Analysis of eligibility criteria in Alzheimer's and related dementias clinical trials.

Overly restrictive clinical trial eligibility criteria can reduce generalizability, slow enrollment, and disproportionately exclude historically underrepresented populations. The eligibility criteria for 196 Alzheimer's Disease and Related Dementias (AD/ADRD) trials funded by the National Institute on Aging were analyzed to identify common criteria and their potential to disproportionately exclude participants by race/ethnicity. The trials were categorized by type (48 Phase I/II pharmacological, 7 Phase III/IV pharmacological, 128 non-pharmacological, 7 diagnostic, and 6 neuropsychiatric) and target population (51 AD/ADRD, 58 Mild Cognitive Impairment, 25 at-risk, and 62 cognitively normal).

Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials.

Clinical trials for Alzheimer's disease (AD) are slower to enroll study participants, take longer to complete, and are more expensive than trials in most other therapeutic areas. The recruitment and retention of a large number of qualified, diverse volunteers to participate in clinical research studies remain among the key barriers to the successful completion of AD clinical trials. An advisory panel of experts from academia, patient-advocacy organizations, philanthropy, non-profit, government, and industry convened in 2020 to assess the critical challenges facing recruitment in Alzheimer's clinical trials and develop a set of recommendations to overcome them.

Facilitators, Challenges, and Messaging Strategies for Hispanic/Latino Populations Participating in Alzheimer's Disease and Related Dementias Clinical Research: A Literature Review.

Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD) disproportionally affect Hispanic and Latino populations, yet Hispanics/Latinos are substantially underrepresented in AD/ADRD clinical research. Diverse inclusion in trials is an ethical and scientific imperative, as underrepresentation reduces the ability to generalize study findings and treatments across populations most affected by a disease. This paper presents findings from a narrative literature review (N = 210) of the current landscape of Hispanic/Latino participation in clinical research, including the challenges, facilitators, and communication channels to conduct culturally appropriate outreach efforts to increase awareness and participation of Hispanics/Latinos in AD/ADRD clinical research studies.

Factors Affecting Combination Trial Success (FACTS): Investigator Survey Results on Early-Phase Combination Trials.

Experimental therapeutic oncology agents are often combined to circumvent tumor resistance to individual agents. However, most combination trials fail to demonstrate sufficient safety and efficacy to advance to a later phase. This study collected survey data on phase 1 combination therapy trials identified from ClinicalTrials.

Leveraging National Cancer Institute Programmatic Collaboration for Uterine Cervix Cancer Patient Accrual in Puerto Rico.

Women in the U.S. Commonwealth of Puerto Rico (PR) have a higher age-adjusted incidence rate for uterine cervix cancer than the U.

Meeting the Challenge: The National Cancer Institute's Central Institutional Review Board for Multi-Site Research.

The National Institutes of Health (NIH) issued a new policy that requires a single institutional review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs.

Raising Public Awareness of Clinical Trials: Development of Messages for a National Health Communication Campaign.

Clinical trials are essential for developing new and effective treatments and improving patient quality of life; however, many trials cannot answer their primary research questions because they fall short of their recruitment goals. This article reports the results of formative research conducted in two populations, the public and primary care physicians, to identify messages that may raise awareness and increase interest in clinical trials and be used in a national communication campaign. Results suggested that participants were primarily motivated to participate in clinical trials out of a self-interest to help themselves first.

Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual.

Accruing patients in a timely manner represents a significant challenge to early phase cancer clinical trials. The NCI Cancer Therapy Evaluation Program analyzed 19 months of corrective action plans (CAP) received for slow-accruing phase I and II trials to identify slow accrual reasons, evaluate whether proposed corrective actions matched these reasons, and assess the CAP impact on trial accrual, duration, and likelihood of meeting primary scientific objectives. Of the 135 CAPs analyzed, 69 were for phase I trials and 66 for phase II trials.

Power of an effective clinical conversation: improving accrual onto clinical trials.

The National Cancer Institute (NCI) is actively transforming clinical trials to revitalize the clinical trials system and improve patient accrual. For more than 30 years, NCI has provided information and communication resources about cancer clinical trials. The Institute supports a clinical trials Web site (www.

AccrualNet: Addressing Low Accrual Via a Knowledge-Based, Community of Practice Platform.

Purpose: Present the design and initial evaluation of a unique, Web-enabled platform for the development of a community of practice around issues of oncology clinical trial accrual.

Methods: The National Cancer Institute (NCI) conducted research with oncology professionals to identify unmet clinical trial accrual needs in the field. In response, a comprehensive platform for accrual resources, AccrualNet, was created by using an agile development process, storyboarding, and user testing.

Stakeholder research on biospecimen needs and reactions to the development of a national cancer human biobank by the National Cancer Institute.

An initial survey conducted by the National Cancer Institute (NCI) in October 2008 with cancer researchers around the country revealed both a need and support for the development of a national cancer HUman Biobank (caHUB). NCI sought additional feedback from decision makers whose organizations are potential users of a caHUB and who would have a direct influence on whether or not their organizations would participate in a caHUB. NCI commissioned online discussion groups with executive-level decision makers at academic institutions with cancer research programs and pharmaceutical/biotechnology organizations.

