Drybench Pipeline.

What the app shows, how it works and how it was built, in the words of its own write-up, followed by the parameter defaults and the data sources with their licences.

What it shows

Pick a disease and the explorer shows the registered clinical-development landscape: how many trials sit at each phase and whether they are recruiting, finished or stopped; which modalities (small molecules, antibodies, cell and gene therapies and so on) have been tested over time; who sponsors the work; how long completed trials took; and why stopped trials stopped.

Beside the live trials it lists the US-approved products whose labels mention the condition and, for those FDA lists as new molecular entities or new biologics, the FDA precedent: pathway, designations, review time and any published complete response letter, each cited to the FDA record.

How it works

Trials come live from the ClinicalTrials.gov API (version 2). The search sends your condition as query.cond and limits results to interventional studies with a drug, biologic or genetic intervention; phase, status, sponsor class and start-year filters are added to the same request. Only 15 fields are requested, 1,000 trials per page, newest start date first, and at most 10 pages are loaded, so the tool always says how many of the matching trials it analysed. Everything else, from the charts to the medians, is computed in your browser.

Each intervention is given a modality from its name. The tool reads keywords such as vaccine and CAR-T, spots antibody-drug conjugates from their two-part names, and otherwise uses International Nonproprietary Name stems: -mab for monoclonal antibodies, -tinib for kinase inhibitors, -siran for siRNA, -rsen for antisense drugs, -cel for cell therapies and 146 more. Names that match nothing, such as company codes, are shown as unclassified rather than guessed. Radiolabelled tracers and contrast agents are marked as diagnostic, and trials that test only those are set apart from the charts.

Approvals come from openFDA: a label search on the Indications and Usage section, counted by application number (brand-name, biologic and generic applications separately, because each count returns at most 1,000), then Drugs@FDA for the sponsor, the original approval date and the marketing status, and the NDC directory for products Drugs@FDA does not cover. Where a label's indications contain a negative phrase, the tool reads them sentence by sentence and flags labels that mention the condition only to rule it out, or only as the group of patients in which another benefit was shown. openFDA cannot search Greek letters, so for a condition such as β-thalassaemia (β-thalassemia on US labels) the tool also searches the other words and keeps the labels whose indications name the condition with the letter. The FDA precedent joins those applications by application number to FDA's compilation of new drug and biologic approvals and its breakthrough therapy lists, and to the complete response letters FDA has published.

How it was built

Every API parameter, field name and enum value was checked against the live services before use. FDA's files behind the precedent are saved as dated snapshots with their licence and checksum, by scripts that read the spreadsheets and PDFs rather than retyping them and stop when a header or value changes. A second script checks all 151 naming stems against the WHO stem book.

A Node script saves dated snapshots of the seven example searches, using the same code as the page, so the tool can fall back to them if ClinicalTrials.gov is down or slow. It also does two jobs too heavy for a browser: it reads the wording of every matching label, and it traces labels that openFDA links to no application through the NDC codes printed on them; the page reuses both results for the examples. The classifier, the stop-reason grouping, the label checks, the query builders and the aggregations have unit tests, and the charts are hand-written SVG with keyboard-readable values and a data table behind each one.

Parameter defaults

Trials per search

1,000 trials per page, newest start date first, at most 10 pages; the page always says how many of the matching trials it analysed.

Study scope

Interventional studies with a drug, biologic or genetic intervention.

Modality naming stems

151 International Nonproprietary Name stems, checked against the WHO stem book; names that match nothing are shown as unclassified.

FDA precedent

FDA's Compilation of CDER NME and New Biologic Approvals (1985 to 2025 edition) and its CDER breakthrough therapy lists, joined to openFDA by application number; review time runs from receipt of the first complete application to approval.

Saved snapshots

Dated snapshots of the seven example searches, shown only while they are 60 days old or less.

FDA precedent

For the condition's US products, the view shows how FDA approved each one's original application. Every value carries a mark that names its source: the sheet and row of FDA's compilation, the breakthrough list and its date, Drugs@FDA, or the published letter. A product that Drugs@FDA does not record shows its NDC marketing start instead, labelled as such and cited to the NDC Directory; it is not an approval date.

