Blog# 4: Procter & Gamble Case #1 Pre- & Post-Notes

Case: Procter & Gamble: Electronic Data Capture and Clinical Trial Management

Problem/Issue Statement

• The problem presented in the Procter & Gamble case involves the Associate Director for Clinical Data Management (Ray D’Alonzo) determining if he should recommend the Web-based Electronic Data Capture software as the standard for all future drug trials at P&G.
• The distinction between the problems and symptoms within the case analysis are as follows:
• Main Problem: Reducing the time it takes to complete the three phases of P&G’s current paper based system. These three phrases include trial preparation, data collection and verification, and data management and review.
• Symptoms: The symptoms discussed in the case analysis include having to double enter information on the case report forms, having inconsistent information, having the clinical research associates have to visit sites to check on the forms, and errors that resulted in delays and drawbacks.
• This problem goes beyond Procter & Gamble’s core company to also include the sponsors, investigator sites, clinical research associates, and even the patients. With the decision that D’Alonzo has to make, this will affect anyone that is involved in the clinical trials, specifically those who would have to enter the information in the EDC system.

Situation Assessment

• The context of the problem includes the current state of utilizing a paper-based system for documenting, recording, reviewing, and processing clinical trials within Procter & Gamble. The time frame leading up to “locking” the database would be dependent on any outliers, questions, or review of all the information.
• The decision criteria are based on costs associated with implementing an EDC system, the time it takes to train and get everyone up to speed, and the relevancy of making this the standard for all future clinical trials. I would also recommend that one should get feedback from all the parties involved to see if adopting an EDC would alleviate those time constraints and reduce errors.

List of Plausible Alternative Courses of Action

• The three alternative courses of action presented in the case study include:
• Improving the Paper-Based Process
• Digital Imaging
• Web-Enabled EDC
• Each of these address the key problem as follows:
• Improving the Paper-Based Process: This option would offer the use of express mail shipments and increased staffing for site monitoring and source-data verification. While it would not eliminate the need for double entry, it would speed up the time frame between steps of the process as well as be able to review information at a quicker pace than before.
• Digital Imaging: This option focused on sending completed forms and documents electronically to be stored digitally. This would help to reduce the physical copies of paper as well as let clerks use a split screen with the document image while doing data entry on the same computer. This would allow for easier and more accurate data entry.
• Web-Enabled EDC: This option would have the data entered into the EDC system directly and could even have pre-defined validation rules in place. This could spot certain order entry errors/inconsistencies early on and reduce the need for backtracking and double entry. 

Evaluation of Alternatives

• Given the three choices of alternatives, one has to carefully look at the costs associated with undertaking one of these options. Aside from a financial cost, you must also look at the cost of time, and the overall impact it would have in the long-run.
• When evaluating the three alternatives, I would reference the concept of what I am basing my decision(s) on. In this particular case:
• Paper-Based Process: Whereas the only additional expenses would be the type of mail service provider and hiring additional staff, everyone is already familiar with the current process. However, when looking at the long-term picture, paper is still a very manual process and with all the individuals who have to utilize the CRFs, there is still a lot of room for error and human mistakes.
• Digital Imaging: Whereas costs may increase for additional storage space on servers, the case still presented multiple restrictions and problems with this option. One problem that can arise is with delays. If the staff at a particular site received a lot of work, the process of scanning/faxing the CRFs to the server can start to pile up and cause delays. Also, with all of the patients that are being studied, there ends up being many images that need to be stored. Given the fact that every change that is made to the CRF has to be re-scanned/faxed, this can cause further time management issues.
• Web-Enabled EDC: With the third option, there would be an initial delay as employees and personnel would have to learn and become familiar with the system. One may also run into connectivity issues or slow responses when inputting data. Then, there is also the convenience factor of easily pulling up a physical CRF, looking through it, and finding the information you need. Now, you have to locate your piece of information electronically. An additional concern would be the immediate edit checks put in place by the software. If an error was found, it would have to be resolved immediately, which can delay those involved and increase the amount of time needed for data entry.
• One should be imaginative to the point of practically. You would have to look at all the benefits and potential problems that can arise from each of the three alternatives. Each one has its own merits, but Procter & Gamble would want to roll this out to all of their clinical trials. In the long-run, what would the best option be? This would be my basis of thinking for making a recommendation.

Recommendation

• A quality and logical recommendation in this scenario would be (in my opinion) adopting the Web-Enabled EDC. The reason for my decision is that I look at being efficient and saving time. In the long-run, if everyone was brought up to speed on how EDC operates, it would reduce the amount of data entry, double work, errors, and physical paper.
• The case study lists multiple benefits of the EDC, one of the most critical being that significant data lock reduction, data management, and review process. Based on their trial run, they saw a decrease in locking from eight weeks to eventually four-five weeks. Another benefit was the improved average quality of data for all patients in a trial, as it required many inconsistencies to be corrected at the point of data entry.
• Finally, P&G started to see responsibilities among CDMs and CRAs overlap, creating relationships and an understanding of how the other members work.

Presentation

• If I were presenting, I would sum up the case by stating that P&G wants to find an alternative to its current paper-based system to a more efficient method of operation. One such alternative is the EDC system, which would ultimately reduce the time it took complete clinical trials for prescription drugs.
• The key visual aids I would present would include:
• PowerPoint Presentation listing the benefits of EDC vs. the other two alternatives
• Samples of the EDC system as well as a quick demonstration of how it works
• Cost saving analysis that focuses on the reduction of time (paper vs. EDC) as well as monetary cost savings.
• I would “sell” the recommendation by explaining the long-term benefits and how much more P&G could be efficient in completing clinical trials. Plus, I would explain how many more trials could be performed, focusing on the potential volume in sales for releasing prescription drugs into the market (with a patent).
• The other delivery considerations I should keep in mind include:
• Confidence in the EDC alternative
• Hard facts stating the cost benefits and benefits of the EDC system
• Clear explanation of how the EDC system works to alleviate any doubts or concerns
• Be concise and right to the point of making more money and reducing delays in the clinical trial phases. 

Follow-Up

• After having the evening to review and reflect upon the information presented by the consultants, my decision would be to seriously consider moving forward with testing the EDC system. I do have some doubts in regard to the risks of making such a drastic change from the paper-based process, but I have confidence of the long-term practically of moving to a web-based system. Our objectives are to reduce inefficiencies with respect to double checking and to also lessen the time to data lock and completing the trial at the various phases.
• Even though the other alternatives, digital imaging or not making any changes, might be less riskier, the EDC system offers the most benefits. However, I would like to further discuss the issues of Internet safety, security, and the learning curve this will bring to those that will be directly involved with the software.