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Compliance, Noncompliance, and Discontinuation of Study Subjects
Compliance is an important consideration in working with subjects in a clinical trial. In order to accurately evaluate the safety and efficacy of the investigational product, it is essential that study subjects comply with its use as prescribed by trial control. As part of achieving this objective, it is important to communicate with subjects before the commencement of a study in order to optimize the potential for compliance. Communicating with subjects before the start of a study to optimize the likelihood for compliance requires careful planning during recruitment of subjects. While compliance in a clinical trial is voluntary and largely directed or controlled by the study subject, it can sometimes be coerced given its significance in the trial.
In this case, communicating with study subjects prior to the commencement of a study to optimize the potential of compliance would entail designing protocols and models of health-related behavior. The investigator will then share these protocols and models with the participants or subjects with the aim of engaging them in the clinical decision-making process. These protocols and models will be designed in a manner that they address issues of confidentiality, which is also vital in the clinical trial. The study subjects will...
The informed consent will require demonstrating an understanding of the need for compliance and various aspects relating to it in a clinical trial.
Apart from communicating with study subjects before commencement of the study, it is also important to maintain communication in order to encourage compliance during the clinical trial. Some of the approaches that will be used in this process include responding swiftly and respectfully to inquiries, arranging meetings with study subjects to explain and discuss concepts relating to the trial and compliance, and designing explanatory documents to subjects (Robinson et. al., 2011, p.50). Throughout the clinical trial, the investigator will demonstrate willingness to participate in dialogue and discussions to address any emerging issues and encourage compliance during the trial. These approaches are important since they will keep the study subjects informed, ensure ongoing dialogue, and help remind subjects of the importance of compliance.
While efforts to promote and encourage compliance in a clinical trial are beneficial, there is likelihood of the emergence of a noncompliant study subject. Consequently, the investigator is mandated with the task of developing suitable strategies to handle…
References
Lamb, M. (n.d.). Improving Patient Compliance in Clinical Trials: Smart Packages or Smart Design? Retrieved September 29, 2015, from http://www.almacgroup.com/wp-content/uploads/Improving_Patient_Compliance_in_CTS2.pdf
Robinson et. al. (2011). Communications handbook for clinical trials. Washington, DC: Microbicides Media and Communications Initiative.
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