ERT's Scientific and Regulatory Consultants Support Phase III Oncology Trial
Provectus Biopharmaceuticals Collaborates with ERT's COA Experts to Understand Patient Perspective during Melanoma Drug Development
ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced that Provectus Biopharmaceuticals (NYSE MKT: PVCT) is collaborating with ERT’s Clinical Outcome Assessment (COA) consultants on their Phase III trial of agent PV-10 for intralesional (IL) treatment of locally advanced cutaneous melanoma.
PV-10, an investigational new drug designed for injection into solid tumors, has received orphan drug designation from the U.S. FDA for its melanoma and hepatocellular carcinoma indications. Provectus recently presented data from their Phase II trials showing PV-10’s ablative and bystander effects, including its potential to relieve symptoms of cutaneous melanoma.
“We are thrilled to collaborate with ERT’s scientific and regulatory experts on this important program,” said Eric Wachter, PhD and Chief Technology Officer of Provectus. “Their expertise in developing and evaluating symptom measures to support clinical trial endpoints will be instrumental in helping us understand the patients’ perspective as we continue to explore the therapeutic potential of PV-10.”
ERT’s COA consultants are working with Provectus to select a patient-reported outcome (PRO) measure of symptoms in this population that can be implemented in the Phase III clinical trial of PV-10 and ultimately support treatment benefit claims in the product label.
“Provectus is a true innovator in oncology clinical research,” said Dr. Chad Gwaltney, ERT’s Chief Scientist and Regulatory Advisor, Endpoints. “By applying scientific rigor to the implementation of established PRO measures, they are not only striving to meet regulatory guidelines, they are putting the patient at the heart of clinical research. We applaud Provectus for placing such importance on understanding the patient perspective in oncology drug development, and we are delighted to work with them on this program.”
For additional information on ERT’s scientific and regulatory consulting services, visit www.ert.com/consulting.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
