Accessibility 101: How to Write Alt-Text and Map Participant Journeys

Webinar

Presented on: July 9, 2024

The MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) presented the first webinar in the Accessibility 101 series on July 9, 2024

People with disabilities are the largest minority population in the United States, yet they are often excluded from clinical trials, both as participants and as researchers. Federal regulations, such as the recently updated Section 504 of the Rehabilitation Act, prohibit discrimination based on disability. Many accommodations are easy and low or no cost. It is incumbent upon all of us to build accessibility into our everyday thinking, meetings, presentations, and planning.

This webinar featured two interactive exercises in which participants learned:

  • Basic information about disability statistics and disability rights, and, as shown through the Accessibility by Design in Clinical Research Toolkit, different types of support that you can readily implement.
  • How to find the Check Accessibility and Alt Text features in PowerPoint and write appropriate Alt Text.
  • How to map out the participant’s (and family caregiver’s or supporter’s) journey from different disability perspectives, from getting to/into the site location, navigating within the site to the different areas they must access, and interacting with different forms of medical equipment and technology.

More about REACH: Research Ethics Action Collaborative for HRPPs (REACH) is an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community. Click here to learn more.

Related Resources

Accessibility Resources by webinar slide
Accessibility by Design (AbD) Toolkit

Comments Submitted: Cancer Clinical Trial Eligibility Criteria: Performance Status

Public Comment

Submitted on: June 25, 2024

Submitted to: U.S. Food and Drug Administration; FDA-2024-D-1377

We responded to a series of three FDA draft guidance documents addressing eligibility criteria for U.S.-based cancer clinical trials. For all three documents, we were supportive of the efforts FDA has taken to make clinical trials more representative of the intended post-approval patient population. We encouraged additional clarity and granularity with regard to operationalizing these draft guidelines, in advance of their final issuance. Further, we agreed that eligibility criteria should be carefully considered, caution against copying and pasting eligibility criteria from the protocol of one study into the draft protocol of a new study and advocate that exclusion criteria should be clearly justified based on safety or ethical reasons.

The main takeaway from the public comments that we submitted on the second guidance in the series (ii) “Cancer Clinical Trial Eligibility Criteria: Performance Status is that we took a strong stance against using Performance Status as an eligibility criterion at all. The measures of performance status commonly used across cancer trial eligibility criteria, the Karnofsky Performance Status Score  (first developed in 1948) and ECOG Performance Status Scale (first developed in 1960), are outdated and highly subjective constructs. Their use as a proxy for disease progression in cancer trial eligibility criteria conflates illness with disability, and results in the discriminatory exclusion of many people with disabilities, which is counter to Section 504 of the Rehabilitation Act, Titles II or III of the Americans with Disabilities Act, and Section 1557 of the Affordable Care Act. We encourage FDA to adopt alternative measures that more appropriately reflect both the clinical risks (assessed by laboratory and diagnostic testing) and the individual participant’s experience and preferences.

Ethics Review of Human Research Involving Artificial Intelligence (AI)

Artificial Intelligence (AI) refers to machine-based systems that learn from data and “learn” to perform tasks such as making predictions. Using algorithms and models, AI systems can process vast amounts of information to make recommendations or decisions that influence real or virtual environments. AI can be narrowly focused on completing a specific task but can also be purposed more generally, aiming to replicate human intelligence across multiple domains.

In 2024, the MRCT Center – in collaboration with WCG Clinical – convened a task force to address ethical and regulatory challenges in the IRB review of clinical research protocols involving AI. The task force includes representatives from academia, industry, AI technologists, and IRB ethicists, members, and chairs.

The task force will evaluate AI’s use in various aspects of clinical trials, including protocol design, consent considerations, patient safety, privacy and confidentiality, and participant recruitment. In addition, it will examine AI when it is being studied as an investigational product for use in medical care. The group’s mandate is to create guidelines and tools to strengthen the capacity of IRBs, ethicists, and investigators to protect participants in research as AI’s role continues to grow.

OBJECTIVES

  • Define and analyze the current critical ethical and regulatory challenges when reviewing clinical research involving AI.
  • Discuss and develop practical and actionable resources to strengthen the capacity of IRBs, ethicists, and investigators to protect participants in research as AI’s role continues to grow.
  • Identify new practical and actionable resources and tools needed by stakeholders.

KeY MILESTONES

  • March 2024: Convened first meeting of subject matter experts, including representation from academic medical centers and universities, industry, AI technologists, and IRB ethicists, members, and chairs.

project Leadership & sTAFF

  • Barbara Bierer, MD., Faculty Director, MRCT Center
  • Donna Snyder, MD, MBE, Executive Physician, WCG Clinical
  • Trevor Baker, MS, Program Manager, MRCT Center

Project Resources

Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Laboratory Values”

Public Comments

Comments provided on: June 24, 2024

Comments provided to: U.S. Food and Drug Administration

Summary: We stated in our public comment submission that the MRCT Center agrees with the FDA that overly restrictive laboratory value-based eligibility criteria are problematic and that such criteria may well exclude the very cancer patients that may benefit from the treatment under study, particularly when the malignancy (or its prior treatment) is affecting those lab values. The MRCT Center also asked for more specific examples of how to describe the potential variation of lab values (e.g., by race) and any additional/confirmatory testing needed in the eligibility criteria so as to better support a position of inclusion-by-default and exclusion-only-when-necessary.

Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications”

Public Comments

Comments provided on: June 24, 2024

Comments provided to: U.S. Food and Drug Administration; FDA-2024-D-1376

We responded to a series of three FDA draft guidance documents addressing eligibility criteria for U.S.-based cancer clinical trials. For all three documents, we were supportive of the efforts the FDA has taken to make clinical trials more representative of the intended post-approval patient population. We encouraged additional clarity and granularity with regard to operationalizing these draft guidelines, in advance of their final issuance. Further, we agreed that eligibility criteria should be carefully considered, caution against copying and pasting eligibility criteria from the protocol of one study into the draft protocol of a new study, and advocate that exclusion criteria should be clearly justified based on safety or ethical reasons.

Our public comments on the third guidance (iii)Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications,” asked the FDA to clarify its use of the term “medication,” whether either the recommendations regarding concomitant medications or the washout period differ in the case of early (Phase 1/2a) versus late (Phase 3 and post-approval) trials, and when additional data and sub-studies might be needed to understand potential drug-drug interactions when participants are taking concomitant medications for chronic conditions.

Public Comments submitted: “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products”

Public Comments

Comments provided on: June 20, 2024

Comments provided to: U.S. Food and Drug Administration

FDA continued its guidance series on RWE, issuing “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.” In support of the guidance, the MRCT Center submitted public comments requesting further development of FDA’s concerns that are unique to RWE-based studies and the cross-referencing of the current guidance to specific sections of other RWE guidance documents to streamline the end-user experience.

Public Comments submitted: “FDA-NIH Terminology for Clinical Research”

Public Comments

Comments provided on: June 18, 2024

Comments provided to: National Institutes of Health, Office of Science Policy

Summary: The MRCT Center submitted public comments on a proposed glossary of innovative clinical research terms published jointly by FDA and NIH, “FDA-NIH Terminology for Clinical Research.” We encouraged clarification of the scope and intended audience of the draft glossary and recommended additional terms for inclusion in the final version. The FDA-NIH glossary will complement the MRCT Center’s Clinical Research Glossary efforts.