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.