Guide to Writing Clinical Trial Papers

Aug 1, 2024

How to Write a Clinical Trial Research Paper

Introduction

  • Topic: Writing a clinical trial research paper.
  • Example Paper Title: 'The Effects of Vitamin D Supplements on Obesity: A Randomized Clinical Trial Study'.
  • Purpose: Teaching example, not an actual research paper.
  • Tool Recommendation: Install Ref-n-write software for referencing, paraphrasing, and academic phrasebank.

Introduction Paragraph

  • Purpose: Explain the topic and its importance.
  • Hook: Start with an attention-grabbing fact, statistic, or question.
  • Narrow Topic: Introduce specific focus (Vitamin D and obesity).
  • Establish Importance: Highlight health issues and benefits to the community.
  • Final Statement: Explain the research benefit (e.g., better treatment options).

Literature Review

  • Purpose: Provide a summary of previous research.
  • Broad Statement: Confirming link between Vitamin D and obesity.
  • Specific Studies: Report recent studies on the topic.
  • Mixed Evidence: Mention conflicting results in existing studies (Vitamin D causing obesity vs. obesity causing Vitamin D deficiency).
  • Research Gap: Lack of clear evidence and studies on healthy populations.
  • Research Question: Investigate the effect of Vitamin D on weight loss among healthy populations.
  • Hypothesis: Define a specific hypothesis to be tested.

Materials and Methods

  • Study Design: Randomized double-blinded placebo trial.
  • Location and Period: Mention where and when the trial was conducted.
  • Ethical Approval: Necessary ethical approvals and registration on clinicaltrial.org.
  • Good Clinical Practice (GCP): Quality standards and monitoring information.
  • Inclusion Criteria: Characteristics for subject eligibility (e.g., non-smoking, non-diabetic, BMI > 25).
  • Exclusion Criteria: Subjects excluded from the study (e.g., those in weight loss programs).
  • Recruitment: Procedure, including interviews, questionnaires, and informed consent.
  • Grouping: Participants split into intervention and control groups (double-blinded).
  • Follow-Up Period: Importance of follow-up duration (12 months, measurements every 6 months).
  • Measurements: Parameters measured (BMI, waist circumference, BP).
  • Statistical Analysis: Tools used (independent sample t-test, p-value significance < 0.05).

Results

  • Presentation: Logical sequence, use figures/tables, no interpretation.
  • Preprocessing: Exclude participants with health issues or dropouts.
  • Main Findings: Significant drop in BMI with Vitamin D; provide p-value.
  • Additional Results: No significant difference in BP; present in specified format (mean ± SE).

Discussion

  • Interpretation: Compare findings with previous work, discuss limitations, future direction.
  • Main Result: Support for hypothesis (Vitamin D reduces BMI).
  • Negative Result: Association between waist circumference and Vitamin D (possibly due to study duration).
  • Unexpected Result: Higher BP in Vitamin D group (limited data).
  • Implications: Significance and contributions to existing research.
  • Novelty: Unique aspects of the study (first on healthy population).
  • Limitations: Small sample size; honest reporting of limitations.
  • Future Work: Possible larger study to reconfirm findings.

Conclusion

  • Summary: Overview of key findings and their significance.
  • Future Direction: Suggest future research possibilities.

Additional Information

  • Questions: Encourage viewers to ask questions.
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