GCP and Clinical Trial Costs

Fundamentally designed to protect the rights and safety of human beings, the Good Clinical Practices (GCP) guidelines have recently been bearing the brunt of inflating clinical trial costs. In a pursuit of achieving the high quality and credibility that GCP imparts to clinical trials, the industry finds itself overwhelmed with the documentation and administrative set up required for establishing GCP compliance. While the issue of rising costs is usually brought to the forefront, benefits of GCP that could possibly outweigh these costs go unnoticed. Discussed herein are the numerous ways through which GCP by virtue of its implications offers to either save costs or presents opportunities that clearly offset the research expenditure.

Effective patient recruitment and retention

Failure to reach patient recruitment goals is undoubtedly a major cause of costly and increased risks of losing out to market competition. Over 85% of all completed medical research studies experience recruitment delays ¹ and more than half of U.S clinical trials experience enrollment delays between one and six months². The GCP stipulated process -a good quality informed consent; is adequately equipped to act as a precursor step to deal with this challenge. While concerns of safety and confidentiality may inhibit patients from enrolling, informed consent provides a comprehensive understanding of the trial to enable the subject to carefully weigh the pros and cons before entering a trial. An effectively performed informed consent assures the safeguard of rights, safety and well- being of a subject and could thereby encourage the subject to enroll for the study. Moreover, a subject’s realization of how valuable his contribution to research is to the overall benefit of the society, certainly improves the chances of retaining the subject into the trial.

Reduced risk of adverse events

Mounting pressure of recruitment targets may sometimes induce investigators to enroll subjects beyond the inclusion criteria described in the protocol. Risks entailed are jeopardized safety of the subject and high incidence of adverse events. A considerable extent of these risks could be avoided by GCP- prescribed clinical monitoring where qualified monitors at a frequency appropriate to the study, check the compliance of patient recruitment and other study procedures with protocol. It also saves the sponsor costs of medical care required for managing adverse events (costs of hospitalization etc) and costs of compensation and litigations. Furthermore, clinical monitoring is equally capable of detecting frauds and misconducts in the study which otherwise would result in costly implications for the sponsor and most importantly on the well being of the patient.

Improved quality of data

Successful outcome of a clinical trial is largely dependent on the quality and quantum of data collected during the course of the study. Through procedures of data verifications and clinical monitoring, GCP compliance ensures that the clinical trial data is credible, accurate, devoid of discrepancies and has minimal traces of missing data. High quality GCP compliant data has wider recognition and is crucial for facilitating acceptance with regulatory authorities. It empowers the sponsor to create a strong scientific basis for the research product and to successfully counter market competition.

Enhanced standard of health care

A few therapeutic segments which earlier presented with limited scope for conducting research, have now progressed to extending advanced research based health care to afflicted patients; only due to the provisions of Good Clinical Practices. Pediatric studies for example; shunned by researchers for many years are today considered acceptable and even mandated by law ³. In such cases the resulting benefits accrued to the industry and society at large, are far beyond those that would commensurate with the costs of research involved.

Conclusion

GCP apparently has a demanding effect on the clinical trial budget. Alternatives of adaptive trial designs and EDC systems have been offered and implemented to reduce clinical trial costs. A viable option would be to invest in GCP quality and reap the longstanding dividends of fruitful outcomes.  This will be accomplished when there is a change in approach from observing GCP as an ethical or legal obligation to GCP as a mutual advantage for all stakeholders of clinical research. 

References:

1. Gamache V. Minimizing Volunteer Dropout. CenterWatch Monthly. 2002;1:9-12.
2. Diana L Anderson. The Patient Recruitment Market: An overview of today’s issues. Applied Clinical Trials Online, Published Nov 2, 2003. Accessed 12 May 2010
3. Carl Naraynassamy. Maintaining good clinical research practices in paediatric studies. Paediatric and Perinatal Drug Therapy, 2007; 8 (3)