The success of a Phase 1 clinical trial can come down to how optimally
you assign clinical site personnel. Without strategic planning, a study
could potentially incur high costs or face other obstacles for trial
sponsors. How, then, can you ensure that the staff chosen for your Phase 1 clinical trial units
is being assigned correctly to keep costs down and create efficient
processes? Here are some tips for evaluating the variables at your
clinical trial location.
Utilize General Training
Each Phase 1 clinical trial unit will have general training and
onboarding for new staff. This may consist of reviewing the employee
handbook, completing coursework and certification requirements,
competency testing before receiving a procedural assignment, ICH (E6)
and GCP guidelines, and other types of training. However, what’s most
important is that staff are trained for specific procedures in your
clinical trial protocol. For optimal efficiency, staff should be
familiar with protocol-specific requirements, such as a specific type of
blood draw.
Determine Route of Administration
During early clinical development,
a route of administration will be determined for the clinical trial.
The trial drug could be administered intravenously, through a
transdermal patch, inhalation, or another route. The staff assigned to
the clinical trial, especially the dosing staff and study coordinator,
should have experience with the specific route of administration your
trial’s protocol calls for.
Is the Interval of Dosing Specified?
The dosing interval may or may not be specified in the protocol,
depending on whether you are allowing for flexibility in determining the
time between participant doses. The dosing interval can affect your
staffing needs because participants may overlap. Can two staff members
safely cover multiple procedures over the course of the day, given a
specified dosing interval? Viewing procedure logs can help determine the
overall number of staff needed on a given day.
Staff Procedural Times and Conflicting Schedules
Procedures take time to prepare, and dosing intervals may not account
for preparation times. Staff should have time between procedures to
gather necessary supplies, such as blood collection tubes or other tasks
like confirming an accurate tube count per subject draw. A staff that
feels rushed could lead to mistakes, negatively impacting the study.
Assigning Staff Based on Procedural Complexity
Understanding the level of certification or training needed for each
procedure can affect the trial’s budget and the way the research is
conducted. For example, a registered nurse is not needed for simple
tasks like measuring height and weight, so these assignments can be
handled by staff members with fewer certifications. It is usually best
practice to reserve higher-trained staff for more complex tasks, such as
dosing.
Staff Experience with Equipment or Instrumentation
If a Phase 1 site needs to bring in new equipment to perform the
procedures outlined in your protocol, it can be best practice to assign a
staff member with prior experience with these procedures to avoid as
many risks as possible. Otherwise, an outside vendor, external location,
or qualified trainer may be needed. The best Phase 1 clinical trial
units will use their resources to the fullest potential to benefit the
study.
About WCCT Global, an Altasciences company
WCCT
Global, an Altasciences company, is a full-service early phase contract
research organization (CRO) that caters to the pharmaceutical,
biotechnology, and medical device industries. When sponsoring a trial
with WCCT, partners can take advantage of a collaborative, innovative,
and agile approach to clinical research. WCCT employs specialized
regulatory and clinical professionals, giving trial sponsors an
unmatched research experience. The CRO offers partners access to crucial
resources for early clinical development, including an
80,000-square-foot clinical pharmacology unit (CPU) with 180 beds for
Phase 1 clinical trials. The CPU includes a USP-797 compliant sterile
room for drug preparation, a Peripheral Blood Mononuclear Cell (PBMC)
processing laboratory, and a CLIA-certified and CAP-accredited on-site
Safety Reference Laboratory. With extensive Phase 1 clinical trial
experience, WCCT also offers trial partners expertise in Ethnobridging,
First-in-Human, infectious disease and vaccines, ophthalmology and
women’s health clinical trials. Plus, the CRO is recognized as an
industry leader in Asian Ethnobridging studies, specifically with
Japanese participants.
Partner with WCCT and utilize their trained, experienced staff at https://sponsor.wcct.com/
Original Source: https://bit.ly/3zZhT7W
Optimize Labor and Skills in Early Phase Clinical Trials with Intelligent Staff Resourcing
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