Background and Problem
To get
approval to market a drug in the US could take several months to several years
to complete. P&G is devising potential strategies for reducing the length
of time P&G takes to complete clinical trials for their prescription drugs.
For the average prescription drug, each day of delay in market entry for the
product costs the sponsor roughly $1 million in lost sales. It is important to
have an efficient and cost effective way to perform and store information from
clinical trials. In May 2011 six pilot trials using web enabled electronic data
capture (EDC), a technology for collecting trial data from investigator sites (i.e.
Physician offices and hospitals) on the internet.
In a typical
paper-based trial at P&G there are 3 stages – trial preparation, data
collection and verification, data management and review. Once all the data has
been verified, the database is reviewed by several staff members. These reviews
often generate queries that have to be sent off for resolution. Upon completion
of the review, which is normally 8-12 weeks after the final patient for the
trial; the database was “locked” so that no additional changes could be made to
the studies information.
P&G like
most other pharmaceutical firms have relied heavily on paper based methods for
collecting information from trials. The pilots suggest that EDC could significantly
shorten the lead time for clinical trials, it was also clear that the use of
the technology would require substantial changes with respect to trial
management inside and outside of P&G.
The key
problem is should P&G implement EDC for their
management of their clinical drug trials. Could the use of EDC add value and how
would the process changes brought on by using EDC effect the relationships
within P&G, between the company and the investigative sites for trials.
Situation Assessment
The context of the problem is that the use of paper-based process is
antiquated and time consuming for the people involved. For example after the
verification stage, the information in a case report form (CRF) page would be double entered into
the back end database. The double entry process requires two different individuals
to each enter the information given on a CRF page. For a typical CRF binder of
50 pages, this process would take approximately 25 hours of labor time spread
out over the course of the trial. The paper based process historically served
as the backbone of clinical trial management at P&G however, the process
suffered from long lead times driven in part by the need for extensive manual
processing.
One of the key challenges P&G faced was its performance with
time to data lock. Time and data lock was measured as the elapsed time between
the collection of the last piece of data on the final patient of the study and
locking the database. With using a paper method, this process is not as
efficient as using something electronic. P&G would benefit from having a
system that is easy to use, had better quality checks for errors and accuracy, shorter
process length, and provided clean and viable data sets.
Plausible Alternative Courses of Action
1. Improving the Paper Based Process:
P&G could attempt to speed up the data management process through
adjustments to the paper based system. This could include the use of express
mail shipments from the sites on a daily basis and increased staffing to perform
site monitoring and source data verification. Though requiring additional resources,
this approach had the benefit of familiarity for all participants in the trial management
process.
2. Digital Imaging: Digital
Imaging followed the same process as the paper based system with the exception
of the method for transmitting data from investigator sites to the
pharmaceutical sponsor. The investigator sites faces completed CRF’s to a
processing site at the sponsor. Faxes were digitally received and stored by the
system. During the double entry process, clerks used a split screen with the
document image on one side and an entry form on the other. The two entries were
reconciled in the same manner as in the paper based process. One of the drawbacks
with using digital imaging is that the technology involves moving images around
which takes a lot of memory and capacity on large drug studies there are a lot
of images that need to be handled. Anytime you make a change to a CRF, another
image has to be stored and tracked. With large studies you run the risk of
scaling up.
3. Web Enabled EDC: This approach
allowed data to be entered into the data management system directly by the
investigative sites. Pre-determined validation rules were immediately applied to
each record to identify potential errors during the initial data entry. Once
entered, records were immediately available to the sponsor for the purpose of
monitoring the trail and conducting preliminary analyses on blinded data. No
double entry of data is required. Despite the additional information provides
to CRA’s they still need to make visit to sites to perform source data
verification.
Recommendation
Based on the case, I recommend to go forward with the web enabled
EDC. One of nice the features with EDC
is that it does not require double entry of data which can reduce error and
have immediate accurate data collection. Although there is a higher cost in the
initial set up and training of employees, there is a much higher return in the
long run for P&G.
Reflection
After listening to the American “A” Experts’ consultant’s
recommendation on alternatives for P&G, I agree with the recommendation to
go with the web enables EDC. Some of the benefits for going with the EDC are
the time efficiency, secure and accurate data collection, quality, web cloud storage,
and that other competitors are using similar systems. It provides the best
opportunity of increasing efficiency in the data collection and verification
process. The layout provided by the consultants (see below) provides a good process
flow chart of how the EDC implements its current system and with EDC. As you
can quickly see, step 3 has been streamlined with less steps using EDC and with
quicker timeline for reviewing the data.
Current Paper Based Process Layout
Web Enabled EDC Layout
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