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.
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.
Merck Stops HYPERION Trial for Winrevair in PAH Following Positive ZENITH Trial Results
January 30th 2025The Phase III HYPERION trial was stopped early after strong positive interim results from the ZENITH trial demonstrated the efficacy of Winrevair (sotatercept-csrk) in treating pulmonary arterial hypertension, making it unethical to continue.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
