Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|June 19, 2006
- Applied Clinical Trials-06-20-2006
- Volume 0
- Issue 0
Fighting Fraud and Noncompliance
In the afternoon, ACT columnist Ken Getz, MS, MBA, chaired the session: "Prevention of Fraud and Noncompliance in Clinical Research." Ken was joined by speakers David Cocchetto, PhD, RPh, of GlaxoSmithKline, and Dara Katcher, JD, of the Washington, DC law firm, Hyman, Phelps & McNamara.
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In the afternoon, ACT columnist Ken Getz, MS, MBA, chaired the session: "Prevention of Fraud and Noncompliance in Clinical Research." Ken was joined by speakers David Cocchetto, PhD, RPh, of GlaxoSmithKline, and Dara Katcher, JD, of the Washington, DC law firm, Hyman, Phelps & McNamara.
This is the seventh year that the DIA has held this session on fraud and noncompliance. In today's meeting, Getz described some of the factors that are cited as drivers of increased noncompliance and fraud, including a high turnover rate of investigators and the rapid migration of private-sector sponsored trials not connected to academia.
Katcher wrapped up the session by stressing how critical the role of clinical trial monitor is in detecting fraud. "Your monitor is your first line of defense, ensuring that the protocol is adhered to and looking to make sure that the information is consistent," she said.
Articles in this issue
over 20 years ago
Keynote Address: Making Medicine Meaningfulover 20 years ago
Awards Ceremonyover 20 years ago
Every Potential Patient Is Preciousover 20 years ago
Considering the Critical Path in Oncology Drug Developmentover 20 years ago
PROs and Drug Labeling Undergo Scrutinyover 20 years ago
SAS Drug Development Adds Genomic-Analysis CapabilitiesAdvertisement
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