FAQ's - Learn more about medical trials and volunteering
Your medical research volunteer questions answered
Answers for volunteers
Clinical trial safety & regulation:
Types of medical trials:
Money:
Restrictions/ responsibility:
General:
After the trial:
The drug trial process varies slightly depending on the type of trial being conducted. You will go through a thorough informed consent process which will generally include the following:
- An introductory meeting involving one or more members of a research team, who will provide you with the informed consent document and explain its content to you. This information should be thorough, yet easy for you to understand, written in a way that makes it easy for you to take on board what is being explained and prompts you to ask questions if you are unsure or feel information is missing.
- Receive time to take on board and consider the information provided. This is your chance to think over and review all aspects to a trial, at your own pace and in the presence of family and friends. You can create a list of questions or concerns to discuss with your contact
- Check your understanding and ask questions. Next the clinical centre or research unit should then ensure that you clearly understand the information provided, either by having you fill out a questionnaire, asking you questions orally, or having you explain certain aspects of the drug trial in your own words. Make sure you ask questions and express concerns, no matter how minor they may seem to you. Keep asking questions until you have all the information you need to feel comfortable with making your decision to give your informed consent by signing a consent form indicating that you understand the nature of the trial and are willing to take part.
- Take a medical examination. This is required to check you are suitable and in good health before entering the trial.
- Receive continual updates on new information. As the trial proceeds, the research team may discover new information that could affect your health, welfare, or willingness to remain in the study. They will share this with you and may ask you to sign a new informed consent document. Of course, you are free to leave the study if this information leads you to have doubts about continuing to participate.
Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include:
- Why the medical research is being done.
- What the researchers aim to accomplish.
- What will be done during the trial and for how long.
- What potential risks are involved in the trial.
- What benefits can be expected from the trial such as the level of reimbursement.
- What other treatments are available, especially if you are a patient volunteer with an existing condition.
- The fact you have every right to leave the trial at any time after it has started.
If you have enrolled with a clinic and have been offered the chance to join a particular clinical trial, the research staff will give you informed consent documents that include important details about the study as listed above.
If English is not your native language, ensure you ask for the consent documents in a language you can clearly understand. Since joining a clinical trial is an important decision, you should not hesitate to ask the research team any questions you may have about the study and the consent forms before you make a decision, to sign and agree. Even after signing you may still withdraw from a trial. The informed consent covers does not end once you have signed and agreed to participate, so do not hesitate to ask questions during the trial.
Medical examinations will often include a blood and urine sample, height, weight, and an ECG to monitor heart and blood pressure. Volunteers will also be tested for recreational drugs. This is an additional safety measure to detect any illegal drug substance which may react with the medicines on trial. Each study is different so there may be additional tests to the above which may require additional visits.
For volunteers, involvement is usually only a matter of weeks, with occasional follow up visits. For paid trials, the longer your onsite involvement at a trial unit, the more you will be reimbursed. The entire research process for some trials can last for many years depending on how well the treatment works, with individual phases sometimes lasing many months.
Safeguards for healthy volunteers and patient volunteers are strict and the industry is very heavily regulated. The ethical and legal codes that govern medical practice also apply to clinical trials. Trial units are required to comply with guidelines on good clinical practice, good laboratory practice and good manufacturing practice.
A very basic way of determining if a drug trial should be safe is to ensure the following:
- The risks of side-effects to the drug being investigated are known, documented and explained clearly to all potential volunteers before they decide to take part – and you as a participating volunteer are happy to accept the risk of these side effects
- From the information presented and conversations had, you are confident the trial is being monitored carefully to help ensure volunteers don’t experience serious side-effects
- The protocol has been checked to make sure it is good quality science as well as being ethically sound
- The trial is run by an approved, regulated researcher and/ or organisation that is well-qualified and experienced at running trials
There are risks of side-effects with almost all treatments. This is one of the important reasons for carrying out clinical trials. Before you decide to take part in a trial, the researchers should tell you the background to the trial, in particular what is already known from the results of any earlier trials and other relevant research? They should also tell you about the possible benefits and risks of the treatments being compared. But as well as telling you what could happen they should also tell you their best estimates of how likely the risks are.
Serious side-effects may be very rare. For example, the risks of serious harm in a clinical trial may be much less than the risk of an accident when driving a car.
It will be up to you to weigh up the possible risks and benefits of all the possible treatment options. Your doctor and the researchers will have some information. But they will not know for sure – which is why the trial is necessary. As you could end getting any of the treatments being tested, it is important to consider whether any of the possible treatments have particular drawbacks for you.
Doctors and medical researchers cannot make you join a clinical trial – they must get your informed consent to take part.
