Clinical Trials – questions to ask

In order to discover what the safest course of action is for all sorts of aspects of care clinical trials and research studies are undertaken to test whether one outcome is better/safer/cheaper than another or to develop our understanding of a particular condition. NHS trusts may run or opt to join in with these trials with a view to improving care.

You may be asked during your pregnancy to be part of one of these trials. Women often report that it is difficult to decide whether to say yes or no. The member of staff you are talking to may be very enthusiastic about the research being undertaken, it is easy to be swept along in this enthusiasm and later on begin to question whether it is right for you as individual. Take some time to think about what is involved and how you feel about that, you can always go back and ask more questions before giving a final answer. What is right for the majority may not feel right for you, that is OK.

There are a few questions worth asking when considering whether you want to take part in a clinical trial. It isn’t something you should be asked to make a decision about on the spot because there can be implications for you and your baby.

You should be given some information about the research you have been asked to take part in. This may be an information sheet or leaflet, a website to look at or a telephone number to ring to discuss and ask questions.

You should also have information about the option to change your mind and opt out.

Sometimes what is involved is a particular intervention or package of interventions being tested against the currently ‘norm’. In other studies you may not notice any difference in the care you receive, it may involve your notes being analysed during and/or after your birth. In others extra blood tests or scans may be used to measure different things.

When looking at the information consider what the study is aiming to do. Will you be ‘randomised’ into one of a number of groups? This means you will be placed in a group at random and each group will be treated differently according to the design of the study.

You may wish to look at what the different treatments entail, whether the interventions are known to impact upon what is likely to happen to you – for example if early induction of labour is being suggested, look into what the pros and cons of induction of labour are.

If you have been asked to be part of a study because a risk factor has been identified, ask what the increase in this risk is to you as an individual – consider whether you feel this risk justifies opting into an intervention. If you are being told a risk doubles, or that most women in your situation have a particular outcome that isn’t particularly helpful without some numbers. ‘Most’ for example could mean 52% or it could mean 90% and it is quite obvious that the first of those is barely more than a 50:50 chance and the other is much more of an increased chance.

Does the risk double from 0.2% to 0.4% which means there is still a 99.6% chance that it won’t happen. Or is it doubling from 15% to 30%? Again these two can be presented as the same but are actually vastly different.

We all have a different version of what levels of chance or risk are acceptable and what constitutes an increase that is unacceptable to us. So it’s OK to say that you don’t feel an increased chance of x or y happening is worth undergoing an intervention which may itself carry another set of risks.

In some research trials there may be a package of interventions that are being tested. Each of these may have known or unknown success at influencing the outcome being tested. Consider how you feel about the package as a whole and if some elements feel unacceptable to you then tell your Midwife this.

My intention is not to put you off participating in research. Without clinical trials and research projects practice cannot move forwards and be improved. My intention is to make sure that you feel happy with what may happen rather than finding out at the point of an intervention that you don’t feel comfortable with it and then feeling powerless or unable due to the circumstances to speak up.

In essence, consider the different elements of what is being offered ahead of time so you can make an informed decision like with every other aspect of care.