Clinical trials are vital in the healthcare industry. Any mistake can be dreadful to the trial and its participants. As such, clinical trials by organizations like Veristat run smoothly because the participants fully adhere to the requirements.
What is adherence?
Participant adherence also known as compliance is the extent to which a patient follows the instructions given for participating in a clinical trial. There are various things participants in a clinical trial are required to do. This can include things like recording any side effects related to the trial, attending visits on the set times and dates for tests to be done among others. These activities are used to measure the participants’ adherence, there are different ways used in measuring as will be discussed later in the post. As such, it is important to ensure the participants have a clear understanding of what they are required to do and they fully stick to the virtual clinical trials protocols. There is more than one way of doing this;
Rearranging the Rules
With clinical trials, participant adherence may be followed by strict rules and consequences that trigger fear in the participant. If they fail to follow the guidelines, then something bad is bound to happen. However, a win-win situation is not a guarantee of adherence. By win-win, it means a participant following all the requirements and the trial running successfully. When rearranging the rules, turn them into statements of ‘if and then’. Such statements sound less threatening, unlike rules. This helps ensure the clinical trial gets what you expect from participants with little need for conflicts and the need to use force or power.
Boundaries can also be used instead of rules. They are proactive and mitigate problems positively. Boundaries are stated positively and not in the form of threats, they take in a reward-oriented approach, one in which positive consequences happen when participants do their part. With boundaries, the term ‘consequences’ is redefined; it shows that good things happen when the participant adheres.
Measuring Participant Adherence
Different methods are used to measure participant adherence, these include;
Patient diaries
Diaries are designed to capture the needed information from patients during the trials. They record when the patient took their medication. Diaries come in two forms; electronic and paper-based. Electronic diaries are the most preferred as they are more reliable. They capture the exact time and date and entry is made. Paper-based diaries are easier to keep but patients are prone to forgetting to fill them daily. They also take a lot of time to enter the information into electronic tools.
Measuring medicine levels in blood or urine
Some trials require the levels of the IMP in blood and urine to be monitored. Though the way the IMP is broken down by the body may differ across the patients, it is a good process that can help in measuring adherence. It ensures that patients take the medicine at the specified time.
Clinical trials run smoothly when participants do something willingly without feeling forced or threatened. They should know that a positive consequence can occur if they adhere to the requirements.