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 for 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 are free to access on NIHR’s e-learning hub. Each module takes approximately two hours to complete. When you access the learning, you will find a navigation page within the module introduction. This navigation page will describe how you can interact with the learning and navigate through the content.
Please note any technical issues in logging on etc must be addressed to NIHR, they have a help section at log in here
As a guide, 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.
These modules aim to support clinical practitioners from across the professions forming multidisciplinary teams in a wide range of healthcare settings. With these modules and our wider work (RCP Research and innovation hub), we aim to help increase research participation opportunities for healthcare professionals and patients everywhere, but particularly in geographical areas, populations and organisational settings where such opportunities are currently limited.
Financial support was provided as an Independent Medical Education Grant by Pfizer. Pfizer have had no input or involvement in the design, development and content creation.
If you have any questions about the learning modules, content or cannot get help from NIHR, please contact the Royal College of Physicians education team at elearning@rcp.ac.uk.
Module 1: Getting involved in clinical research in the NHS
The overall aim of this module is to introduce learners to how research is organised and delivered in the NHS, appropriate methodological approaches for the range of questions and evidence that is needed, including how they contribute to population health as a whole and enthuse learners with the excitement of contributing new knowledge to improve patient care.
The module covers topics relevant to the journey of a patient through a clinical trial and equips clinicians with the knowledge to participate in the processes involved. Real life examples of clinical trials are used to bring the content to life and learners are signposted and challenged to identify opportunities for access to research in their own practice.
Topic 1: Where do clinical trials come from?
Topic 2: Should all patients have the chance to take part in a clinical study or trial?
Topic 3: Which patients are eligible for clinical trials?
Topic 4: How are patients identified and recruited?
Topic 5: What happens after recruitment and what are a clinician’s responsibilities?
Topic 6: What information will come out of this trial?
Module 2: Getting up to speed with the scientific language and processes of clinical trials
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.
Module 3: Working with investigational medicines
This module will introduce you to the general principles of underlying research with investigational medicines. 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.
Module 4: How clinical research interacts with populations, public health and prevention
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.