SUNRISE, Fla.--()--Medicine advances when people participate in research studies, yet many clinical trials fail to enroll a single patient, resulting in wasted time, money and resources in bringing new treatments to market, according to Deena Bernstein, director of clinical research for Sheridan Healthcare, Inc., a hospital-based, multispecialty practice management company.
“The consequences of zero enrollment can be devastating to the investigator site, the sponsor, and ultimately to those who would benefit from new, approved drug therapies and treatments”
Dubbed “zero enrollment,” this trend was the focus of a recent national industry conference (Drug Information Association) at which Bernstein presented strategies that investigator sites can employ to limit the number of failed clinical trials.
“The consequences of zero enrollment can be devastating to the investigator site, the sponsor, and ultimately to those who would benefit from new, approved drug therapies and treatments,” said Bernstein. “Failure to enroll a single patient results in uncompensated labor costs, wasted time and resources, and a tarnished reputation with the sponsor.”
Successful clinical trials often hinge on effective, two-way communication between the research sponsor and the investigative site, according to Bernstein, who notes that investigator sites can improve efficiency by conducting a thorough feasibility study before accepting a protocol, and can later track and measure the study’s performance, making critical adjustments along the way.
Bernstein advises sites to select metrics that are meaningful to the sponsor and can be improved upon and use the data to improve decision-making, alter staff ratios and communicate with sponsors.
Bernstein notes a sponsor’s cost to open a single research site is approximately $34,000. A site that never enrolls a single volunteer in a study can cost on average more than $15,000. In one study of clinical trials being conducted at Oregon Health & Science University, investigators analyzed uncompensated costs associated with low enrollment and estimated them to be about $1 million per year.
Under Bernstein’s direction, Sheridan Healthcare oversees several clinical trials a year.
About Sheridan Healthcare, Inc.
Sheridan Healthcare, Inc. is a national hospital-based, multispecialty practice management company that provides anesthesia, radiology, emergency medicine, neonatology and other pediatric subspecialties. Sheridan, its subsidiaries and affiliates currently operate in 23 states and employ more than 2,200 providers. Sheridan’s anesthesia division, established in 1953, has become the leading anesthesia services provider in the country. In addition to physician and allied health services, Sheridan also provides support, training and management in non-clinical areas. Sheridan is recognized by the National Committee for Quality Assurance as a certified physician organization.