02/04/2015
This was a great article from one of our sponsor's, Rebiotix!! ENJOY!!
Site Spotlight: Chevy Chase Clinical Research
Congratulations again to Dr. Hardi and Kathy Tracey, LPN at Chevy Chase Clinical Research, in Chevy Chase, MD who were the first to enroll in the PUNCH CD 2 trial. Dr. Hardi and Kathy kicked-off the PUNCH CD 2 study on December 16, 2014 when they enrolled the first patient, and have since enrolled two more patients in the study. Dr. Hardi’s site was also the first to enroll in the PUNCH CD study and they quickly ranked as the top enroller. In addition to enrollment success, Dr. Hardi has also submitted a manuscript for publication, “Relative Importance of the Donor in the Outcome of Next-Generation F***l Transplant for Clostridium difficile Infection” to the Journal of Clinical Gastroenterology and Hepatology. In addition, Kathy has had a poster, Successful Implementation of a Phase 2 Study of a Novel Microbiota-based drug for Recurrent Clostridium difficile Infection and a presentation and poster, Perspectives on the PUNCH CD Trial of a Microbiota-Based Drug Targeted at Recurrent C. difficile Infection accepted at the 2015 SGNA meeting.
"I am happy to be participating in the Punch CD 2 study. There is a general belief that microbiota transplantation works well to treat patients with recurrent C. diff. infection, however, this study will demonstrate the actual therapeutic potential of this new drug in those patients who have not responded to standard antibiotic therapy," said Dr. Hardi.
Kathy attributes her success in recruiting patients to proactively seeking out C diff patients. Below are some of the tactics she employs:
• Periodically sends mass emails to all physicians within Capital Digestive Care reminding them about the PUNCH CD 2 study.
• Works closely with the medical assistants in her clinic, providing a worksheet for them to write down the names of all patients that have an order for C diff testing. She then seeks out the test results and contacts the physician whose patient has a positive C diff result to see if they are truly study candidate.
• Reminds clinicians she encounters on a daily basis about the PUNCH CD 2 study.
Chevy Chase Clinical Research (CCRC), established in 1996, is an independent research site and is the largest research center of its kind in the region with more than 300,000 patients in its database. We are privileged to have Dr. Hardi as a PI for the PUNCH CD 2 clinical research study as he has served as a PI in more than 300 studies. He is Board Certified in Gastroenterology and Internal Medicine with areas of clinical expertise covering more than 25 digestive and general health conditions.
The majority of studies at Chevy Chase Clinical Research are Phase II and Phase III, although Phase I and Phase IV studies have been piloted as well. The research team is involved in a breadth of research including device, instrument validation and patient questionnaire studies, such as the Functional Dyspepsia Questionnaire.
Under the direction of Dr. Hardi, the PUNCH CD 2 trial is supported by a collaborative team of sub-investigators and study research staff including: Michael Weinstein, MD, Lawrence Widerlite, MD, Louis Korman, MD, Michael Schwartz, MD, Kathryn Kirk, MD, Kathy Tracey, LPN, CCRC, Suzy Hernandez, CMA, CCRC, Matthew R. Burkemper BA, CCRC, Delmonica Glaze RN and Laure Kouyoudjian, PA.
