Everyone has different ideas of what are acceptable risks. Some people choose to sky-dive, race fast cars or bungee jump, whereas others would feel too uncomfortable with the risks to ever try them. In that sense, assessing the risk of taking part in a clinical trial will also be an individual decision, because different types of trials have different levels of risk.
Some people are quite happy to take part in phase I trials because their perception is that level of risk (the drug has never been tried in humans before) is lower than the potential benefit for themselves (financial reward). Others would not be comfortable with that decision.
You will need to assess each trial on its own merits according to your own risk profile. Here are 13 things you might like to consider:
- Is this a phase I, II, III or IV trial? Is it a screening, treatment, or prevention trial? What types of trials am I be happy to take part in?
- What is an “acceptable” level of side effects? This will be different for every new treatment. Before an ethics committee approve a study they will have made their professional opinion on whether the trial has an acceptable level of risk, based on what the expected benefits of the treatment are compared with the known or anticipated risks or side effects. The ethics committee would never approve a trial if it considers the risks outway the benefits. If you are not sure what the ethics committee has reviewed, you should contact them using the details provided in the patient information sheet, or through the institution that the researcher works for.
- What do you know about the side effects of the treatments you would be taking if you weren‟t in the trial? How new are those other treatments and how many people have used them in order to collect the safety information on those treatments? Think about how many people you would feel comfortable knowing had used the treatment, before you‟d be comfortable with the amount of safety information known and therefore willing to use the treatment yourself.
- Is this a new treatment being tried, or is it a different use for a treatment that has already been approved?
- What is my chance of getting the test treatment in this trial, rather than the approved comparator?
- Is there a placebo arm, and if so, would I be willing to risk no treatment compared to some type of treatment? As background, you should know that ethics committees look very closely any trial that has a placebo arm. While it is the best way to find out if a treatment works is to compare it to no treatment, it is considered unethical to give no treatment if there is what is considered to be a “good” treatment currently on the market. If there are treatments on the market, trials might still have a placebo arm if current medical thinking suggests the impact of those treatments is not great.
- What types of side effects might I be willing to put up with compared to the benefits if the new treatment works? As an example, you might think that feeling sick for a few weeks while you receive a cancer treatment is OK if that treatment might slow down or stop the cancer. However, you might not be prepared to feel sick every day taking an arthritis medication whenfor you, feeling sick is worse than having to put up with the arthritis pain.
- What is the chance you will get any of the side effects listed in the patient information sheet? Early in the life of a new treatment, it is hard to know how often particular side effects occur. Researchers may have some limited data, but may also need to guess at the types of side effects that might occur based on experience with other drugs that work in a similar way.
- For example, if they have only tested 200 people, the side effect that will happen in only 1 in 10,000 people may not yet have appeared. Or it may have appeared, but because only 200 people have been tested, they don‟t know it will happen less often than 1 in 200 people. You might like to look at other similar drugs to see how often the side effects happen. You might also like to see how often the same types of side effects happen the treatments you would get outside of the trial to see if there is much difference between the trial treatment and your other choices.
- What is the impact of some of the side effects on my health? For example, if swelling is a listed side effect, what is the cause for that? Is the treatment causing fluids to be retained that I could take a pill to relieve or is it likely to have a more serious effect such as causing congestive heart failure that I could get hospitalized for? This is something you should discuss with the researcher who should be able to provide you with more information if you need it.
- Does the trial have any risks that are not associated with the treatment itself, but with some of the procedures that take place? For example, taking blood can cause bruising, regular X-rays expose you to radiation, or some people can be allergic to the contrast agents used in MRI or CT scans. You might be comfortable with the blood draws or CT scans because you have had them before and didn’t have a problem, or the procedures are not often enough for you to be worried, or these may be risks you aren’t prepared to take.
- Do you feel that the research team have the time, experience and qualifications to look after your safety while you are in the trial? One advantage of being in a trial is the close medical attention you should receive from the research team, but you need to be confident they have the resources and experience to look after you.
- Finally, do you have a good rapport with the research team and do you feel they have been open and up-front with you about the risks? If you feel comfortable with the research team, it is more likely that you will comfortable with the risks of the trial as you will have confidence in their expertise and ability to take care of you in the case of a problem.
At the end of the day, only you can decide whether you are happy to accept the risk of taking part in a particular trial. You should feel confident to ask the researcher if you need any help getting more information to help you decide on the risks.