as a quiet deterrent for sponsors comparing Kenya against jurisdictions that have already published a clear DCT position, since ambiguity about what PPB will actually accept from a remote-visit protocol adds real diligence cost to a multi-country study. A PPB guidance note, even a short one, addressing how remote visits interact with existing GCP and ethics requirements, and how a local healthcare provider’s role differs from a site investigator’s, would remove that ambiguity without requiring a new statute. Given that Kenya’s fifth revision of its clinical trials guidelines only took effect on 2 January 2026, the regulator has clearly shown it is willing to update its framework regularly, which makes a targeted decentralized-trials addendum a realistic near-term step rather than a distant legislative project.