To All the Members of the R&D Leadership Team,
Before I begin, I would like to thank you all for being here
and for giving me the opportunity to present my findings on whether or not to move forward with electronic data capturing (EDC) in order to minimize costs
associated to the clinical trials related to the launching of a new drug.
We currently perform on clinical trials using a paper base
method which takes a substantial amount of time to be finalized or in others
words, entered into our database without any errors in order for final analysis
to be performed. Our investigator sites,
medical offices who participate in our drug trials, have been entering all the patients’
medical history and outcomes/side effects of every visit on a paper form for
years now. However, has been proven to
be lengthy as we must have a third party enter this data into an electronic
form database, which is entered three times by three different entities, in
order to very that all data is accurate to the tee.
This is costly and very archaic when the move to electronic
data has been moving at such as fast pace.
Our cost per case report form (CRF) entered manually is currently $6 to
$9 dollars per page while if entered electronically the cost is only $3 to $4
dollars, meaning EDC is cutting our CRF costs in half. We have ran test trials
in order to verify that the electronic data capturing would decrease the amount
of time a drug take to go from its trial phase to being sold to patients. The trial was conducted using participating sites
whom some already have advanced skills using the internet and some did not even
have a computer onsite. The cost in purchasing
computers for some sites was not substantial, however, the time it took to
train them with the usage of computers was found to be tedious. Overall, the time it takes to enter a
patients full case from begin to end and then locking it up for analysis, error
free I might add, has been cut by half. This
shows how it is instrumental that we move forward with this implementation and there
are a few methods which can be used to help us with this.
The roles played by our clinical research associates (CRA’s)
can be revamped in order to include usage facilitation, a customer service role
addition to their job description. They are
able to perform this as they are now fully trained on our EDC program as they
are the one who visit the clinics in order to verify that the data is entered
correctly into the online web-based program.
They can offer full-time support if we create course materials and
actual in person courses for all personnel. This may be lengthy in the beginning
of implementation, however, in the long-run we predict a fully self-sufficient
program which might decrease the number of personnel we currently require.
Next, the creation of compliance training so that clinics
can be reminded on why the data entered is so important, how it should be
entered, what happens to the data after it is locked up, what they can do to help
improve the process and finally their feedback.
Feedback will be very important as it will be our only method of
understand what the sites require and how we can facilitate this process for
them.
If well planned out EDC can improve our process in many
ways, not only by decreasing costs associated to the clinical trial process but
as well as increasing productivity in launching new medical drugs faster. This will help us recover funds used in the
creation and implementation of the medical drug as well as decrease the amount
of sales lost due to launching time.
I hope this helps all the members in the R&D Leadership
Team come to a concise decision on the implementation of electronic data
capturing.
If you have any question, please let me know as I will be
more than happy to answer them for you.
Sincerely,
Jennifer Couto
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