Join

By application number only (method appno-exact 1.0.0): a product joins FDA's Compilation of CDER NME and New Biologic Approvals when one of its applications equals one of a row's, or one the row's own note names (products moved from NDA to BLA on 23 March 2020 keep their digits; some older biologics were given a new licence number). Nothing is joined by name. FDA's breakthrough therapy lists carry application and submission numbers, so they join exactly too.

Review time

Method review-time-receipt-approval 1.0.0: FDA Approval Date minus FDA Receipt Date, in days, both from the compilation, whose data dictionary defines receipt as the date the first and complete marketing application was received. It includes any complete-response cycle and the sponsor's time between cycles. Months are days divided by 30.4375. Where the compilation holds no receipt date the view says “Receipt date not in a structured public source” and why; no review time is ever estimated, from a PDUFA goal or otherwise.

Designations

As the compilation records them at the original approval, qualifiers kept (“Yes (indication [A] only)”). “N/A” reads “Programme did not exist” only for approvals before the programme began: accelerated approval 15 April 1992, fast track 21 November 1997, breakthrough therapy 9 July 2012, priority review vouchers 27 September 2007 (the data dictionary). For products the compilation does not cover, breakthrough therapy comes from FDA's lists and priority review from Drugs@FDA; a product absent from the lists is “not on CDER's list as of” the lists' date, never “No”. Where the compilation and the lists disagree the cell says so.

Figures

Over the products in the compilation only, each compilation row once, as recorded at original approval: the median review time with how many products it covers (the values themselves when fewer than five), priority and standard medians apart and priority reviews bought with a voucher left out of both; accelerated approval as a share of products where the programme existed; an expedited designation (fast track, breakthrough therapy, priority review not bought with a voucher, accelerated approval) as a share of products approved from 9 July 2012; orphan designation apart.

Complete response letters

From openFDA's published letters, reduced at build time to application, company, date, letter type, FDA's centre and the file name. A letter is shown only beside the later approval it preceded: a COMPLETE RESPONSE on the original application dated before that application's original approval; the interval is in days. Letters on supplements are not shown in this release. Once per visit the view asks openFDA how many letters each application has, with no search sent, and links any letter published after the snapshot.

Trials in a label

When a product is opened, the NCT numbers in its current label's Clinical Studies section (openFDA's clinical_studies and clinical_studies_table), in the label's order, each checked on ClinicalTrials.gov. They are the trials the label names; the label does not say which supported approval.

Snapshots

FDA's files are saved with their checksums and licences (pipeline/drug-pipeline-explorer/precedent/README.md). The view marks them stale after 90 days and keeps showing them, because they are public domain with no currency term.

Data sources, licences and versions

Times on screen are local time with the UTC offset; times in exports are UTC. Dates with no time are shown at the precision the source gave them.

The Export menu offers seven CSV tables: the full loaded trial result, the current trial list, US products (with source_date, date_kind and details_not_loaded, so an original approval, an NDC marketing start, an unknown date and a failed load stay distinct), the filtered FDA precedent result, trials by phase and status, top sponsors, and modality by period. The full trial export and aggregate tables use the loaded search result, without chart or list filters; the current-list export includes all matching rows across every page, in list order. FDA precedent applies its pathway, designation, review-time and letter filters before table text search, sorting, paging and selection; its CSV comes in a ZIP with a README, provenance and row citations, including when the settled filtered result has no rows. Trial-table ZIPs also carry scope and source information, including download limits, interrupted downloads and snapshot qualifications. Saved snapshots retain recent trial records separately from their stored aggregate counts. Two figure actions export the timeline by phase and lead sponsors as SVG or PNG. Saved research views retain the applied search, display settings and research note; reopening runs the search again and may reuse recently loaded data, so results are not frozen. Copy link shares public search and view state, without the private saved-work identifier, research note or list-only display settings.

Release gate: before the app leaves the preview, its exports and printed reports will carry the data versions, parameters, limits and a timestamp needed to reproduce a result, as the regulatory position says. This section will describe each format as it ships.

