Problem/Issue Statement
The problem Procter & Gamble faces pertains to inability of
the company to realize efficiencies due to their manual, paper based clinical
trial documentation process. This situation causes inevitable delay in bringing
the Company’s pharmaceutical drugs to market, which costs roughly $1 million in
lost sales for every day of delay in market entry. Symptoms discussed in the
case include numerous errors, conflicting entries, duplication of data and
effort, as well as inefficient and costly on-site support. The entire process,
which contains multiple applications, FDA approvals, test trials and on-site support,
is further delayed by inefficiencies in documentation. The scope of the problem
includes the entire clinical trial application, documentation and record-keeping process. It relates to evaluating strategies for reducing the length of time it
takes P&G to complete clinical trial for its prescription drugs.
Situation Assessment
Drug development and approval process
in the United States is very lengthy and uncertain. The average out-of-pocket
cost associated with developing a new drug is over $403 million. As stated in
the case, when capitalized to the point of marketing approval, these costs grew
to $802 million. The approval process occurs in phases, each one of which has
particular characteristics, requires very robust documentation and procedures.
In the discovery phase (2-6 years) the firm tests biological activity of
various compounds in a laboratory setting and, if successful, applies for investigational
new drug (IND) to FDA. Once approval is obtained clinical trials can begin. At
that point the Company can also apply to FDA for patent approval that will grant
the Company 20 years of protection from the date of application. Due to the length
of the entire process, 10 or even more years of that protection will be
consumed before the drug is even introduced to the market. It is therefore
imperative for P&G to shorten the process in order to be able to capitalize
on the investment. The next steps are clinical trials. Clinical trials consist
of at least three, often four phases. Each one of those phases has to be documented;
patients have to be screened multiple times for complete qualification for the
study, patient files (stored in binders) have to be updated and verified, which
requires repeated annual verification involving of 2-3 people. Furthermore, testing
sites have to be visited by the sponsor at various points to ensure data
consistency and accuracy as well as compliance with guidelines. The entire
process requires cooperation and active participation from the sponsor
(P&G), investigator sites, site coordinators, clinical research associates
(CRAs) and clinical data managers (CDMs).
P&G already tested implementation of
the Web-enables EDC system but feared the reaction and implications of implementation
on a broader spectrum.
List of Plausible Alternative Courses of Action and Evaluation
of Alternatives
Possible solutions referenced in the case and developed by
D’Alonzo and his colleagues for addressing the inefficiencies in P&G’s
current process include improving the paper based process, digital imaging, and
Web-enabled electronic data capture. Each one of the solution types referenced
above has advantages as well as disadvantages. One of the main factors that
should be considered in this case is the value, functionality and long term
impact of the solution. Let’s discuss the implications of implementation of
each one of the potential solutions:
-
Improving the paper based process – this option would attempt to
speed up the data management process through adjustments to the paper based
system, such as use of express mail shipments from the sites on a daily basis
and increased staffing to perform site monitoring and source data verification.
Nevertheless, potential significant improvement through this process is
limited. This solution appears to be addressing the symptom as opposed the
problem.
-
Digital imaging – this approach followed the same process as the
paper-based system with the exception of the method of transmitting data from investigator
sites. Completed CRFs would be faxed, digitally received and stored by the
system. Clerks would then use a split-screen with the document image on one
side and data entry form on the other during their review. This system appears to
be a mere improvement as it does very little to mitigate the delay and workload
involved in data entry and error verification. Furthermore, it required
significant investment in data storage facilities. Again, this appears to be a
solution that addresses the symptom rather than the underlying problem.
-
Web-enabled EDC – this approach allows data to be entered into
the data management system directly by the investigative sites. Pre-determined
validation rules are immediately applied to each record to identify potential
errors during initial data entry. Records are instantly available for
monitoring the trial and conducting preliminary analyses on blinded data by the
sponsor. No doubling entry of data is required. CRAs can use the system to
identify record discrepancies and immediately identify site investigators.
Visits to the sites, while still necessary, would be less frequent.
Although this system
appears to address the problem, it comes with a few obstacles that have to be addressed
by the Company. Since the sites have a limited access to computers, P&G will
have to purchase laptop computers at a cost of approximately $1,200 per
computer. P&G also has to cover the costs associated with the initial
assessment of the site’s computing capabilities at a cost of roughly $400 per
site. In addition, the Company also covers the cost for a help desk to provide
sites with assistance in using EDC, which amounts to around $50 per month per
site. Based on the following data, the initial cost to for 10 sites with one
computer would total to $22,000.
With the improvement to
the process, P&G could also avoid up-front-payment problem that were
created by the inefficiencies of the paper-based process. Furthermore, the case
references that the data entry cost per CFR page would be $3-$4 per page as
opposed to $6-$9 with the manual process, a reduction of nearly 50%.
Despite the apparent
savings and increased efficiencies, some of the investigator sites were
hesitant to adopt the technology. Question of patient security was a major
concern. Connectivity also appeared to be a substantial issue. The sites were
resistant to the new technology citing elimination of some convenient features
of paper-based entry and cumbersome nature of the eCRFs.
Recommendation
Based on the understanding of business requirements, evaluation
of the alternatives, characteristics and future, long term benefits of each
option, I believe that the logical and quality recommendation that will best
suit the business needs would be to select the Web-enabled EDC. Based on the
initial implementation and testing of the Web-enabled EDC on the data
management and review process P&G saw significant reduction in the time to
data lock. The company observed a fall in data-lock time from eight to four
weeks over the first several trials. This translated to 50% time-lapse decrease
and a potential sales increase of $28 million ($1 million per day saved when
drug on the market). The option also offered improved access to data and
immediate reporting. Furthermore, the company saw improvement in average
quality of data for all patients in the trial. Any problems with the data were
corrected almost instantaneously while the patient visit was still vivid in the
mind of the site coordinator.
Presentation
If I were presenting the case, I would walk through the current
state to highlight the problems and delays caused by errors and manual
processing of the clinical trial process. Furthermore, I would clearly state
the requirements and how each of the available options fits and meets, or does
not meet, those requirements. I would utilize a timeline presentation form as
well as cylinder type diagrams to depict the comparison and time savings
offered by the implementation of the Web-enabled EDC system. This type of
presentation will ease the decision making process. I would also highlight that
change, even if it brings initial anxiety, is inevitable, especially when
immediate efficiencies can be observed. A solution that provides such significant
improvement to this extremely costly and risky process can benefit the company
by creating competitive advantage and enable P&G to capitalize on early
drug release to the market.
I would also support the recommendation and time savings with
calculations affecting sales (each day delay in the market entry for the
product costs the sponsor roughly $1 million in lost sales).
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