& Investigator Appraisals
To achieve the specified
numbers of evaluable subjects, the selection of sites is critical
to the success of the study. A good feasibility survey must be
undertaken at an early state in the selection process to ensure
that a study can be conducted in the country or at the site of
choice. The survey will gather and analyze data on the availability
of potential subjects fulfilling the inclusion and exclusion criteria,
realistic recruitment rates within stated timelines, current and
comparator treatments, competitor studies and regulatory and ethical
issues. The initial feasibility survey may also check investigators
for proven experience in trials in a particular indication. The
questions asked must provide sufficiently well-founded responses
to permit a decision on which countries and sites are to be used.
A good feasibility
will make an immeasurable difference to a study. The monitor will
feel comfortable about the site’s capabilities and there
should be fewer drop-outs and fewer site replacements due to poor
or no recruitments. The feasibility survey should complete those
parts of the selection process that can be performed by telephone,
fax and e-mail prior to visiting the site for a site selection
We at Consortium
Clinical Research deploy our technical
expertise and networking skills in ensuring
that the best picks are done out of the massive pool of credible
sites and interested investigators who are available in the country.
Thus, we add value to the drug development process of a sponsor,
by performing meaningful evaluations to understand the status
quo of various sites’ performances in a particular clinical
study under consideration.
has been referenced from Principles of Clinical Research, 2001.