Page 31 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

10.1.5 Special Concerns

10.1.5.1 Multicenter Trials

A multicenter research trial is a clinical trial conducted at
more than one medical center or clinic. Most large clinical
trials, particularly Phase III trials, are conducted at several
clinical research centers. The benefits of multicenter trials
include a larger number of participants, different geographic
locations, the possibility of inclusion of a wider range of
population groups, and the ability to compare results among
centers, all of which increase the generalizable of the study.
Ideally, these trials should be initiated at the same time at
all the centers.

i. All investigators should give a written
acceptance of the protocol. The protocol may be
modified to suit the local requirements, as well as
should be appropriately approved by the ethics
committee of the host institutes/country.
ii. In a meaningful multicenter trial, all study
sites should be conducted in the same way and should
follow standardized procedures and evaluation
criteria. So, meetings should be arranged at the
initial and intermediary stages of the trial to ensure
consistent procedures at all centers.
iii. All research staff at the participating centers
should be trained to familiarize them with the
uniform procedures, data entry in the case record
forms, ethics and GCP.
iv. For recruitment, evaluation/monitoring of
laboratory procedures and conduct of trial,
standardization of methods should be carried out.
v. If necessary, in the protocol there should be
monitoring of adherence to protocol including
measures to terminate the participation of some
centers. For this purpose a central monitoring
committee could be set up including ethics committee
members.
vi. Specific role of coordinators and monitors
should be defined.
vii. According to WHO’s “Operational Guidelines
for the Establishment and Functioning of Data and
Safety Monitoring Boards”, centralized data
management and analysis should be planned.
Viii. Drafting procedure for common final report
and publication should be decided at the outset. No

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 27