Manage Research Operations

Researchers looked at how enrollment factors made a difference, broken out by race, on the progression of mild cognitive impairment and dementia. Using Alzheimer’s Disease Research Center data, they examined the rate of impairment between white participants and Black participants with age-at-progression survival models.

According to the article authors, the ideal participants for Alzheimer's disease clinical trials would show cognitive decline in the absence of treatment (i.e., placebo arm) and also would be responsive to the therapeutic intervention being studied (i.e., drug arm). This investigation tested whether machine learning models can effectively predict cognitive decline in people with mild to moderate Alzheimer’s disease during the timeframe of a phase III clinical trial. Data from 202 participants...

This article describes a validated two-step process for recruiting asymptomatic amyloid-positive individuals into clinical trials. The process was tested using cohorts from three Alzheimer’s studies (ADNI-MCI, ADNI-CN and INSIGHT). During a pre-screening phase, researchers pre-selected a subset of individuals who were more likely to be amyloid positive, based on the automatic analysis of data acquired during routine clinical practice, before doing a confirmatory PET scan for these selected...

For the Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) trial, 462 new participants were enrolled. Recruitment metrics were recorded on 82,003 unique visitors to the recruitment website and 3,335 calls to study phone numbers. The recruitment sources that produced the most screening and enrollment included online advertisements, local radio and newspaper coverage, and emails and referrals from patient registries. According to the authors, ADNI3 is an example of how a data-driven approach to...

This article describes the study design of a dual-objective, Phase III clinical trial in individuals presymptomatic for Alzheimer’s disease. It addresses the particular challenges for delay and prevention studies. These include: Ensuring that the trial population, cognitively normal at outset, contains a sufficient number of participants at increased risk of cognitive impairment onset during the trial time frame to avoid prohibitive trial size and duration. Finding appropriate measures to detect...

Rush Alzheimer's Disease Center (RADC) has created a searchable research database that includes recruitment-related information, such as study designs, enrollment and autopsy timelines, and other relevant information.

The Patient-Centered Outcomes Research Institute (PCORI) created this repository of more than 150 tools and resources for use with patient-centered, stakeholder-engaged research. Repository items are developed by recipients of PCORI research grants, and the Institute makes them publicly available to encourage the use of these engagement practices and methodologies within the broader healthcare research community. The database can be searched by keywords or by criteria in the following categories...

Two articles and an editorial address the question of whether paying research participants could be considered coercive. The first article notes concerns about risks, consent, and exploitation. The second article examines coercion as subjection, in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. The editorial weighs the arguments and views participation as work that should be fairly compensated. Malmqvist E. “Paid to endure”: Paid...

This resource page for cultural competency training focuses on implicit bias, which is an unconsciously held set of assumptions about a social group that affects judgment and decision-making without conscious awareness of that influence. In health care, implicit bias has been associated with disparities in provider–patient communications and relationships. The website provides links to a video series, reports, research articles, and an implicit bias test.

This website provides resources to support effective communications with potential, enrolled, and past participants in clinical trials. The target audience includes sponsors and funders, investigators, study teams, and institutional review boards/ethics committees.

The NIH website, NIH Clinical Trials and You, contains several pages for researchers and trial sites: Improving Visibility of NIH-Supported Clinical Trial Activities and Results: Describes the NIH policy, similar to the FDA “Final Rule” reporting requirement for funded clinical trials: Trials must be registered at ClinicalTrials.gov, and summary results must be submitted no later than 1 year after the primary completion date. Clearly Communicating Research Results Across the Clinical Trials...

This online tool helps patient groups and clinical research sponsors identify high-value opportunities for patient engagement.

The NIH Strategic Plan for Tribal Health Research FY 2019–2023 is designed to improve NIH's relationship and collaborative efforts with American Indian/Alaska Native communities by enhancing communication and collaboration, building research capacity, expanding research, and enhancing cultural competency and community engagement.

This 58-page document provides guidance for engaging stakeholders in reviewing and providing feedback on research questions before a project is implemented.

This study modeled Alzheimer’s disease prevention clinical trials in order to assist investigators in making trial design choices. The authors used data from the National Alzheimer's Coordinating Center Uniform Data Set to model trial sample sizes, the numbers needed to enroll to account for dropout, and the numbers needed to screen to successfully complete enrollment. Researchers then examined how enrichment strategies affected each component of the model. For example, enriching for subjective...

In this review, researchers summarize some of the available methods to improve Alzheimer’s disease research recruitment, the available literature to support or refute these strategies, and experiences at the Alzheimer’s Disease Research Centers. This article also addresses the application of community-based participatory research principles and the use of participant registries to enhance research enrollment and increase diversity of research samples. Grill JD, Galvin JE. Facilitating Alzheimer...

This five-page document presents a standardized retention plan for prevention, symptomatic, and observational trials conducted at the Center for Alzheimer Research and Treatment (CART), Brigham and Women’s Hospital and Harvard Medical School. The plan describes strategy and tactics designed to keep patients enrolled in clinical trials, and from discontinuing their participation or dropping out. It covers pre-initiation, study start-up, and study initiation phases.

