Taking Your Research From The Bench To The Bedside

Entering the clinical trial phase of your research at CHB

You might enter the clinical trial phase of your research when an experimental agent you have is ready to test on humans, or when you have devised a new application for a drug that has already been approved by the FDA. You might get involved when you agree to participate in a clinical trial based at another institution, or when you are invited to participate in an industry-sponsored drug study.  Whatever your starting point, a wealth of resources are available to you within CHB and the larger Harvard-Longwood community. The IDDRC Administrative Core can help you access the various types of support available to you. The following list describes how each process would begin.

If you have developed a new therapy (drug, intervention, etc):

  1. First contact is the Hospital Intellectual Property Office re: patents and licensing (617) 919-3019 or x43019
  2. Next contact is typically a drug company- they might contact you, or you can propose an investigator-initiated study.
  3. Once you have a sponsor, you would contact the Clinical Trials Office (CTO) at 617-919-2714.

If you have devised a new application for FDA-approved drug:

  1. First step is to secure an IND from the FDA. The process starts with a call to Carleen Brunelli’s office.
  2. Next you would contact the Clinical Trials Office (CTO) for patient care cost budget items
  3. You would then prepare a Human Subjects Protocol and submit it for department scientific review.
  4. After obtaining internal approval (and your Chair’s signature) you would submit your protocol to the hospital’s Office of Clinical Investigation/Institutional Review Board (IRB).
  5. Once your protocol has been approved, if your study involves patient care costs, the CTO provides you with a study tracking sheet (STS) used to pay for hospital-based charges.
  6. Members of the CHB Clinical Research Program and the EQUIP Program assist with planning and project execution.

If you plan to participate in a clinical trial based at another institution:

  1. If a Letter of Support (from PI) is all that’s requested for a grant proposal, you can handle this yourself.
  2. If a Letter of Intent is required from your institution with accompanying budget figures:
    - You contact the Clinical Trials Office (CTO) for help with budgeting patient care costs;
    - You submit your budget and a statement of work to the Office of Sponsored Programs for review
    - OSP provides you with a signed letter of intent or a signed contract.
  3. Before or after you secure study funding, you prepare your Human Subjects Protocol as described above.
  4. The Clinical Research Program and the EQUIP Program can help you assemble your study documentation and develop good clinical practices.

If you are about to participate in an industry clinical trial:

  1. The CHB Clinical Trials Office (CTO) handles all confidentiality disclosure agreement (CDA) and contract issues.
  2. Next step is a Site Qualification Visit that involves the PI and the staff who will assist with the trial.
  3. A budget is then prepared by the CTO based on a protocol provided by the sponsor or by you.
  4. Once negotiations are complete, you obtain IRB approval of your Human Subjects Protocol as described above.
  5. A Site Initiation Visit with the sponsoring organization takes place before the trial commences.
  6. Site Monitoring visits continue to take place throughout the trial.  The Clinical Research Program and the EQUIP Program can help you assemble your study documentation and develop good clinical practices.

For all types of clinical and translational research

All members of the Harvard community may access the Harvard Clinical and Translational Science Center (also known as Harvard Catalyst) a pan-Harvard University enterprise and a member of a national consortium of medical research institutions funded through the NIH Clinical and Translational Science Awards.  One component of the Harvard CTSA is its Human Research Laboratories (HRL) which incorporate dedicated in- and out -patient clinical research sites, clinical research personnel and core laboratory services to participating institutions.  The CHB HRL (also known as the CTSU and the Clinical & Translational Study Unit at Children’s Hospital Boston) provides a facility where patient oriented research studies can be conducted. It is equipped with specialized research equipment and expertise to enable sophisticated physiologic subject monitoring and experimental drug delivery and monitoring. Controlled environment test areas for specialized studies such as sleep and neurologic testing are also available and are staffed by experienced research nurses, nurse practitioners and technicians. The facility also provides core services including skilled bionutritionists, metabolic kitchen and body composition assessment. Specimen processing is conducted in an on-site core laboratory. For more information about using this facility, contact Kristine Jordan, Administrative Director, at 617-355-7541.

Links:

Intellectual Property Office
http://www.childrenshospital.org/cfapps/research/data_admin/Site49/mainpageS49P0.html

CHB Clinical Trials Office (CTO)
http://www.childrenshospital.org/research/Site2032/mainpageS2032P4.html

Carleen Brunelli’s office
jessica.moran@childrens.harvard.edu

Human Subjects Protocol
http://www.childrenshospital.org/cfapps/research/data_admin/Site2206/mainpageS2206P19.html

Committee on Clinical Investigation/Institutional Review Board (IRB)
http://www.childrenshospital.org/cfapps/research/data_admin/Site2206/mainpageS2206P0.html

CHB Clinical Research Program
http://www.childrenshospital.org/research/Site2030/mainpageS2030P3.html

EQUIP Program
http://www.childrenshospital.org/cfapps/research/data_admin/Site2207/mainpageS2207P0.html

Office of Sponsored Programs
http://www.childrenshospital.org/research/Site2032/mainpageS2032P3.html

Harvard Catalyst
http://catalyst.harvard.edu/home.html

CHB Human Research Laboratory
http://crp-apps/Intranet/Default.aspx?alias=crp-apps/intranet/gcrc

Kristine Jordan
Kristine.jordan@childrens.harvard.edu