Evidence map›Paper›PMID 19959672›Full record

ReviewCancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology2009

Clinical trials methods for evaluation of potential reduced exposure products.

Dorothy K Hatsukami, Karen Hanson, Anna Briggs, Mark Parascandola, Jeanine M Genkinger, Richard O'Connor, Peter G Shields

Abstract readReview
In one paragraph

Review in Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
–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

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Measures for assessing subjective effects of potential reduced-exposure products.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2009
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Biomarkers of Exposure to Nicotine and Selected Toxicants in Individuals Who Use Alternative Tobacco Products Sold in Japan and Canada from 2018 to 2019.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2025
    Article
  6. Article
  7. Consortium on Methods Evaluating Tobacco: Research Tools to Inform US Food and Drug Administration Regulation of Snus.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2018
    Review
  8. Review
  9. Biomarkers of Tobacco Exposure: Summary of an FDA-Sponsored Public Workshop.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2017
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Research opportunities related to establishing standards for tobacco products under the Family Smoking Prevention and Tobacco Control Act.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2012
    Article
  18. Tobacco and nicotine product testing.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2012
    Review
  19. Postmarketing surveillance for "modified-risk" tobacco products.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2012
    Review
  20. 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

7 authors.

Dorothy K HatsukamiUniversity of Minnesota Tobacco Use Research Center, Minneapolis, 55414, USA. hatsu001@umn.edu
Karen Hanson
Anna Briggs
Mark Parascandola
Jeanine M Genkinger
Richard O'Connor
Peter G Shields

Funding

MUTAGENESIS OF THE PRB POCKET DOMAINR01CA064402 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI DYSON, NICHOLAS J · 1994 to 2015
$4.1M
NCI NIH HHS N01 PC064402NCI NIH HHS N01-PC-64402
6 · The paper itself

Abstract

Potential reduced exposure products (PREPs) to tobacco toxicants may have promise in reducing tobacco-related morbidity or mortality or may promote greater harm to individuals or the population. Critical to determining the risks or benefits from these products are valid human clinical trial PREP assessment methods. Such an assessment involves determining the effects of these products on biomarkers of exposure and effect, which serve as proxies for harm, and assessing the potential for consumer uptake and abuse of the product. This article identifies critical methodologic issues associated with PREP assessments, reviews the methods that have been used to assess PREPs, and describes the strengths and limitations of these methods. Additionally, recommendations are provided for clinical trial PREP assessment methods and future research directions in this area based on this review and on the deliberations from a National Cancer Institute sponsored Clinical Trials PREP Methods Workshop.

Indexed as

Clinical Trials as TopicConsumer Product SafetyEnvironmental ExposureHumansSmoking CessationTobacco Smoke PollutionTobacco Smoke Pollution

Identifiers

PMID19959672
PMCPMC2799338

What OpenQuestion 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 OpenQuestion graph.