Assessing the need for a standardized cancer HUman Biobank (caHUB): findings from a national survey with cancer researchers.

Background: Before developing a national standardized cancer HUman Biobank (caHUB), the National Cancer Institute sought feedback from the cancer research community.

Methods: NCI conducted an online survey (N = 727) about current biospecimen needs and reactions to creating a national resource cancer researchers and others.

Results: Most (56%) participants obtained biospecimens within their own institutions, and 63% wanted more information about their biospecimens.

Usability and accessibility in consumer health informatics current trends and future challenges.

It is a truism that, for innovative eHealth systems to have true value and impact, they must first and foremost be usable and accessible by clinicians, consumers, and other stakeholders. In this paper, current trends and future challenges in the usability and accessibility of consumer health informatics will be described. Consumer expectations of their healthcare providers and healthcare records in this new era of consumer-directed care will be explored, and innovative visualizations, assistive technologies, and other ways that healthcare information is currently being provided and/or shared will be described.

Representing randomness in the communication of individualized cancer risk estimates: effects on cancer risk perceptions, worry, and subjective uncertainty about risk.

Objective: To test the effect of novel representations of randomness on risk perceptions, worry, and subjective uncertainty about individualized colorectal cancer risk estimates.

Methods: A web-based factorial experiment was conducted, in which 225 adults aged 40 years and older were provided with hypothetical individualized colorectal cancer risk estimates, using 5 different textual and visual representations varying in expressed randomness. Outcome measures were perceived cancer risk, cancer worry, and subjective uncertainty about cancer risk; the moderating effect of dispositional optimism was also examined.

Assessing the impact of user-centered research on a clinical trial eHealth tool via counterbalanced research design.

Objective: Informatics applications have the potential to improve participation in clinical trials, but their design must be based on user-centered research. This research used a fully counterbalanced experimental design to investigate the effect of changes made to the original version of a website, http://BreastCancerTrials.org/, and confirm that the revised version addressed and reinforced patients' needs and expectations.

Communication of uncertainty regarding individualized cancer risk estimates: effects and influential factors.

Objective: To examine the effects of communicating uncertainty regarding individualized colorectal cancer risk estimates and to identify factors that influence these effects.

Methods: Two Web-based experiments were conducted, in which adults aged 40 years and older were provided with hypothetical individualized colorectal cancer risk estimates differing in the extent and representation of expressed uncertainty. The uncertainty consisted of imprecision (otherwise known as "ambiguity") of the risk estimates and was communicated using different representations of confidence intervals.

Opportunities and barriers to disease prevention counseling in the primary care setting: a multisite qualitative study with US health consumers.

The purpose of this study is to understand people's receptivity to seeking out disease prevention counseling from their primary care provider. Since patients' openness to health messages may vary depending on how they seek out their health information, participants were segmented into one of four unique information-seeking groups. This study explores the differences among these groups, what approaches would be most effective in motivating different health consumers to seek out behavioral counseling in the primary care setting and the opportunities during the medical visit most appropriate for this counseling.

Validating a health consumer segmentation model: behavioral and attitudinal differences in disease prevention-related practices.

While researchers typically have segmented audiences by demographic or behavioral characteristics, psychobehavioral segmentation schemes may be more useful for developing targeted health information and programs. Previous research described a four segment psychobehavioral segmentation scheme-and a 10-item screening instrument used to identify the segments-based predominantly on people's orientation to their health (active vs. passive) and their degree of independence in health care decision making (independent vs.

Outside the box: will information technology be a viable intervention to improve the quality of cancer care?

The use of health information technology (IT) to resolve the crisis in communication inherent within the fragmented service environment of medical care in the United States is a strategic priority for the Department of Health and Human Services. Yet the deployment of health IT alone is not sufficient to improve quality in health service delivery; what is needed is a human factors approach designed to optimize the balance between health-care users, health-care providers, policies, procedures, and technologies. An evaluation of interface issues between primary and specialist care related to cancer reveals opportunities for human factors improvement along the cancer care continuum.

Laypersons' responses to the communication of uncertainty regarding cancer risk estimates.

Objective: To explore laypersons' responses to the communication of uncertainty associated with individualized cancer risk estimates and to identify reasons for individual differences in these responses.

Design: A qualitative study was conducted using focus groups. Participants were informed about a new colorectal cancer risk prediction model, and presented with hypothetical individualized risk estimates using presentation formats varying in expressed uncertainty (range v.

Conceptual problems in laypersons' understanding of individualized cancer risk: a qualitative study.

Objective: To explore laypersons' understanding of individualized cancer risk estimates, and to identify conceptual problems that may limit this understanding.

Background: Risk prediction models are increasingly used to provide people with information about their individual risk of cancer and other diseases. However, laypersons may have difficulty understanding individualized risk information, because of conceptual as well as computational problems.

Correlates of weight-bearing physical activity among adolescent girls: results from a national survey of girls and their parents.

Background: Despite the potential benefits of reducing the risk of osteoporosis in later life, research on adolescent girls' weight-bearing physical activity (WBPA) is limited. This study explores correlates for WBPA in this population.

Methods: A nationally representative telephone survey sponsored by the National Bone Health Campaign was conducted with 1000 girls age 9 to 12 years and a parent.