By the time a medicine reaches the clinical trial stage it has already been extensively tested and researched in laboratories for likely side effects. However, part of the purpose of the clinical trials is to see what unexpected side effects emerge, and how severe or common they are. So as well as experiencing the benefits of a new medicine, there may also be side effects for some people. The doctor or study nurse will carefully record any problems or side effects you have, and these are relayed to the principal researcher to ensure that you are kept as safe as possible.
Ethics Committees examine every aspect and detail of a trial which could affect volunteers, to ensure participants are fully informed on all risks and potential side effects and can make an informed decision before participating. In the UK an Ethics Committee is an independent committee of physicians, statisticians, community members, and other suitably qualified experts that ensure a clinical trial is ethical and the rights of study participants are protected. The ethics committee working on a trial will ensure all written information given to potential volunteers, including the consent form, is reviewed for its accuracy and clarity.
Clinical research in the UK is a highly regulated industry; clinical studies must comply with the EU Clinical Trials Directive which is enforced in the United Kingdom by two governmental bodies, The Medicines and Healthcare products Regulatory Agency (MHRA) and by Approved Ethics Committees. The Clinical Trials Directive dictates that written consent from a volunteer is mandatory. As a volunteer you have to be fully informed about all aspects, risks and possible side effects of a trial before you give written consent.
Types of Trials:
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help the investigational research team answer different questions.
- In Phase I trials (Healthy Volunteer Studies), researchers test a new drug or treatment in a typically small number of volunteers (20 - 80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. These trials are usually paid trials, and are non-placebo controlled.
- In Phase II trials, the drug or treatment is given to a larger number of people (100 - 300) to better evaluate how effective it is and further evaluate its safety, often with patients who actually have the condition.
- In Phase III trials, the study drug or treatment is given to a large group of people (1,000 - 3,000) to determining whether the treatment offers clinical benefit in the disease/s for which effectiveness was demonstrated in Phase II of the clinical trial. They also help determine the nature and likelihood of any side effects. Phase 3 is conducted if Phase II results indicated the treatment has potential benefits which outweigh any side effects or safety concerns.
- In Phase IV trials, post marketing studies clarify and confirm information such as the drug's risks, benefits, and optimal dosage levels. Those clinical trials undertaken after the medicine has been approved for the treatment of a particular disease. Phase IV clinical trials are undertaken to compare a new medicine to a wider range of existing medicines/ therapies. Such clinical trials are used to establish where, in the range of treatment options, the new medicine is best used.
Are there different types of trials – other than phases?
- Treatment trials (also called interventional trials) test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials test the best way to detect certain diseases or health conditions.
- Quality of life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
- Observational trials address health issues in large groups of people. Trial participants may be asked to answer questions about their family histories or give blood samples, but they do not receive treatment for their diseases.
Most CRO’s provide incentives to healthy volunteers to compensate you for the amount of time you spend participating in a trial, and reimburse you for any inconvenience and travel expenses incurred along the way. Generally speaking, Phase I clinical trials will pay you for participating, while others will not. In some trial studies, you may be reimbursed for expenses associated with participating in the research such as travel costs, child care, meals, and accommodations.
As a healthy volunteer, you may be compensated £80-150 per day for your inconvenience, depending on the trial and unit. Study-related medical care and study medication(s) or treatment(s) are generally provided free of charge.
The trial sponsor and investigator jointly make a decision about how much volunteers are paid. An ethics committee then reviews the level of payment to make sure it is appropriate. The amount you could receive for participation is largely in proportion to the amount of time required of you to be in the trial. Some trials may require you to visit a site for just two hours, stay overnight or live in for 2 weeks. Hence the total amount you can receive as a healthy volunteer could be as little as £20 or well over £2,000. For patient volunteers one of the possible benefits is gaining access to promising new treatments before they are widely available.
Every clinic has its own payment scheme. Generally speaking, payment is usually in the form of two bank cheques. 50% of the study compensation fee is usually given to you at the end of a study, and the remaining 50% at post study medical. If the study is of long duration, the clinic may make an additional payment at a specified time point.
A majority of the time clinical trials are funded by pharmaceutical companies who are testing new products, however a variety of different organisations might pay for trials to take place including:
- The NHS or Medical Research Council - run trials funded by the MRC and the NHS looking at various treatments for different types of cancer, HIV/AIDS and other illnesses
- Other government agencies such as the Department for International Development - which work on helping address health problems in developing countries. For example trials looking at a treatment that might prevent HIV/AIDS, which are funded by the Department for International Development.
- Charities, (Cancer Research UK, Arthritis Research Campaign) who want to find out more about best treatments for a particular illness.
- Pharmaceutical (drugs) companies conduct most clinical trials in this country and elsewhere. They need to run trials to test new drugs or other treatments. Drugs companies will often help fund trials which are being run at dedicated research centres.
