External review launch · framework v0.7

The infrastructure is ready. The protocol has since been hardened in v0.8.

This historical v0.7 release repaired the evidence corpus and launch gates. Continue to the v0.8 hardening page for the corrected two-product protocol and revised outcome hierarchy.

Reconciled13 records

CSV, RIS, detailed corpus, family registry, and version metadata now agree.

Specified10 sources

Database, registry, citation, sponsor, and author-search routes.

Pending0 searches

No independently executed search is being claimed.

Unfilled2 + 1 + 1

Two reviewers, adjudicator, and information specialist are required.

01 · Corpus integrity

A quiet data mismatch was fixed before it could become a scientific one.

v0.6 problem

The public CSV contained four records.

The RIS file and version metadata described 13. A reviewer relying on the CSV would receive an incomplete candidate universe while the site reported a larger one.

v0.7 repair

Five independent representations now agree.

The legacy CSV, RIS, detailed corpus, study-family registry, and machine-readable version metadata each resolve to 13 seed records. `validate_launch.py` enforces the agreement.

Separation

Author hints are explicitly quarantined.

Directness guesses and pilot statuses live only in author-side fields. Every independent-screen status is blank or `not_started`.

Family linkage

Reports can no longer silently inflate denominators.

Each study receives a family ID so protocols, primary reports, secondary analyses, follow-ups, and registry records can be linked without double-counting participants.

02 · Launch sequence

The next steps are operational, ordered, and falsifiable.

Information-specialist review

Peer-review the search syntax and translations before any registered database run.

Recruit and disclose

Assign two reviewers, an adjudicator, and an information specialist; document conflicts and independence.

Prospective registration

Submit the independent phase to PROSPERO if eligible and time-stamp the protocol and forms on OSF.

Execute and archive searches

Export untouched records, exact histories, counts, dates, platforms, and SHA-256 hashes.

Deduplicate and link study families

Preserve source provenance while identifying duplicate citations and companion reports.

Freeze a blinded corpus

Remove author decisions, hash the corpus, then generate concealed Reviewer A and Reviewer B packets.

Independent review and adjudication

Screen, extract, assess result-level RoB 2, and grade certainty without seeing the pilot answer.

The packet builder intentionally refuses to run today.

`build_reviewer_packets.py` checks the launch gates and exits with a blocked status until registration, search execution, corpus freeze, and reviewer assignments are real. That failure is a feature.

03 · Public horizon corpus

Thirteen seed records, now visible without pretending they are systematic results.

The set contains two direct primary candidates, multiple indirect MDD/TRD trials, and ongoing or unreported registry records. It exists to test the workflow and help the independent search verify recall—not to pre-fill eligibility decisions.

IDRecordPopulation/regimen issueIndependent status
PSI-CAND-001Raison CL et al. Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial. JAMA.
NCT03866174
Closely matches diagnosis, dose, monitored setting, and controlled comparison.Not started
PSI-CAND-002Yngwe H et al. Short-Term and Late-Term Effects of Psilocybin on Symptoms in Major Depression: A Randomized Clinical Trial. JAMA Network Open.
NCT04630964
Direct dose and diagnosis match; exact safety windows still require independent extraction.Not started
PSI-CAND-003Goodwin GM et al. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. New England Journal of Medicine.
NCT03775200
Important safety evidence but differs in population and comparator.Not started
PSI-CAND-004Mertens LJ et al. Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression: the EPIsoDE Randomized Clinical Trial. JAMA Psychiatry.
NCT04670081
Recent randomized evidence in a treatment-resistant population; retain as an indirect stratum.Not started
PSI-CAND-005Psilocybin for Major Depressive Disorder (uAspire).
NCT06308653
Potentially direct first administration; optional repeat dosing must remain separable.Not started
PSI-CAND-006von Rotz R et al. Single-dose psilocybin-assisted therapy in major depressive disorder: a placebo-controlled, double-blind, randomised clinical trial.
NCT03715127
Population is relevant, but the dose is not the fixed 25 mg primary estimand.Not started
PSI-CAND-007Davis AK et al. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial.
NCT03181529
MDD evidence, but repeated dosing and comparator structure differ materially.Not started
PSI-CAND-008Sloshower J et al. Psilocybin-assisted therapy for major depressive disorder: an exploratory placebo-controlled, fixed-order trial.
PMID 36938991
Fixed order and dose details prevent direct pooling.Not started
PSI-CAND-009Carhart-Harris R et al. Trial of Psilocybin versus Escitalopram for Depression. New England Journal of Medicine.
NCT03429075
Repeated dosing and an active-treatment comparator differ from the primary estimand.Not started
PSI-CAND-010Phase II multicentre study of single COMP360 administration in recurrent major depressive disorder.
NCT05733546
Potentially relevant, but exact dose, comparator, and report availability require formal registry review.Not started
PSI-CAND-011Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder.
NCT04620759
MDD is present, but co-occurring alcohol use disorder changes the population.Not started
PSI-CAND-012COMP005: single-dose COMP360 25 mg versus placebo in treatment-resistant depression.
NCT05624268
Large and important but treatment-resistant population is indirect to the primary MDD estimand.Not started
PSI-CAND-013COMP006: two administrations of COMP360 in treatment-resistant depression.
NCT05711940
Both population and repeated-dose regimen differ from the primary estimand.Not started
04 · Honest barriers

The project cannot code its way around missing people and database access.

Licensed databases

Embase, PsycINFO, Scopus, and Web of Science require institutional access or collaborators. Their absence must be documented rather than disguised.

Independence

The author cannot be Reviewer A and Reviewer B. An LLM cannot count as an independent human replication team.

Prospective registration

The already completed author pilot remains retrospective. Only the new independent phase can be prospectively registered.

Research governance

A real team must accept responsibility for searches, decisions, conflicts, authorship, and release approval.

05 · Launch files

Everything needed to recruit, review the search, and freeze the next corpus.