Methodology

The rule

FDAAA 801 (Section 801 of the Food and Drug Administration Amendments Act of 2007, Public Law 110-85) and the Final Rule (42 CFR Part 11, effective January 18, 2017) require the responsible party of an "applicable clinical trial" to submit results information to ClinicalTrials.gov no later than one year after the primary completion date, absent a certification or approved extension.

How we flag

1. We query ClinicalTrials.gov API v2 for studies with ResultsFirstPostDate MISSING.
2. We default the scope to LeadSponsorClass=INDUSTRY and IsFDARegulatedDrug=true — the population most squarely "applicable" and most relevant to public-company buyers.
3. We restrict primary completion to on/after 2017-01-18 (the Final Rule era) — keeping every flag inside the bright-line window.
4. We compute the deadline as primary completion + 365 days. If today is past the deadline and hasResults=false, the trial is flagged overdue, with exact days-overdue.
5. For industry sponsors we best-effort map the sponsor name to a public ticker/CIK via the SEC EDGAR company-ticker file. This is a name match and may be wrong — always verify on EDGAR.

Partial dates

When ClinicalTrials.gov records only a year or year-month, we resolve to the last day of that period — the most sponsor-favorable reading (latest possible completion, fewest days overdue).

Known limitations (honest scope)

• Certificates of delay / extensions. The Final Rule permits a certification to extend the deadline (e.g., pending FDA approval of a new use). The v2 API does not cleanly expose every such certification, so a flagged trial may have a filed extension. We report the public posting facts only — never a conclusion of non-compliance.
• Applicability is ultimately a legal determination. Not every registered trial is an "applicable clinical trial." We use sponsor class + FDA-regulation flags as a conservative proxy; the responsible party's legal status is theirs to assert.
• Ticker mapping is best-effort. Subsidiaries, foreign issuers (ADRs), and renamed entities can mismatch. Confidence is shown; verify on EDGAR.

Source of record for every flag: the trial's own ClinicalTrials.gov page, linked on each record.