Frequently asked questions
What is a clinical trial?
- A clinical trial is conducted to find better ways to prevent, diagnose and treat diseases.
Trials of new potential treatments may show which medical approaches are better for different illnesses or groups of people.
A clinical trial is designed to find which treatments are most effective.
A clincal trial is one of the final stages in the long and careful research and development process to find better healthcare solutions.
Are clinical trials safe?
- There are very strict guidelines and safeguards to protect participants in clinical trials
Whilst in a clinical trial, participants are seen regularly by the research team to monitor their health, and to determine the safety and effectiveness of their treatment
Governing bodies and independent review boards oversee all studies and ensure risks are as low as possible
Who pays for clinical trials?
Trials may be sponsored by pharmaceutical companies, biotech agencies, medical research institutions, foundations or trust organisations
What is a protocol?
- A protocol is a study plan carefully designed to safeguard the health of the participants and answer specific research questions.
The protocol describes the purpose of the trial, how it will be preformed, the types of people who can participate, the schedule of tests, proceedures, medications and length of the study.
What is informed consent?
- Informed consent is the process by which an individual voluntarily confirms their willingness to participate in a particular trial.
You will be given a copy of the informed consent document, which contains information regarding all aspects of the trial
The informed consent form states why the research is being done, what will happen during the study, the time involved, the risks and benefits, your rights as a participant and how your privacy will be protected.
An informed consent form must be signed before any study proceedures can be undertaken
Who can participate ia a trial?
- All clinical research studies have guidelines called eligibilty criteria which determine who can participate.
These guidelines are based on factors such as age, medical history, current medical conditions and medications
These criteria are used to identify suitable potential participants
How much time is involved?
- Trials vary in length and time requirements
All this will be fully explained to you before you decide whether or not to participate
What if I change my mind?
- Involvement in clinical research trials is voluntary
You are able to change your mind and withdraw at any time
Withdrawal will not effect any future medical care
How are my rights protected?
- All trial particpants are protected by the Health and Disabilty Act Code of Rights
There are very strict international standards and regulations for all trials involving human participants
All your medical records and information will remain completely confidential
What is a placebo?
- A placebo is an inactive substance that has no therapeutic effect
In clinical trials experimental treatments are often compared with a placebo to assess the effectiveness of the treatment
Will I learn the results?
- The results will be made available to you when the trial has been completed
Will I be paid?
- This varies depending on the trial
You will be reimbursed for your expenses while participating in the trial e.g. travel costs
Where can I find out more about clinical trials?
- The CGM Research staff are happy to answer all your questions
You can talk to your own doctor or specialist
You can also contact the Health & Disabilty Committee (HDEC) ph 0800 384427