Working in partnership with the British Pharmacological Society (BPS), the Faculty of Pharmaceutical Medicine (FPM) and the Faculty of Public Health (FPH), and co-produced with patients and carers, we have developed this e-learning programme with the National Institute for Health and Care Research (NIHR).
There are four modules:
- Module 1: Getting involved in clinical research in the NHS.
- Module 2: Getting up to speed with the scientific language and processes of clinical trials.
- Module 3: Working with investigational medicines.
- Module 4: How clinical research interacts with populations, public health and prevention.
The modules will be relevant to clinicians who have been in practice for approximately four years or more, without post-graduate academic research training, and with little experience of research delivery. The modules incorporate elements needed to increase confidence while growing knowledge, skill, and insight.
Modules
2 CPD Credits
This module will introduce you to how research is organised and delivered in the NHS. It covers methodological approaches to deliver high quality evidence to inform development of new treatments and will equip you with the knowledge to contribute effectively to clinical research in practice.
Learning outcomes
After completing this module, you should be able to:
- Outline how clinical trials are initiated and conducted, including their organisation, funding and regulation
- Describe the benefits for patients, physicians and the NHS of participating in clinical research
- Identify how patient eligibility for clinical trials is determined, and where there are challenges in ensuring diverse representation
- Explain the processes of screening, recruitment and informed consent
- Discuss what happens after recruitment into a clinical study and the clinician’s responsibilities, including conduct of the trial, data acquisition, and safety monitoring
- Explain how clinical trial data are managed, analysed and disseminated
2 CPD Credits
This module will introduce you to the scientific language of clinical trials, clinical trial phases, trial design, and outcome measures and endpoints for efficacy and safety.
Learning outcomes
After completing this module, you should be able to:
- Explain the framework under which new medicines are developed, and how decisions are made on which clinical trials are run
- Outline how clinical trial populations are selected
- Outline the process of selecting appropriate drug doses for testing in clinical trials
- Describe placebo and nocebo effects
- Describe outcome measures and endpoints
- Identify key features of a clinical trial protocol, and where potential problems may arise
- Critique clinical trial results and identify strengths and weaknesses of research papers
2 CPD Credits
It explores how to interpret information in investigator’s brochures, calculating effective dose ranges, identifying target organ toxicities, and devising risk monitoring and mitigation schemes.
Learning outcomes
After completing this module, you should be able to:
- Describe and identify the properties of an investigational medicine.
- Explain how the likely effective dose range is calculated, and how to select the starting and maximum doses of new medicines to be investigated in early-stage studies.
- Identify target organ toxicities observed during preclinical testing.
- Devise risk monitoring and mitigation schemes to ensure patient safety during trial participation.
2 CPD Credits
This module will introduce you to how research conducted in health care settings can contribute to populations and community health.
It explores population health, public health and prevention, and how to move from an individualistic approach to a population wide perspective in your research practice.
Learning outcomes
After completing this module, you should be able to:
- Outline what is meant by public health and some commonly used key terminology
- Explain how clinical research can contribute to achieving population health impact as well as individual benefit (or harm) over the short, medium and long term
- Understand the implications of this for your own practice.