scholarly journals Recruitment of Older African Americans in Alzheimers Disease Clinical Trials Using A Community Based Research Approach

2020 ◽  
Author(s):  
Ashley R. Shaw ◽  
Jaime Perales-Puchalt ◽  
Briana Bright ◽  
Todd Moore ◽  
Melissa Robinson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
African Americans ◽  
Clinical Research ◽  
Research Approach ◽  
Alzheimers Disease ◽  
Recruitment Method ◽  
Community Based ◽  
Culturally Tailored ◽  
Older African Americans

African Americans are disproportionally affected by Alzheimers disease and related dementia (ADRD) and are two times more likely to develop ADRD compared to their White counterparts. Despite the higher prevalence of ADRD among older African Americans, less than 5% of African Americans participate in clinical research trials. Purpose: The purpose of the study was to explore how a culturally tailored community-based recruitment method impacts 1) enrollment in ADRD research studies among older African Americans in the Midwest and 2) ADRD knowledge and perception of clinical trials. Methods: Using a community-engaged research approach, we collaborated with two predominately African American serving organizations to support the content development and the delivery of Aging With Grace (AWG); a culturally tailored dementia educational curriculum. Results: A total of five AWG presentations were presented to 66 attendees. Most attendees (67%) expressed interest in participating in clinical trials after attending AWG, 18.2% of attendees enrolled in an observational clinical research study and 4.5% enrolled in a lifestyle prevention clinical trial within 5 months of the AWG presentation. Attendees (32%) also perceived an increase in ADRD knowledge from attending AWG and 89.1% believed more African Americans should participate in research. Conclusion: The study has demonstrated the effectiveness of a community-based recruitment method using AWG to enhance knowledge, clinical trial interest, and recruitment into observational and lifestyle ADRD clinical trials among older African Americans. Future studies should assess long-term efficacy of this AWG community-based recruitment method among other underrepresented minority populations.

scholarly journals EDUCATIONAL OUTREACH IN ALZHEIMER’S DISEASE AMONG OLDER AFRICAN AMERICANS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S862-S862
Author(s):  
Ashley R Shaw ◽  
Briana Bright ◽  
Jaime Perales Puchalt ◽  
Eric Vidoni ◽  
Gabriela Amparan ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
African Americans ◽  
Clinical Research ◽  
Community Members ◽  
Prevention Education ◽  
Culturally Tailored ◽  
Older African Americans ◽  
Clinical Research Trials

Abstract Alzheimer’s disease (AD) is a growing public health problem that continues to disproportionally impact African Americans. African Americans are twice as likely to be afflicted with AD compared to non-Latino Whites. However, continued lack of inclusion of African Americans in clinical research trials may reduce the generalizability of future treatments. We investigated how culturally tailored prevention education impacted knowledge, attitudes, and beliefs of AD among older African Americans. We also assessed how culturally tailored prevention education impacted participation in clinical research trials among older African Americans. Researchers delivered “Aging with Grace,” a culturally tailored dementia program to community and faith-based organizations. Demographic information, knowledge of AD, and beliefs of clinical research trials were collected using pre- and post-surveys. In addition, information from community members interested in enrolling in a clinical research study was acquired. A total of 66 community members attended “Aging with Grace” from March to August 2019. 32% of participants perceived an increase in AD knowledge. Most participants (89.1%) believed that more African Americans should participate in research and 29 (44%) expressed interest in enrolling in clinical trials (observational – 73.2%, prevention – 68.2%, treatment – 24.4%). Most participants (93.1%) rated the presentation highly informative and 78% reported that the presentation was very applicable to their daily life. Overall knowledge of AD and interest in participating clinical trials improved with culturally tailored education. Future research should explore ways of enhancing knowledge and participation to enhance inclusion in prevention and treatment trials.

Evaluation of drug cost avoidance resulting from conduct of cancer clinical trials in a community-based oncology practice.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 66-66
Author(s):  
Amit Sanyal ◽  
James M. Heun ◽  
Brittany Glynn ◽  
Ryan Porter ◽  
Daniel Wellner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Health Plan ◽  
Cost Savings ◽  
Investigational Drug ◽  
Cancer Clinical Trials ◽  
Community Based ◽  
Hospital System ◽  
Cost Avoidance

