The “Big Issue” – informed consent and recruitment to clinical studies
Informed consent and recruitment to clinical studies is now recognised as one of the best ways to increase recruitment for clinical trials, clinical study teams have found a number of issues that need attention during the informed consent process.
Countering communication concerns
While people are going through the process of gathering enough information to be able to give their informed consent, they are not yet participants in a clinical trial. They are just prospects at this point, and since pharma typically don’t market directly to consumers, sponsors often have no idea how to keep people engaged in the early stages of the recruitment process.
As a result, the messages that sponsors are delivering don’t always provide enough information for people to reach the point of giving their informed consent without a hitch. Sponsors that are looking for people to take part in clinical trials need to make sure they use the right communication methods and channels, which speak to the groups they want to reach, using language they easily understand.
Understanding the lingo
The legal language demanded by the authorities in informed consent documentation makes it difficult for people with limited health literacy to understand the terminology. This means they don’t always appreciate the risks and benefits of taking part, either, because they don’t fully understand what the documents actually say.
Research shows that many of the people who consider taking part in a clinical trial aren’t able to remember or understand the information they were given during the consent process. Since this also applies to those who do end up taking part in the trial, it should be no surprise that there is a high drop-out rate once they start to fully realise what participation actually means.
Informed consent and recruitment to clinical studies for vulnerable populations
Many of the people with medical conditions that are ideal for clinical trials may fall into the category of “vulnerable populations”, including:
- People with physical or learning disabilities
- Those from economically-disadvantaged backgrounds
- People who are educationally disadvantaged.
For various reasons, these people are even more difficult to educate about the risks and rewards of drug trials, and that means the number of participants from these groups is even lower than others. This is one of the factors that contributes to the problem of having a diverse group of people participating in trials, as well as making recruitment and retention more complicated.
Achieving limited educational value
As a result of many of these issues, getting informed consent and recruitment to clinical studies can be very difficult, both because the level of consent we can get doesn’t measure up to best practices, as well as because people don’t fully understand what they are being asked to do. In one review of over 500 consent forms, researchers found that most of the information either wasn’t read, or wasn’t understood by the readers.
Making changes to recruitment methods
Clearly, changes are needed in the pharmaceutical world of clinical trials to improve their recruitment method. The planning and development stage is vital, and this is the ideal time to make changes that impact recruitment. It’s a complex process that needs input from everyone involved, ranging from the prospective participants to sponsors, funders, doctors and other team members.
It’s important to understand the psychology behind getting informed consent, such as the emotions stirred up by using striking images in the marketing, and dependable and trustworthy messaging that builds a relationship with the potential participants.
Addressing reasons for dropping out
People drop out of clinical trials for multiple reasons, many of which could be resolved by making sure they understand the materials and the processes upfront and give informed consent for whatever outcome they can reasonably expect to get. Some of the main reasons people drop out mid-trial include:
- The concern that they are getting the placebo, which means they aren’t receiving any actual treatment (usually, participants stop their current treatment when going into a trial)
- The inconvenience of going to all the medical appointments they need to for the trial
- The feeling that their involvement in the trial won’t make any difference to the results
If you can convince them that there’s value in the treatment and the ongoing medical appointments that are monitoring them, and that they’re still providing valuable information even if the patient is getting the placebo, you can probably reduce the drop-out rate.
Making participation personal
One way to get people emotionally involved in a trial is to give their participation a personal meaning, by convincing them of the value of their action. In addition, research shows that the earlier you get them involved, the harder it is for them to drop out. Giving them some digital access to their own treatment records also allows them to feel connected to the process, and the need for formal informed consent can be used to impress on them the importance of what they are doing.
The value of informed consent and recruitment to clinical studies
Informed consent and recruitment to clinical studies is a big issue for clinical trials, not only because it’s required by law in just about every country, but because it helps trial participants to understand what they are doing and why, and the importance of their actions for their own health and others.
Download our white paper for more information on informed consent and some creative strategies to address this, based on the three key requirements of information disclosure, decisional capacity, and voluntarism.