Evidence map›Paper›PMID 37325959›Full record

ArticleThe journals of gerontology. Series A, Biological sciences and medical sciences2023

Optimizing the Design of Clinical Trials to Evaluate the Efficacy of Function-Promoting Therapies.

Shalender Bhasin, Peggy M Cawthon, Rosaly Correa-de-Araujo, Thomas W Storer, Elena Volpi, Anne B Newman, Waly Dioh, Cendrine Tourette, William J Evans, Roger A Fielding

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The journals of gerontology. Series A, Biological sciences and medical sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.3field-weighted citation impact, top 8% 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, 4 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
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 at 7 institutions in 2 countries.

Shalender BhasinResearch Program in Men's Health, Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-3982-6200
Peggy M CawthonCalifornia Pacific Medical Center Research Institute, San Francisco, California, USA.
Rosaly Correa-de-AraujoDivision of Geriatrics and Clinical Gerontology, National Institute on Aging, National Institutes of Health, U.S. Department of Health and Human Services, Bethesda, Maryland, USA.
Thomas W StorerResearch Program in Men's Health, Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Elena VolpiSealy Center on Aging; UTMB Claude D. Pepper Older Americans Independence Center, University of Texas Medical Branch, Galveston, Texas, USA.ORCID 0000-0001-8776-0384
Anne B NewmanDepartment of Epidemiology, University of Pittsburgh School of Public Health, Pittsburgh, Pennsylvania, USA.ORCID 0000-0002-0106-1150
Waly DiohBiophytis SA, Paris, France.
Cendrine TouretteBiophytis SA, Paris, France.
William J EvansDepartment of Nutritional Science and Toxicology, University of California at Berkely, Berkely, California, USA.
Roger A FieldingNutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center in Aging, Tufts University, Boston, Massachusetts, USA.
Biophytis (France) · FRBrigham and Women's Hospital · USCalifornia Pacific Medical Center · USJohn Sealy Hospital · USNational Institutes of Health · USTufts University · USUniversity of Pittsburgh · US

Funding

UTMB OAIC Research Education Component (REC)P30AG024832 · NIA · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI JAMES S. GOODWIN, MD, MELISSA M. MORROW · 2005 to 2026
$26.7M
TUFTS--FIELDINGP30AG031679 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI LEWIS LIPSITZ · 2008 to 2026
$23.9M
Core B - Pilot StudiesP30AG048785 · NIA · BRANDEIS UNIVERSITY · PI LACHMAN, MARGIE E · 2014 to 2023
$4.5M
NIA NIH HHS P30 AG024832NIA NIH HHS P30 AG031679NIA NIH HHS P30 AG048785NIH HHS
6 · The paper itself

Abstract

backgroundSeveral candidate molecules that may have application in treating physical limitations associated with aging and chronic diseases are in development. Challenges in the framing of indications, eligibility criteria, and endpoints and the lack of regulatory guidance have hindered the development of function-promoting therapies.

methodsExperts from academia, pharmaceutical industry, National Institutes of Health (NIH), and Food and Drug Administration (FDA) discussed optimization of trial design including the framing of indications, eligibility criteria, and endpoints.

resultsMobility disability associated with aging and chronic diseases is an attractive indication because it is recognized by geriatricians as a common condition associated with adverse outcomes, and it can be ascertained reliably. Other conditions associated with functional limitation in older adults include hospitalization for acute illnesses, cancer cachexia, and fall injuries. Efforts are underway to harmonize definitions of sarcopenia and frailty. Eligibility criteria should reconcile the goals of selecting participants with the condition and ensuring generalizability and ease of recruitment. An accurate measure of muscle mass (eg, D3 creatine dilution) could be a good biomarker in early-phase trials. Performance-based and patient-reported measures of physical function are needed to demonstrate whether treatment improves how a person lives, functions, or feels. Multicomponent functional training that integrates training in balance, stability, strength, and functional tasks with cognitive and behavioral strategies may be needed to translate drug-induced muscle mass gains into functional improvements.

conclusionsCollaborations among academic investigators, NIH, FDA, pharmaceutical industry, patients, and professional societies are needed to conduct well-designed trials of function-promoting pharmacological agents with and without multicomponent functional training.

Indexed as

FrailtyNeoplasmsSarcopeniaAgedAgingClinical Trials as TopicHumansClinical trial designFunctional decline with agingFunction-promoting drugsSarcopeniaSkeletal muscle dysfunction

Identifiers

PMID37325959
PMCPMC10272979
OpenAlexW4380869415

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.