Campus
Birmingham (Edgbaston)
Successfully incorporating patient-reported outcomes (PROs) in clinical trials Non-credit
- Delivery formatIn person
- Start date10th - 11th December 2025Duration2 days
- AwardNon-credit bearing
- Entry requirementsThis course is aimed at Chief and Principal Investigators, trial managers, clinical researchers, research nurses, data managers, study co-ordinators and academics working within clinical trials.
- Fees (UK/Ireland)CPD course fees vary. Please see fee details for more information.
Course overview
This 2-day course will provide a detailed understanding of the importance of PROs in clinical trials and best practices for their selection and successful incorporation into a trial. The course will also consider the capture of PROs, their analysis and reporting and how their impact on clinical practice can be maximised.
Outcomes assessment is a fundamental aspect of clinical trial design and implementation. Patient reported outcomes (PROs) provide unique information on the impact of a medical condition and its treatment from the patient’s perspective and are increasingly recognized by regulators, clinicians, and patients as valuable tools to collect patient-centred data. PROs should be included as primary or secondary outcomes in clinical trials to ensure the impact of a trial intervention is comprehensively assessed.
Course delivery
Programme team:
The course will be delivered by Professor Melanie Calvert and colleagues from the Centre for Patient-Reported Outcome Research (CPROR), University of Birmingham.
Dates of the course:
10th - 11th December 2025
Place availability:
15 attendees
Accreditation:
The course is not accredited.
Course results:
Certificate of completion
Learning outcomes:
- Identify the different types of Patient-Reported Outcomes (PRO) and when to use them in clinical trials
- Describe approaches to selecting an appropriate PRO measure for a study
- Recognise and describe PRO-specific components that should be included in a trial protocol using the SPIRIT-PRO Extension
- Describe approaches to minimising missing data and enhancing data quality
- Describe the challenges and potential management strategies for PRO Alerts
- Recognise basic methods of PRO analysis
- Critique the reporting of a trial using the CONSORT-PRO extension
- Evaluate ways to maximise the impact of PRO trial data to inform clinical practice and health-policy
Teaching staff
Programme Team
Professor Melanie Calvert
Professor of Outcomes Methodology
Staff Profile for Professor Melanie Calvert who is Professor of Outcomes Methodology, School of Health Sciences at the University of Birmingham
Entry requirements
This course is aimed at Chief and Principal Investigators, trial managers, clinical researchers, research nurses, data managers, study co-ordinators and academics working within clinical trials.
Fees and scholarships
2024 course fees
£295
Application process
For enquiries, please complete our enquiry form.
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