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Quality
data at the right time to back-up the study drug of interest. How do you get that? On-time enrolment. So,
how is this done? At first by getting the clinical study design and the
resulting protocol right. Secondly, by matching the right investigational sites
to the protocol; sites that are able to deliver the needed patients in a rapid
pace and excluding the investigational sites that will not enroll.
It’s
important to understand that a well designed clinical study and the resulting
protocol can have a tremendous positive effect on the slope of the typical
recruitment curve. The protocol’s inclusion and exclusion criteria that
restricts recruitment should be analyzed and minimized if possible. Protocols should
be consistent and be clear and precise on the inclusion and exclusion criteria to
avoid any misinterpretation. The patient’s load in terms of visits, exams and
procedures should be minimized. All this to ensure high enrolment.
Support of
an academic CRO could prove to be very useful to identify the strengths and
weaknesses of the protocol, to aid in the clinical study design. Academic CROs
have a background in protocol design through built-up knowledge and have access
to experts in the therapeutic area. The CRO’s investigator network can be used
for this purpose as well since the investigational sites are able to understand
best how a protocol will enroll. Based on the particularities of the final
protocol, a CRO is able to pick the best investigational sites for the protocol
and to examine the investigators motivation since enrolment is strongly
affected by this.
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