| Course | HCR 566 Clinical Research Management Capstone |
|---|---|
| Module | Module 5 |
| Paper type | Literature review |
| Length | About 784 words, 5 pages |
| Format | APA 7 student paper |
| School | Arizona State University |
| Program | MS in Clinical Research Management |
| Updated | October 2026 |
Free sample paper for HCR 566 Module 5
Older Adults and the Evidence for Heart Failure Treatment: A Review of Age Exclusion in Clinical Trials
Student Name
MS in Clinical Research Management, Arizona State University
HCR 566: Clinical Research Management Capstone
Instructor Name
Month Day, Year
Older Adults and the Evidence for Heart Failure Treatment: A Review of Age Exclusion in Clinical Trials
Introduction
Most people living with heart failure are older adults, and many have other chronic conditions. Treatment decisions for them depend on trials that may not have included people like them. This review examines what is known about the exclusion of older adults from heart failure and cardiovascular trials, how exclusion happens, why it matters and what policy has done about it, in order to establish the purpose and questions of a registry-based capstone study.
The Age Gap Between Trials and Patients
A systematic review of 118 heart failure trials of more than 400 participants, published from 2001 to 2016, found that participants averaged 65 years of age, with no meaningful change over 15 years. In U.S. epidemiologic studies, patients averaged 69 years with reduced ejection fraction and 73 with preserved ejection fraction or acute decompensation (Tahhan et al., 2018). Women were also underrepresented, at 27% of participants. The gap is largest in the populations where older adults are most common.
How Often Trials Set Upper Age Limits
Two snapshots from the late 2000s measured direct exclusion. Among 251 heart failure trials registered with the World Health Organization's platform in December 2008, 64 (25.5%) excluded patients through an arbitrary upper age limit, and such limits were more common in European than U.S. trials and in publicly than privately sponsored drug trials (Cherubini et al., 2011). Among 109 Phase 3 and 4 trials published in 2007 in five major medical journals, 22 (20.2%) excluded patients above a specified age (Zulman et al., 2011). The two studies used different samples but agree that roughly one trial in four or five set an upper age limit at that time.
Indirect Exclusion
Upper age limits are only the visible part of the problem. Almost half of the trials without an age limit in the 2007 sample excluded patients through criteria that disproportionately affect older adults, such as limits on kidney function, cognitive impairment or other illnesses (Zulman et al., 2011). In the 2008 heart failure sample, 43.4% of trials had at least one poorly justified criterion that could limit older participants (Cherubini et al., 2011). Any study of upper age limits therefore measures a minimum level of exclusion.
Why It Matters
When older adults are excluded, clinicians must extrapolate from younger participants to patients whose kidney function, drug interactions and competing risks differ. Zulman et al. (2011) found that only about a quarter of trials examined outcomes especially relevant to older adults, such as health status or quality of life, and fewer than half of age-specific subgroup analyses accounted for comorbidity. The evidence that exists may answer questions older patients care less about.
Policy Responses
Regulators and funders have responded. The NIH's Inclusion Across the Lifespan policy, effective for applications from 2019, requires funded clinical research to include individuals of all ages unless a scientific or ethical reason justifies exclusion (Bernard et al., 2018). The FDA, for its part, has advised sponsors to drop exclusions that lack a clear rationale and to recruit trial populations resembling the patients who will take the drug, older adults among them (U.S. Food and Drug Administration, 2020). Whether these policies have changed the eligibility criteria of recent heart failure trials is not yet clear from published data.
Gap in the Literature
The most recent measures of upper age limits in heart failure trials come from 2007 and 2008, before current FDA guidance and NIH policy. No study has examined the trials started in the decade since 2015, and none has compared sponsor types in the current era. The proposed capstone addresses this gap.
Research Questions Aligned With Methods
| Question | Method |
|---|---|
| How many Phase 3 heart failure trials begun from 2015 through 2024 list a maximum eligible age of 85 or less? | Registry extraction of maximum age; proportion with 95% confidence interval |
| Does the proportion differ by sponsor class and start period? | Chi-square comparisons |
| What share of enrollment is in trials with such limits? | Sum of enrollment counts by group |
Minimizing Bias
Selection bias will be limited by including every registered trial meeting the search criteria rather than a sample. Measurement bias will be addressed by a fixed definition of an upper age limit and a validation check of 20 records against the full registry entries. The study will not claim to measure indirect exclusion, which it cannot capture.
Conclusion
Older adults have been underrepresented in heart failure trials for two decades, partly through explicit upper age limits that affected about one trial in four in 2008. Policy has since pushed for inclusion. The capstone will measure whether recent Phase 3 trials still set such limits.
