OneFlorida

Promising Research on Cancer Treatment Will Leverage the PCORnet® Infrastructure

Posted on by Jodi Snare

An observational study conducted by researchers at the University of Texas MD Anderson Cancer Center and the University of Florida (UF), the lead site of the OneFlorida+ PCORnet® Clinical Research Network, showed promising results for the potential of mRNA vaccines to improve health outcomes for people who have advanced lung or skin cancer.

The preliminary research, published in Nature, found that patients who received an mRNA COVID vaccine within 100 days of starting immunotherapy lived significantly longer than those who did not receive an mRNA vaccine.

These results suggest that mRNA COVID vaccines could be powerful tools in treating cancer by improving the body’s response to a type of immunotherapy called immune checkpoint inhibitors. While personalized mRNA cancer vaccines can help a patient’s immune system better recognize and target cancer cells, these vaccines can be expensive and hard to make.

Leveraging the PCORnet infrastructure

To confirm the study’s findings that the low-cost, widely accessible mRNA COVID vaccines can also be used to train the body’s immune system to kill cancer cells, researchers at UF will leverage the infrastructure and data resources available through PCORnet to plan and conduct a large, nationwide Phase II/Phase III clinical trial. The trial, called UNIFIER (UNiversal Immunization to Fortify Immunotherapy Efficacy and Response), will enroll patients who have lung cancer.

“The results of the clinical trial may inform the development of a universal mRNA vaccine to help spark the immune system’s response to a variety of different cancers. This research has the potential to improve health outcomes for millions of people,” said UNIFIER Co-Principal Investigator Elias Sayour, MD, PhD, University of Florida.

“We are excited to support this research to determine the effects of mRNA COVID vaccines on immunotherapy treatments in real-world settings,” said Betsy Shenkman, PhD, One Florida+ Principal Investigator.

Studies leveraging PCORnet resources have already answered critical patient-centered questions on heart disease, metabolic conditions, obesity, and more — demonstrating the power of PCORnet to improve patient care through efficient, high-quality research.

To conduct this important next phase of their research to advance cancer treatments, the clinical trial team at OneFlorida+ plans to collaborate with PCORnet® Clinical Research Network sites across the nation.

Are you ready to find out how PCORnet can support your next patient-centered study? Contact the PCORnet® Front Door to start the conversation.

MedWeight Study Uses PCORnet® to Assess Medication-Induced Weight Gain

Posted on by Jodi Snare

Medication-induced weight gain is a common challenge and often triggers concerns among patients who want to know if and how much weight they might gain if they take certain drugs. MedWeight, a PCORnet® Study, was launched to provide evidence that will help determine which medications contribute to weight gain and how much. Providing this evidence will help patients make better-informed choices that could lead to improved health outcomes. The study team is collaborating with three Network Partners of PCORnet®, the National Patient-Centered Clinical Research Network, to conduct the study, which will be the most comprehensive assessment to date of the risks of weight gain associated with taking certain drugs.

“Patients consistently flag concerns about weight gain from commonly prescribed medications as a reason for non-adherence, and yet there are still significant knowledge gaps around which medications contribute the most to weight gain and what role, if any, specific patient characteristics play in weight fluctuations,” said Jason Block, principal investigator of study. “Our goal with MedWeight is to fill in these gaps, offering patients and their clinicians data-driven insights into what they can expect from their medications so they can choose carefully and adhere with confidence.”

The study will include both children and adults and involve separate evaluations of the the five medication classes, comparing effects between subclasses and commonly prescribed individual medications. The MedWeight team will examine the medical records of the children and adults within each class up to 10.5 years after initiating treatment to evaluate how different drugs affected the weight of different types of people.

Deep patient involvement

PCORnet Network Partners PedsNet, OneFlorida, and STAR are the collaborating Clinical Research Networks (CRNs) on the MedWeight Study. From each CRN, a designated patient representative serves in a leadership role on the MedWeight team, advising on all project components from protocol design to dissemination.

“MedWeight is a study inspired by patient feedback, and their input is critical in the development and execution of the work,” said Block. “Once the study is complete, we hope to disseminate our results in a way that is helpful to patients and clinicians. We intend to develop an educational document for patients and providers to help guide choices. The patient perspective on how we disseminate results will be a critical component of this work.”

Patient partners have been with MedWeight from day one. In fact, many of them previously worked on other PCORnet observational studies on obesity and will carry forward lessons learned from those projects to MedWeight.

“Patient partners from our past work in obesity were huge proponents for MedWeight, and our work on the prior observational studies set the stage for us to carry out this new study on medications and weight,” said Block. “The extensive data curation and exploration of available data those studies required are assets that will allow us to hit the ground running with the MedWeight study.”

MedWeight is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The MedWeight team expects to have initial data characterization established in autumn 2020, with an estimated completion date of spring 2023.