Frequently asked questions

What kind of medication will I have to take? Clinical trials units help the world’s leading pharmaceutical companies develop existing and potential new medicines. Each study is different and volunteers may be asked to trial an existing medication that requires further testing or they may be asked to trial a new medication that has not been tested in humans before. If you decide to put yourself forward for a clinical trial you will be given a patient information sheet (typically at the screening visit, although this can be requested before you attend a screening visit) that will give you detailed information on the medication being tested. This information will include what the intended use of the medication, the trials that have already taken place, (if any) and the known potential side effects.

Will I be told everything that is involved in the study? Yes you will initially be provided with a patient information sheet (before you attend the consent visit) that will give you detailed information on the medication being tested. This information will include what the intended use of the medication, the trials that have already taken place, (if any) and the known potential side effects. If you are happy to move forward you will then be given an opportunity to speak to a doctor working on the study. In this meeting the doctor will explain the study in detail and you will have an opportunity to ask any questions you may have. Remember if you are not satisfied with the information you are provided at the meeting with the doctor, you do not have to progress this enquiry any further.

Can I drink alcohol? Usually not for 24 to 48 hours before each session of a study, and whilst on a study. You may be allowed alcohol between sessions, but this will be outlined in the protocol and discussed at the pre-study information session.

What happens at a pre-study medical? You meet a doctor first who will answer any questions you may have. You should then be asked to sign a consent form to give your permission to undergo the screening procedures to determine if you would be suitable to take part in the study. If you decide to consent to the screening procedures, the doctor will then ask you about your medical history and give you a thorough medical examination. You will then have certain procedures performed, usually urine and blood samples, blood pressure, height and weight and ECG (Electrocardiogram – a heart activity tracing). Each study is different, so there may be additional tests to the above, which may require additional visits and procedures at the information session.

Why do we have to eat at set times? In studies where you are asked to stay in a clinical trials unit each person on the same study must eat at the same time so that consistent results regarding absorption of the drug from your “stomach” are obtained. The timepoints are set by the pharmaceutical company sponsor and must be adhered to. In some studies, you are not required to be resident in the clinical trials unit for the duration of the clinical trial and therefore it is harder to control what volunteers eat and when. However, if you take part in a study that does not require you to be resident in the clinical trials unit for the duration of the clinical trial there will eb certain foods and drinks you will be asked to avoid until you have completed the clinical trial. These include eating foods containing poppy seeds and drinks containing caffeine.

Will the insertion of the small plastic tube (cannula) into my vein through which you draw blood hurt? The insertion of the cannula should not hurt. A cannula can be left in the vein for 24-48hrs and is used to avoid having to continuously puncture veins to get blood samples on days where multiple blood samples are required, (PK days). On days where only a few samples are required, and no cannula has been inserted into the vein, a member of the clinical team will insert a needle attached to a blood collection tube only for the duration of the blood collection.

What short or long-term side effects might there be? Each medication is different and will have different side effects affecting different people. The common short-term side-effects are short term feelings of sickness, headaches, drowsiness and possibly a slight change in blood-pressure (feeling faint). Any expected side-effects will be explained at the pre-study information session with the research physician. Usually, any side-effects are short-lived and will have disappeared prior to your post-study medical examination. If you are suffering from a longer lasting side effect, the clinical trials unit you did the trial with will monitor your situation until the side effect has resolved or they will refer you to specialist if this is needed.

Has anyone died or become seriously unwell due to their participation in a study? Over twenty years ago there were two fatalities. In both instances the fatalities were a consequence of the volunteers withholding information of drug/medicine use from the study doctor. More recently in 2006 some volunteers became ill at a clinical trial taking place at a clinical trials unit within Northwick Park. None of the volunteers affected died, however some were very ill. Since this case, the regulation regarding the conduct of clinical trials and those units that can perform clinical trials has become much stricter. Clinical trial’s units are regularly assessed by the Medicines and products Healthcare Regulatory Agency, (MHRA) to ensure they meet the requirements to perform clinical trials. Ensure you ask if the trials unit you are approaching to do a clinical trial with has been accredited by the MHRA. Also be honest about your medical history and recreational / prescribed drug use.

Are all studies reviewed by an Ethics Committee and who are they? All clinical study protocols are reviewed by an Ethics Committee and the Committee should be entirely independent from the clinical trials unit conducting the trial for whom you are doing the study. Typically the advertising of a trial and the patient information sheet will state that the trial has been approved an independent ethics committee, however if this is not clear you should ask the doctor when you meet with them to discuss the study initially. The Committee is responsible for ensuring that the information provided to you is fair, balanced and accurate and that your rights as a volunteer are maintained. The Committee should consist of technical people (including doctors and pharmacists) and non-technical people such as lawyers and teachers. The mixture of technical and non-technical people means that both scientific and medical information is thoroughly reviewed and that the information is put in clear, non-technical terms for potential volunteers. The Ethics Committee also reviews all volunteer advertising material.

Will taking part in the study have any effect on an application for health or life insurance? There is no evidence that anyone has been refused cover because of participation in a clinical trial. Different insurance companies have different rules and should you have concerns you should discuss this with your insurer.

When can I do my next study? Usually 3 months after the post-study medical, although this can be more or less depending on the rules of the next study you wish to take part in.

Do CROs have a financial interest/share in the companies (sponsors) developing medications? In most cases the clinical trials units will have no financial interest in sponsors, other than the fees charged for conducting the study, and these are dependent on the scientific outcome. In some situations the trials unit will be owned by the pharmaceutical sponsor, however they will still act impartially.

Will I be paid for taking part in a clinical trial? The answer is yes. You will be paid for the time you give up for a clinical trial and this payment is only for time and NOT linked to risk or inconvenience. You will be paid for the time you spend with the clinical trials unit and payment is proportional to the time you spend on a study. For example, you will be paid a lot more if you take part in a 2-week study with lots of extra visits than if you take part in a single overnight study. You should not view participation in clinical trials as equivalent to employment and under no circumstances should you participate in more than one clinical trial at a time.

What is a placebo? A placebo is an inactive, fake, or "dummy" medication or treatment designed to resemble a drug or treatment and given in the same way. Any improvement in health that is measured, observed, or felt after the placebo is given is called the "placebo effect". In clinical trials, a placebo may be given to one group of participants instead of the active drug or treatment in order to assess whether the latter is actually effective

For further information on participating in clinical trials in plain english visit https://clinicaltrialsexplained.com