Within the realm of clinical research, participant compliance in clinical trials continues to be a significant problem area. If you’re considering a career in clinical research, you’ll be responsible for overseeing different clinical trials, ensuring that data is correctly obtained, organized, and stored throughout the duration of the trial. As a clinical researcher, one of your duties will be to ensure that any participants in the trial are adhering to the medical orders they must complete as part of the collection of accurate data. Participant compliance can be defined as the degree to which the subject correctly follows the prescribed taking of medications as pertaining to the trial in question – in addition to their adherence to study visits and their accurate reporting of any events or unique symptoms that occur during the trial.
When participants do not adhere to a clinical trial, this can result in distorted data, reducing both the data’s validity and a researcher’s ability to generalize. During your clinical research career, your ability to ensure that participants are complying during a clinical trial will enable you to avoid hefting funding costs and even reduce the cycle time of trials. Below, discover some tips for assessing compliance among participants.
1. After Your Clinical Research Program, Assess Compliance by Simplifying Consent Forms
Once you complete your clinical research program, one of the ways that you can assess participant compliance is by improving the clarity of the consent forms used in the trial at hand. Consent forms are a way to educate participants about the methods and goals of the research that the trial is attempting to conduct. When these forms are unclear, it may negatively affect a participant’s ability to understand their responsibilities and duties within the scope of the project. As a researcher, this can affect your ability to accurately assess the level of participant compliance in the trial. Without clear roadmaps and responsibilities, it grows more difficult to establish where participants may not have adhered to the trial. Throughout your career, you can avoid this issue by developing consent forms using terms that are easy to understand, and provide participants with different visualizations and educational tools to enhance their comprehension.
2. Increase the Number of Clinic Visits
As a clinical researcher, one of the keys to assessing participant adherence is having sufficient levels of contact with participants throughout the course of the trial. Increasing the number of clinic visits that participants are required to complete is a great way to increase the level of participant engagement during a clinical trial. When participants are consistently brought in to speak about their experience with a treatment or medication, they’ll be less likely to neglect their duties as trial participants and more likely to complete the study requirements, given the higher level of accountability. If you’re having trouble assessing participant adherence after getting your clinical research diploma, consider increasing the amount of clinic visits required of your participants, as this will give you a better gauge on how your participants are complying throughout the trial.
3. Utilize the Right Technology
There are many different technological resources that can be taken advantage of in order to accurately assess participant compliance during a clinical trial. Technology can be used both to remind participants of their duties and to help them gain a better grasp of how the study is progressing. Text messaging is one form of technology that can be used to assess and improve participant compliance. Sending out text messages as reminders to fill out a symptom check or to take medication can help participants to stay engaged with the trial process and confirm that they’re remaining compliant.
Additionally, gamification – a strategic approach which integrates elements of game playing into the filling out of questionnaires or surveys to encourage engagement – is a tool that has proved useful for assessing participation in clinical trials. With gamification, participants may feel more rewarded for complying with a trial, as they’ll enjoy inputting the necessary information and feedback. In turn, this will enhance your ability to assess participant compliance as a clinical research professional.
Using these different methods to assess participant compliance will enable you to obtain accurate data and keep trials both efficient and cost-effective during your career as a clinical researcher. Consider trying them out once you complete your training!
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