A joint Montefiore/Einstein Office of Clinical Trials (OCT) is being re-engineered to formalize an infrastructure that will provide local, national and global leadership in clinical trials and evidence-based health care. The Department of Ophthalmology is taking a leadership in this effort. Our OCT will be a locally and nationally recognized leader in showing that trials can efficiently be conducted at an academic medical center. This program is designed to guide, inspire and implement sponsored human trials, industry sponsored and NIH sponsored as well as investigator-initiated pilot programs based upon scholarship and intellectual engagement of the Montefiore/Einstein community.
Our OCT is designed to facilitate:
- Discovery and garnering of proposed clinical trials to bring them to Montefiore/Einstein;
- Active pursuit of sponsors and CROs in establishing the Montefiore/Einstein community as a willing and successful partners in such trials;
- Guidance in acceptability and appropriateness of potential trials for our center;
- Coaching and management of local PIs to get us chosen as a study site;
- Coaching and management of local PIs after we are accepted as a study site;
- Guidance and management of subject recruitment and retainment in trials we support;
- Enrollment and active participation of the medical center's clinical departments within currently assembled networks of clinicians able and willing to participate in clinical research;
- A protected, convenient and accessible facility for in-patient and out-patient clinical trials that neither interferes with nor cannibalizes the ongoing clinical mission of the medical center;
- Management for a scatter-bed in-patient clinical trials model;
- Appropriate facilities for the conduct of such trials, to include interview rooms, phlebotomy access, specimen processing, ancillary testing, appointment scheduling accessible through IDX, study coordinator services and training on a shared basis, with technical support and training of personnel.