Problem/Issue
Statement
- Proctor & Gamble’s health care division faces significant delays within its Clinical Data Management Process. P&G needs to identify new strategies to reduce the length of time it takes to complete clinical trials for prescription drugs. The FDA required clinical trials can take several months to years to complete. The faster the prescription drug can be put on the market, the faster P&G can begin to earn a profit. It has been estimated that for each day the drug is delayed, it causes the sponsor roughly $1 million in lost sales. P&G is also racing against the 20 year patent protection.
- P&G relies on a paper-based system, which is the main problem, for collecting all clinical patient information from investigator sites. The patient information is entered twice, reviewed for errors and inaccuracies, corrected on multiple occasions and takes a significant amount of man power and time. Once the trial is complete, the data is reviewed and one last round of corrections occurs. Once the data is verified the database is locked, where the data can no longer be corrected. The current duration of time from the last patient visit to the data-lock is between 8 and 12 weeks. The symptoms of the problem are the long lag times, data entry corrections and verification.
- The scope of the problem is the entire clinical trial data management process. This process needs to be reviewed from start to finish to reduce the length of time and inefficiencies with the data.
Situation
Assessment
- The issue is within the paper-based system, where all clinical patient information is kept in hard copy form. This current process is slowed due to human double-entry of each page. Each page of data costs $6 to $9 per CRF form. This overall system causes significant delays in the prescription drug being available to the market.
- P&G needs to assess alternatives that reduce the time it takes to enter patient information into the database, so double entry can be eliminated. Another point to address is the duration of time from the final patient visit to the data-lock. If there are less inaccuracies and errors to correct, this time should be greatly reduced. Lastly, a unified system that all departments have access too should be created. Paper form documents move slowly through the departments which also causes delays.
- P&G can utilize the EDC (the Web-enabled electronic data capture) to address the reduction of data entry time. However, P&G needs to assess the effects of implementing this process including the learning curve necessary to operate the system and ensure cooperation by the investigator sites where the trials are conducted. The EDC system would also aid in speeding the data verification process to ultimately the data-lock phase.
List
of Plausible Alternative Courses of Action
·
Three options have been identified in
addressing the inefficiencies in the current process: (1) improving the current
paper-based process, (2) digital imaging and (3) Web-enable electronic data
capture (EDC).
o
Improving the paper-based process includes using
express mail shipments from the investigator sites on a daily basis. It also
includes adding employees to perform site monitoring and data verification to
speed the process. This solely addresses the time delays of receiving the hard
copy forms from the sites.
o
The digital imaging process 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 lieu of maintaining hard copy forms in patient binders.
This alternative also reduces the amount of time from receiving the hard copy
forms from the sites. However, this is solely predicated on the sites ability
to fax the documents to the sponsor in a timely manner.
o
Web-enabled EDC 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. The EDC process addresses all of the problems P&G faces: (1)
the paper-based system, (2) the errors and inaccuracies when entering data from
hard copy forms (3) the double-entry process, (3) moving physical forms from sites to
sponsor and (4) ultimately reduces the amount of time needed to enter the
data-lock phase.
Evaluation
of Alternatives
·
The three options have both benefits and
potential costs that need to be evaluated.
o
Improving the paper-based process will incur additional
costs when using express mail on a daily basis.
These costs need to be calculated especially since the sites can be in
international locations. If P&G were to hire additional personnel for data
entry, employee costs including salary, benefits and overtime will be incurred
by the company. There is no learning curve associated with this alternative
since everyone knows the paper-based system. However, this process still does
not address the human errors and data entry inefficiencies.
o
The digital imaging process will require additional
storage space on servers to store all the patients’ digital forms. Since there
can be over 10,000 patients the amount of memory and capacity will be
excessive. 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.
o
Web-enabled EDC system requires the most significant
learning curve by both P&G employees and the sites’ employees. The employees
will need to be well versed in operating a computer and navigating the Internet.
An additional issue that can occur 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.
- P&G can be imaginative in its decision making process however it needs to be realistic of the situation. P&G should not chose 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
- Based upon the facts of the case study, the quality and logical 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 versed in 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 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 from CRAs which will significantly reduce travel costs. In addition, the CRAs and CDMs responsibilities began to overlap, which helped P&G employees have a better understanding of the EDC functions.
Presentation
- If I were presenting as a consultant to the class, I would state that I have been commissioned to identify strategies for improving the current clinical data management process. I would discuss the problems that arise from the current paper-based system and stress the time it takes from the final patient visit to the data-lock phase, the double entry of data, human data errors and inaccuracies within patient information.
- I would detail the benefits and drawbacks of the three options for improving the system: (1) improving the current paper-based process, (2) digital imaging and (3) Web-enable electronic data capture (EDC).
·
Visual aids to be used in presentation:
o PowerPoint presentation for
the benefits and drawbacks of three alternatives;
o A sample paper CRF form used
by the sites to complete patient medical history;
o A sample electronic CRF form
available on with the EDC system; and
o Cost analysis of the current
paper-based system versus the cost analysis of the EDC system.
- I would “sell” the EDC system to P&G by stressing the significant time reduction in the entire clinical trial process. By using the EDC system, P&G will be able to maximum the amount of time the drug is on the market under patent protection which will create higher earnings. As stated above, for every day the drug is not available on the market, it is estimated to cost the sponsor $1 million per day.
·
Other Delivery Consideration
to Keep in Mind:
o Facts/evidence of EDC system
benefits and costs;
o Obstacles with the EDC
system including learning curve, the site’s access to computers, slow
connectivity etc.; and
o Concise explanation of EDC
system to reduce questions and concerns.
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