SFU-019 - Module 4 (Model answer)

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Model Answer

Expected Outcome

Reflection Task (10 minutes)

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.

Create Task (40 minutes)

Analysis Task (30 minutes)

Research Task (30 minutes)

Preparation Task (10 minutes)

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Entire Clinical Research Process Explained

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:

Preparation task (10 minutes):

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

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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.

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:

Research task (30 minutes):

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

Read Article 1

Read Article 2

Read Article 3

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

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

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Objective: Analyse the information gathered and outline protocol components.

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

Analysis task (30 minutes):

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

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

Create task (40 minutes):

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

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).

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

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.

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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.

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.

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.

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.

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).

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.

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.

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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.

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

Reflection task (10 minutes):

1. Recruitment and Retention: Challenge: Finding eligible participants who meet the inclusion criteria can be difficult, especially in a multicenter trial. Additionally, retaining participants over the study duration may be challenging due to the chronic nature of BPH and potential side effects of the treatment. Learning Point: Developing effective recruitment strategies, such as community outreach and education, can enhance participant enrollment. Implementing retention strategies, like regular follow-ups and engagement, can help maintain participant involvement. 2. Blinding and Randomisation: Challenge: Ensuring that both participants and investigators remain blinded to treatment assignments can be difficult, particularly if the treatment has noticeable side effects. Learning Point: Careful planning of the blinding process and using placebo formulations that are indistinguishable from the active treatment can help maintain the integrity of the trial. 3. Data Management: Challenge: Collecting and managing data from multiple sites can lead to inconsistencies and errors, especially if different sites have varying levels of experience with data collection protocols. Learning Point: Implementing standardised data collection procedures and training for all site personnel can improve data quality and consistency. 4. Adverse Events Monitoring: Challenge: Monitoring and reporting adverse events can be complex, particularly if participants experience side effects that may not be directly related to the treatment. Learning Point: Establishing clear guidelines for adverse event reporting and ensuring that all staff are trained in recognising and documenting these events can enhance safety monitoring. 5. Regulatory Compliance: Challenge: Navigating the regulatory landscape and ensuring compliance with ICH E6 and local regulations can be time-consuming and resource-intensive. Learning Point: Engaging regulatory experts early in the trial design process can help streamline compliance efforts and avoid delays. 6. Statistical Analysis: Challenge: Analysing data from a multicenter trial can introduce variability that complicates statistical interpretation. Learning Point: Pre-defining statistical analysis plans and consulting with biostatisticians during the design phase can help ensure appropriate analysis methods are used.

1. Interdisciplinary Collaboration: Collaborating with urologists, statisticians, regulatory experts, and patient advocacy groups can enhance the trial's design and execution, leading to more robust results. 2. Patient-Centric Approaches: Engaging patients in the trial design process can provide insights into their needs and preferences, improving recruitment and retention strategies. 3. Flexibility in Protocols: Being open to modifying protocols based on interim findings or participant feedback can improve the trial's relevance and applicability. 4. Importance of Communication: Maintaining clear and consistent communication among all stakeholders (investigators, participants, regulatory bodies) is crucial for the trial's success. 5. Long-Term Follow-Up: Understanding the long-term effects of treatments for chronic conditions like BPH may require extended follow-up periods, highlighting the need for planning beyond the initial trial duration. 6. Ethical Considerations: Continuous reflection on ethical considerations, including informed consent and participant welfare, is essential throughout the trial process.