Trials, regulators, literature and patents

In short: NCT numbers, statuses, phases and eligibility: what a registry record tells you and what it does not.

Identity and status

Each registered study has an NCT number. Status values such as "Recruiting", "Active, not recruiting" and "Completed" describe the study, not whether it suits any individual. Records are updated by sponsors and can lag reality.

Phases

• Phase 1: first studies in people, focused on safety and dosing.
• Phase 2: early evidence of activity and further safety.
• Phase 3: larger comparisons that can support approval.
• Phase 4: studies after approval.
• Diagnostic imaging studies may not use phases at all.

Eligibility and results

Eligibility criteria are listed but only the study team decides who can join. A registered study is not evidence that an intervention works; results, when posted or published, are separate.

In short: How the same product can look different in a label and in a trial registry, and why RadioGx shows the match confidence.

Different documents, different purposes

A label (in the United States, the prescribing information) describes an approved product. A trial record describes an intervention under study, which may be an approved product used in a new way, a new formulation, or something unapproved.

Matching them

RadioGx matches labels and trials by names and known aliases. When a match relies on names rather than identifiers it is marked "Likely" or "Possible", never "Exact", and conflicts are shown side by side without adjudication.

In short: Drugs are approved; most devices are cleared. The difference matters for radiopharmaceuticals, scanners and microspheres.

Drugs and biologics

In the United States, new drugs are approved through new drug applications and biologics through biologics licence applications. Radiopharmaceuticals are regulated as drugs.

Devices

Most moderate-risk devices are cleared through premarket notification, known as 510(k), by showing substantial equivalence to a legally marketed device. Higher-risk devices go through premarket approval (PMA). De Novo classification creates a new device type when there is no equivalent. Scanners are devices; some radioactive implants, such as yttrium-90 microspheres in the US, are also regulated as devices.

Other jurisdictions

The EU, UK, Canada, Australia, Japan, China, India and Brazil each have their own pathways and terminology. A product can be approved in one place and not another.

In short: Why FAERS and MAUDE counts cannot tell you how often harm happens or what caused it.

What the systems collect

Spontaneous reporting systems gather reports from manufacturers, health professionals and the public. They are valuable for spotting signals that need investigation.

What they cannot show

• Causation: a report says an event happened while a product was used, not that the product caused it.
• Frequency: there is no denominator of how many people used the product.
• Completeness: many events are never reported; others are reported more than once.
• Comparisons: reporting rates are influenced by publicity, time on market and reporting habits.

In short: How to weigh a paper, a preprint, a review and a meta-analysis, and how to reach legal open-access copies.

Kinds of publication

• Primary research reports a study.
• Preprints are posted before peer review and can change.
• Narrative reviews summarise a field from an author’s perspective.
• Systematic reviews use a protocol to find and appraise all relevant studies; meta-analyses combine their results statistically.

Open access, legally

Many papers have a legal free version: in the publisher’s open-access journal, in PubMed Central or Europe PMC, or in an institutional repository. Tools such as Unpaywall locate these copies. RadioGx never bypasses paywalls; when no legal copy exists it shows metadata and the official link.

Identifiers

A DOI identifies a published object permanently; a PMID identifies a PubMed record. Both help you find the official version.

In short: What a patent document shows, what it does not, and why freedom to operate needs a patent attorney.

Applications and grants

A published application is a request; a granted patent has been examined in one jurisdiction. Claims, not titles or abstracts, define what is protected.

Families and jurisdictions

The same invention is often filed in many countries, forming a patent family with shared priority. Each member has its own status, which can change through fees, oppositions and court decisions.

What a patent is not

A patent is not evidence that a product works, is safe or is approved. Freedom-to-operate questions require a qualified patent attorney.