| About the Clinical Trials Unit
How we operate
Services for JHU faculty
The Johns Hopkins University School of Medicine Clinical Trials Unit
serves as a gateway to foster the growth of clinical research within
the SOM by means of the highest ethical and scientific standards in
a time sensitive and cost effective manner. We strive to 1) facilitate
routes of communication between Industry sponsorship and Hopkins investigators
and 2) provide the infrastructure to perform the collaborative work
forged from these connections. By facilitating these key relationships,
the CTU aims to ensure groundbreaking, efficient clinical investigation
leading to improved patient care.
How we operate
Increasingly, pharmaceutical companies, government research agencies
and private foundations seek academic medical centers to test new
therapies. A daunting challenge exists in identifying both specialty
physicians and willing participants in the bureaucratic mazes typical
of academic centers. Johns Hopkins has positioned itself at the top
of this new wave in clinical research by overcoming this obstacle.
The Clinical Trials Unit, directed by a noted researcher familiar
with the work of Hopkins' clinical faculty, serves as the catalyst
that intertwine the sponsor and the academic researcher. Once the
pharmaceutical company and investigator agree upon the study and approve
the protocols, the CTU helps both parties carry out the trial, by
facilitating all contract and regulatory approvals, assisting in patient
recruitment and enrollment, and monitoring progress and quality assurance.
We have conducted over 100 clinical trials with numbers steadily increasing.
Projects are funded through the NIH, private foundations, and industry
and encompass Phase II, III and IV studies. We also maintain a physician
database enabling us to place research studies around the Institution,
allowing us to choose from almost 300 interested clinical researchers.
Our staff has participated in the development and phenomenal success
of various novel therapeutics and biomedical devices for various diseases.
Recently our principal investigators participated in studies evaluating
transdermal delivery systems, COX-2 technology, and anti-platelet
Our Services for Johns
Hopkins University faculty
Creation and negotiation of internal and external budgets for the
University with outside sponsors.
Communication with the funding agency for all initial study administration.
Contract negotiation, follow-up, and passage through the Office of
Draft of Internal Review Board (IRB) submission
and consent forms.
Protocol tracking through the IRB.
Draft responses to IRB queries until full committee approval.
Collection of all regulatory documents and maintenance of regulatory
Full study coordination at JHU, Greenspring Station or Bayview.
Complete clinical, laboratory, and technical support including specimen
preparation, processing, and shipping.
Clinical space for study visits and storage of laboratory supplies.
Regular meetings with the investigator(s), or designated person for
Monthly administration and reconciliation of financial statements.
Management of contract payments and receivables.