CASE: P&G -- Electronic Data Capture and Clinical Trial Management

Problem/Issue Statment:

• Procter & Gamble’s Health Care division completes clinical data trials as a requirement in order to receive approval to market a prescription drug in the United States.  The problem for the Company was what they refer to as the time to data lock.  As defined in the case, the “time to data lock was measured as the elapsed time between the collection of the last piece of data on the final patient in the study (at the site) and the locking of the database.”  It was quoted that for the average prescription drug, each day of delay in market entry for the product costs the sponsor roughly $1MM in lost sales.
• The main problem as mentioned above is the time to data lock.  The longer it takes, the more money the Company is losing from not having the given drug on the market.  The symptoms are what are causing the delay in data lock.  The symptoms here are in the paper based process, the need to complete double entry of data for reconciliation purposes, incorrect data entry which would need to be re-done, etc. The case focuses on the paper-based process, digital imaging and Web-enabled data capture as three possible altneratives to assist in aiding with these symptoms.
• The scope of the problem would be the entire clinical trial management process.  Obviously, clinical trials are necessary in order to have prescription drugs approved for marketing in the United States, the scope of P&G’s problem is looking at this process from start to finish and analyzing all of the areas where the length of time may be shortened in order to speed up the process, without affecting the results. 

Situation Assessment

• Thinking about the context of the problem, it would seem almost ludicrous that clinical trials were taking place on paper and not through some type of electronic technology; how can technology aid in the clinical trial process and decrease the amount of time necessary to complete the trials.  D’Alonzo realized that there is only so much you can do to quicken a paper process, can digital imaging or web-enabled electronic data capture help here?
• The decision criteria are actually quite simple, will the offered alternatives decrease the length of time to data lock while at the same time not raising costs.  Basically, will these process improvements add value to the organization by having the ability to bring drugs to market faster and not increase costs in the meantime.

List of Plausible Alternative Courses of Action

• The case evaluates improvements to the paper based process including using express mail shipments from sites on a daily basis and increased staffing to perform site monitoring and source-data verification more rapidly.  This alternative tries to cut down on time, however there are still many people that need to touch the data and there is only so much that can be done in order to cut down on time.
• The second alternative was for the use of digital imaging.  In this alternative, as opposed to case report forms (CRF’s) being maintained on site in a binder, they would be faxed after verification and stored digitally.  However, this alternative still followed the paper based process, other than the digital image being captured.  Again, this alternative is working toward cutting down time, however the data still needs to be captured on paper and faxed for entry into the back end database.  The data still goes through a double entry process for reconciliation and now there is the cost of storing this data.  Thinking about very large studies, the cost of storage could add up significantly while not really cutting down on time.
• The third alternative was for web-enabled electronic data capture (EDC).  The process allowed for CRF data to be captured into a web based data management system on site.  Predefined validation rules were built into the system, meaning there would be no need for double data entry.  This alternative is the most viable in terms of the ability to cut down on the time to data lock. 

Evaluation of Alternatives

• In order to evaluate the alternatives, the Company should use process flow maps to see where there may be overlap or duplication of duties/efforts where additional time can be saved.  There should also be an evaluation of the costs of each alternative compared with the amount of time that the Company will save.  The evaluation of each criterion will lead to a decision of whether or not to move forward with the alternative.  The evaluation should not be imaginative, but realistic in how much money the Company could be saving and how much more in revenues they could be earning by decreasing the amount of time to data lock.

Recommendation

• A logical recommendation would be to choose the alternative or alternatives that would cut the most time since that is the biggest problem here, but the quality recommendation would also include the actual costs associated with each alternative.

Presentation

• The best way to sum up the case is to go through the clinical trial process and why it was taking P&G so long to complete a trial.  Some good visual aids may show the actual millions of dollars that are being lost during the process.  Selling the recommendation will rely on proving the best alternative saves time and does not add significant costs to the process.  This could tie back to the visual aid showing the amount of money being lost with a new version showing how much more money the company could be earning when cutting time in half.