Bringing Patient recruitment and retention; A revolution to Clinical trials – eBook Dr.Sreedhar Tirunagari, Dada Hayath Shaik, Anil Golani Introduction: Over the last few years, clinical research departments have incurred worsening delays in conducting clinical trials. Nearly 80% of trials fail to meet milestones, thus delaying the delivery of potentially life-saving drugs to market. Operations professionals are constantly expected to improve efficiency and productivity, to deliver cost-effective studies to deadlines and within budget, while maintaining quality and ethical standards. A recent study from Cutting Edge Information* showed that average clinical trials overrun across all therapeutic areas and phases, mainly because of patient enrollment: some sites never manage to enroll a single patient; even worse, others wait a long time and eventually recruit one patient but still have to expend time, resources and supplies until the patient completes the study or withdraws. (Data from Covance Xcellerate® Knowledge base provides a breakdown of non- performing sites per therapeutic area, with Oncology showing 60%) Selecting under-performing sites leads to delays in patient recruitment, adding an average of 10.8 months to every trial. If you multiply this by 30 trials per pharmaceutical company, the annual cumulative loss reaches a staggering 26 years per company! (Beasely, “Recruiting”. 2006) These delays affect not just study costs but subsequent sales, causing potential losses of $600,000 to $8 million per day, according to a recent CenterWatch study.** Enrollment delays cost pharmaceutical companies $8 million each day a study is delayed, according to a recent report from Cutting Edge Information. These delays are normally due to recruiting patients into the trial. According to the Center for Information and Study on Clinical Research Participation, missed enrollment deadlines extend phase I studies by 42% on average, while phase II and III studies last 31% and 30% longer, respectively. Achieving clinical trial research participant enrollment is essential to conducting a successful trial. Adequate enrollment provides a base for projected participant retention, resulting in evaluative patient data. Without sufficient patient retention from the time of study initiation to closeout, the number of remaining participants may prove to be too small a pool from which to derive conclusive proving or disproving the goal of the clinical trial sponsor. Obtaining final evaluative data is dependent on successful patient and principal investigator retention. Patients cannot be retained without an initial pool of enrolled volunteers. This initial pool of screened, then enrolled participants, depends on designing sound strategies for patient and investigator recruitment