Procter & Gamble: Electronic Data Capture and Clinical Trial Management

Problem/Issue Statement

The problem in this scenario is that Proctor and Gamble needs to reduce the time it takes for clinical trials for its pharmaceutical products before they can be brought to market.  The company is currently operating on a data collection process that is paper based and tedious as the data is first manually collected on site by the site coordinator, verified by the clinical research associate, and then again entered manually into P&G’s database by the clinical data manager.  Considering the claim that each day of delay in releasing a pharmaceutical product cost the sponsor company 1$million, the problem is how to effectively reduce that time while insuring accurate data in the collection process as well as keeping all parties involved satisfied with the methodologies of the process. 

The problem is a data collection process that is unnecessarily lengthy and the symptoms of that problem are the parts of the current method that are time consuming such as the double entry of data, the required third entry of data if discrepancies were found between the two original entries by the CDMs, and the significant lag time in sending and receiving the data that is associated with using a traditional paper approach rather than utilizing the internet through Electronic Data Capture (EDC).

The scope of this problem is the whole clinical trial methodology.  Although this case is mainly focused on “data lock”, or the time from when the last piece of data is collected from a patient to when a database is locked at the completion of data entry, the scope of this case includes every step in the data collection process and focuses on what steps should be taken to expedite it. 

Situations Assessment

The decision being made by Associate Director for Clinical Data Management Ray D’Alonzo takes place towards the end of 2001 or the beginning of 2002.  At this time, the health care segment of Proctor and Gamble was rapidly growing in comparison to its other divisions.  From 1999 to 2001, earnings from health care had increased by over 150%, while profits from food and beverage, beauty care, and fabric and home care had all risen by less than 10% and earnings from paper had actually decreased.  Most importantly, the choice to adopt a web-based approach is being made at a time when Internet technology is on the precipice of wide scale adoption but has not yet been fully embraced.  Many of the investigative sites for P&G’s clinical trials had limited or no computer access and very few of P&G’s competitors in the pharmaceuticals markets had already chosen web-enabled electronic data collection

The decision criteria are the amount of savings the company can derive from decreasing the time necessary to conduct the entirety of its data collection, the short-term and long-term position that a new strategy places the company in by selecting a particular method, and the difficulty of either enhancing the current operation or selecting a new model with regard to the necessary learning curve for and acceptance by sponsor (P&G) and medical personnel

List of Plausible Alternative Courses of Action

The possible courses of actions are:'

1.  One option is to improve the paper-based process by using express mail shipments on a daily basis and hiring more workers to speed up the data verification process.

2.  The second choice is to use digital imaging, where the site coordinator would fax case report forms to the processing site and these faxes are then stored as digital images that can be shown in a split screen with the data entry form for the CDMs.

3.  The last alternative is the use of Web-enabled EDC where data would be entered into a data management system directly by the investigative sites.  This information is then immediately available to the sponsor, as CRAs checking for discrepancies between entered data and medical records and other sponsor personnel could monitor the trial and conduct preliminary analyses on blinded data.

Each of these options addresses the key problem in cutting down time to data lock differently.  Improving the current paper based process seeks to mitigate the time needed between when the data is entered on site and when it can be received by the sponsor through express mail shipments, in addition to the time taken to verify the data with increased staffing levels. Digital imaging reduces the time of the process by eliminating the need for paper deliveries through faxing digital images.  The web-enabled EDC method completely changes the model by making the time between on-site data collection and its availability to P&G instantaneous and negating the need for double-entry into the P&G database (or even single entry). 

Evaluation of Alternatives

The selection of how to properly upgrade or reform the clinical data collection should focus on efficiency and long-term viability of the alternative chosen.  The option should be accepted on the basis of whether or not it places P&G in a better position to effectively and with as few errors as possible conduct its clinical trials in the shortest time period.  The evaluation must be based on legitimate cost figures as opposed to instinct.  The decision should be more clinical than imaginative, although the vision of the future nature of clinical trials across the industry should be taken into account when deciding whether or not to adopt a forward leaning technology such as web-based EDC.

Recommendation

A quality recommendation would take into account all the factors of the decision instead of just financial figures.  In this case, a quality recommendation would consider the reluctance of site coordinators to learn a new technology, the strategic position of the health care division in the context of the company, and the competitive position other pharmaceutical companies have taken with regards to EDC technology.  A logical recommendation would simply take the problem of reducing time for clinical trials and choose the alternative that best shortens that period with he least amount of financial resources necessary.    

Presentation

The ideal presentation would acknowledge that the case really appears to be more of a referendum on web-based EDC than an actual selection of choices, recognizing that even the man making the decision realizes that the current method has limited potential for improvement.  Therefore, the presentation should give a significant amount of time to demonstrating the merits of implementing an EDC system within the context of the industry and the health care division’s growing influence at P&G.  Each choice would be sold differently, as improving the current process would focus on how disruptive a massive technology change could be to all parties, implementing digital imaging would center on the merits of moderate change, and the choice of an EDC program would highlight the long-term benefits of overhauling the status-quo and why being an industry leader in this instance is appropriate.  The presentation, overall, should give a fair assessment of each alternative and avoid skewing towards an overwhelming support of one method.  

Reflection

After careful consideration of the information presented by the consulting team, I feel confident that of the three options to improve our current paper-based process, adopt a digital imaging system, or implement web-based electronic data capture (EDC), EDC gives Proctor and Gamble the best chance at increasing efficiency in the data collection and verification process.  Considering that the "out-of-pocket" costs for each new drug our company introduces to the point of marketing approval is approximately $802 million, it must be our top priority to reduce the time to data lock.  Embracing an EDC approach has the added benefit of significantly cutting costs of data collection after the initial expenses associated with purchasing new laptops for sites and training site coordinators to manage the technology.

The choice to select an EDC methodology is made with the other two alternatives in mind.  Improving our current paper based process has real limitations on saving time, since express mail shipments or additional staff cannot compare to the instant collection of data associated with web-based technology.  Digital imaging suffers from the same delay from manual data entry and the storage costs when scaled up for all of our trials require significant investment.  An EDC system is definitely not without its flaws, though, as it is the riskiest approach since it represents the greatest change to our existing system.  The complaints from site coordinators about EDC technology that it takes longer to uses and does not allow for a quick scan of data like flipping through tangible pages are genuine concerns for us.  However, with the direction of technology, the learning curve for EDC should diminish as more hospital employees become more familiar with our interface system that is very similar to navigating a basic web page.  We should become leaders in the industry by pushing forward with EDC, which will quicken the clinical trial process and by doing so make the health care division significantly more profitable.