TYAResearch:
Clinical Trials
FAQs Clinical Trials
All the questions below were developed focus group discussions with our TYA group.
What’s it like to be on a clinical trial?
It can all depend on the clinical trial itself, but generally speaking if the treatment you are getting works and is stopping your cancer grow you can stop on the trial.
But if the treatment you are getting is causing you to be unwell, and you are not getting any benefit the clinical trial would stop then. Taking part in a clinical trial is completely voluntary, so you can decide to stop taking part in one, at any time for any reason. If you are asked to take part in one, this will all be explained to you before you consent to taking part.
You might want to take part because the treatment within the clinical trial has been show to maybe better than the treatment you are currently getting.
In some cases when chemotherapy and radiotherapy stops working, clinical trials offer patients a different kind of treatment for their cancer. Without people taking part in clinical trials, we wouldn’t be able to make new or better treatments for cancer patients.
Yes, they are completely free. You do not pay anything to take part in a clinical trial.
That’s a hard question to answer as every clinical trial treatment is very different.
Some clinical trials stop at phase one, as there is not enough information to prove it is a good treatment for stopping cancer, while other clinical trial treatments can get approval to be used in the NHS. If you are asked to take part in a clinical trial, ask your doctor what the evidence is for doing the trial, what is the success rate of the treatment. They will be able to provide you with this information, it might be some you want to consider before deciding to take part.
Similar to when you get chemotherapy, you may have to have a needle called a cannula put into your arm, to be able to get the treatment.
Patients in clinical trials have blood samples taken at appointments, to check you are well and to see how the treatment is affecting you. For some people this can be painful, if you are asked to take part in a clinical trial you may want to ask your doctor how the treatment is given to you, and how many blood tests will be taken.
You don’t get paid anything, taking part is voluntary.
At the beginning of the clinical trial there can be quite a few visits to hospital, this is normally before you receive a clinical trial treatment.
There are a lot of visits at the beginning as you need to have scans, blood tests and been seen by the medical team to make sure it is safe for you to take part. Once your doctor says it is safe for you to receive treatment you are normally seen 2-3 times a month, while getting the treatment.
A clinical trial participant , someone that has consented to taking part to received an clinical trial treatment.
You can also get involved in Patient and Public Involvement (PPI) group in clinical research. PPI aims to ensure that research is relevant, meaningful, and responsive to the needs, preferences, and priorities of the people it seeks to benefit. This is very different to being a clinical trial participant, it often involves being part of group that supports researchers develop research ideas or patient protocols / information for clinical trials. If you are interested in getting involved in PPI contact.
When a clinical trial stops, patients maybe able to start another clinical trial, go back under the care of the doctor that referred them for the clinical trial or be referred to another medical department for support. At the end of the trial you will have a discussion with your doctor, at this meeting you will agree what is the best option for you.
Several factors can disqualify individuals from participating in clinical trials. Some common reasons for disqualification from clinical trials include:
Medical History: Certain medical conditions, illnesses, or comorbidities may disqualify individuals from participating in a clinical trial. These conditions may interfere with the study’s objectives, affect treatment safety or efficacy, or confound the interpretation of study results.
Medications: Some medications, treatments, or therapies may be contraindicated for participation in a clinical trial due to potential interactions with the investigational treatment, safety concerns, or effects on study outcomes.
Laboratory Test Results: Abnormal laboratory test results, such as abnormalities in blood counts, liver function tests, renal function tests, or other biomarkers, may disqualify individuals from participating in a clinical trial. These abnormalities may indicate underlying health issues or potential safety risks associated with the investigational treatment.
Performance Status: Clinical trials may assess participants’ performance status or functional capacity to determine their eligibility for enrollment. Poor performance status, functional impairment, or inability to tolerate study procedures may disqualify individuals from participating in certain trials.
Psychological or Cognitive Factors: Psychological or cognitive impairments, such as severe mental illness, dementia, or cognitive deficits, may affect individuals’ ability to provide informed consent, comply with study requirements, or accurately report study outcomes, leading to exclusion from clinical trials.
Previous Treatments: Prior exposure to certain treatments, therapies, or interventions may disqualify individuals from participating in clinical trials, particularly if they have received investigational treatments, experimental therapies, or other interventions that could confound study results.
When you are asked to take part in one, read the information you are given about the clinical trial.
Take it home, let your friends and family look at it, and only when you are happy to take part do so. Clinical trials are often offered to cancer patients by their doctors, as they think it is the best option. However, always read the clinical trial information and ask your doctor any questions you have about the trial – there is no such thing as a stupid question if you don’t know the answer. And remember, taking part in one is your decision, you don’t have to take part and if you decide not too, it wont affect any of your care.
More information on the different phases of clinical trials.
Phase 4 cancer trials, also known as post-marketing or post-approval trials, occur after a treatment has been approved by regulatory agencies and is available for use in clinical practice. These trials aim to further evaluate the safety, effectiveness, and long-term outcomes of the treatment in larger and more diverse patient populations than those studied during earlier phases of clinical development.
Below are some of the common types of cancer clinical trials
Treatment trials
Researchers run treatment trials in stages. These stages are called phases.