Each module below is a set of automated tests in the app's source code, with the expected results written into the tests. They check the app's logic against recorded inputs and stored reference records; none of them calls a live service.

FDA precedent: draft fixture sets

Unit tests

src/components/tools/drug-pipeline-explorer/modality.test.ts

The modality classifier: antibodies under old and new naming schemes, antibody-drug conjugates, small molecules by stem, peptides, nucleic-acid drugs, cell and gene therapies, vaccines, placebos and diagnostic agents, names that stems misread, and a well-formed rule table.

src/components/tools/drug-pipeline-explorer/ctgov.test.ts

The ClinicalTrials.gov query: filters combined into one request, paging tokens, cleaned condition text, partial dates, phase buckets and the parsing of a page of studies.

src/components/tools/drug-pipeline-explorer/openfda.test.ts

openFDA label searches (phrases, possessives, accents and Greek letters), application counts, Drugs@FDA and NDC fallbacks, label wording that rules a condition out, and parent names without salt words.

src/components/tools/drug-pipeline-explorer/aggregate.test.ts

Quantiles, status groups, durations from completed trials with actual dates only, the breakdowns by phase, period, sponsor and modality, and tracer-only trials set apart.

src/components/tools/drug-pipeline-explorer/why-stopped.test.ts

Stop reasons grouped by the first matching rule, with mentions that are not the reason and denials left out.

src/components/tools/drug-pipeline-explorer/filters.test.ts

Filter checks with the failing input named, and filters that round-trip through the address with bad values dropped.

src/components/tools/drug-pipeline-explorer/snapshot.test.ts

Snapshots older than the limit are not shown, and shipped snapshots carry their terms.

src/components/tools/drug-pipeline-explorer/precedent/snapshot-age.test.ts

Every FDA precedent snapshot carries its source, licence id, read date, retrieval date and each file's SHA-256, and none is within 14 days of turning stale; the example snapshots are checked the same way.

scripts/removed-sources.mjs

Fails on any mention of the removed industry success-rate tables outside docs/.

pipeline/drug-pipeline-explorer/precedent/verify.ts

Weekly once its workflow is merged: the openFDA fields FDA precedent reads, the fda.gov table headers and the request count of the seven examples' US approvals.

pipeline/drug-pipeline-explorer/verify_stems.py

Build-time check: all 151 stems checked against the WHO stem book.

Release gate: before the app leaves the preview, each release will publish a verification dataset with expected outputs on this page, so you can run your own checks.

No verification set has been published for this app yet.

Scientific computation runs in your browser, and individual apps need no account. Optional Bench accounts and backups use the site server and configured providers. The privacy statement, the hosts it contacts and the headers its workspace is served with are generated from its registry entry, the same record that sets the browser's policy.

What leaves your browser

Hosts the app contacts

• clinicaltrials.gov

  Operator

  U.S. National Library of Medicine

  What for

  Trial records for the condition and filters you search, and the registry's processing date; for a product opened in FDA precedent, a check that the NCT numbers its label names are registered; on a trial's object page, that trial's record.

  What it receives

  the condition and filters you search, NCT numbers taken from a label, and the NCT number of a trial whose page you open

  When

  on lookup

  • FDA precedent: at most 1 request for each product you open, to check the NCT numbers its label names.

• api.fda.gov

  Operator

  U.S. Food and Drug Administration

  What for

  US drug labels that name the condition, with the Drugs@FDA and NDC records of their applications; for FDA precedent, how many complete response letters each application has (no search is sent), the file names of any published after the snapshot, and the label of a product you open, for the trials its Clinical Studies section names; on a US product's object page, the Drugs@FDA and NDC records of its applications.

  What it receives

  the condition you search, application and product codes taken from openFDA's own answers, and the application numbers of a US product whose page you open; the complete response letter count is requested with no search

  When

  on lookup

  • Per condition: at most 12 requests for the US approvals (measured weekly on the seven examples).
  • FDA precedent: 1 request per visit to count complete response letters, with no search sent, plus 1 for each application with a letter published after the snapshot; 1 label request for each product you open.

Headers the workspace is served with