Before
you build that new home or put an addition on your house, you sit down and
sketch out a variety of looks and features that you would like to have included
in the project. You take your notes and prints to some area contractors
and ask them to propose upon your project. In some cases, you learn that
the project is within your budget, or some sacrifices have to be made to meet
those budgets. Then, the work begins.
During
the project, you find out that an allowance was included for your bathroom
fixtures which is something above the least expensive item at Home Depot; you
learn that the budget proposed a certain number of light fixtures which falls
far short of your expectations, so this is added. You learn that your
measurements are off just enough that you now require an extra piece of granite
to be purchased for your kitchen island. What went wrong?
There
are often many references made to the construction industry when speaking about
clinical trial execution, but arguments from both industries are very similar
when it comes to identifying your plan, whether it is a blueprint and
specifications book or a protocol and defined vendor agreements. If the
protocol is cut and pasted, or it is something that was constructed 10 years
prior using out-dated procedures, you will find challenges and difficulty in
executing your program, regardless of your vendor choice.
The
basic tenets of writing a protocol – the regulatory input, the identification
of primary/secondary/tertiary endpoints, etc. – are understood. A few additional considerations can
help to ensure that you have the appropriate detail and information to lean on
a well-constructed protocol to guide your service providers:
1.
Be sure that the protocol considers
Standard Of Care practices. Our team has been involved with two
studies that exceeded the Standard Of Care practices in the field. In both situations, the trial proceeded
forward despite many physicians not allowing patients to use higher doses of
toxic drugs or allow patients to reach measurable levels of disease that
exceed protocols of many healthcare organizations. In many cases, across international lines, the standards of treatment
can vary from country to country.
Consider the field conditions when developing your program.
2.
Be certain that physicians can actually
identify subjects who match your needs (feasibility). Site selection
is continually a challenge; physicians want the business and their teams feel
that they can recruit the required number of subjects, yet 70% of sites fail to
meet the minimum accrual requirement. Canvassing treating physicians to
review your protocol is one way to ensure that the procedures referenced are
current, patients do fit the profile required and the sites can be successful
when engaged. In addition, there are services that will mine databases to
locate patient pools and validated physicians to further validate the protocol
and identify areas that have patients to support your needs.
3.
Ensure that patients who exist will want
to participate (viability). Many protocols include a variety of
tests, blood draws and data collection that impede on a patient's quality of
life. In addition to ensuring that sites see the appropriate patients, a
consideration is strongly suggested to inquire with patients who have the
condition to determine if they will comply with the requirements of the
program. In addition to site selection, patient compliance is also a
great challenge for sponsor companies.
4.
Walk through the logistics of the
program to identify any outliers in terms of service support. Your
program requires interesting logistics around sample collection, and it is
assumed that your CRO partner has addressed it. But, they have only
budgeted for the basics of sample handling while your requirement is much
greater and more involved. Working out the logistics of the entire study
with each participating functional area can help identify some areas of
challenge that should be discussed proactively and addressed in the timeline
and budgeting process.
5.
Be sure that your selected CRO partners
have an opportunity to contribute enhancements. CROs, whether full
service, or functional/specialty blends, have a wealth of experience and history.
Many of these people have had experiences across multiple programs in similar
areas. If they have the experience, use it - get it during your protocol
development or during the logistics discussion. It is one of the reasons
that you chose your partner, so get them involved - it will also help them
provide a better service if they are making suggestions to enhance the study.
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