Post-trial access planning
The trial is closing.
What needs to continue?
Bring the treatment question, the programme commitments and the delivery plan into the same conversation.
Close-out is a milestone. Continuity needs its own plan.
A clinical operations team is preparing for the final visit. Sites are asking what happens next. Medical affairs needs a consistent answer. Supply, safety and regulatory teams may be working to different assumptions.
IAE brings those assumptions into one assessment: what has been committed, what routes need consideration, who can decide and what must be ready before a transition is communicated.
Separate the commitments from the delivery assumptions.
- Establish the starting pointReview the protocol, participant information, relevant commitments and country context with the responsible teams.
- Assess the possible arrangementsConsider the proposed route, product status and local input needed. Identify unresolved decisions and their consequences.
- Connect the operating responsibilitiesBring sponsor, provider, site, pharmacy, safety and supply interfaces into a shared transition plan.
- Define readiness and reviewSet evidence of readiness, decision owners, communication dependencies and review points for change or closure.
An output your team can act on.
A focused review can produce a decision brief and a prioritised list of unresolved questions. A wider assignment can develop the transition plan, responsibility map and readiness criteria with the teams that will use them.
The scope can cover one study, a programme or a change of provider. Clinical decisions and formal sponsor, regulatory and quality responsibilities remain with the appropriate parties.
Independent judgement across the handover.
Daniel’s experience connects post-trial transitions, international access programmes and regulatory governance. IAE’s advice is independent of a medicine supply or logistics sale, so the assessment can start with the programme’s needs.
Ethical principles and local requirements both matter.
The 2024 Declaration of Helsinki addresses post-trial provisions before a clinical trial begins. Applying those principles requires attention to the actual commitments and applicable local requirements; they are not a universal import or treatment authorisation.
World Medical Association: Declaration of Helsinki · source checked 26 September 2026.
Patients and families seeking an answer about their trial should contact the study team or advertised programme channel. Find information and signposting
Post-trial access: a working responsibility map
A transition plan becomes more useful when each unresolved question has a decision owner, an evidence requirement and a clear handover. The map below is a starting point for agreeing responsibilities for the specific programme.
| Work to resolve | Parties to involve when assigning responsibility | Record before the handover |
|---|---|---|
| Programme commitments and scope | Sponsor and responsible study teams, with relevant local input | Applicable protocol and participant commitments; population and activities in scope; unresolved questions |
| Clinical treatment decisions | The appropriate treating and study teams | The responsible decision route and how participants will receive information |
| Possible access arrangements | Responsible sponsor, regulatory and local specialists | Product and country context, proposed arrangement, outstanding decisions and limits |
| Delivery interfaces | Responsible provider, site, pharmacy, supply and safety teams | Named activities, handovers, escalation routes and evidence of readiness |
| Change, review and closure | The programme's agreed decision owners and delivery teams | Review points, change dependencies, communication responsibilities and closure criteria |
IAE can help develop the assessment, responsibility map and transition plan. Clinical decisions and formal sponsor, regulatory and quality responsibilities remain with the appropriate parties.
Plan the transition. Start with the situation.
Tell Daniel what is changing, when and which decisions remain open. You do not need a complete brief.
Discuss post-trial planningScope, responsibilities and fees are agreed before work begins.