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Investigator-Initiated Studies

Who knew Tracy may help bring significant pain relief to people across the globe with chronic pancreatitis?

photo: Tracy Hale

Tracy Hale, a single mom, suffers from excruciating pain due to chronic pancreatitis. She was born with a hereditary form of the disease. In the hopes of finding some relief, Tracy agreed to be part of an investigator-initiated study on the use of the drug Secretin for pain relief. Though she had inconsistent pain relief, the results were encouraging. According to Tracy, "If researchers can find out the best dosage, there may be hope of this treatment working for me or for someone else. If it isn't this medication, there may be other trials that might help me. I trust Dr. Gardner with my life." Thanks to the effort of research participants like Tracy and the talent of Dr. Tim Gardner in Gastroenterology & Hepatology, this study that originated at Dartmouth-Hitchcock Medical Center will likely move into a larger national multicenter clinical trial to further test the medication's effectiveness and proper dosing level.

What is Investigator-Initiated Research?

  • A physician/researcher has an idea from a pattern they see in treating their patients, which leads to a hypothesis, which leads to building a study plan
  • The researcher can be creative and explore their own novel ideas of how they can ultimately help patients
  • Differs from a "sponsored study" which is developed and supported financially by an organization such as the National Institutes of Health, a pharmaceutical company, or a device manufacturer

Examples of this Type of Study

Secretin Infusion for Pain Due to Chronic Pancreatitis (trial described above)

  • Dr. Tim Gardner from Gastroenterology is evaluating a medication called Secretin which causes the pancreas to empty its enzymes
  • Key question the study is looking to answer: how effectively can Secretin help eliminate pain for patients with chronic pancreatitis?
  • How this study started: Dr. Gardner noticed that his patients who were taking Secretin to help diagnose their pancreatitis, seemed to feel better after receiving the medication
  • How this clinical trial works: patients come in for 3 days and get various doses of Secretin and their pain level is measured
  • Results so far: 12 DHMC patients have completed the study and most have seen an improvement in their immediate pain
  • What's next?: Since there have been some positive results from this small study, the GI team will be setting up a larger placebo-controlled study involving other hospitals to further investigate the role of Secretin and the best dosing to help with pain from chronic pancreatitis

OPERA: Outcomes, Preferences, Education, Resource Utilization, Assessment

  • This study involves a group of inflammatory bowel disease (IBD) specialists from the US, Canada, and Australia; however, the program was started by DHMC's Dr. Corey Siegel in Gastroenterology
  • The work: a web-based patient database is used to look at novel and controversial research topics in IBD
  • Why this work is unique:
    • patients enter their own health and quality of life information in the database and agree to be available for future research studies
    • researchers gain an understanding of the broad range of personal, clinical, social and economic variables contributing to the IBD patient's daily life
  • The future: the research group collectively cares for over 10,000 IBD patients which means data on health outcomes and patient preferences will build up fast; the information from patients will ultimately help create more effective ways to deliver care to and educate IBD patients across the globe – an effort that began at Dartmouth-Hitchcock
  • Learn more at www.BRIDGeIBD.com