D-T-P enters the guideline: from pioneer practice to regulatory default
In twenty-four months, direct-to-participant research has moved from 'innovation' to the way GCP is now written. A short reading of the FDA final DCT guidance and ICH E6(R3) with its Annex 2.
Insight · · 3 min
In the space of twenty-four months, direct-to-participant (D-T-P) research has crossed a line that matters. It is no longer an innovation sponsors defend to a regulator. It is the way Good Clinical Practice is now written. Our founding team has practised it for years, before there was a term for it, and the regulatory text of 2024–2026 has caught up with years of field evidence.
The term itself is not new. The first fully virtual, direct-to-participant clinical trial is usually traced to Pfizer's REMOTE study in 2011, an overactive-bladder trial that consented, enrolled and followed participants entirely from home. What followed was a long decade of experimentation: registries, patient-generated data programmes, hybrid designs, and, from 2020, a forced field test at industrial scale during COVID. What was missing was a regulatory text that named the practice and set the expectations. That gap closed between late 2022 and mid-2026.
Four regulatory moments matter. First, December 2022: the EMA/HMA/EC Recommendation paper on decentralised elements in clinical trials, the first coordinated European position that DCT-style conduct is compatible with existing law. Second, May 2023: the FDA draft guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Third, and decisively, 18 September 2024: the FDA finalised that text as "Conducting Clinical Trials With Decentralized Elements" (Federal Register vol. 89 n. 181), the first final US guidance that treats remote and D-T-P elements as ordinary tools of trial conduct rather than exceptions to justify. Fourth, the ICH pillar: ICH E6(R3), Step 4 adopted 6 January 2025, is deliberately technology-neutral and principle-based, opening the door to decentralised models by design; its Annex 2, adopted at Step 4 on 3 June 2026, is the first ICH text that names non-traditional trial designs and decentralised elements and spells out how sponsor and investigator responsibilities extend when activities happen at home, in a pharmacy, or via a mobile nurse.
Read in plain language, the texts converge on four things. Sponsor accountability does not dilute when the study moves to the participant, it travels with them. Data provenance and audit trail follow the participant across settings, not the site. Informed consent, safety oversight and investigator oversight explicitly extend to remote and D-T-P touchpoints, with clear allocation of duties. And risk-based quality management is the operating system underneath, proportionate controls, documented rationale, and evidence that the sponsor understands where the risks actually sit.
For sponsors, three practical consequences follow. One: D-T-P and decentralised elements are no longer a derogation to justify, they are a design option the regulator expects sponsors to evaluate, and to defend when they choose not to use them. Two: the qualification bar has moved. What sponsors now assess in CRO due diligence is the underlying evidence, QMS, 21 CFR Part 11 compliance, data governance and security, GCP training records, GDPR posture, because the guidance assumes those are in place. Three: for rare, dispersed, or hard-to-recruit populations, phygital design, hospitals · community HCPs · pharmacies · home, connected on one backbone, is now the compliant default, not the imaginative alternative.
This is the moment Evidilya was built for. Our product, ECS®, was designed as a virtual research ecosystem for direct-to-participant research long before the guidance existed, and our organisation is Sponsor-Qualified across eight due-diligence domains, QMS, Data Security, 21 CFR Part 11, GDPR, GCP, Pharmacovigilance, Business Continuity and Ethics. People & Research First® is not a slogan; it is the reason the operating model reads the way the guideline now does.
Sources. FDA, Conducting Clinical Trials With Decentralized Elements, final guidance, 18 Sep 2024 (fda.gov, Docket FDA-2022-D-2870). ICH, E6(R3) Good Clinical Practice, Step 4, 6 Jan 2025 (database.ich.org). ICH, E6(R3) Annex 2, Step 4, 3 Jun 2026 (database.ich.org). EMA, ICH E6 Good Clinical Practice scientific guideline (ema.europa.eu). EMA/HMA/EC, Recommendation paper on decentralised elements in clinical trials, Dec 2022.
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