US-based contract research organisation (CRO) Parexel International Corporation has launched a new drive to improve patient recruitment and retention in clinical trials.
The problem of patient recruitment has continued to grow “at an alarming rate,” despite the emergence of “an impressive array of recruitment tactics” over the last decade, Parexel notes. In response, the CRO has set up a global Start-up and Accelerated Recruitment Team (START), designed to integrate all the drivers of successful patient recruitment.
Paraxel’s ‘Predictive Management’ strategy aims to streamline and analyse all the disparate factors across an organisation that can affect Last Patient In (LPI) recruitment goals. The START team will draw on a new suite of proprietary data assets and tools to plan more accurately for recruitment milestones. These resources include a feasibility database, a worldwide site-selection database, a site tracking and readiness tool, site-specific recruitment plans and a Scenario Planning and Recruitment Calculator (SPARC).
The SPARC tool integrates data from across an organisation to help pharmaceutical sponsors avoid costly delays caused by slow recruitment or poor patient retention. These data can also be exploited to implement pre-arranged contingencies based on ongoing information if potential difficulties arise, Parexel said. On top of this comes a complete range of patient-outreach and site-support services, such as information and training, to “minimise delays that can add millions of dollars to the cost of a clinical trial.”
Another critical element of Parexel’s expanded recruitment capabilities is an enhanced clinical investigator database that can be used in conjunction with SPARC to plan trials and identify high-potential investigators, the company added.
“Investigator databases are often limited to lists of contact information, trial participation and therapeutic speciality,” pointed out Joshua Schultz, vice-president, patient recruitment for Clinical Research Services. “Parexel enhances these basic data with comprehensive information on patient enrolment success and other historic recruiting performance indicators.”
Patient recruitment “is not a single activity but rather a host of responsibilities that range from protocol development and study feasibility to site selection and the various activities from First Patient In to LPI,” Parexel said. “Our Start-up and Accelerated Recruitment Team offers the full breadth of services and capabilities clients need to ensure that their clinical trials begin on time and are effectively managed from start to finish.”
Speaking earlier this year at the 28th Annual Conference and Exhibition of the Institute of Clinical Research (ICR) in Birmingham, UK, Philippa Smit-Marshall, executive medical director of CRO Pharmanet BV, cited US CenterWatch data to the effect that 72% of US clinical trials were delayed by more than one month in 2003, compared with 57% in 2001. The proportion of delayed US trials was now approaching 90%, she added.
Out of 114 studies conducted in the UK between 1994 and 2002, patient recruitment targets were met in fewer than one third while 53% of trials were extended, Dr Smit-Marshall pointed out.
The cost of patient recruitment in the US rose from US$375 million in 2000 to more than US$1 billion in 2005, she added. The outset was that companies were running trials in Central and Eastern Europe or the Asia Pacific region, where patient recruitment was easier and studies could be turned over more quickly.
Another CenterWatch survey in 2003 found that volunteer retention rates for clinical trials in the US were 73.2% overall, with a 93.8% retention rate in Phase IV but 75.4% for Phase I and 69.7% for Phase II/III.