NEW YORK, June 18 /PRNewswire/ -- In designing and conducting clinical trials, it is critical to meet FDA objectives while preventing program "drift," according to Matthew Lehman, chief operating officer of SPRI Clinical Trials-Global, LLC in his remarks at a recent seminar for biotechnology companies.
Lehman spoke on "Designing Trials for Success: Balancing FDA Expectations and Operational Reality," at the Trout Group Investor Relations Seminar: Management's Guide to Wall Street, held recently in Munich, Germany. He addressed CEOs and CFOs from private and small and mid-cap life science companies.
The FDA and other regulators are the gatekeepers to realizing shareholder value and future profits, Lehman said. FDA goals of drug safety, efficacy and economic cost/benefit are consistent with those of the other key stakeholders in the drug development process: patients, clinicians and payors. To maximize long term shareholder value, companies must conduct research that is scientifically and statistically valid, clinically meaningful, and that optimizes the use of capital from a time and effectiveness standpoint, he said.
To meet FDA objectives for clinical trials, companies must assure patient safety and evaluate efficacy with validated, clinically meaningful endpoints and statistical significance for the study, Lehman said.
"The FDA expects good science and good medicine. Meetings are serious, specific and formal and should have a defined purpose," he said. "Reviewers want to speak scientist to scientist. Companies should deliver reasoned proposals and obtain yes/no answers."
Although it should be simple to secure agreement with the FDA and then follow through on a development plan, competing interests and operational realities can take programs off track. Management and shareholders need to be aware of this "program drift" and plan accordingly, Lehman said.
"Management must keep the program on track by getting to the meaningful proof of the concept quickly, killing losers swiftly and honestly, and investing in the planning of clinical development to ensure data quality," he said. "Investors should understand the goals of each trial vis-a-vis FDA approval, be clear about the operation and costs of clinical trials, and acknowledge and reward management that kills losing drugs."
SPRI Clinical Trials (www.spriclinicaltrials.com) was founded by Dr. Ari Kiev in 1970 to provide top rate clinical trial services to the pharmaceutical and biotech industry. With nearly 40 years of experience managing studies in the New York area, SPRI expanded internationally in 2003. Today, in addition to the U.S., the company conducts studies throughout Eastern and Western Europe. SPRI Clinical Trials-Global, LLC has principal offices in Kiev, Ukraine.
|SOURCE SPRI Clinical Trials|
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