HCR 593 Module 5 Introduction and Background (Review of the Literature) Example

Reviewed by Emmett Rockwell, MBA Arizona State University Updated October 2026

This HCR 593 Module 5 sample is the Introduction and Background in the Applied Project course, due in the methodology module for ASU's Clinical Research Management master's students. Worth 50 points and at least five pages, the section in ASU HCR 593 asks students to synthesize the literature on their topic, support their thesis, identify the gap their study fills and align their research questions with their methods. The composite student builds the background for a study of results-submission timeliness on ClinicalTrials.gov. The review explains why reporting matters, traces the legal requirement, synthesizes studies of compliance from 2008 to 2019, identifies factors linked to timely reporting and recent enforcement, then names the gap and aligns three questions with registry methods.

CourseHCR 593 Applied Project
ModuleModule 5
Paper typeLiterature review
LengthAbout 738 words, 5 pages
FormatAPA 7 student paper
SchoolArizona State University
ProgramMS in Clinical Research Management
UpdatedOctober 2026

Free sample paper for HCR 593 Module 5

1

Introduction and Background: Why Results Reporting Matters and What Is Known About Its Timeliness

Student Name

MS in Clinical Research Management, Arizona State University

HCR 593: Applied Project

Instructor Name

Month Day, Year

What this page is doingThe title states the two things the section establishes: importance and current knowledge.
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Introduction and Background: Why Results Reporting Matters and What Is Known About Its Timeliness

Introduction

Every clinical trial asks people to accept risk so that others may benefit from what is learned. When results are never reported, that bargain is broken: the evidence base is skewed toward published findings, other researchers may repeat failed studies and clinicians and patients lose information about benefits and harms. ClinicalTrials.gov, the public U.S. registry, was given a results database by federal law to address this problem. This section reviews what is known about how promptly sponsors use it.

Why Results Reporting Matters

Journal publication alone cannot be relied on. Among NIH-funded trials completed by 2008, fewer than half were published in a peer-reviewed journal within 30 months of completion, and about a third remained unpublished after a median of more than four years (Ross et al., 2012). Unpublished trials are not a random sample; results that are negative or inconvenient are less likely to appear, which biases the evidence clinicians use. Structured registry results, posted regardless of outcome, are a partial remedy.

The Legal Requirement

The 2007 amendments to the federal drug law (FDAAA) required sponsors of applicable clinical trials, generally controlled trials of FDA-regulated drugs, biologics and devices beyond Phase 1, to register them and to submit summary results. The final rule, issued in 2016 and effective in 2017, clarified which trials are covered, extended results reporting to products not yet approved and set the general deadline at one year after the primary completion date, with certifications that can delay submission in specified circumstances (Zarin et al., 2016; 42 C.F.R. § 11.44).

What this page is doingPlacing the legal requirement before the compliance studies lets the reader judge each study against the standard it measured.
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Compliance Before the Final Rule

Early compliance was poor. Among 13,327 trials likely to be covered by the law and completed or terminated from 2008 to 2012, only 13.4% reported results within 12 months and 38.3% at any time by late 2013 (Anderson et al., 2015). Industry-funded trials and those under FDA oversight were more likely to report on time, while trials funded by the NIH and academic institutions lagged.

Compliance Under the Final Rule

The first trials covered by the final rule became due in 2018. Of 4,209 trials due by September 2019, 40.9% submitted results within one year and 63.8% at any time, and the median delay from primary completion to submission was 424 days (DeVito et al., 2020). Compliance had not improved during the 18 months the authors tracked. Industry sponsors were about three times as likely to comply as non-industry, non-government sponsors, and sponsors with many trials were far more likely to comply than those with few.

Factors Linked to Timely Reporting

Across studies, three factors recur. Industry sponsors comply more often, likely because they have dedicated disclosure teams and regulatory incentives. Larger sponsors comply more often than small ones. Later-phase trials and those under FDA oversight report more promptly. Academic sponsors, by contrast, often lack central support for registry work, and responsibility may fall to individual investigators.

Enforcement Since 2019

The law allows civil monetary penalties and, for federally funded trials, withholding of grant funds. For years these powers went unused. Since 2021, the FDA has issued notices of noncompliance to sponsors with overdue results, and public tracking of compliance by sponsor has added reputational pressure. Whether these steps have changed sponsor behavior for trials completing after 2020 has not been measured in the published literature.

The Gap

The most recent comprehensive measurement covers trials due to report by 2019. No published study has examined timeliness for trials completing in 2021 and 2022, after the pandemic disruption of research operations and the start of FDA enforcement. Nor is there a recent comparison of industry and non-industry sponsors for late-phase drug trials specifically.

