Case
Study: P
& G – Electronic Data Capture and Clinical Trial Management
Problem/Issue
Statement
Proctor
& Gamble’s Health care division faces significant delays within its clinical
trial management process. P&G needs to identify a strategy to its existing paper based process to reduce the length
of time it takes to complete clinical trials for prescription drugs. The FDA
requirement for clinical trials can take several months to years to complete.
The faster the prescription drug can be put on the market, the quicker P&G
can begin to earn a profit. It has been mentioned that for each day the drug is
delayed, it causes the sponsor about $1 million in lost sales. Therefore, the
problem statement for P&G is
How to effectively reduce the
time it takes to get the prescription drug through trials while ensuring an accurate data collection
process and satisfy all parties involved in the workflow process?
The problem
is that the existing paper based data collection process is lengthy and the symptoms of the problem is
the current process which is time consuming & involves the double entry of
data, as well as an additional review of entries if discrepancies are found in original
entries by the CDMs, which leads to the significant lag time in sending and receiving the
data that is associated with using a paper based approach.
The scope of the problem is to find the exact reasons for time lags in clinical trial
methodology. This process needs to be reviewed from start to
finish for reducing the length of time and inefficiencies with the data.
Situation
Assessment
The context of the issue is the paper-based system
of clinical trial management, where all the patient information is kept in hard
copy format. This current process is slow due to double-entry for each page which
costs $6 to $9 per CRF form (consist of 50 pages per patient) & ultimately
causing significant delays in the prescription drug before entering the
market.
P&G decision criteria is to assess alternatives
that reduce the time it takes to enter patient information into the database in the most cost efficient way,
so as to avoid double entry and also consider the duration of
time from the final patient visit to the data-lock. If there are less inconsistencies
and errors, the time would be reduced. Paper form documents move slowly
through the departments which also causes delays. P&G can utilize the Web-enabled electronic data
capture (EDC) to address the reduction of data entry time. However,
P&G needs to assess the cost of implementing this process including the long
term benefits of a significant learning curve to operate the system
and ensure cooperation by the investigator sites where the trials are
conducted.
List
of Plausible Alternative Courses of Action
P&G
has three options in addressing the reduction
of time to data lock and the inefficiency in its current process:
Improving the paper-based process:
This option will allow P&G to use
express mail shipments from investigator sites which address the time delays
in receiving the hard copy forms from the investigator sites.
Digital imaging process:
It uses the same paper-based system but transmits the data from the sites to
sponsors via faxes. The faxes are stored in the system and double-entry clerks,
use digital images to prepare the CRFs. This is in addition to maintaining hard
copy forms in patient binders. This alternative also reduces the amount of time
in receiving the hard copy forms from the sites. However, this is solely dependent
on the sites ability to fax the documents to the sponsor in a timely manner.
Web-enabled EDC: It allows data to be
entered into the data management system directly from the investigator site via
the Internet. EDC has pre-defined validation rules in place to immediately
identify potential errors. The EDC system is accessible by the sponsor who can
view data immediately after it is entered.
EDC
process addresses most of the problems P&G faces; the paper-based system, the
errors and inaccuracy when entering data from hard copy forms, the double-entry
process, the movement of physical forms from sites to sponsor and ultimately the
reduction in time needed to enter the data-lock phase.
Evaluation
of Alternatives
The
three options have advantages as well as potential costs that need to be
evaluated.
To improve the paper-based process by using express mail on a daily basis, it will increase the head count for site monitoring and source-data verification, thereby increasing the cost to the company.
The digital imaging process will require
additional storage space on servers for over 10,000 patients digital
forms, which can lead to increasing the amount of memory and capacity & in
turn additional cost on a regular basis. This process is only as efficient as
the sites ability to transmit the digital images to P&G. If the site is
experiencing delays, P&G will be delayed. The only learning curve will be
for the sites’ employees to transmit the data via fax.
The EDC system would aid in expediting the data verification process to the data-lock phase & enables a significant learning curve by both P&G
employees and the sites employees. The employees will need to be well accustomed
in operating a computer and navigating the Internet. The data gets filtered by pre-defined validation rules thereby eliminating the double entry system & alleviating errors. However an additional issue with EDC implementation is slow connectivity when entering the data. The immediate accuracy
checks in place will slow the process since they need to be addressed prior to
moving on. CRA's were able to reduce the number of physical visits to the sites as they could access information from EDC and inform the errors at investigator sites.
P&G can be imaginative in its decision making process however it needs to be realistic of the situation. P&G should not choose an alternative that addresses one issue within the clinical data management process; the alternative should address the majority of the issues or all of them. P&G should look at the long-run and future, not just the present situation.
Recommendation
A
logical recommendation would be to choose the alternative that
would cut the most time since that is the biggest problem here, but the quality
recommendation would also include the actual costs associated with each
alternative.
Based
upon the facts of the case study, the
recommendation for P&G would be to implement the
EDC system. This is the only system that addresses the problem and the
symptoms; the other two alternatives only address symptoms. Once the sites and
sponsors are well accustomed to the EDC system, the entire process will be more
efficient and effective.
As
described in the trial, the EDC system greatly reduces the errors and
inaccuracies of human data entry and completely eliminates the double-entry
system. During the first few trial of the EDC, the duration of time from
the final patient visit to data-lock improved from eight weeks to a mere four
weeks. There was also an improved quality of patient data, since errors were
being addressed throughout the process.
P&G
also could reduce the frequency of site visits by CRAs which will
significantly reduce travel costs. In addition, the CRAs and CDMs
responsibilities made them more interactive, which helped P&G employees have a better
understanding of the EDC functions.
Presentation
The best
way to present the case is to go through the clinical trial process and why it
was taking P&G so long to complete a trial.
Some good visual aids may show the actual millions of dollars that are
being lost during the process. Selling
the recommendation will rely on proving the best alternative that saves time
and does not add significant costs to the process, as for every day the drug is
not available on the market, it is estimated to cost the sponsor $1 million per
day. The process is not only faster and cheaper in the long term, but it is
also very secure and precise. This could be related to the visual aid showing the
amount of money being lost with a comparison showing how much more money the
company could be earning when cutting time in half.
Visual aids to be used in presentation are:
·
PowerPoint
presentation explaining the advantages and drawbacks of three alternatives;
·
Cost
analysis of the current paper-based system versus the cost analysis of the EDC
system.
·
Develop
flow charts for each of the alternatives to show how efficient is the web-based
EDC.
Finally, other delivery consideration to keep in
mind is the facts/evidence
of using EDC in the initial phase; i.e. obstacles which include employee training, the site’s access
to computers, slow connectivity issues etc. and most importantly the cost to implement EDC should be considered along with the calculating the sum of present value of future cash flows to implement the project.
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