Evidence map›Paper›PMID 34510619›Full record

Trial reportThe oncologist2021

Physician Interpretation of Data of Uncertain Clinical Utility in Oncology Prescription Drug Promotion.

Vanessa Boudewyns, Amie C O'Donoghue, Ryan S Paquin, Kathryn J Aikin, Kate Ferriola-Bruckenstein, Victoria M Scott

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 29% 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

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Perceptions and Preferences for Defining Biosimilar Products in Prescription Drug Promotion.Journal of the American Board of Family Medicine : JABFM · 2025
    Trial
  3. Trial
  4. Review
  5. Article
  6. Review
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

6 authors at 2 institutions in 1 country.

Vanessa BoudewynsRTI International, Durham, North Carolina, USA.ORCID 0000-0002-1777-290X
Amie C O'DonoghueCenter for Drug Evaluation and Research, Office of Prescription Drug Promotion, US Food and Drug Administration, Silver Spring, Maryland, USA.
Ryan S PaquinRTI International, Durham, North Carolina, USA.
Kathryn J AikinCenter for Drug Evaluation and Research, Office of Prescription Drug Promotion, US Food and Drug Administration, Silver Spring, Maryland, USA.
Kate Ferriola-BruckensteinRTI International, Durham, North Carolina, USA.
Victoria M ScottRTI International, Durham, North Carolina, USA.
RTI International · USUnited States Food and Drug Administration · US

Funding

FDA HHS HHSF223201510002B
6 · The paper itself

Abstract

backgroundLittle is known about how physicians interpret data displays that depict preliminary or exploratory clinical data in physician-targeted sales aids for oncology drugs. Using three factorial experiments, we examined whether disclosures of data limitations and clinical uncertainty adequately communicate the limitations and practical utility of this type of data. SUBJECTS, MATERIALS, AND

methodsThe studies used a 2 (disclosure of data limitations: technical, nontechnical) × 2 (disclosure of clinical uncertainty: present, absent) + 1 (control: no disclosure) between-subjects experimental design to examine the impact of disclosures as they relate to presentations of preliminary or exploratory data in promotional communications for oncology products. In each experiment, we randomized oncologists and primary care physicians with oncology experience to view one version of a two-page sales aid. Following this exposure, physicians completed a web-based survey. The design was replicated in three concurrently conducted experiments using sales aids for different fictitious oncology drugs, each featuring one of three common data displays: a forest plot (n = 495), a Kaplan-Meier curve (n = 504), or a bar chart (n = 532).

resultsResults provide initial evidence that in some contexts disclosures can improve understanding of the clinical utility of certain information about a drug and the limitations of results presented in a data display. Disclosures can also temper perceptions of how much evidence is presented that supports a conclusion that the drug is an appropriate treatment. In terms of the language used in the disclosure of data limitations, physicians in all three experiments strongly preferred the nontechnical disclosures.

conclusionThe findings from the three experiments in this study suggest that disclosures have the potential to increase relevant knowledge, but more research is needed to establish best practice recommendations for using disclosures to convey contextual information relevant for interpreting data displays in promotional communications. IMPLICATIONS FOR PRACTICE: This article reports the results from three large, online experimental studies that address a growing concern that drug companies often share favorable clinical trial results with physicians in promotional materials that lack important context for physicians to interpret the data. This series of studies investigates whether strategic use of two types of disclosures (disclosure of data limitations and a disclosure of clinical uncertainty) improves understanding and reduces misinterpretations among physicians. The results from these studies help identify communication factors that impact how physicians critically appraise preliminary or exploratory clinical trial data to inform policy and regulatory efforts.

Indexed as

Physicians, Primary CarePrescription DrugsClinical Decision-MakingDisclosureHumansUncertaintyPrescription DrugsClinical trial dataData displayDisclosuresPharmaceutical promotionRegulatory science

Identifiers

PMID34510619
PMCPMC8649057
OpenAlexW3200922886

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.