Lost and Found: L2FU Recovers 100% of Clinical Trial Patients for Recent Pivotal Study
By Mediciglobal, PRNEWednesday, July 21, 2010
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, Pennsylvania, July 22, 2010 - Recovering unnecessarily lost patient information is now a viable
reality. Lost to follow up (L2FU) 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 HIPAA
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 www.L2FU.com
or call Bernard Hall at +1-484-674-6816.
Ann Armillei, +1-484-674-6856, aarmillei at mediciglobal.com
Tags: July 22, King Of Prussia, Mediciglobal, Pennsylvania, United Kingdom