Clinical trial, expanded access or named-patient access: which route fits?
Three different routes to a medicine, explained side by side for families and doctors.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.
The short answer
A clinical trial tests an investigational treatment under a research protocol. US expanded access lets a patient who cannot join a trial use an investigational drug, with the manufacturer's agreement and FDA authorization. Named-patient access, run by your own country's regulator, is for a medicine already approved elsewhere but not registered locally. Regulators expect trials to be considered first for unapproved drugs.
- Clinical trial: Research study; eligibility set by the protocol.
- Expanded access (US): Investigational drug outside a trial, for one patient or a group.
- Named patient: Approved-abroad medicine, unregistered at home.
- Our scope: FDA-approved medicines only.
Clinical trials
The US National Cancer Institute describes clinical trials as research studies that test how well new medical approaches work in people, and the main way new treatments are found to be safe and effective.[1]
Trials have strict eligibility rules. They may offer access to a new treatment, but some participants receive the standard treatment or a comparator, and travel to trial sites is often needed.
US expanded access
Expanded access lets a patient with a serious or immediately life-threatening condition use an investigational product outside a trial when there is no comparable or satisfactory alternative and the patient cannot enrol in a trial. The treating physician requests it, the manufacturer must agree, and FDA must authorize it.[2, 3]
For a non-emergency single-patient request, the application takes effect 30 days after FDA receives it, or sooner if FDA says treatment can begin. In fiscal year 2023, FDA's drug center allowed 1,318 of 1,326 non-emergency single-patient requests and all 634 emergency requests, but these figures do not show how many requests manufacturers declined.[4, 5]
A company may charge for an investigational drug only with FDA's written authorization, and for an individual patient only its direct costs.[6]
Named-patient access
Named-patient access is for medicines already approved somewhere, most often by the US FDA, that are not registered in the patient's country.
In Saudi Arabia, the SFDA Special Access Program lets a patient with a serious or immediately life-threatening condition receive a medicine that is not registered when no comparable alternative exists. The request comes from the manufacturer or sponsor, or from the licensed treating physician if there is no sponsor. We give you a written timeline estimate for your case before you commit.[7]
In Bahrain, NHRA Circular 41 of 2020 lets government and private hospitals import a non-registered medicine with the authority's permission before the purchase order, when the medicine is important and has no registered alternative in Bahrain, is registered with the Gulf Health Council, a GCC state or a reference regulator such as the US FDA, and is marketed in its country of origin.[8]
How to choose
- If the medicine is FDA-approved, named-patient access at home is usually the most direct route.
- If it is not approved anywhere, ask about a trial first. EMA notes patients should always be considered for trials before compassionate use.
- If no trial fits, the treating physician can ask the manufacturer about expanded access. For a patient abroad, the home regulator must also approve.
- Weigh travel, cost and follow-up. Trials and some expanded access programs require visits to specific centers.
EMA's guidance makes the same point for Europe: trials come first, then compassionate use.[9]
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us about a medicine
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Is expanded access the same as a clinical trial?
No. A trial is a research study with a protocol. Expanded access is treatment use of an investigational drug outside a trial for a patient who cannot join one.
How long does FDA take to respond to a single-patient expanded access request?
A non-emergency request takes effect 30 days after FDA receives it, or sooner if FDA allows treatment to begin. Emergencies can be authorized by phone.
Can a company charge for expanded access?
Only with FDA's written authorization, and for an individual patient only its direct costs.
Does Reserve Meds arrange trials or expanded access?
No. We coordinate FDA-approved medicines. We can explain the routes, but the treating physician makes expanded access requests.
Where can I search for clinical trials?
FDA's physician fact sheet points to its clinical trials search tool and to ClinicalTrials.gov. Ask the treating specialist to check eligibility and site locations.
Sources for these answers: [2, 4, 6, 3]
Sources
All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- US National Cancer Institute: What Are Clinical Trials? (accessed 17 October 2026)
- US FDA: Expanded Access (accessed 17 October 2026)
- US FDA: Physician Fact Sheet, Expanded Access (accessed 17 October 2026)
- US FDA: IND Applications for Clinical Treatment (Expanded Access): Overview (accessed 17 October 2026)
- US FDA: Expanded Access (Compassionate Use) Submission Data (accessed 17 October 2026)
- US FDA: Charging for Investigational Drugs Under an IND, Questions and Answers (February 2024) (accessed 17 October 2026)
- SFDA: Special Access Program (SAP) guidance, version 1.0 (accessed 17 October 2026)
- NHRA Bahrain: Circular No. (41) of 2020, procedures for importing non-registered medicines (accessed 17 October 2026)
- European Medicines Agency: Compassionate use (accessed 17 October 2026)
Related
- Right to Try
- Glossary of access terms
- Answers to common access questions
- Named-patient access, explained
- US expanded access (compassionate use)
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.