Restrictions/Responsibility:
Restrictions depend on the trial; smoking may be permitted, or restricted to generally no more than 10 cigarettes a day. If smoking is allowed there are designated areas in the unit. Restrictions on alcohol depend on the trial and usually no alcohol is permitted 24 – 48 hours before each session; however this is in the trials protocol and something that would be discussed with you.
YES, you will be tested at screening and often at every admission period for recreational drugs, which includes cannabis, "E’s", and other hard drugs. It is advised to potential volunteers that cannabis stays in your system for at least 3 weeks.
Can a volunteer leave a clinical trial after it has begun?
Yes. A participating volunteer can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Yes. A participating volunteer can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Your responsibilities will be explained to you by the clinical trial staff. In general, however, you must see your study doctor as scheduled and take your medication as prescribed. You may also be asked to keep a diary of your experience with treatment; this may help to give your study physician information on the safety and effectiveness of the treatment. You should also contact your own doctor as well as the study physician as soon as possible if you are hospitalised for any reason. In addition, it is important to let all of your non-study physicians (i.e. your GP/ Doctor) know that you are participating in a clinical trial. They will need the name and telephone number of the study physician in order to let him or her know about any pertinent medical information which may affect your treatment in the trial. You may consider keeping the study physician's name and number with you at all times at all times in case of emergency.
General:
What is a trial protocol?
All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the clinical study. While in a trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the clinical study. While in a trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
Both male and female volunteers may apply, depending on the criteria for the trial. The age range is most commonly between 18 and 45; however a number of trials are run for volunteers of all ages. Trials being advertised on Enter Trials list application criteria for that specific trial.
Clinical trials have application guidelines using inclusion/ exclusion criteria, which determines whether you are suitable based upon criteria such as medical history, gender, age, stage of a disease or condition you may have, and other such criteria. You must match the set criteria before you will be allowed to participate as this helps to produce reliable results and ensure safety of participants. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". Some clinical research studies seek participants with illnesses or conditions called patient volunteers to be studied in the clinical trial, while others need healthy volunteers.
Many clinics in the UK require you to have been registered with a Doctor in the UK for 6 – 12 months, however in places such as London, Ireland and Scotland a number of CRO’s will accept your enrolment to a clinical drug trial if you were registered with a Doctor in your home country for at least 6 months, and that Doctor could provide a referral upon request from the clinic. A number of London clinical trials and some in Scotland and Ireland will also accept 3 month registrations with a UK Doctor.
Clinical trials can pay quite well, but that does not mean they should or could replace a part or full time job. There are some regulations around the frequency that you participate in clinical trials, and most clinical units and research organisations will have policy restrictions. Many students and travellers treat trials as a short term alternative to part time jobs or temporary jobs, however trial participation cannot replace the ongoing benefits of permanent part time jobs. It is recommended that volunteers aim to participate in no more than 4-5 trials a year. It is usually 3 months after the post study medical before it is considered safe and ethical to take part in another trial, although this can be more or less depending on the rules of the next trial you wish to participate in.
TOPS is a database shared by most Clinical Research Organisations in the UK to record when healthy volunteers take part in trials and to help prevent them from taking part too often. Healthy volunteers must not take part too often in trials of new medicines, for scientific, medical and ethical reasons:
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if the gap between 2 trials is too short, or 2 trials overlap, the medicines might interact;
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taking too many blood samples could cause anaemia; and
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it's unethical to expose healthy people too often to medicines they don't need
At the end of the trial, the researcher should make the results available to everyone who took part. If not, you can always ask the researcher or your doctor to tell you about the conclusions. The results should provide more information about the possible risks and benefits of the different treatments that have been tested. They may help you and others like you to make more informed decisions about your healthcare.
Some researchers will also work with patient groups to ensure that the results of trials reach other patients. Researchers have a responsibility to publicise the results of their trial even if the results show that a new treatment doesn’t work. They might do this at a conference, in a medical journal or in the press.
Do all participants receive the trial medicine being investigated?
In order to determine objectively the benefits of a new medicine it is necessary to remove any subjective bias. This is particularly the case in Phase III and IV clinical trials where participants are normally divided into 2 or more groups.
In order to determine objectively the benefits of a new medicine it is necessary to remove any subjective bias. This is particularly the case in Phase III and IV clinical trials where participants are normally divided into 2 or more groups.
One group (the test group) is given the trial medicine while the other group (the control or reference group) is given the standard treatment for the disease or condition. Where there is no pre-existing standard treatment, a placebo — a look-alike or dummy medicine containing no active ingredient — may be given to the control group instead. Participants are randomly assigned to either group.
Ideally, neither researchers nor participants should know which group a particular patient is in. Clinical trials where this occurs are referred to as double blind trials. However, safety does come first. Should a participant develop an unexpected or serious side effect the blinding of the trial can be broken so that appropriate action can be taken.
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