The Wisconsin Registry for Alzheimer's Prevention is a longitudinal observational cohort study enriched with people with a parental history of probable Alzheimer's dementia. Since late 2001, this registry has enrolled 1,561 people at a mean age of 54 years. Participants return for a second visit 4 years after baseline, then every 2 years. Eighty-one percent of participants remain active in the study after 9 years of follow-up. Assessments of cognition, self-reported medical and lifestyle...

Identifying healthy individuals with amyloid pathology is an important challenge for Alzheimer's prevention clinical trials. This paper reported on noninvasive, cost-efficient techniques to detect preclinical Alzheimer's to meet this need. Researchers applied machine learning to structural MRI of 96 cognitively normal subjects to identify amyloid-positive ones. Used for subject classification in a simulated clinical trial setting, the proposed method saved 60 percent on unneeded CSF/PET tests...

This study evaluated the yield and cost of three recruitment strategies—direct mail, newspaper advertisements, and community outreach—for identifying and enrolling dementia caregivers into a trial testing a nonpharmacologic approach to enhancing quality of life of individuals with dementia and their caregivers. A total of 237 dyads enrolled. The total cost of recruitment was $154 per dyad, with direct mail found to be the most effective and least costly method, at $63 per dyad. That compared...

The goals of the Arizona Alzheimer's Registry were to increase awareness of Alzheimer's disease research among adults age 18 and older and to accelerate enrollment into clinical studies sponsored by the Arizona Alzheimer's Consortium. Participation was by open invitation. Earned media was the most effective recruitment strategy. More than 1,000 people consented and underwent an initial cognitive screening. The Registry created an infrastructure and process to screen and refer a high volume of...

TabCAT is a software platform developed at the University of California, San Francisco that provides tablet-based neuropsychological tests translated into 10 languages. Tools available include cognitive tests of executive function, memory, visuospatial skills, and socioemotional functions, as well as symptom questionnaires.

This report describes the process used to develop the content for culturally relevant health information fact sheets targeted to Indigenous communities.

"Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies" is a 36-page document, issued in 2017, that provides guidance for industry and Food & Drug Administration (FDA) staff outlining the FDA’s data-reporting expectations and recommendations for the evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and...

The "NIH Scientific Workforce Diversity Toolkit," published by the Scientific Workforce Diversity (SWD) Office of the National Institutes of Health (NIH), is a free, downloadable interactive resource that institutions can use to help advance their own faculty diversity and inclusion practices. The toolkit guides users through evidence-based activities to foster an inclusive culture including diversifying the talent pool, conducting unbiased talent searches, conducting outreach and networking...

This webinar series covers regulatory documentation for clinical trials, informed consent, good clinical practice, and many other topics.

Researchers who work with human subjects should address indirect burdens related to research duration, intensity, and invasiveness. This paper introduces the concept of perceived research burden. The authors developed, tested, and validated a new instrument, the Perceived Research Burden Assessment (PeRBA) and found that it has good internal consistency and acceptable validity. Lingler JH, Schmidt KL, Gentry AL, et al. A new measure of research participant burden: Brief report. Journal of...

This article assesses the psychometric properties of the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) when used in individuals thinking about participating in Alzheimer’s disease research. The UBACC was administered to a sample of individuals with mild to cognitive impairment and a sample of healthy controls as part of a broader study to evaluate perceived burden of research participation. Researchers concluded that the UBACC shows promise when used to...

This randomized controlled trial tested whether a memory and organizational aid, the MacArthur Competence Assessment Tool, improves Alzheimer’s disease patient performance on measures of capacity and competency to give informed consent. Eighty patients with very mild to early moderate Alzheimer’s disease and 30 cognitively normal older adults were recruited from an NIA-funded Alzheimer's Disease Center using the center's patient database. Based on expert reviews of the interview transcripts, the...

The National Strategy for Recruitment and Participation in Alzheimer’s and Related Dementias Clinical Research outlines practical, proactive approaches to help study sites engage a wider, more diverse number of volunteers.

This five-page document is intended as a tool to support investigators, research managers, recruitment/outreach staff, research assistants, and coordinators involved with the Harvard Aging Brain Study (HABS) and to help inform sponsors of the resources and the planning process used to support recruitment needs. Study-specific needs are addressed during the pre-initiation stage by the HABS research team, and the plan is tailored to support study-specific recruitment needs. Recruitment efforts are...

This five-page document presents a standardized recruitment plan for prevention, symptomatic, and observational trials conducted at the Center for Alzheimer Research and Treatment (CART), Brigham and Women’s Hospital and Harvard Medical School. The plan covers pre-initiation, study start-up, and study initiation phases. It is intended as a tool to support investigators, recruitment/outreach staff, research assistants, and coordinators and to help inform sponsors of the resources and the planning...

BUILD EXITO is an NIH funded program that provides undergraduate minority students opportunity to work with a research mentor for 2 years.

This six-page document outlines critical questions related to participant recruitment and retention for investigators to consider when developing a clinical research funding application.