Training activity information
Details
Appraise a clinical trial protocol
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Recruitment criteria
- Clinical trial strategy
- Randomisation strategy
- Follow up and monitoring
- Outcome measures
- Application to patient care and management
- Commercialisation and conflict of interests
Reflective practice guidance
The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.
Before action
- What aspects of the protocol are you expected to focus on?
- What are the key elements of a clinical trial protocol? What are the ethical and regulatory considerations involved in clinical trials, particularly concerning human tissue and novel therapies? What are the scientific principles underpinning the trial design and methodology?
- Will you familiarise yourself with the principles of clinical trial design and relevant regulatory guidelines?
- Will you discuss with your training officer or experienced colleagues what aspects of the protocol to focus on?
- What challenges might you face in understanding complex statistical or methodological aspects?
- How confident do you feel about appraising a complex document like a clinical trial protocol?
In action
- As you read through the protocol, how are you systematically evaluating different sections (e.g., aims, methods, statistics)?
- When you encounter aspects that are unclear or raise questions, what decisions are you making about how to note these and seek clarification?
- Are some parts of the protocol easier for you to understand and appraise than others? What accounts for this difference?
- What challenges are you facing (e.g., complex statistical analysis, unfamiliar terminology)? How are you trying to understand these aspects?
- What are you learning about clinical trial design and the key elements of a protocol as you appraise it?
- If you are unsure about the rationale behind a specific design choice, are you considering alternative approaches and why the chosen one might be preferred?
On action
- Summarise the key components of the clinical trial protocol you appraised.
- What were the main objectives, design features, and outcome measures?
- What did you learn about the essential elements of a clinical trial protocol and the rationale behind different design choices (e.g., inclusion/exclusion criteria, randomisation, blinding)?
- What sections of the protocol were clearer or more challenging to understand?
- Were there any unexpected aspects of the protocol that stood out to you (either positive or negative)? What did you learn from these observations?
- Reflecting on your appraisal process, how did your real-time evaluation of different sections influence your overall understanding of the protocol’s strengths and weaknesses?
- How important is a thorough appraisal of a clinical trial protocol for ensuring the safety and efficacy of novel treatments and the validity of the research findings?
- What specific aspects of clinical trial design or statistical analysis do you want to develop a better understanding of?
- How will this experience influence your approach to reading and interpreting clinical trial literature in the future?
- What are your next steps in terms of discussing your appraisal with your supervisor or seeking further resources on clinical trial methodology?
- Do you need any support or resources in understanding the ethical considerations or regulatory requirements associated with clinical trials?
Beyond action
- Have you had opportunities to appraise other clinical trial protocols since completing this training activity? Did you focus on similar or different aspects?
- Have you reviewed your initial reflections (reflect-on-action) for this activity in light of your growing understanding of clinical research?
- Consider other training activities or experiences where you have had to critically evaluate documents or procedures. How did your approach compare?
- Have you discussed clinical trial protocols with researchers or clinicians? Did these discussions provide new insights into their design and implementation?
- Has this training activity enhanced your understanding of the regulatory and ethical considerations involved in clinical trials?
- Do you now have a better appreciation for the role of the laboratory in supporting clinical research? Can you identify instances where your understanding of clinical trial design has informed your approach to laboratory testing for patients enrolled in such trials?
- Have the critical appraisal skills developed in this activity been transferable to the evaluation of scientific literature or new laboratory methods?
- How will your experience in appraising clinical trial protocols prepare you for potential involvement in research activities or the implementation of new therapies based on trial outcomes?
- Will your ability to understand the design and objectives of clinical trials be a valuable asset in ensuring the appropriate use of laboratory tests in this context?
- How might this experience contribute to your professional development and potential involvement in research governance or ethics committees?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Practice in accordance with legislation regarding use of human tissue. |
| # 3 |
Outcome
Appraise the application of novel and evolving therapies in the treatment of haematological conditions. |
| # 4 |
Outcome
Evaluate the application of gene therapy for the treatment for malignant and non-malignant haematology. |