Advanced Endoscopy Research Program
Research Director: Monica Gaidhane, MD, MPH
Investigators:
Amy Tyberg, MD
Avik Sarkar, MD
Haroon Shahid, MD
Monica Gaidhane, MD, MPH
Data Manager: Monica Gaidhane, MD, MPH
The Robert Wood Johnson Advanced Endoscopy Research Program (AERP) program has been established to implement Therapeutic and Advanced Diagnostic endoscopy-related translational and clinical research trials. We conduct single-center or multicenter pre-clinical, pharmacokinetic (PK), phase I-IV, randomized controlled, device, drug, observational, chart review, and epidemiological studies.
Our focus is not only on conducting research with new, minimally invasive devices, procedures and drugs, but also to compare and evaluate existing procedures and algorithms to improve safety and efficacy. Our ongoing clinical research includes studies evaluating diagnosis and treatment of malignant and benign gastrointestinal disorders including esophageal cancer, achalasia, stomach cancer, bile duct cancer, pancreatic cancer, acute and chronic pancreatitis, pancreatic fluid collections, and more.
Our epidemiological research focus is on the burden of digestive diseases and cost-effective treatment outcomes.
Additionally, we are also working on learning curves, education milestones, and credentialing studies to establish a minimum set of required skills and experience for interventional endoscopic procedures.
Our research program’s salient features:
- Experienced GCP compliant investigators who have conducted over 34 trials and published more than 200 publications
- Trained ancillary staff for research coordination, data entry, specimen collection and shipping, monitoring patients, and research care navigators for potential subjects
- Experienced data manager with biostatistics provision for power analysis, data querying/resolution, data validation, and clinical trial data analyses
- Clinical Research Center to support PK studies, active monitoring, patient visit or consults, overnight stay, dispensing and administering drugs, and screening tests
- Accredited Investigational Pharmacy
- Multiple labs on premises
- Electronic source documentation
- Support for Electronic Data Capture system, electronic regulatory documents, Clinical Trial Management System, eLearning modules for investigators and patients, and electronic invoicing
- Support for budget, contract, agreement, and data sharing development
- Support for remote monitoring, online investigator meetings, and live interactive webinars
- Dedicated space and event organization support for study related conferences or workshops, as well as study related activities, including monitoring, audits or other related consortiums
- Protocol, consent form, feasibility assessment, case report forms, standard operating manuals, logs, annual reports, final study report, and manuscript development
- NIH Grant development assistance
- IND/IDE consulting and study development assistance
- Support for Medical Monitoring plans, Safety Monitoring reports, pharmacovigilance, and risk-based monitoring strategies plan
- Online and offline trial recruitment and trial advertisement strategies, including website development support, brochures, booklets, one-page summaries, and collaboration with dedicated foundations to increase recruitment
- Online pre-screening modules, support for web-based or app-based surveys and active subject monitoring
- Collaborations with other divisions and departments for study development and implementation
- Support for research mentoring
