Evidence map›Paper›PMID 35344202›Full record

ReviewTherapeutic innovation & regulatory science2022

Digital Health Technologies in Pediatric Trials.

Leonard Sacks, Elizabeth Kunkoski, Marianne Noone

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Therapeutic innovation & regulatory science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

3 authors.

Leonard SacksOffice of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Leonard.Sacks@fda.hhs.gov.
Elizabeth KunkoskiOffice of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.ORCID http://orcid.org/0000-0002-4272-829X
Marianne NooneOffice of Pediatric Therapeutics, Office of Clinical Policy and Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, MD, USA.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

backgroundAdvances in the miniaturization of sensors and other technologies provide opportunities to collect physiological and/or functional data directly from patients participating in clinical trials. The use of such technologies in children is particularly promising. Objective, quantifiable measurements made by these technologies, often on a continuous or frequent basis, may provide more robust data than the episodic reports from caregivers that are used in traditional pediatric trials.

methodsWe reviewed the pros and cons of these technologies for use in a variety of pediatric diseases, including seizure and neuromuscular disorders, cardiorespiratory diseases, and metabolic disorders.

resultsCorrelation between sensor measurements and patient observations or traditional clinical measurements varied depending on the disease being evaluated. There was a notable dearth of reports on the use of digital health technology in pediatric patients. Given the range of sensors and measurements that can be made by DHTs, selection of the design, metrics and types of sensors best suited to disease evaluation presents challenges for adoption of these technologies in clinical trials.

conclusionTraditional measurements of drug effects are often deficient, particularly in the evaluation of infants and young children. The opportunity to make objective, frequent measurements may increase our power to detect and quantify responses to therapy in these populations. Further research and evaluation are needed to realize the full scientific potential of remote monitoring in pediatric clinical trials.

Indexed as

TelemedicineBiomedical TechnologyChildChild, PreschoolHumansTechnologyDigital health technologyDrug developmentFDAMobile technologyPediatricRegulatoryWearable

Identifiers

PMID35344202
PMCPMC9622205

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.