Regardless of how effective and safe a new investigational medicinal product seems; without the full compliance of participating subjects there will be no meaningful data generated in the clinical study. Thus, it would not be an overstatement to state that subjects are the determining factor and the key controller of the success of any investigational medicinal product or approved medicinal products in the market (Smith, 2004). Therefore, in order to achieve and encourage the best or optimal subjects’ compliance in a clinical study, it is imperative to understand the importance of subject’s involvement in a clinical trial. Furthering the mutual understanding in a comprehensible language; participating subjects must be reminded of their autonomy rights and responsibilities in a clinical research (Smith, 2007). Hence, ensuring subjects understanding and the free will to withdraw from a trial at any time if they are unable or have any reason, to complete the trial (ICH, 1996). Further establishment of this kind of relationship and trust is important to engage the subjects in a clinical trial with the mindset that they are in control of their decision. Nonetheless, subjects must be reminded how important complying or integrating their clinical trial participating role with their daily activities is to their well-being and the success of the study in general (Smith, 2004).

Furthermore, it is to the researcher’s best interest to protect and ensure the subjects are in compliance with the research instructions and understand what is required of them in the clinical trial (Sullivan, 2004). Thus, in the event where subjects are in noncompliance with the investigational medicinal regimens, several corrective measures could be employed to get the subject back in track and in compliance. One of the key mechanism would be to identify the factor that is discouraging the subject from complying with the trial’s regimens as instructed. Identifying the hurdles causing human subjects to a noncompliance state may help investigators re-assess whether the subjects are in a stable psychological, psychosocial and physical state to continue with a trial as scheduled (Lamb, n.d.). However, in the case where subjects are deemed capable of continuing with the study, extra-help or reminder-prompt such as phone calls or automated text messages etc from the trial site could be recommended as an innocuous motivator reminding the subjects the importance of their role in the trial and thus encourage them to comply as instructed.

Perhaps, if a participant is continuously in the state of noncompliance, and is incapable of establishing a normal drug routine regimen as instructed, the investigator has the responsibility to withdraw the subject’s participation in the study and take the subject off the investigational product (Pullar, Kumar, & Feely, 1989). Consequently, taking subjects off any trial due to noncompliance may have a negative effect on the trial depending on the number of retained subjects at the end of the trial, and whether the final number retained is sufficient to establish valid statistically data.

References

ICH Expert Working Group. (1996). Guideline for good clinical practice E6(R1). Retrieved from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy /E6R1/Step4/E6R1Guideline.pdf.

Lamb, M. (n.d.). Improving patient compliance in clinical trials: Smart packages or smart design? Retrieved May 11, 2009, from http://www.almacgroup.com/wp- content/uploads /ImprovingPatient_Compliance_in_CTS2.pdf.

Pullar, T., Kumar, S., & Feely, M., (1989). Compliance in clinical trials. Annals of the Rheumatic Diseases, 48(10), 871–875. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/P MC1003898/pdf/annrheumd00432-0079.pdf.

Smith, D. (2004). Want lifetime customers? Pharmaceutical Executive, 24(10), 127–130. Retrieved from http://search.ebscohost.com.ezp.waldenulibrary.org/login.aspx? direct=true&db=bth&AN=1 4770886&site=bsi-live.

Smith-Tyler, J. (2007). Informed consent, confidentiality, and subject rights in clinical trials. Proceedings of the American Thoracic Society, 4(2), 189–193. doi: 10.1513/pats. 200701- 008GC. Retrieved from http://pats.atsjournals.org/cgi/content/full/4/2/189 .

Sullivan, J. (2004). Subject recruitment and retention: Barriers to success. Applied Clinical Trials, 13(4), 50–54. Retrieved from http://ezp.waldenulibrary.org/login? url=http:// search.ebsc ohost.com/login.aspx?direct=true&db=a9h&AN= 12756095&site=ehost-live&scope=site.