New Affinity Group Informs Researchers About Changing Face of Clinical Trials

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Families of sick children who come to Children’s Hospital of Philadelphia are often looking for something new. They want to learn new information, find a new drug, or try a new approach that will help them to diagnose and resolve their child’s complex conditions and rare diseases. Increasingly, our clinician researchers are discovering these latest diagnostic methods and therapies by leading robust clinical trials.

“You get cutting-edge care here because we’re investigating emerging and targeted treatments that may not yet be commercially available,” said Pam Weiss, MD, MSCE, a pediatric rheumatologist who is leading a new Clinical Trials Research Affinity Group (CTAG) for investigators and research teams engaged in clinical trials research. “That’s what people expect when they come to CHOP.”

Since 2013, the number of interventional clinical trials approved by CHOP’s Institutional Review Board has doubled to 600, and these studies are wider in scope than ever before. This expanding interest in clinical trials gave rise to the CTAG that launched in October. It will establish a vibrant, collaborative network of investigators from CHOP and the greater University of Pennsylvania community who want to know more about the start-up, conduct, and enhancement of clinical trials at CHOP.

The CTAG will offer a forum for discussion about the ever-changing methodologies, regulations, and types of consent processes that affect clinical trials. In addition, it will allow members to present a collective opinion in developing clinical trial support systems and streamlining solutions that could be implemented by administrators.

Building an integrated research infrastructure and improving the ways clinical trials are executed at CHOP is an emphasis of the Research Institute’s strategic plan. At an October meeting marking the kickoff of the CTAG, attendees learned about the rollout of the new OnCore Clinical Trial Management System across CHOP’s enterprise. Originally implemented by CHOP’s Cancer Center in 2010, OnCore will enable all clinical trial research teams to use a single, comprehensive system to manage studies, simplify data management, and improve compliance. The RAG will devote an upcoming meeting Feb. 28 to introduce attendees to how OnCore works.

“If we’re going to continue to support an ever increasing number and diversity of trials, we all have to get on the same platform, so that we can better offer institutional support,” said Dennis Durbin, MD, MSCE, Research Institute assistant vice president and chief clinical research officer, who set the stage for the first CTAG meeting. “I promise you, you’re going to be clamoring for OnCore as soon as you hear about it. You’re going to want this because it’s going to make your life easier.”

In much the same way as the entire research community is benefiting from what the Cancer Center learned from its familiarity with OnCore, Dr. Weiss envisions the RAG will encourage members to share success stories and navigate potential barriers that they may encounter during the life cycle of a clinical trial. One way she hopes to foster this dialogue with the clinical trial research community is by pairing CTAG members for occasional lunch dates. Getting to know one another could prompt members to realize common interests, spark potential collaborations, and facilitate trouble-shooting.

“So many trials are going on at CHOP, but until now, many of us had limited opportunities to talk with other investigators about our experiences,” Dr. Weiss said. “It’s a shame to reinvent the wheel to solve a problem; the CTAG will allow us to capitalize on others’ prior similar challenges and solutions. The CTAG will also enable clinical trialists to have a more unified voice in communications with administration.”

For instance, Dr. Weiss recently came to an impasse during a pharmaceutical trial that her team is conducting to test a drug for juvenile arthritis. Tuberculosis (TB) screening must be performed before a patient can enter the study, but CHOP’s research laboratory services didn’t offer the specific type of TB test that the pharmaceutical company’s protocol mandated. After months of back and forth, Dr. Weiss’ team was able to negotiate a solution, and she wondered if this same issue had stalled progress on patient recruitment for other studies. This is the type of question that Dr. Weiss could pose to CTAG members and see if anyone else had figured out a workaround.

Over the next year, the CTAG will embark on several initiatives that they identified in a survey sent this summer to gauge areas of interest and importance to research teams engaged in clinical trials. These include helping members to obtain biostatistical support services, creating a centralized way to provide access to resources such as guides to setting up different types of trials, and hosting a half-day retreat with speakers from both within and outside of CHOP.

The CTAG’s next meeting is scheduled for Dec. 6 at Abramson Research Center when Fran Balamuth, MD, PhD, and Scott Weiss, MD, MSCE, will discuss “Trials and tribulations of starting a pragmatic trial.”

If you’d like to learn more about the CTAG and how it will support investigators, email clinicaltrialsRAG@email.chop.edu.

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