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Research in Progress

Research-in-Progress (RIP) is a place for graduate students and postdocs to present their ongoing research results and to receive feedback from other researchers (i.e.

‘Good progress’ on research excellence framework panel diversity

UK research funders have reported significant progress on improving diversity on the panels that will assess submissions to the 2021 research excellence framework.

Analysis published on 12 August finds that representation of ethnic minorities and women on the influential panels has advanced since the 2014 assessment, with further progress on ethnic minority membership being achieved in the three years since the panels considered the criteria for the 2021 assessment.

The funders said that the improvements followed a range of measures designed to improve the representativeness of REF panels, including the introduction of fairness training for panel chairs and a requirement for nominating institutions to describe how they had taken account of equality and diversity when selecting candidates.

Research in Progress | Office of Prescription Drug Promotion (OPDP) Research

In these cases, sponsors typically include disclosures of information somewhere in the promotional piece.  This research is designed to examine how effectively healthcare professionals and consumers are able to use these disclosures to appropriately qualify the claims presented in the display or claim.   During the prescription drug approval process, sponsors propose proprietary names for their products.

The proposed study is designed to provide systematic, empirical evidence to answer two research questions: 1) Primary research question: How, if at all, do names that suggest the drug’s indication affect consumers’ and/or healthcare providers’ perceptions of the prescription drug?, and 2) Secondary research question: How, if at all, do names that overstate the efficacy of the drug affect consumers’ and/or healthcare providers’ perceptions of prescription drugs?

We will examine four levels of secondary claim disclosure to explore the effects of disclosing that the secondary benefit is not one of the indicated uses of the product (e.g., not a treatment for [the secondary benefit claim], quantitative information about claim, not a treatment for [claim] and quantitative information about claim, or no disclosure), and two levels (presence or absence) of a comparative element regarding the secondary claim, for a total of eight experimental conditions.

Pursuant to section 506(c) of the FD&C Act and 21 CFR part 314, subpart H (or 21 CFR part 601, subpart E for biological products), FDA may grant accelerated approval to a drug product under section 505(c) of the FD&C Act or a biological product under section 351(a) of the Public Health Service Act.  This pathway enables faster approval of prescription drugs intended to treat serious or life-threatening illnesses.  Accelerated approval may be based on a determination that a drug product has an effect on a surrogate endpoint (for example, a blood test result) that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit (i.e., an intermediate clinical endpoint).  Under FDA’s regulations governing physician labeling for prescription drugs, the INDICATIONS AND USAGE section of the FDA-approved prescribing information (PI) for a drug approved under accelerated approval must include “a succinct description of the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits, with reference to the ‘Clinical Studies’ section for a discussion of the available evidence.” 21 CFR 201.57(c)(2)(i)(B).

 For example, products designed to treat high blood sugar associated with type 2 diabetes are known to have similar risk profiles, and thus HCPs may rely on previous knowledge about risks for similar products rather than read through specific risk information for a newly promoted product.

We propose to test three different contextual presentations of drug information (medical journal abstract, sales aid without graphic design elements, sales aid with graphic design elements), and two types of study methodological rigor used by Kesselheim et al., 2012 (classified as high or low).  We have chosen to test a mock sales aid presentation and a medical journal abstract in order to examine the potential differences in perception that may arise by presenting the same information in different vehicles.

Mirroring the time constraints of practicing physicians, we will examine the role of time pressure by randomly assigning half of the study participants to a limited amount of available time to read the materials.  Pharmaceutical firms sometimes choose to disseminate publications to health care providers (HCPs) that include data that appear to support an unapproved use of an approved product.

This study will provide preliminary information on whether consumers face challenges when multiple indications are promoted in a single television ad.  The study also will explore whether similarity of the indications affects participants’ likelihood to recall and understand the indications, and whether its effect would be positive or negative.  We plan to test three types of fictional DTC television ads – one that promotes a single indication, one that promotes an indication plus a similar indication, and one that promotes an indication plus a dissimilar indication – in two different medical conditions (diabetic peripheral neuropathy and rheumatoid arthritis).

We will ask attendees who are prescribers within different disciplines (primary care physicians, specialists, nurse practitioners, and physician assistants) general questions about their attendance at medical conferences, including questions about their motivations for attending, activities they participate in (e.g., symposia, poster sessions, social events, exhibit halls), and their opinions about the prescription drug treatments promoted at medical conferences.