Innovation and Inequality: A Randomized Experiment with Patients

Last registered on February 16, 2022

Pre-Trial

Trial Information

General Information

Title
Innovation and Inequality: A Randomized Experiment with Patients
RCT ID
AEARCTR-0008957
Initial registration date
February 14, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
February 16, 2022, 1:51 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
Harvard University

Other Primary Investigator(s)

PI Affiliation
Stanford University
PI Affiliation
Stanford University
PI Affiliation
Stanford University

Additional Trial Information

Status
In development
Start date
2022-02-15
End date
2023-03-01
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Randomized clinical trials play a critical role in generating knowledge about the safety and efficacy of new pharmaceuticals. However, many clinical trials are not representative of the patient population the resulting pharmaceuticals would serve. In a randomized experiment, we aim to measure the extent to which patients have more demand for results from clinical trials that are more representative of their demographic group.
External Link(s)

Registration Citation

Citation
Alsan, Marcella et al. 2022. "Innovation and Inequality: A Randomized Experiment with Patients." AEA RCT Registry. February 16. https://doi.org/10.1257/rct.8957-1.0
Experimental Details

Interventions

Intervention(s)
We will present patients with information on actual clinical trials that differ in demographic diversity. The trials will be for the same drug but vary in demographic composition.
Intervention Start Date
2022-02-15
Intervention End Date
2022-09-01

Primary Outcomes

Primary Outcomes (end points)
Assessment of study relevance for one's own condition
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Belief updating and value of trial results
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
We will survey Black and white patients with chronic health conditions online. Respondents will complete a demographic module and answer basic questions on their condition. They will then be randomized to learn about a recent clinical trial that either had a diverse sample of subjects (such as 15+% Black) or a less diverse sample (such as <1% Black). They will also be given information on the efficacy of the drug, which will be held constant across the arms (reported as the average of the two trials' results). Respondents will answer questions aimed at understanding how much they value the study information and the extent to which they consider the trial results relevant for their condition.
Experimental Design Details
Randomization Method
Randomization will be done in Qualtrics.
Randomization Unit
The unit of randomization will be the individual, stratified by race and sex.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
N/A
Sample size: planned number of observations
1000-1500 Americans with hypertension, with Black Americans oversampled (50-60% of the sample depending on accrual)
Sample size (or number of clusters) by treatment arms
Half in each group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Harvard University
IRB Approval Date
2022-02-14
IRB Approval Number
IRB21-1384

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials