Evidence map›Paper›PMID 42761731›Full record

ReviewInnovations in clinical neuroscience

Lessons Learned from Drug Development Programs in Autism: Implications for Future Programs.

Gahan Pandina, William J Martin, Christopher Chatham, Declan Murphy, Jane Myles, Robert H Ring, Amir Kalali

Abstract readReview
In one paragraph

Review in Innovations in clinical neuroscience. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Gahan PandinaDr. Pandina is with Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey.
William J MartinDr. Martin was SVP/Global Therapeutic Head of Neuroscience R…D, Johnson and Johnson, San Francisco, California, at the time of writing.
Christopher ChathamDr. Chatham is with Medical Biomarker Research, Shionogi, Inc., Florham Park, New Jersey.
Declan MurphyDr. Murphy is with Institute of Psychiatry Psychology and Neuroscience, King's College, London, United Kingdom.
Jane MylesMs. Myles is VP, Programs and Initiatives, Decentralized Trials and Research Alliance, Pacifica, California.
Robert H RingDr. Ring is with Kaerus Bioscience Ltd., London, United Kingdom.
Amir KalaliDr. Kalali is with the International Society for CNS Drug Development (ISCDD), San Diego, California.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There are no approved drugs for autism core features; the heterogeneous biology, symptom presentation, and clinical outcomes complicate drug trials design, and have hampered therapeutic drug development. We synthesized expert viewpoints from industry and academia on recent diagnostics and biomarker advances as well as pharmacotherapy evidence, aligned to patient-focused drug development outcomes and key concepts. Key learnings include: (i) measure what matters to patients and caregivers; (ii) enrich populations where they can be rationally matched to mechanism; (iii) do not use diagnostic tools as efficacy endpoints; (iv) align biomarker science with a potential qualification pathway associated with relevant behavior and biology; (v) design trials that reduce placebo response, burden, and attrition; (vi) assess co-occurring conditions and treatments explicitly. Observations and recommendations serve as a practical roadmap for sponsors and clinicians to increase trial informativeness and chance of success.

Indexed as

Autism spectrum disorderbiomarkerscaregiver burdenclinical trial methodologyenrichmentpharmacotherapyregulatory sciencetreatment outcomes

Identifiers

PMID42761731
PMCPMC13588654

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.