Recruiting and Retaining Clinical Trial Patients
Recruiting and Retaining Clinical Trial Patients
By Dave Betz, Dana Betz and Diane Leahy – OmniTrace Corp.
What is a major area of concern and associated consequences in clinical trial conduct?
Clinical trial failure is a major concern, as 80% of failures are caused by the inability of research sites to find and enroll sufficient patients and meet timelines.1 Failure in recruiting and retaining clinical trial patients has the greatest impact on trial costs, delays, and failures. Sites that optimize clinical trial patient recruitment so that patients are retained and not lost to follow-up (LTFU) will be more successful in the long term.2
What procedures can be implemented to recruit clinical trial patients more successfully?
Several clinical trial patient centric approaches can increase success rates. One such approach that has shown success is recruitment web-based systems.3 For potential patients, these systems offer online clinical trial information including the therapeutic area under study; inclusion / exclusion criteria; investigational drug benefits and side effects; instructions on patient consent; and site locations. For investigators, such tools can expedite the recruitment development process, collect performance metrics in real time, and streamline ongoing recruitment management.3
What approaches have shown success in retaining clinical trial patients more successfully so they are not LTFU?
Incorporating case management and clinical trial patient education approaches into the care process for study subjects has been shown to improve patient compliance and patient satisfaction,2 factors that subsequently reduce clinical trial patient dropout rates. Additionally, a process to assure that patient dropouts are located expeditiously so they can be placed back into the study so as not to lose important data is essential.
What process should be implemented to find patients LTFU?
Companies with expertise in finding people can offer a valuable service in locating clinical trial patient dropouts. Therefore, contacting a people locate company with this proficiency, such as OmniTrace, during patient recruitment may avoid the consequences of patient dropouts becoming forever LTFU.
Who is OmniTrace and how can it assist drug manufacturers in finding patients LTFU?
OmniTrace is a people locate company that has been in operation for 8 years. OmniTrace has a stellar record of success in locating tens of thousands of people worldwide, servicing several sectors including the pharmaceutical /biotechnological industry in finding clinical trial patient dropouts and those LTFU. As mentioned, as every participant in clinical research is a valuable source of safety information, locating patients LTFU is critical to maintaining a robust risk management system.
1. D. Myshko, “Global Development,” PharmaVoice, March 2009, 24 -29.
2. E. Moench, “The Business of Recruitment,” Applied Clinical Trials, March 2009, Trends in Subject Recruitment Insert, 8-10.
3. Streamlining Clinical Trials, www.clinicaltrial benchmarking.com (2008).