66 Background: Aim: To prospectively evaluate cost avoidance during routine conduct of cancer clinical trials in a community based integrated delivery network (IDN) consisting of a health services provider group, a health insurance plan and a hospital system. Only 2%–7% of adult cancer patients participate in clinical trials nationwide [1]. Inadequate funding and concerns about financial viability have been identified as factors that impede clinical trial accrual in the community oncology setting. ‘Cost-avoidance’, defined as dollars that would have been spent to purchase medications but were not spent because of study-related interventions [3] has been proposed as one mechanism to overcome this. Methods: Anti-cancer and hematology drugs provided by intergroup as well as pharmaceutical industry-based trial sponsors to patients enrolled in oncology clinical research were tabulated. Analysis of cost avoidance was restricted to patients covered by the IDNs health plan. Additionally, drugs provided by the trial sponsor were included in the analysis only if they represented a normal standard of care for the disease state. Cost avoidance was defined as the net ingredient cost of the drugs that would have been spent by the health plan for patient care if drugs provided by trial sponsors were not available. Results: Between January 2020 and April 2021, 25 patients covered by the IDN were recruited into clinical trials. Cost savings resulted from 7 targeted and immuno-oncology medications. Net cost avoidance in 2020 was $1,229,798 while that in 2021 till date has been $892,783. The realized cost savings has allowed recruitment of additional clinical research staff as well as expansion of clinical research to rural regional sites served by the IDN. Conclusions: Anticancer drugs provided free of charge by clinical trial sponsors render significant cost savings, ensuring viability and even expansion of oncology clinical research in community based IDNs. References: National Health Expenditure Data. 2018, U.S. Centers for Medicare & Medicaid Services: Baltimore, MD 21244. McDonagh MS, M.S., Naden E., Costs and savings of investigational drug services. American Journal of Health-Systems Pharmacy, 2000. 57: p. 40-43.[Table: see text]

scholarly journals Development of “Advancing People of Color in Clinical Trials Now!”: Web-Based Randomized Controlled Trial Protocol (Preprint)

2019 ◽  
Author(s):  
Alicia Chung ◽  
Azizi Seixas ◽  
Natasha Williams ◽  
Yalini Senathirajah ◽  
Rebecca Robbins ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Intervention Group ◽  
People Of Color ◽  
Control Group ◽  
Research Approach ◽  
Web Based ◽  
Culturally Tailored ◽  
Clinical Trial Enrollment

BACKGROUND Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of “Advancing People of Color in Clinical Trials Now!” (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. OBJECTIVE This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. METHODS ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed <i>t</i> test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. RESULTS We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. CONCLUSIONS ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. CLINICALTRIAL ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17589

scholarly journals Development of “Advancing People of Color in Clinical Trials Now!”: Web-Based Randomized Controlled Trial Protocol

10.2196/17589 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e17589
Author(s):  
Alicia Chung ◽  
Azizi Seixas ◽  
Natasha Williams ◽  
Yalini Senathirajah ◽  
Rebecca Robbins ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Intervention Group ◽  
People Of Color ◽  
Control Group ◽  
Research Approach ◽  
Web Based ◽  
Culturally Tailored ◽  
Clinical Trial Enrollment

Background Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of “Advancing People of Color in Clinical Trials Now!” (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. Objective This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. Methods ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. Results We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. Conclusions ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. Trial Registration ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401 International Registered Report Identifier (IRRID) DERR1-10.2196/17589

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Clinical Trials ◽  
Clinical Research ◽  
Substantial Reduction ◽  
Text Message ◽  
High Volume ◽  
Text Messages ◽  
Shared Task ◽  
Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

scholarly journals Estimands: bringing clarity and focus to research questions in clinical trials

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e052953
Author(s):  
Timothy Peter Clark ◽  
Brennan C Kahan ◽  
Alan Phillips ◽  
Ian White ◽  
James R Carpenter
Keyword(s):  
Clinical Trial ◽  
Sensitivity Analysis ◽  
Clinical Trials ◽  
Clinical Research ◽  
Recent Work ◽  
Treatment Effect ◽  
Research Question ◽  
Probability Of Success ◽  
Research Questions

Precise specification of the research question and associated treatment effect of interest is essential in clinical research, yet recent work shows that they are often incompletely specified. The ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials introduces a framework that supports researchers in precisely and transparently specifying the treatment effect they aim to estimate in their clinical trial. In this paper, we present practical examples to demonstrate to all researchers involved in clinical trials how estimands can help them to specify the research question, lead to a better understanding of the treatment effect to be estimated and hence increase the probability of success of the trial.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

Using Social Media to Increase the Recruitment of Clinical Research Participants

2018 ◽  
pp. 7181-7189
Author(s):  
Saliha Akhtar
Keyword(s):  
Clinical Trial ◽  
Social Media ◽  
Clinical Trials ◽  
Clinical Research ◽  
Recruitment Strategies ◽  
Primary Role ◽  
Trial Recruitment ◽  
Recruitment Methods ◽  
Pros And Cons ◽  
Clinical Trial Recruitment

Research has shown that clinical research continues to have difficulty recruiting participants. This problem is expected to increase as the number of clinical trials increases and as there continues to be more focus on complex diseases and treatments. Researchers have typically relied on traditional recruitment methods to recruit participants, which revolve around the physicians and their support staff having the primary role to locate and recruit these participants. However, with individuals using online platforms such as social media to retrieve information, this creates an opportunity for research site personnel to use it as a way to relay information on clinical trial opportunities. Studies that have used social media as a way to recruit participants are discussed. Furthermore, pros and cons of social media for recruitment, along with recommendations that future researchers should consider when deciding whether to implement this type of strategy in their clinical trials will be shared. In general, clinical trial recruitment strategies need to shift to an approach that is not only more targeted, but also has a larger reach. By evaluating the success of studies that have used social recruitment strategies so far, it is evident that future researchers can also achieve recruitment success through social media. Moreover, social media could be a promising new avenue for clinical trial recruitment that allows for a more positive experience for both investigative site personnel and potential participants.

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