MD7123 Clinical Research Methods & Biostatistics Assessment 1 Brief 2025

Proposed Structure

1. Introduction ( ̴250 words)

Define the research/health question

• Briefly describe which is the scientific topic of the proposed project.

Explain why it is important

• Describe what is the reason for conducting this research, e.g. what is not yet known, what is the gap that should be filled by this project in the specific topic.

Clearly state the research question (not in the form of a question).

2. Background ( ̴ 400 words)

• Briefly describe the previous studies, their findings, and what were the conclusions by using appropriate references.

Clearly state what is the research gap.

3. Aims/Hypotheses ( ̴ 150 words)

• What are the specific aims of this project, e.g. the aim of the study was to compare the serum levels of biomarker A between healthy individuals and patients for the diagnosis of disease B. A second aim was to assess the correlation of A with a new biomarker C, etc.

Clearly state the aims of the study with bullet points.

What are your assumptions for the expected findings?

• Describe what is the hypothesis of the proposed project, e.g. based on published reports (with references), we hypothesise that biomarker A is increased in patients with disease B as compared to healthy individuals, and that could lead to the discovery of a new diagnostic tool.

Clearly state your expected outcomes with a small paragraph or bullet points. The null hypothesis is not needed.

4. Samples and methods ( ̴600 words)

Describe in detail the following:

• Methodology- for example, RCT
• Who is your target population (e.g. patients suffering from disease B)
• What control(s) will be used (e.g. healthy individuals or patients receiving drug D)
• Sample size and power (how many samples you will include and why this gives statistical power (references if needed).
• What will you measure and why is this relevant to the target subjects (e.g. biomarker A, as this has been used for the diagnosis of disease B)
• Which data collection methods will be used in the study (Primary? Qualitative?
  Experimental? Questionnaires? etc)
• Which methods will be utilised for the measurements (e.g. ELISA will be used for the measurement of biomarker A)
• Statistical analysis methods and tests with detailed and justified description (describe in detail which groups will be compared, what statistical tests will be used and why, e.g. the levels of biomarker A will be compared between healthy and patients using the unpaired t-test because samples do not have normal distribution)
• What are the risks/biases, and how could these be overcome? (e.g. maybe the oncologist will show a preference to administer drug D to patients with severe disease, so blinded approaches will be used)
• Timeline for the study

5. Ethics ( ̴ 250 words)

Details of what information you will provide for participants (Participant Information Sheet), e.g. age, gender, socioeconomic status, etc.

How will you obtain consent (Consent Form), e.g. all participants will be provided a written form to sign off.
How can participants withdraw? e.g. participants can withdraw at any time.
How will you store and manage data? e.g. hard drives, notes, images, etc.
How will you anonymise data? e.g. use of codes for serum samples, etc.
How will you deal with GDPR?
At which Institutional Ethics Board will you apply for ethical approval of the study?

6. Future perspectives ( ̴ 200 words)

What is the impact of the study on society (e.g. what will this project add to previous knowledge, which group(s) of patients/participants will benefit from this research, how can health professionals can use the findings from this research, will it help to set guidelines for the treatment of disease etc).

What are the next steps after completion (e.g. which are the plans/perspectives)?

7. References

References: Reference List as APA 7 (in alphabetical order according to the first letter of the surname of the first author)

Word count:
2000 words (+10%)

Learning Outcomes of MD7123

• Provide evidence of having systematically applied a range of research-relevant information retrieval systems.
• Prepare a research proposal (including review of research literature, statement of protocols and consideration of ethical matters).
• Demonstrate systematic understanding of current literature and of research methods in order to identify areas for investigation and develop a feasible, level 7 research study.