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News-At-A-Glance (Highlighting Clinical Researchers at Penn)
Clinical Research Forum announces 2019 Top Ten Clinical Research Achievement Awards
Please click on this link to read the entire article: https://www.clinicalresearchforum.org/page/AwardsBanquet
The Clinical Research Forum has announced the 2019 Top Ten Clinical Research Achievement Awards. We would like to recognize three awardees have been chosen from the University of Pennsylvania.
- Hemophilia B Gene Therapy, nominated by University of Pennsylvania and represented by Dr. Lindsey A. George, Assistant Professor of Pediatrics. This is the first gene therapy trial to report a clinical cure for hemophilia B patients.
- Medical Management of Early Pregnancy Loss, nominated by University of Pennsylvania and represented by Dr. Courtney A. Schreiber, Associate Professor of Obstetrics and Gynecology. This study is the only rigorous, randomized clinical trial for miscarriage management that compares a combination therapy of mifepristone and misoprostol to misoprostol alone. The rate of expedited success was 84 percent among women who received both drugs, and 67 percent for among those who received misoprostol alone.
- Predicting response of patients with chronic lymphocytic leukemia to chimeric antigen receptor (CAR) T cell therapy, nominated by the University of Pennsylvania, represented by Dr. Joseph A. Fraietta, Director, Tumor Immunotherapy Laboratory, Center for Cellular Immunotherapies and Adjunct Assistant Professor of Pathology and Laboratory Medicine. This study focused on understanding why CAR T cell therapy is highly effective in some patients, but not others. The long-term goal is to advance the cure rates of adult leukemia without the side effects typically seen with conventional treatments, and ultimately to extend the benefits of CAR T cells to other cancers.
ClinicalTrials.gov does not offer a “pre-review” of the study record as part of our regular QC review process. After record Release, registration record reviews take 2-5 business days and review of records with results take up to 30 days if the study appears to be an applicable clinical trial or is NIH-funded. Other types of study records with results will take longer.
Instead of “pre-review”, we offer targeted assistance to help investigators with specific issues and one-on-one assistance for investigators new to submitting results information. For example, if an investigator would like a brief overview of the required information before beginning data entry, assistance with learning how to enter results information, or would like to discuss strategies for entering a complex study design or unique outcome measure or analysis, then we are happy to provide email assistance or schedule a teleconference. In addition, we can also provide assistance in addressing QC Review Comments when there are questions. Requests for email assistance or for a teleconference should be submitted to firstname.lastname@example.org.
To understand the criteria that ClinicalTrials.gov staff use for QC review, we recommend consulting the review criteria for both registration and results information (included below). These are intended to assist you with improving data quality and avoiding major issues.
- ClinicalTrials.gov Protocol Review Criteria (PDF): Describes review criteria for study records submitted to the registry (June 2018)
- ClinicalTrials.gov Results Review Criteria (PDF): Describes review criteria for each scientific module in the results section of the study record submitted to the results database (June 2018)
- PSOM Research Consent Guidance Memo
- Additional Guidance Regarding Consenting Subjects in Interventional Studies
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