Patients ‘lost' from a clinical trial result in study delays, increased patient recruitment costs and compromised study data. L2FU provides critical solutions.
KING OF PRUSSIA, PA - July 22, 2010 - Recovering unnecessarily lost patient information is now a viable reality. Lost to follow up (LTFU) rates in clinical research trials can range from 20- 60%. As a result, patients who drop from a clinical trial and ‘go missing' can impart a major set-back in pharmaceutical research. Failure to contact patients and obtain final closure data, or bring them back into the clinical trial (if the protocol allows) results in study delays, increased patient recruitment costs, compromised study data, and in some cases an insufficient amount of information to prove the safety and efficacy of a drug.
Consequently, regulatory agencies such as the FDA, are requesting that clinical trial sponsors perform comprehensive follow up measures as part of a clinical trial's due diligence efforts or during the conduct of long term safety surveillance studies to monitor patient outcomes.
L2FU, a company specializing in helping clinical trial sites and biopharma companies to locate, contact and collect data from patients deemed ‘Lost to Follow-Up', is building a portfolio of successes and an industry reputation for its quality work. The L2FU team proudly reports its latest successful recovery of 100% of a recent study's lost clinical trial patients. This was achieved in only one month to meet a truncated timeline.
The client, a leading integrated managed care organization, with operations in a number of major states across the US and nearly 10 million patient members, required the information rapidly.
The L2FU team worked diligently to recover the lost patients, who were located in other states while acquiring new addresses. "Finding these lost patients several years after their clinical trial participation goes a long way to ensuring that our client's study meets its primary endpoints, and that all of their data is accepted by the Food and Drug Administration (FDA)" noted Bernard Hall, L2FU's manager and main point of contact.
L2FU works closely with clinical research sites and data managers at clinical research organizations (CROs) and biopharmaceutical companies to transmit collected patient data in a secure manner; adhering to HIPPA regulations for privacy and data security. The L2FU team is experienced in proactively recovering lost study subjects and sensitively communicating with patients and their families. Team members are trained on the procedures required for the licensed access to many databases containing millions of vital records.
Employing L2FU to manage lost patients allows already overworked study coordinators to focus their time on active patients in the study, and the L2FU team provides clinical trial sponsors the reassurance that missing patients and required outcome data will be accounted for.
L2FU is part of MediciGlobal, a global leader in the recruitment and retention of patients for clinical trials. With more than 20 years of clinical trials experience in patient recruitment-retention, MediciGlobal is a company dedicated to the recruitment-retention and reconnection of patients for clinical trials. For more information on L2FU visit http://www.L2FU.com or call Bernard Hall at 484-674-6816.