Evidence map›Paper›PMID 34007464›Full record

ArticleJournal of clinical and translational science2021

Advancing medical technology innovation and clinical translation via a model of industry-enabled technical and educational support: Indiana Clinical and Translational Sciences Institute's Medical Technology Advance Program.

Andrew O Brightman, R Lane Coffee, Kara Garcia, Aaron E Lottes, Thomas G Sors, Sharon M Moe, George R Wodicka

Erratum issuedOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 44% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Andrew O BrightmanWeldon School of Biomedical Engineering and Indiana CTSI Medical Technology Advance Program, Purdue University, West Lafayette, IN, USA.
R Lane CoffeeDepartment of Emergency and Indiana CTSI Translational Research Development Program, Indiana University School of Medicine, Indianapolis, IN, USA.
Kara GarciaDepartment of Radiology & Imaging Sciences and Indiana CTSI, Indiana University School of Medicine, Evansville, IN, USA.
Aaron E LottesWeldon School of Biomedical Engineering and Indiana CTSI Medical Technology Advance Program, Purdue University, West Lafayette, IN, USA.
Thomas G SorsInstitute of Inflammation, Immunology and Infectious Disease and Indiana CTSI, Purdue University, West Lafayette, IN, USA.
Sharon M MoeDepartment of Medicine and Indiana CTSI, Indiana University School of Medicine, Indianapolis, IN, USA.
George R WodickaWeldon School of Biomedical Engineering and Indiana CTSI Medical Technology Advance Program, Purdue University, West Lafayette, IN, USA.
Indiana Clinical and Translational Sciences Institute · USPurdue University West Lafayette · USIndiana University School of Medicine

Funding

Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval ProcessUL1TR002529 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI MOE, SHARON M, WIEHE, SARAH ELIZABETH · 2018 to 2022
$27.2M
NCATS NIH HHS UL1 TR002529
6 · The paper itself

Abstract

The success rate for translation of newly engineered medical technologies into clinical practice is low. Traversing the "translational valleys of death" requires a high level of knowledge of the complex landscape of technical, ethical, regulatory, and commercialization challenges along a multi-agency path of approvals. The Indiana Clinical and Translational Sciences Institute developed a program targeted at increasing that success rate through comprehensive training, education, and resourcing. The Medical Technology Advance Program (MTAP) provides technical, educational, and consultative assistance to investigators that leverages partnerships with experts in the health products industry to speed progress toward clinical implementation. The training, resourcing, and guidance are integrated through the entire journey of medical technology translation. Investigators are supported through a set of courses that cover bioethics, ethical engineering, preclinical and clinical study design, regulatory submissions, entrepreneurship, and commercialization. In addition to the integrated technical and educational resources, program experts provide direct consultation for planning each phase along the life cycle of translation. Since 2008, nearly 200 investigators have gained assistance from MTAP resulting in over 100 publications and patents. This support via medicine-engineering-industry partnership provides a unique and novel opportunity to expedite new medical technologies into clinical and product implementation.

Indexed as

academic–industry collaborationengineeringmedical technologyregulatory affairsTranslational research

Identifiers

PMID34007464
PMCPMC8111604
OpenAlexW3123008578

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.