M ulticenter
A cademic
C linical
R esearch
O rganization

Contact Phyllis Klein at
314-747-4289 or kleinp@msnotes.wustl.edu
Multicenter Academic Clinical Research Organization
    The MACRO Advantage
  • 4 premier institutions, 1 IRB process
  • standard set of SOPs, improved QC
  • optimal advantage to sponsors with master contractual agreements

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MACRO is a one-of-a-kind partnership that represents an innovative academic collaboration in clinical research to expedite the clinical trial process. Through MACRO, industry sponsors and CROs have access to investigators at leading academic centers with a reciprocal IRB approval process authorized by OPRR, now OHRP, via cooperative amendment to our Federal Wide Assurance for compliance with DHHS Regulations.

We seek to participate in Phase II, III and IV NIH and Industry sponsored clinical trials.

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What is MACRO ? MACRO (Multicenter Academic Clinical Research Organization) is an alliance of 5 academic health centers that have agreed to cooperate on the process of IRB review of clinical trial protocols through a policy of limited reciprocity.
What is “limited reciprocity”? Limited reciprocity is an arrangement by which IRB review of a clinical trial at one institution can be accepted by the other institutions. It is “limited” because there are provisions to protect local differences or interests, and because information is shared by all the institutions.
How did MACRO develop? Who (which institution) initiated it? MACRO was born as the result of discussions at an early meeting of the “Academic Health Center Clinical Research Forum”, an informal association of academic centers to discuss various issues related to clinical research (trials, training, funding, etc). Dr. Daniel Schuster at Washington University (WU) brought forward the idea of "IRB reciprocity", building on similar arrangements that already existed in some of our more local regions.
How were the specific AMCs chosen? Why five centers? Centers were not “chosen”. The current five MACRO institutions each had at least one invidivual who was committed to and capable of moving the process of approval forward at their own institution.
Might other AMCs join this group? Can similar arrangements be made by other AMCs? Membership in MACRO will be limited to the existing 5 centers for the first year, until we prove we can deliver on our promises, establish some benchmarks for others to reach if they join at a later time, and to demonstrate that the industry values this new alliance by sending trials to it. After that time, other academic centers will be invited to join if they are willing to agree to our sops. Other AMCs can of course create similar, or different, alliances if they want to, or choose to.
What makes this arrangement different than other academic alliances in the past? The essential "product" that MACRO offers at present is an improvement in the IRB approval process at multiple academic centers distributed across the eastern half of the united states. To our knowledge, this is a first.
Why is this arrangement better than an AMC creating its own SMO? MACRO is not an SMO. Indeed, nothing precludes each of the MACRO member institutions from establishing its own SMO. What we hope is attractive about MACRO is that a sponsor can now assume, barring unusual circumstances, that IRB approval at one of the MACRO institutions effectively will mean simultaneous approval at the other participating institutions.
Will each of the partners continue to do studies under separate arrangements with a sponsor/CRO? Yes.
What agreement(s) have been made among these five AMCs? The essential agreement is that we will accept each other's IRB review of clinical trials. Standard operating procedures are in place to ensure that "hot button" or "red flag" issues, and that "local" issues can be identified through administrative review of the primary reviewing institution's proceedings. This sharing of each other's reviews, we believe, will actually enhance the whole process and further serve to protect human subjects.
How will the arrangement work? Are there administrative staff who will be added that will simply be MACRO staff? Who will initiate discussions with the sponsor regarding a particular trial? Each member institution has identified a single Protocol Coordinator for implementation of the Cooperative Amendment (PCCA) . This person is charged with making sure that each participating institution on each trial will be in compliance with our sops. In most cases, this will mean making sure that investigators and nurse coordinators understand the MACRO process for any trial conducted under the MACRO agreement. Each institution has a clinical trial office. In general, the PCCA is a member of that unit. These offices will continually look for opportunities for MACRO participation. To initiate discussions about using MACRO , sponsors may contact any of the PCCAs, or alternatively, PCCAs may contact a sponsor that is planning to do a study at one of the MACRO institutions.
How will the IRB review work? Will it rotate among the five AMCs? Who will determine which IRB reviews a study? For each trial, one center will serve as the "primary reviewing institution". Information about that review will be circulated to the other participating institutions for that trial (not every institution is obligated to participate on every trial). The timeline for review will be driven by the review of the primary institution. Which institution actually serves as the primary reviewing institution for a particular trial will depend on the sponsor, on which of the members choose to participate in the trial, and on procedures we have agreed to for Sharing the reviewing work.
Who/how will the study be monitored for human subject protection? The IRB of the primary reviewing institution will be responsible.
How will SAEs be reported? To which IRB? The standard procedures of each institution, in compliance with GCP, will be followed. Ultimately, the IRB of the primary reviewing Institution will be responsible for any particular trial.
Will these IRBs have the same membership as the current IRBs at each of these five institutions? If so, how will they manage the time for the MACRO protocol review with other applications for approval? No separate or special IRB will be established. The standard procedures and timeline of the primary reviewing institution will dictate. MACRO trials will not be given any special treatment, but neither will they be held up. The goal will be that when the primary reviewing institution gives final approval for the protocol, the protocol can be considered approved at each of the other participating institutions.
Who (which institution/researcher) will have the intellectual rights to any study findings? publication rights? How will this be ironed out? The MACRO agreement does not cover contractual agreements with The sponsor. These must still be obtained individually with each Institution. Obviously, those sponsors who have master contractual agreements with the MACRO members will have a special incentive for taking advantage of the MACRO alliance.

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MACRO Protocol Coordinators for the Cooperative Amendment (PCCA)
University of Alabama at Birmingham
Sheree C. Carter, RN, MSN
Program Director II, Arthritis Clinical Intervention Program
University of Alabama at Birmingham
SRC 068, 619 19th Street South
Birmingham, AL 35294-7201
Phone 205-934-7754
Fax 205-975-5554
Email sheree.carter@ccc.uab.edu
University of Pennsylvania
Marcia Markowitz
Director, Clinical Research Development
Office of Human Research
University of Pennsylvania School of Medicine
3620 Hamilton Walk
151 Anatomy-Chemistry Building
Philadelphia, PA 19104-6061
Phone 215-746-7406
Fax 215-662-4939
Email mmarkowi@mail.med.upenn.edu
Vanderbilt University
Gail Mayo, RN
Research Services Consultant
Research Support Services
Vanderbilt University
3319 West End Avenue Suite 550
Nashville, TN 37203-8820
Phone 615-322-7072
Fax 615-936-8545
Email gail.mayo@vanderbilt.edu
Washington University
Phyllis Klein, RN, CCRC, BSN
Center for Clinical Studies
Washington University School of Medicine
Campus Box 8009, 660 S. Euclid Ave
St. Louis, MO 63110
Phone 314-747-4289
Fax 314-747-1404
Email kleinp@msnotes.wustl.edu

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