Key Problem
In
the Proctor & Gable case study, Ray D’Alonzo the Associate Director for Clinical
Data Management at Proctor & Gamble (P&G) was looking for an
opportunity to reduce the amount time to complete clinical trials for its
prescription drugs. The trials needed to be approved first before entering the
US market and it took several months to several years to complete. The delay in
the approval process is significant and the product costs the sponsor to lose
approximately $1 million a day. The delay in time came from a paper-based
process. The paper-based process was the backbone of clinical trial management
and the P&G executives knew it was time to make a critical change. P&G was
looking to streamline their daily process. P&G’s goal is to reduce the time
to complete clinical trials for prescription drugs and reduce the amount of
paper. D’Alonzo knew there was an opportunity
to find a practical solution that will help save the time and money. P&G
and D’Alonzo implemented six pilot trials using a Web-enabled electronic data
capture (EDC) that was completed in May 2001. Overall, it was time for D’Alonzo
to make a decision to either use EDC as the primarily source for all future
trials or use other alternatives.
Assessment
of the Three Alternatives
One alternative is to improve the
paper-based process. P&G would need to use express mail shipments on a daily
basis. The improved paper-based process would add headcount, increase postage
and would be an additional expense. D’Alonzo would have to notify upper
management that an improved paper-process would require additional headcount. This
short term fix of express mail shipments is a pro but this isn’t something
D’Alonzo envisioned long term. There are too many cons for an improving
paper-based process and adding headcount won’t solve the key issue. Overall,
D’Alonzo knew the paper-based process improvement was outdated and P&G
would not benefit in the long run.
The second alternative is to move to
digital imaging. Digital imaging has several cons like the paper-based process.
Digital scanning still needs two entries and would require the same amount of
time like paper-based process. There is no advantage with digital imaging
especially with large studies as it requires memory and capacity. P&G did implement International Records
Imaging System (IRIS). IRIS did have some short term improvements but wasn’t a
long term investment. Often times, there were delays and the review process wasn’t any
better than the paper process.
The third alternative is the
Web-enabled EDC for the data management content. There was a six pilot trial completed
in May 2001 using the Web-enabled EDC for collecting data trial data. The pilot
trials suggested that the Web-enabled EDC could significantly shorten time for
clinical trials. The new technology would be an excellent tool for trial
management both within P&G and between the physicians and hospitals
throughout the world via internet.
D’Alonzo did have several concerns about price and was uncertain about
the benefits, but the six pilot trials did extremely well. Overall, the Web-enabled
EDC is the most efficient solution and had the most significant reduction in
time by reducing the time by fifty percent to complete clinical trials.
Recommendation
After
reviewing the three P&G alternatives, I would recommend the Web-enabled EDC
as the standard default for all future trials. In my opinion, the Web-enabled
EDC would add a significant value in the long run for P&G’s company. There
are five major pro’s: 1) reduction in time, 2) reduction in paper-based
methods, 3) a possible reduction in administrative staff, 4) adding lost sales
to sponsors and 5) increasing growth/sales.
The
first pro is the reduction in time and the Web-enabled EDC would significantly
cut the time in half. There were several Web-based EDC trial runs and the
amount of time reduced by two weeks after each trial run. The first EDC trial
was eight weeks and the second trial was six weeks. The next three weeks for
trial were from four to five weeks. Lastly, the fifth week was down to half
amount of time and this was a clear indication that Web-enabled was the most
efficient process. The second pro was the reduction in paper. There is less
data entry errors and less clinical research associates (CRA) needed to visit the
sites. The third pro could be a reduction in administrative staff with the
coordinators or entry level employees. The Web-based EDC could reduce the hours
or even some coordinators since this would eliminate the paper work filing. The
reduction in headcount could offset the cost of the implementation of the EDC.
The fourth pro is P&G would keep key sponsor roles happy as the potential
$1 million a day lost in sales wouldn’t be delayed. The last pro would be increasing
sales/growth. P&G has the opportunity to take on more clients due less
administrative type tasks.
There
are several cons I see with P&G. There needs to be adequate training
sessions and seminars to get all employees on board with the new program. In my opinion, there was a lack of training
and the inability to get employees trained with Web-Enabled EDC during the six
pilot trials. Some of the feedback from the site coordinators focus group,
August 9, 2001 was not positive with the EDC trials. There were a lot of issues
with the edit check and this is an area where D’Alonzo can partner with the web
developers and find ways to customize the edit check field. The Web-enabled EDC
is going to take time and will require training employees and support from the
web developers. The employees are not equipped with the paperless program and
would need assistance and support.
I
would recommend a contest with the P&G employees for sites who have adapted
to EDC in a timely manner. For example, the coordinator who performs the best
and finds the most efficient process on EDC could earn 2 free extra days off throughout
the year of EDC implementation. A
contest is a good ice breaker and would ease the “pain” of learning EDC.
P&G
did pay $250,000 to $500,000 per-trial fee for EDC depending on the size. This
is a significant amount of money but P&G needs to look at their Rate of
Investment – ROI. You need to see the benefits or the long term investment that
EDC would provide. P&G can continue to grow and take advantage of EDC
especially that healthcare was a major driver of growth within the company.
I don’t
think the computer expenses would even be a con or a concern for several
reasons. The costs of new computers were $1,200 each employee for each site,
$400 per site assessment and $50 a month for a monthly service fee. The sites
had old computers and it would be good opportunity to provide new laptops for
the staff. The staff struggled as some of the new laptops didn’t have any
instructions and I would recommend training session to help assist them.
Also,
it was noted that data entry costs were $4-$6 per page manual paper compared to
$3-$4 per page via EDC. P&G would have cost savings in data entry costs with
the implementation of EDC.
Final
Thoughts
I
don’t think new technology is too early for the pharmaceutical industry especially
after running Web-enabled EDC trials as this successfully reduced the amount of
time in half to complete clinical trials for subscription drugs. D’Alonzo sees
the value of new technology and he has the opportunity to grow P&G business
with a faster approval method. In my
corporate experience, employees tend not to like change especially in
technology. The coordinators are going from a paper-based environment to a
paperless environment which is a significant office culture shock. Also, technology can sometimes replace staff
so employees can be resistance at times with any technological changes.
Employees can feel intimated and may not cooperate on training on a new IT product.
The Web-enabled EDC will have long term benefits for P&G and this could
eventually become the future for all pharmaceutical companies.
In my opinion, the Web-Enabled EDC will become
a technological platform for P&G. I would recommend D’Alonzo to be confident
as he has an opportunity to change the culture within P&G. There needs to
be positive reinforcement with EDC and P&G must support their employees. P&G
can learn from other pharmaceutical companies that were slow to adapt EDC, that
training is a critical part of business.
Employees need the education and need the resources to bring them up to
be speed on today’s technology. I would
use EDC as the default standard for all future trials and start training staff.
In this case, the IT change is good!!!
Don’t look back and go for it!!! Go D’Alonzo!!!
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