Research Questions and Methods

Research questionMethod
What proportion of completed Phase 3 and 4 U.S. drug trials with primary completion in 2021 or 2022 submitted results within 365 days?Registry extraction of primary completion and results submission dates; proportion with 95% CI
How many had submitted results by the October 2026 access date?Presence of a results submission date
Do proportions differ by sponsor class and completion year?Chi-square tests

Conclusion

Results reporting matters because publication is incomplete and biased, and the law has required it for nearly two decades. Compliance was poor before the final rule and only moderate after it, with persistent gaps between sponsor types. The applied project will provide the first measure for recent late-phase drug trials.

References

Anderson, M. L., Chiswell, K., Peterson, E. D., Tasneem, A., Topping, J., & Califf, R. M. (2015). Compliance with results reporting at ClinicalTrials.gov. New England Journal of Medicine, 372(11), 1031-1039. https://doi.org/10.1056/NEJMsa1409364

Clinical trials registration and results information submission, 42 C.F.R. § 11.44 (2025).

DeVito, N. J., Bacon, S., & Goldacre, B. (2020). Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: A cohort study. The Lancet, 395(10221), 361-369. https://doi.org/10.1016/S0140-6736(19)33220-9

Ross, J. S., Tse, T., Zarin, D. A., Xu, H., Zhou, L., & Krumholz, H. M. (2012). Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis. BMJ, 344, d7292. https://doi.org/10.1136/bmj.d7292

Zarin, D. A., Tse, T., Williams, R. J., & Carr, S. (2016). Trial reporting in ClinicalTrials.gov: The final rule. New England Journal of Medicine, 375(20), 1998-2004. https://doi.org/10.1056/NEJMsr1611785

What the HCR 593 Module 5 instructions ask for

The Introduction and Background is due in Module 5 of HCR 593, worth 50 points, and the syllabus sets a minimum of five pages. It is a synthesized review of the literature on your topic that supports your thesis, identifies the gap your study helps fill and outlines clear research questions aligned with your planned methodology; the same module treats study design, populations, settings and bias. Synthesized is the important word: organize by theme or question, compare studies and draw conclusions across them, rather than summarizing one article after another. Your annotated bibliography from Module 3 should supply the core sources, supplemented as needed. This section becomes the opening of your final paper, so write it in the form you want to submit.

How the HCR 593 Module 5 example is put together

The section opens with why reporting matters to participants and evidence. Thematic subsections follow in a logical order: why journal publication is not enough, the legal requirement, compliance before the final rule, compliance after it, factors linked to timeliness and enforcement since 2019. A margin note explains the ordering. The gap is stated in its own short section. A closing table pairs every research question with the method that will answer it, and three sentences hand the reader on to the study. Sections build on each other, so a reader who stops at any point still knows why the next section matters, and the gap follows naturally from the review rather than being announced abruptly.

HCR 593 Module 5 rubric: what earns full marks

The Introduction and Background is worth 50 points. Credit goes to a review that is synthesized by theme, supported by credible and current sources, clear about the gap the study fills, aligned with research questions and methods and at least five pages in APA style. Points are lost when articles are summarized in sequence, when the gap is implied rather than stated, when questions and methods do not match and when the section falls short of the length requirement. Readers also look for attention to the module's theme of bias, such as acknowledging that unreported trials skew the evidence base. Clear headings that mirror the argument help readers follow a long review.

HCR 593 Module 5 help with common mistakes

Outline by theme before writing. Open every section with the point it makes, then the evidence. Compare numbers across studies and note differences in method. State the gap in plain words. Put research questions and methods in a table. Check the five-page minimum. Write it as the opening of your final paper. If your sources stop short of the most recent years, the desk can help you search for newer studies. Keep each paragraph to one claim and its evidence. Avoid quoting long passages; paraphrase and cite. Read the section once to check that every source appears in your references.

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.

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More HCR 593 and MS in Clinical Research Management sample papers

HCR 593 Module 5 questions, answered

Where can I find a free HCR 593 Module 5 sample paper?

Above on this page is a full Introduction and Background on results reporting at ClinicalTrials.gov.

How long is the HCR 593 Introduction and Background?

At least five pages, synthesizing the literature and stating the gap the study fills.

Why does results reporting on ClinicalTrials.gov matter?

Many trials are never published, and unpublished results skew the evidence, so registry results fill the gap.

How did compliance change after the final rule?

Timely reporting rose from 13.4% for trials in 2008 to 2012 to 40.9% for trials due by 2019.

What is a synthesized literature review?

A review organized by theme that compares studies and draws conclusions across them, rather than summarizing each in turn.