Evidence map›Paper›PMID 27643536›Full record

ArticleClinical pharmacology and therapeutics2016

PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms.

M R Trusheim, A A Shrier, Z Antonijevic, R A Beckman, R K Campbell, C Chen, K T Flaherty, J Loewy, D Lacombe, S Madhavan and 2 more

Open access · bronzeAbstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.6field-weighted citation impact, top 10% of its field
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

13 citing papers in PubMed, 45 citations in OpenAlex.

  1. Article
  2. Aiding the Adoption of Master Protocols by Optimizing Patient Engagement.Therapeutic innovation & regulatory science · 2023
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  3. Review
  4. Article
  5. Review
  6. Review
  7. Issues, challenges, and the way forward in conducting clinical trials among neonates: investigators' perspective.Journal of perinatology : official journal of the California Perinatal Association · 2019
    Article
  8. Article
  9. Recognizing that Evidence is Made, not Born.Clinical pharmacology and therapeutics · 2019
    Article
  10. Article
  11. Review
  12. Article
  13. Review
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

12 authors at 10 institutions in 3 countries.

M R TrusheimMIT, Center for Biomedical Innovation, Cambridge, Massachusetts, USA.
A A ShrierMIT, Center for Biomedical Innovation, Cambridge, Massachusetts, USA.
Z AntonijevicAmgen, Thousand Oaks, California, USA.
R A BeckmanGeorgetown University Medical Center, Lombardi Comprehensive Cancer Center and Innovation Center for Biomedical Informatics, Washington, DC, USA.
R K CampbellBrown University, Providence, Rhode Island, USA.
C ChenMerck & Co., Philadelphia, Pennsylvania, USA.
K T FlahertyMassachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
J LoewyDataForeThought, Winchester, Massachusetts, USA.
D LacombeEuropean Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
S MadhavanGeorgetown University Medical Center, Innovation Center for Biomedical Informatics, Washington, DC, USA.
H P SelkerTufts Medical Center and Tufts University, Institute for Clinical Research and Health Policy Studies and Tufts Clinical and Translational Science Institute, Boston, Massachusetts, USA.
L J EssermanUniversity of California San Francisco Medical Center, Carol Franc Buck Breast Care Center, San Francisco, California, USA.
Georgetown University · USAmgen (United States) · USBrown University · USEuropean Organisation for Research and Treatment of Cancer · BEMassachusetts General Hospital · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USRiptide Autonomous Solutions (United States) · USTufts University · USUniversity of California San Francisco Medical Center · USUniversity of Winchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale platforms, could create superior evidence more efficiently than single-sponsor, single-drug trials. These trial PIPELINEs also could diminish barriers to trial participation, increase the representation of real-world populations, and create systematic evidence development for learning throughout a therapeutic life cycle, to continually refine its use. Comparable evidence could arise from multiarm design, shared comparator arms, and standardized endpoints-aiding sponsors in demonstrating the distinct value of their innovative medicines; facilitating providers and patients in selecting the most appropriate treatments; assisting regulators in efficacy and safety determinations; helping payers make coverage and reimbursement decisions; and spurring scientists with translational insights. Reduced trial times and costs could enable more indications, reduced development cycle times, and improved system financial sustainability. Challenges to overcome range from statistical to operational to collaborative governance and data exchange.

Indexed as

Patient SelectionReimbursement MechanismsResearch DesignClinical Trials as TopicCooperative BehaviorEndpoint DeterminationHumansTime FactorsTranslational Research, Biomedical

Identifiers

PMID27643536
PMCPMC5142736
OpenAlexW2522443079

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.