SFU-019 - Module 4 (Model answer)

Model Answer

Hear from a professional in this role to see how they might approach this task. Below is a detailed model answer for the work simulation on Clinical Research Practitioner, geared towards a student interested in this role.

Preparation Task (10 minutes)

Research Task (30 minutes)

Analysis Task (30 minutes)

Create Task (20 minutes)

Reflection Task (10 minutes)

Expected Outcome

1/8

2/8

Preparation task (10 minutes):

Objective: Understand the key components of a clinical trial and the role of a Clinical Research Practitioner.

Step one: Read a brief article or watch a video that covers the basics of clinical trials and the responsibilities of a Clinical Research Practitioner. In preparation, a video from You tube was selected that explained the clinical research process. Here is the link:

Entire Clinical Research Process Explained

3/8

Research task (30 minutes):

Objective: Identify relevant literature and guidelines to inform the design of your clinical trial.

Step one: Literature Review. I identified three main journal articles related to the condition Benign Prostatic Hypertrophy (BPH), which is more commonly known as Enlarged Prostate:

Read Article 3

Read Article 2

Read Article 1

Step two: Guideline Identification. I used the CONSORT (Consolidated Standards of Reporting Trials) and ICH E6 guidelines to help inform how to conduct a clinical trial related to this condition.

4/8

Analysis task (30 minutes):

Objective: Analyse the information gathered and outline protocol components.

Step one: Identification. The steps required to conduct a clinical trial should include:

• Outcome Measures
• Data Collection and Measurement
• Statistical Analysis
• Ethical Considerations
• Reporting Results
• Monitoring Safety

• Trial Objective
• Study Design
• Participants
• Sample Size
• Intervention
• Randomisation and Blinding

5/8

Create task (20 minutes):

Objective: Develop a detailed clinical trial protocol based on the analysed data and guidelines.

Step one: Protocol Creation. I used the above steps to guide me through the process of conducting a clinical trial for Benign Prostatic Hypertrophy:

2. Study Design Type: Randomised, double-blind, placebo-controlled trial. Duration: 12 months. Setting: Multicenter (to enhance generalizability).

1. Trial Objective Primary Objective: To evaluate the efficacy of a new treatment for reducing symptoms of BPH as measured by the International Prostate Symptom Score (IPSS). Secondary Objectives: To assess safety, quality of life improvements, and changes in prostate volume.

3. Participants Inclusion Criteria:

• Males aged 50 years and older
• Diagnosis of BPH confirmed by clinical evaluation and prostate ultrasound
• IPSS score of 8 or higher
• Exclusion Criteria
• History of prostate cancer
• Previous surgical treatment for BPH
• Significant comorbidities that may interfere with treatment or assessment

4. Sample Size Calculate sample size based on expected effect size, power (80%), and significance level (0.05). For example, aiming for 200 participants (100 in treatment group, 100 in placebo group).

5. Intervention Treatment Group: New pharmacological agent (e.g., a novel alpha-blocker). Control Group: Placebo.

6/8

7. Outcome Measures

• Primary Outcome: Change in IPSS from baseline to 12 months.
• Secondary Outcomes:
• Change in quality of life (measured by the BPH Impact Index).
• Prostate volume changes (measured by ultrasound).
• Adverse events and safety assessments.

6. Randomisation and Blinding Use a computer-generated randomization schedule to assign participants to treatment or placebo.Ensure both participants and investigators are blinded to group assignments.

8. Data Collection and Management Utilise electronic data capture systems to ensure accuracy and compliance with ICH E6 guidelines. Regular monitoring for data integrity and participant safety.

9. Statistical Analysis Use intention-to-treat analysis. Employ appropriate statistical tests (e.g., t-tests for continuous variables, chi-square tests for categorical variables).

10 Ethical Considerations Obtain approval from an Institutional Review Board (IRB) or Ethics Committee. Ensure informed consent is obtained from all participants. Adhere to the Declaration of Helsinki principles.

12. Monitoring and Safety Establish a Data Safety Monitoring Board (DSMB) to oversee participant safety and trial integrity. Implement regular safety assessments and interim analyses as needed.

11. Reporting Results Follow CONSORT guidelines for reporting trial results, including flow diagrams, baseline characteristics, and outcome data. Publish findings in a peer-reviewed journal to ensure transparency and dissemination of knowledge.

By adhering to these guidelines and structuring the trial appropriately, the study can provide valuable insights into the efficacy and safety of new treatments for benign prostatic hypertrophy while ensuring compliance with ethical and regulatory standards.

7/8

Reflection task (10 minutes):

Objective: Reflect on the process and identify areas for improvement.

Step one: Reflect. This trial highlighted key strengths and challenges. Recruitment and retention were difficult due to strict inclusion criteria and the chronic nature of BPH, but improved through community outreach and regular follow-up. Blinding and randomisation were tested by noticeable side effects, yet careful planning and effective placebo use maintained integrity. Data management varied across sites, but standardised procedures and training helped ensure consistency. Adverse event monitoring was complex, underscoring the need for clear guidelines and staff training. Navigating regulatory compliance was time-consuming, but early engagement with experts streamlined the process. Statistical analysis was strengthened by pre-defined plans and biostatistician input. Collaboration with clinical, regulatory, and patient groups proved essential, as did patient-centred design, flexibility in protocols, clear communication, and strong ethical standards. Step two: Future applications. This experience reinforced the importance of early planning, standardisation, and teamwork. Skills in protocol development, participant engagement, and regulatory navigation will be vital in future research. To improve, I aim to further develop knowledge in advanced statistical methods and digital data systems to better support multicentre trials.

8/8