References
Bernard, M. A., Clayton, J. A., & Lauer, M. S. (2018). Inclusion across the lifespan: NIH policy for clinical research. JAMA, 320(15), 1535-1536. https://doi.org/10.1001/jama.2018.12368
Cherubini, A., Oristrell, J., Pla, X., Ruggiero, C., Ferretti, R., Diestre, G., Clarfield, A. M., Crome, P., Hertogh, C., Lesauskaite, V., Prada, G.-I., Szczerbinska, K., Topinkova, E., Sinclair-Cohen, J., Edbrooke, D., & Mills, G. H. (2011). The persistent exclusion of older patients from ongoing clinical trials regarding heart failure. Archives of Internal Medicine, 171(6), 550-556. https://doi.org/10.1001/archinternmed.2011.31
Tahhan, A. S., Vaduganathan, M., Greene, S. J., Fonarow, G. C., Fiuzat, M., Jessup, M., Lindenfeld, J., O'Connor, C. M., & Butler, J. (2018). Enrollment of older patients, women, and racial and ethnic minorities in contemporary heart failure clinical trials: A systematic review. JAMA Cardiology, 3(10), 1011-1019. https://doi.org/10.1001/jamacardio.2018.2559
U.S. Food and Drug Administration. (2020). Enhancing the diversity of clinical trial populations: Eligibility criteria, enrollment practices, and trial designs [Guidance for industry]. https://www.fda.gov/media/127712/download
Zulman, D. M., Sussman, J. B., Chen, X., Cigolle, C. T., Blaum, C. S., & Hayward, R. A. (2011). Examining the evidence: A systematic review of the inclusion and analysis of older adults in randomized controlled trials. Journal of General Internal Medicine, 26(7), 783-790. https://doi.org/10.1007/s11606-010-1629-x
Reading the HCR 566 Module 5 assignment instructions
The Draft Literature Review is due in Module 5 of HCR 566, worth 50 points, in the module on methodology, design, sample populations, settings and minimizing bias. The syllabus asks for a first draft that provides evidence of the project's purpose and outlines clear research questions aligned with the methodology you plan to use. That alignment is the key requirement: the review should lead the reader from what is known, through what is not, to questions your methods can answer. Organize by theme rather than by article, and end by naming the gap. Module 3's Literature Review 101 reading explains the basics, and the capstone template sets the format. Draft 1 of the full capstone follows in Module 7, so a review written now becomes the background section of the paper.
How this HCR 566 Module 5 example is built
The review opens by stating its purpose in relation to the capstone. Thematic sections follow: the age gap between participants and patients, the prevalence of upper age limits from two earlier studies, indirect exclusion, why exclusion matters for evidence and the policy responses from NIH and FDA. A margin note explains the synthesis across two snapshots. A gap section states plainly what is unknown. Questions and methods sit side by side in a table, a short section covers how bias will be kept down, matching the module's focus, and the conclusion summarizes the review in three sentences. Each theme compares at least two sources, and differences between them are explained rather than ignored.
Where the marks sit in the HCR 566 Module 5 rubric
Fifty points ride on this draft. Marks go to a review organized by theme, built on relevant peer-reviewed and policy sources, that synthesizes rather than summarizes, identifies a clear gap and ends with research questions aligned with the planned methods, in correct APA style. A draft slips when it walks through sources one after another, when the gap is not stated, when questions do not match the methods and when the review drifts from the capstone topic. Readers in this module also look for attention to bias, since understanding and minimizing bias is one of the module's stated aims. A review that ends with a clearly stated gap is graded higher.
HCR 566 Module 5 help from the desk
Group your sources by theme before writing. Open each section with a claim and support it with two or more sources. Note differences between studies rather than ignoring them. Write the gap as one or two sentences. Put your questions and methods side by side to check alignment. Add a few sentences on bias. Keep the draft focused on what your capstone needs. If your sources do not yet show a gap, the desk can help you search for the most recent studies. Write the gap section first, then build the themes that lead to it. Check that every source you cite appears in your reference list in correct APA style.
Write yours, or have the desk draft it
This paper is an original model document written by our desk, not a submitted student paper and not an official Arizona State University document. Read it for the moves, then write your own to the instructions in your classroom. If you want one built to your exact prompt and rubric, the first custom sample is free and arrives in 24 to 48 hours.
More HCR 566 and MS in Clinical Research Management sample papers
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- HCR 566 Module 11: Final Capstone Paper
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- HCR 561 Module 3: Assignment 1: Slides for Site Staff on an Ethical Issue
- HCR 557 Module 2: Paper 1: Analyzing a Clinical Study's Design and Endpoints
- HCR 593 Module 3: Annotated Bibliography for the Applied Project
HCR 566 Module 5 questions, answered
Where can I find a free HCR 566 Module 5 sample paper?
The page above carries a complete draft literature review on age exclusion in heart failure trials.
How should a capstone literature review be organized?
Group sources by idea, lead the reader to the unanswered question and finish with questions your methods can answer.
How often did heart failure trials exclude older adults by age?
In a 2008 registry snapshot, 25.5% of heart failure trials set an arbitrary upper age limit.
What is the NIH Inclusion Across the Lifespan policy?
A policy requiring NIH-funded clinical research to include people of all ages unless exclusion is scientifically or ethically justified.
What is due after the HCR 566 literature review?
Progress reports and capstone drafts, then the final paper in Module 11 and a poster.