The results of one treatment are compared to those of another in clinical testing. Patients, healthy people, or both may be present.
I’d like to take part in a clinical trial.
Inquire with your doctor or a patient group to see if there are any clinical studies in which you may be allowed to participate.
You may also register your interest in participating in research and do informative searches on several websites.
Participate in a website research
A variety of UK registries provide information on clinical trials and other research on the Be Part in Research website.
You may browse the Be Part of Research website for research that interest you. You may also contact researchers directly.
World Health Organization (WHO) International Clinical Testing
The WHO International Clinical Trials Registry Platform (ICTRP) website provides access to clinical trials taking place in countries all over the world.
Why should you take part in a clinical trial?
Clinical testing helps doctors find the best strategy to treat a certain condition. It could assist others like you or you in the future.
Participating in a clinical research might make you one of the first people to benefit from a revolutionary treatment.
However, there is a chance that the new treatment will be equally as effective as, if not worse than, the present one.
Visit the website healthtalk.org to read about other people’s clinical trial experiences.
Will you compensate me?
Payment for clinical testing participation varies depending on what is expected of you.
Some clinical trials just cover your travel expenses and may not offer you a compensation.
Before enrolling, it is important to understand about the disadvantages and risks involved and carefully assess if it is beneficial.
Keep in mind that it may take some time. You may be asked to attend many screening and follow-up sessions, and some studies may even require you to stay overnight.
For example, you may be asked to stop from eating or drinking alcohol for a certain period of time. You may also have unforeseen side effects from the treatment.
How does a clinical trial work?
Assessing A New Medicine
All clinical trials go through a variety of steps to assess if new medications are safe and effective.
Typically, the medications will be compared to a control, which is a distinct kind of treatment.
In its place, a placebo or an established conventional treatment will be utilized.
Phase 1 studies include administering the medicine to a limited number of volunteers, some of whom may be healthy.
- The drug is being tried on humans for the first time.
- Researchers investigate possible side effects and identify the appropriate dose for treatment.
- Researchers simply raise the dose after beginning with a modest quantity if subjects experience no negative effects or have minor adverse effects.
Phase 2 studies use a larger number of ill people to assess the new medicine. This is done to have a better understanding of the immediate effects.
Phase 3 studies are carried out on drugs that have passed stages 1 and 2.
To see whether the treatment is more successful in real-world conditions and if it has major side effects, it is tested on larger groups of ill people and compared to an existing therapy or a placebo.
Many clinical testing last a year or more and include thousands of participants.
Trials in the fourth phase:
While the medicine is in use, researchers continue to investigate its benefits, side effects, and safety.
Not all drugs need this.
Only used for pharmaceuticals that have passed all preceding testing and have been issued marketing licenses; a license indicates that the medication is only available with a prescription.
Randomization, blinding, and control groups
If you participate in a clinical trial, you will typically be assigned at random to one of three groups: the treatment group, which will receive the therapy being evaluated; the control group, which will receive an already approved standard treatment; or the placebo group, if no such treatment is available.
Even though the two groups get different treatments, the bulk of the other circumstances are maintained as similar as possible by researchers.
For example, both groups should have a similar age range, gender distribution between men and women, and overall health levels.
The majority of trials will use a computer to choose each patient’s group at random.
In many trials, no one knows who is allocated to which treatment.
Blinding is a strategy that reduces the influence of bias when comparing the outcomes of different treatments.
What should I know before registering?
When you express interest in a research, a doctor or nurse will most likely contact you.
In addition, printed materials will be given for your own use.
When you return, you may have some questions that you believe have not been answered.
General Questions
- What is the objective of the experiment, and how will it help people?
- Who will foot the bill for the trial?
- What type of care will I get if I do not take part in the trial?
- How long will I be expected to engage in the research, and how long will it last?
- How long will it take for the results of the experiment to be made public?
- What happens if I cease the trial’s treatment or leave before it is completed?
- What would happen if anything went wrong? Although it is unusual for patients to be harmed as a consequence of experimental therapy, you may decide to seek compensation in this situation.
Practical investigations
- How much of my time will you require?
- Should I take some time off from work?
- Do I get compensated?
- Will my travel expenditures to take part in the study be reimbursed?
- If the research involves assessing a new medicine, would I have to pick it up from the hospital, will it be mailed to me, or will my doctor supply it to me?
- Will I have to answer questions or keep a journal?
- What are the possible side effects of my medication?
- What physical and psychological consequences can the treatments have on me?
- Who can I contact if I need assistance?
- Is someone available every day of the week?
- How can I find out what happened in the trial?
Consider the following:
As with any other surgery, you cannot foresee the outcome.
It is likely that the new treatment you get will not be as effective as the one you previously received.
Furthermore, you are likely to have severe side effects.
Remember that you may need to visit your treatment facility more often or undertake more tests, treatments, or monitoring than if you were receiving the recommended care.
After A Trial
If you think the treatment is not helping you or that your condition is worsening during a trial, you may choose to withdraw from it.
Furthermore, you have the choice to leave at any moment without giving a reason and without affecting your treatment.
Results
The researchers should publish the results of the experiment and make them available to everybody who participated and was interested in knowing the findings.
If you want to know the results, ask for them if the researchers do not disclose them.
Certain study sponsors, such as the National Institute for Health study (NIHR), publish the results of the studies they have financed on their websites.
For further information, go to the NIHR website.
How are trials regulated and ethically assessed?
Before a new drug’s clinical research can begin, the Medicines and Healthcare products Regulatory Agency (MHRA) must review and approve it.
The MHRA inspects the sites where studies are conducted to verify that they are carried out in compliance with best clinical practice.
Visit the GOV.UK website to discover more about the MHRA.
The Health Research Authority (HRA) works to protect and promote the interests of the public and patients in medical research.
It oversees all research ethics committees in the country.
Every medical study involving people done in the UK, whether for the NHS or the private sector, must first be approved by an independent research ethics board.
The committee protects the rights and interests of trial participants.
To learn more, go to the HRA website.
How are test results used to improve medical care?
Clinical trials may help with:
- testing a vaccine for disease prevention
- Identify or diagnose disorders with a scan or blood test.
- to put new or existing treatments to the test in order to cure illnesses
- Determine how people may control their symptoms or improve their quality of life, for example, by investigating the impact of a certain diet on a disease.
Many clinical investigations are carried out to examine if new drugs work as expected.
The MHRA considers these results before considering whether to allow the medication’s maker to market it for a specified purpose.
The Authorization Of A Cure
Before a new drug found via research may be commercialized, the MHRA must issue a license.
The licensing of a therapy indicates that it has met safety and effectiveness standards.
Safety must be continuously monitored over the first few years of a newly authorized treatment.
This is due to the likelihood of unexpected side effects that were not seen during clinical research manifesting quickly.
In England and Wales, the National Institute for Health and Care Excellence (NICE) decides whether certain treatments should be provided by the NHS.
For further information, go to the NICE website.
Where can I discover trial results that are relevant to me?
Clinical trial results are often published in specialist medical journals and online evidence repositories.
Some of the more well-known examples are as follows:
The medical publication The British Medical Journal, The Lancet BMJ
The Medical Journal of New England Cochrane Library is a credible data source.
You may use a search engine like Google to discover articles and read abstracts.
However, in most situations, you must subscribe to the newspaper to see the whole article.
Furthermore, study publications often include a lot of medical, scientific, and statistical jargon and are not written in plain English. They might be really difficult to grasp.
