Volunteers who elect to participate in clinical trials are vitally important to medical research and development of new drugs as they test the product and help doctors, and indeed pharmaceutical companies, gain a better understanding of how, and if, the drug is effective for its intended purpose.
The role of clinical trials in scientific advancement is crucial as a positive outcome of such a trial can lead to new drugs being licensed or new treatments being recommended. It is hoped that this would help many patients, not just in the UK, but internationally.
Whether you are a healthy volunteer or a patient receiving treatment for an existing condition, taking part in a clinical trial can be a daunting prospect.
When agreeing to take part in a clinical trial you are essentially electing to take a medicinal product that has either:
- not yet been licensed at all or in the country in question;
- been licensed for use in treating certain conditions but has not been authorised for use against another now being trialled; or
- not been licensed for use at a particular dose or in the manner of administration now being considered.
As with all medication, there is always a possibility of suffering from a side effect. As the trial drug has not been through all the relevant, and rigorous, testing stages (or “phases” as they are known as in a clinical trial setting) there may be an increased risk that you could suffer from a side effect that has not previously been associated with that treatment. These side effects can vary from quite minor, short-lived symptoms to potentially life-threatening and permanent effects.
Already this year I have applauded (see Twitter @GeneMatthewsLaw) numerous success stories in clinical research, such as the development of a drug to treat patients with heart valve disease, the identification of a protein which could extend the life expectancy of breast cancer sufferers and the life-extending possibilities of a drug to treat ovarian cancer. Publishing details of clinical trials that are not successful is equally important to drug development and the advancement of medical science.
Clinical trials can result in improved treatments, which could save lives. Increased patient participation allows the benefits of successful treatments to be proven more quickly so they can be made available without delay. Of course every step must be taken to ensure that clinical trials are safely conducted – to protect participants, but equally to encourage public confidence in the process. Therefore, whether you are a patient hoping a new drug will treat your condition or a healthy non-patient volunteer taking part in a trial for the benefit of research, there are some questions you may like to ask before signing up!
We have compiled our “Top 5 Questions” volunteers should ask before participating in a clinical trial:-
1. What stage of testing is the product at? What were the outcomes of previous trials? Has it been tested on humans before?
This may give you some idea as to the purpose of the trial, the trials that have been carried out previously and what the researchers hope to learn.
2. What are the risks/benefits of taking part in the trial?
For patient volunteers, this may help you to establish the pros and cons of taking this new treatment over old-established methods. Don’t be afraid to tell your doctors that you want time to consider your options. Becoming involved in a trial is a big decision!
3. What will my participation in the trial involve? What will be asked of me?
It is important that you get as much detail as possible about the trial before signing up. This should be outlined in writing in the trial documentation, such as the consent form and patient information sheet, and the documentation should be discussed with you in detail. If you are a healthy volunteer remember that your involvement may require one or more stays in hospital, taking unknown quantities of a drug and undergoing a large number of tests or investigations (blood tests, urine samples, ECGs, etc.) which can be quite intensive. You may also be restricted from eating or drinking certain things or prohibited from taking certain medication whilst taking part in the trial, so try to clarify exactly what you can and can’t do whilst participating.
4. What are the known side effects of the drug or treatment?
Trial documents, such as consent forms and patient information sheets, can be technical and include medical jargon. Although any potential, known, side effects should be explained to you in a face to face meeting, there is usually a lot of information to take in. Again, don’t be afraid to ask if you don’t understand a particular term or procedure. You can always ask for more time to consider the documentation in detail and make a note of the questions you would like to ask – don’t feel rushed into making a decision.
5. What happens if I become harmed? Is there adequate insurance in place to cover this?
The clinical trial documentation a participant is invited to sign should incorporate a legally binding obligation to pay compensation to the volunteer in the event of injury, recognising the risks you are taking and the service you are providing by participating. However, it is always best to ask and ensure that you know your rights prior to consenting. Often people think that signing a consent form means they have no right to claim - that they have accepted the risk of taking an unlicensed product and any harm suffered as a result. This is a common misconception. Pharmaceutical companies sponsoring clinical trials are required to ensure suitable insurance arrangements are in place should the participant suffer harm as a result of the trial.
The answers to the above-mentioned questions should help you to make an assessment as to whether or not you wish to proceed. It is important that you get as much detail as possible about the trial before it commences.
Once you have made a properly informed decision to participate you can feel confident that you are making a real difference to medical research and the development of better treatments for all.