The early phases aim to find out more about the safety and side effects of a new treatments. Later phases aim to see if a new treatment works better than the current treatment. Or if a new treatment works better than a dummy drug (placebo Open a glossary item)
For trials that compare two or more treatments, you are put into a treatment group at random. This is a randomised trial. They are the best way to get reliable information about how well a new treatment works.
Multi-arm multi-stage (MAMS) trials
A multi arm trial is a trial that has: several treatment groups as well as the standard treatment group (the control group Open a glossary item)
Multi-arm multi-stage (MAMS) trials have the same control group all the way through. The other treatment groups can change as the trial goes on. As these trials are more complex there are a number of treatments that people might have.
The research team may decide to stop recruiting people to a particular group. This could be because they have enough people to start looking at the results. Or because early results show the treatment isn’t working as well as they’d hoped.
The researchers may add new treatment groups as new drugs become available to look at. This means they don’t have to design and launch a brand new trial each time they want to research a new treatment. So it helps get results quicker.
Cohort studies
A cohort is a group of people, so cohort studies look at groups of people. A cohort study follows the group over a period of time.
A research team may recruit people who do not have cancer and collect information about them for a number of years. The researchers see who in the group develops cancer and who doesn’t. They then look to see whether the people who developed cancer had anything in common.
Cohort studies are very useful ways of finding out more about risk factors. But they are expensive and time consuming. They can be used when it wouldn’t be possible to test a theory any other way.
Cancer clinical trials can fail for various reasons, some common reasons for the failure of cancer clinical trials include:
Inadequate Patient Recruitment: Clinical trials require a sufficient number of participants to generate meaningful and statistically significant results. Challenges in recruiting and retaining eligible participants can lead to delays or premature termination of trials, particularly if the target population is small or difficult to reach.
Lack of Efficacy: Despite promising preclinical or early-phase results, some treatments may not demonstrate the expected efficacy or benefit when tested in larger and more diverse patient populations. The complexity of cancer biology, tumor heterogeneity, and variability in treatment response among individuals can contribute to the failure of treatments to show significant clinical benefit.
Safety Concerns: Unforeseen safety issues or unexpected adverse events may arise during the course of a clinical trial, leading to concerns about the safety profile of the treatment. Serious adverse events or toxicity can prompt the suspension or early termination of trials to ensure the safety of participants.
More information about cancer research and clinical trials.
Cancer research is challenging due to the complex nature of cancer and the multitude of factors that influence its development, progression, and treatment. One of the reasons why cancer research is particularly difficult is because of Biological Complexity.
Biological Complexity: Cancer is not a single disease but a collection of diseases characterized by abnormal cell growth and proliferation. There are over 200 different types of cancer, each with unique molecular characteristics, genetic alterations, and clinical behaviors. Understanding the diverse biology of cancer and its underlying mechanisms and developing cancer treatments requires extensive research and collaboration across multiple disciplines.
Yes, to find out more about Cancer Research UK which leds on cancer research in the UK.
Patients don’t have to pay to take part in clinical trials, but new cancer treatments are expensive to develop and take a number of years. To find our further information visit.
To find out more information
The idea of “curing” cancer is complex and depends on several factors, including the type of cancer, its stage at diagnosis, available treatments, and individual patient characteristics. While complete cure for all cancers may be challenging, significant progress has been made in cancer research and treatment over the years, leading to improved outcomes and survival rates for many types of cancer.
Your Doctor does not get paid extra money for putting you into a clinical trial, this is illegal.
Clinical trials can play a crucial role in the management and treatment of stage 4 cancer.
Stage 4 cancer, also known as metastatic cancer, refers to cancer that has spread from its original site to distant organs or tissues in the body. While stage 4 cancer is generally considered incurable, clinical trials offer valuable opportunities for patients with metastatic disease to access new treatments, experimental therapies, and innovative approaches that may improve outcomes, prolong survival, and enhance quality of life.
Only cancer patients can take part in a cancer clinical trial, some clinical trial enrol patients with stage 4 cancer , while others may recruit patients with stage 1 cancer. It very much depends on the phase of research – click here to find out more about the phases of research in the animation below.
Clinical trials involved an experimental treatment, if you are taking part in one you cannot take part in another one at the same time.
Having two experimental treatments at the same time is not allowed, as you would be able to tell which treatment is work or not, aside this it is potentially extremely dangerous to have two experimental treatments at the same time.
Some research studies involve collecting blood samples from you, or asking you for permission to have some of a biopsy you have had taken in the past from your cancer.
These types of study look at these samples to try and find out how cancer works, cancer is a very complicated disease. Having more information about how cancer works, allows us to make better treatments to treat cancer – so its an important part of cancer research.
All clinical trials have risks, you might get side effects from the treatments which may make you feel unwell.
As part of a clinical trial you are looked after by doctors and nurses, and all of your side effects will be managed by them. If you are asked to take part, ask you doctor what the clinical trial risk are, or what side effects you may get.
If you want to take part in one, and there isn’t one open at the hospital you are receiving you cancer care at you can look at the Cancer Research UK trial finder.
