Clinical Trial Data Extractor - ClinicalTrials.gov & FDA Orange Book Delta Monitor (Global Pharma Intelligence)

Executive Value Proposition

Knowing that a trial's overallStatus just moved from RECRUITING to TERMINATED, or that an FDA Orange Book patent/exclusivity entry just changed, normally means manually re-opening the same ClinicalTrials.gov or Orange Book record over and over on a recurring basis - tedious enough that most sponsor-tracking, competitive-intelligence, and clinical-operations teams either skip it or only check sporadically. This actor automates that comparison against two verified-live, free, public government APIs: it fingerprints the fields that actually matter (overallStatus, lastUpdatePostDate, statusVerifiedDate for trials; patent/exclusivity data per applNo/productNo for Orange Book entries) against a persisted cross-run snapshot, and in delta mode delivers only records that are new or genuinely changed - not a full re-crawl you have to diff yourself every run.

Use Cases

• Sponsor and competitive-intelligence tracking. Watch a competitor's pipeline for trial-status inflection points - a PHASE3 study moving from RECRUITING to COMPLETED or TERMINATED is a real signal for BD, market-access, and competitive-intelligence teams, delivered as a STATUS_CHANGE event instead of something you'd only notice by re-reading the same trial page.
• Clinical-operations self-monitoring. Run this actor against your own organization's trials (via the condition filter or a saved query) to get an automated cross-run check that overall_status and status_verified_date are moving the way your team expects, without a person manually reloading each NCT record on a schedule.
• Loss-of-exclusivity and generic-entry timing. Track the FDA Orange Book source for a watchlisted ingredient or application number to see PATENT_EXCLUSIVITY_CHANGE and NEW_LISTING events as they happen - useful groundwork for generics-entry timing and patent-cliff monitoring.

Input

{
  "sources": ["clinicaltrials"],
  "condition": "non-small cell lung cancer",
  "maxPages": 5,
  "onlyChanged": true
}

Field	Type	Default	Description
sources	array (clinicaltrials, orangebook)	["clinicaltrials"]	Which source(s) to run this call. clinicaltrials hits the ClinicalTrials.gov API v2; orangebook hits the openFDA Orange Book endpoint.
condition	string	-	Passed to ClinicalTrials.gov's query.cond filter, e.g. "diabetes".
orangeBookQuery	string	-	Ingredient name or application number filter for the Orange Book source.
maxPages	integer	20	Hard cap on the number of 100-record ClinicalTrials.gov API pages walked per run.
onlyChanged	boolean	false (prefilled true in the Console)	Delta mode - only new or changed records are delivered. State persists in a named key-value store unique to this actor across scheduled runs.
maxRetries	integer	5	Max retry attempts (full-jitter exponential backoff) per page/request before that fetch is dead-lettered.
fdaApiKey	string (secret)	-	Optional openFDA API key for a higher Orange Book rate limit (1,000/day without a key vs. 120,000/day with one, both capped at 240/min). Not used by the ClinicalTrials.gov source.

sources is the only required field.

Output

One dataset item per delta event, carrying a shared envelope (record_id, event_type, scraped_at, is_new, source_url, data_source) plus source-specific fields. This is a real record from this actor's own smoke test:

{
  "record_id": "NCT05823948",
  "event_type": "NEW_TRIAL",
  "scraped_at": "2026-09-08T19:15:01.188Z",
  "is_new": true,
  "source_url": "https://clinicaltrials.gov/study/NCT05823948",
  "data_source": "clinicaltrials-gov",
  "nct_id": "NCT05823948",
  "brief_title": "A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)",
  "overall_status": "COMPLETED",
  "previous_status": null,
  "last_update_post_date": "2026-04-30",
  "status_verified_date": "2026-04",
  "lead_sponsor": "Novo Nordisk A/S",
  "conditions": ["Diabetes Mellitus, Type 2"],
  "phases": ["PHASE3"]
}

overall_status uses ClinicalTrials.gov's own controlled vocabulary verbatim (RECRUITING, ACTIVE_NOT_RECRUITING, COMPLETED, TERMINATED, WITHDRAWN, etc.) rather than a remapped generic enum, so no information is lost. event_type is NEW_TRIAL or STATUS_CHANGE for ClinicalTrials.gov records, NEW_LISTING or PATENT_EXCLUSIVITY_CHANGE for Orange Book records, or SNAPSHOT_NO_DIFF (only delivered when onlyChanged is off). On a STATUS_CHANGE event, previous_status carries the value seen on the prior run. An Orange Book record instead carries application_number, product_number, trade_name, ingredient, te_code, and the source's own patent_data object, left unflattened since patent entries vary in count per product. Download results as JSON, CSV, or Excel directly from the Apify platform.

Reliability

• Fingerprint-based delta engine. Each trial's tracked fields (overallStatus, lastUpdatePostDate, statusVerifiedDate) and each Orange Book product's patent/exclusivity data are fingerprinted and persisted in a named, cross-run key-value store, so STATUS_CHANGE and PATENT_EXCLUSIVITY_CHANGE events reflect a real prior-run comparison, not a guess.
• Global exception handler. installGlobalErrorHandlers captures full stack trace, memory, and duration telemetry on any unhandled rejection or exception before the process exits, instead of failing silently.
• Full-jitter backoff with a dead-letter queue. Retryable fetches use full-jitter exponential backoff up to maxRetries attempts; a page or request that still fails is dead-lettered rather than silently dropped or left to crash the run.
• Strict ISO 8601 timestamps. Every timestamp field in the dataset schema enforces format: date-time plus an explicit regex pattern, so downstream consumers get consistent, parseable UTC timestamps on every record.
• Verified-live sources. ClinicalTrials.gov API v2 (apiVersion: 2.0.5) and the openFDA Orange Book endpoint were both confirmed live via direct API calls during this actor's development, not assumed from documentation alone.

Pricing

Pay-per-event: $0.002 per new or changed record (result), plus $0.00005 per run start (apify-actor-start). An unchanged record in delta mode is never delivered and never billed - not a discounted tier, simply never an event. Check the Apify Store page for the current live pricing before running at volume.

Support & Enterprise SLA

This is an independently developed and maintained actor, not a vendor product backed by a contractual SLA. Bug reports and feature requests go through the Apify Store's built-in issue tracker for this actor and are typically triaged within about 48 hours.

What this actor does not do: it does not track FDA Complete Response Letters. That data exists only as a static, infrequently-updated table/PDF archive with no queryable API, and the underlying disclosure policy has itself been paused and resumed at least once. Scraping a fragile, policy-unstable source for a low volume of records (hundreds of letters) isn't a good fit for this actor's delta-engine model - a genuine limitation, stated here rather than glossed over.