Efficiency of Clinical Trials

Conducting clinical trials is becoming increasingly arduous for drug manufactures due to several factors including: (a) heightened food and drug (FDA) regulatory scrutiny based on recent safety concerns; (b) inefficiencies and/or unclear guidance imposed by Health Insurance Portability and Accountability Act (HIPAA) guidelines in the research, design, enrollment and follow-up processes; (c) and increased demand and competition for patients due to a plethora of investigational products under study, as well as the increased scope and design of studies.¹ 

An obvious critical determinant of successful clinical trial research and subsequent product approval is to assure full compliance of regulatory/guidelines mandates of governing authorities throughout the entire clinical process. Other key determinants associated with the success and efficiency of clinical trials are recruitment, retention² and return, especially when drop-outs of a study become lost to follow-up (LTFU). This is particularly important because a patient LTFU, if found, may be willing to return to the study. Therefore, effective retention initiatives require means to find those LTFU.  Additionally, participants in clinical studies are invaluable for poststudy pharmacovigilance programs, so retention strategies that include LTFU is imperative, especially as it relates to an adverse event or other development affecting the safety or efficacy of the product either under study, or post marketing.² 

Low rates of recruitment and retention and high rates of patients LTFU have a number of negative implications including longer durations of the clinical trial and a costlier clinical trial, since extra resources may need to be dedicated to the recruitment effort; and there is less statistical power for both the study and the validity of the results.  In fact, almost 90% of trials are delayed, primarily due to patient recruitment and retention / LTFU problems.  Depending on the investigational drugs potential, every day of delay can cost a pharmaceutical company $600,000 to $8,000,000 dollars.¹

Overall, poor clinical trial recruitment, retention / LTFU initiatives is therefore likely to impede the successful evaluation of new and existing interventions, and prevent greater efficiency and safety in clinical development.³ 

Summary:  Efficiency of clinical trials requires strategic iniatives that favorably affect recruitment, retention and lost to follow-up processes. 

 
1. Datamonitor. Online recruitment is streamlining clinical trails. July, 2008. Available at: www.datamonitor.com

 2. J. Weschler. Applied Clinical Trials Oneline. Privacy Restrictions Alarm Clinical Researchers (July. 2002). Available at: www.datamonitor.com

 3. B. Spilker and J.A. Cramer, Patient Recruitment in Clinical Trials (Raven Press, New York, 1992).

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