Evidence map›Paper›PMID 32996107›Full record

ArticleTherapeutic innovation & regulatory science2021

Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development.

Brian Perry, Carrie Dombeck, Jaye Bea Smalley, Bennett Levitan, David Leventhal, Bray Patrick-Lake, Linda Brennan, Kevin McKenna, Zachary Hallinan, Amy Corneli

Abstract read
In one paragraph

Article in Therapeutic innovation & regulatory science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Article
  2. Review
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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

10 authors.

Brian PerryClinical Trials Transformation Initiative, Duke University, Durham, NC, USA. brian.perry@duke.edu.ORCID 0000-0002-4648-7673
Carrie DombeckClinical Trials Transformation Initiative, Duke University, Durham, NC, USA.
Jaye Bea SmalleyPatient Advocate, New York, NY, USA.
Bennett LevitanJanssen R&D LLC, Titusville, NJ, USA.
David LeventhalPfizer, Inc, Groton, CT, USA.
Bray Patrick-LakeDuke Clinical Research Institute, Durham, NC, USA.
Linda BrennanCystic Fibrosis Foundation, Washington, DC, USA.
Kevin McKennaClinical Trials Transformation Initiative, Duke University, Durham, NC, USA.
Zachary HallinanClinical Trials Transformation Initiative, Duke University, Durham, NC, USA.
Amy CorneliClinical Trials Transformation Initiative, Duke University, Durham, NC, USA.

Funding

Increasing the Quality and Efficiency of Clinical Trials (R18)R18FD005292 · FDA · DUKE UNIVERSITY · PI LI, JENNIFER S · 2014 to 2019
$26.8M
Increasing the Quality and Efficiency of Clinical Trials (U18)U18FD005292 · FDA · DUKE UNIVERSITY · PI John H Alexander · 2019 to 2026
$26.1M
FDA HHS R18 FD005292FDA HHS U18 FD005292U.S. Food and Drug Administration U18FD005292
6 · The paper itself

Abstract

introductionPatient group engagement is increasingly used to inform the design, conduct, and dissemination of clinical trials and other medical research activities. However, the priorities of industry sponsors and patient groups differ, and there is currently no framework to help these groups identify mutually beneficial engagement activities.

methodsWe conducted 28 qualitative, semi-structured interviews with representatives from research sponsor organizations (n = 14) and patient groups (n = 14) to determine: (1) how representatives define benefits and investments of patient group engagement in medical product development, and (2) to refine a list of 31 predefined patient group engagement activities.

resultsPatient group and sponsor representatives described similar benefits: engagement activities can enhance the quality and efficiency of clinical trials by improving patient recruitment and retention, reduce costs, and help trials meet expectations of regulators and payers. All representatives indicated that investments include both dedicated staff time and expertise, and financial resources. Factors to consider when evaluating benefits and investments were also identified as were suggestions for clarifying the list of engagement activities. DISCUSSION: Using these findings, we refined the 31 engagement activities to 24 unique activities across the medical product development lifecycle. We also developed a web-based prioritization tool ( https://prioritizationtool.ctti-clinicaltrials.org/ ) to help clinical research sponsors and patient groups identify high-priority engagement activities. Use of this tool can help sponsors and patient groups identify the engagement activities that they believe will provide the most benefit for the least investment and may lead to more meaningful and mutually beneficial partnerships in medical product development.

Indexed as

Biomedical ResearchPatient ParticipationHumansPatient SelectionPatient engagementPatient engagement activitiesPatient group engagementPrioritization toolStakeholder engagement

Identifiers

PMID32996107
PMCPMC7864807

What OpenQuestion holds

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Registered trials

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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.