Clinical trials Flashcards
Clinical trials: Overview
You may look after patients who are participating in clinical trials. For many of these you will not be familiar with the trial therapy or even know which therapy the patient is receiving; a new therapy, an old therapy or a placebo.
Contact the clinical research team to discuss any clinical concerns or change in treatment.
Clinical trials: Advantages
- Possibility of more effective treatment than currently available.
- Close monitoring
- Direct access to a research team
- Reassurance from increased number of clinical encounters
- Gain from altruism
Clinical trials: Disadvantages
- Possibility of receiving therapy that is not better or worse than standard therapy
- Unknown toxicity from new agents
- Time-consuming
- Anxiety from increased number of clinical encounters
Good Clinical Practice: GCP
Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people.
According to the GCP, what must you do in order to be qualified to take consent for a clinical trial?
- Understand that alternatives may be available to potential participants, this may include treatment alternatives
- Have an ability to communicate effectively with potential participants, including explaining complex scientific/medical concepts
- Understand the protocol and potential implications it may have on the people involved
- Appreciate how to optimise the voluntary nature of decision making, avoiding undue influence.
What key information must be given to a patient when discussing a clinical trial?
- They can withdraw from the trial at any time.
- The standard therapy is available if they do not enter the trial.
- Any other information the patient considers necessary to make an informed decision.
- Entry to the clinical trial is entirely voluntary and refusal will not affect their care in any way.
- Details of trial treatment and following up.
According to NICE, how is neutropenic sepsis defined?
Temperature >38 C and neutrophil count <0.5 x 10x9/L
However, patients @ risk should be treated empirically before blood results are available.
Clinical trials Phases: Overview
Clinical trials testing new treatments are divided into different stages, called phases.
- Earliest phase trials: look @ whether a drug is safe.
- Later phase trials: test whether a new treatment is better than existing treatments.
3 main phases of trials - phase 1-3.
Some trials have a phase 0 and there are some phase 4 trials after a drug has been licensed.
Phase 0 trials: Description + Aims
Phase 0 trials aim to find out if a drug behaves in the way researches expect it to from their laboratory studies.
Phase 0 trials aim to find out thing such as:
- Whether the drug reaches the cancer cells
- What happens to the drug in the body
- How cancer cells in the body respond to the drug
Phase 1 trials: Description + Aims
Phase 1 trials are usually small, only recruiting a few patients.
Phase 1 trials aims to find out:
- How much of the drug is safe to give
- What the side effects are
- How the body gets rid of the drug
- If the treatment helps shrink the cancer
Phase 2 trials: Description + Aims
Phase 2 trials can be for people who all have the same type of cancer, or for people who have different types of cancer.
Phase 2 trials aim to find out:
- If the new treatment works well enough to be tested in a larger phase 3 trial
- Which types of cancer the treatment works for
- More about side effects and how to manage them
- More about the best dose to give
Phase 3 trials: Description + Aims
Phase 3 trials compare new treatments with the best currently available treatments (the standard treatment).
Phase 3 trials aim to find out:
- Which treatment works better for a particular type of cancer
- More about the side effects
- How the treatment affects peoples quality of life
They may compare standard treatment with:
- A completely new treatment
- Different doses of the same treatment
- Having the same treatment more, or less, often
- A new way of giving a standard therapy (e.g. radiotherapy)
Phase 4 trials: Description + aims
Phase 4 trials are done after a drug has been shown to work and has been licensed.
Phase 4 trials aim to find out:
- More about the side effects and safety of the drug
- What the long term risks and benefits are
- How well the drug works when it’s used more widely
Trials covering more than one phase
Most trials are just one phase. But some trials cover more than one phase.
For example, the same trial can include both phase 1 and phase 2. So you may see some trials written as phase 1/2 or phase 2/3
GMC Guidance: Clinical trials
InGood medical practice,1 we advise doctors who are involved in research that:
- You must be competent in all aspects of your work, including management, research and teaching.
- You must be familiar with guidelines and developments that affect your work.
- You must keep up to date with, and follow, the law, our guidance and other regulations relevant to your work.
- You must act with honesty and integrity when designing, organising or carrying out research, and follow national research governance guidelines and our guidance.
