A patient support program and a structured study both generate real-world evidence. They differ in what they require before you start, and in what you can do with the result.
Sponsors asking for real-world evidence are usually asking two different questions at once: what does this therapy do outside a trial, and can I put that in a dossier. Those questions have different answers, and the vehicle you pick decides which one you can answer.
A care service, not research. It deploys in routine clinical practice to support patients and their physicians, and it collects patient-reported outcomes, adherence, prescription and usage data as a by-product of care. Because it is care, it launches without ethics committee approval.
The sponsor receives aggregated, non-individual data. The value arrives early, and the program pays for itself in adherence and persistence before any analysis is written.
Research from day one, with a defined protocol, multiple investigators and ethics committee approval before anything starts. Interventional trials add national competent authority approval under the EU Clinical Trials Regulation. Collection can be prospective, retrospective or both, and a publication pipeline is part of the design.
This is the route when the output has to stand up in a market access, HTA or reimbursement dossier, or support a label.
GDPR applies to both routes. And the phrase “no ethics committee” holds only while the data serves care and program monitoring. Any analysis that gets published or submitted as evidence requires an ethics opinion.
For data collected in routine care, that opinion comes through a retrospective submission, which is lighter and faster than a full prospective protocol. But it is only available if consent was designed for it before the program launched. Retrofitting consent is not possible.
Start with what the evidence has to do. If it has to support a payer conversation on a fixed date, the structured study route is built for that and its timelines align to submission dates. If the priority is getting patients supported now and building an evidence base as you go, the program route gets there sooner and converts later, provided the consent is right.
A patient support program is a care service deployed in routine practice; it needs no ethics committee approval to launch and generates evidence as a by-product. A structured study is research from day one, with a protocol and ethics approval up front, designed to produce evidence for market access, HTA or reimbursement.
Only after an ethics opinion. For routine-care data this is a retrospective submission, which is lighter and faster than a prospective protocol, but it is only possible if consent was designed for secondary use before the program started.
No. GDPR applies to both. The routes differ in their ethics position, not their data protection obligations.
The program route starts sooner because it needs no ethics approval to launch. The study route reaches dossier-ready evidence faster, because that is what it is designed to produce and its timelines align to submission dates.
Tell us what you are working on and we will help you get it moving.
