P&G case analysis

 

Problem/Issue Statement

The problem that Procter & Gamble faces is how to reduce the long lead time for completing clinical trials i.e reducing the time most of which is consumed by paper based data capturing technique. 

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. Procter & Gamble Management needs to decide whether the use of technology would add value to the clinical trial processes and how can the change affect the business if the company decides to invest in web-based electronic data capture.

Situation Assessment

For P&G to consider any solution to be feasible in this case it would at very least have to reduce the "time to data lock." This process is driven by extensive manual data entry and processing, and is riddled with process inefficiencies and opportunities for error.  Company should seek options that are already familiar to those involved  and do not require a significant learning curve as this will further delay adoption of the process .The team identified a key blockage associated with the paper-based process as data access and transparency, i.e. that the information on paper can only move (physically) so fast throughout the process. With that in mind a new solution should address the flow and accessibility of the clinical trial data by all participants in the process as another way to improve operations. While P&G could significantly reduce the time to data lock (and ultimately reduce the time to market for new drugs) by using a web-based EDC system, they would need to consider the substantial changes necessary with respect to both their internal processes as well as the interactions with investigator sites. As well, P&G would need to consider the affect that these changes could have on their existing relationships with the investigative sites where the trials are conducted.

List of Plausible Alternative Courses of Action

1. Improving the Paper-Based Process

2. Digital Imaging

3. Web-enabled Electronic Data Capture (EDC)

  1. The paper-based process could be improved through express mail shipments and more employees to perform site monitoring and data-verification quicker. However this decision would limit P&G future because the paper-based process is lengthy, too many people need to touch each CRF, and the time to data-lock cannot get any shorter any eight weeks. 

  2. Digital Imaging is a process that is very similar to the paper-based method besides the fact that it requires large memory and capacity for storing all the images, which could be much cost involving. Overall this process has some improvements to offer, but it is still very lengthy, involves many delays, and the workload continues to be very heavy.

  3. Web-enabled electronic data process offers many advantages among which are reducing the lead time of trial process, reducing the overall cost of clinical trials, maintaining an efficient database, and making the trial collection system efficient. On the other hand, web-enabled EDC requires a big investment up front and unclear security as of what the return on investment will be if the pharmaceutical company implements this new method.

Evaluation of Alternatives

P&G should evaluate the alternatives by seeing which one would work better for their company. The C-team would have to evaluate their template book from the cost side by analyzing productivity, training, and efficiency. Web-based EDC seems to be the best decisions for the company, but there are still some limitations to the use of this system that need to be overcome before Procter & Gamble adopts it fully. The decision developed is that P&G needs to use a new method that will be cost and time efficient without risking the accuracy of the patients’ results. Out of the three options that P&G has, web-based EDC seems to fit the company the best although it will require big investment and training up front.   

Recommendation

After reading the case, and also being a clinical SAS programmer, I would recommend that P&G should implement the EDC to improve their trial process. By implementing EDC, the data would be entered to the data management system directly by the investigative sites.  P&G would also be able to establish rules to perform data validation without having to do double data entry. The biggest advantage of having data captured electronically can benefit the clinical programmers that do hard coding to generate the reports that are finally submitted to FDA. The data can be dynamically updated i.e for every small changes encountered during the trial process, the programmers will not have to change the coding ,rather the change in the captured data will automatically get updated in the final analysis datasets generated. Querying and data validation can be built within the EDC. The EDC would require fewer visits from the sponsors to the sites, hence, providing a cost savings  and time saving to P&G. 

While the implementation of an EDC would potentially reduce the period of time needed to data lock from by half, it is still important to consider the other resources and changes that would be required in order to shift towards the EDC.  This alternative would require upfront investment in development and maintenance of all electronic case report forms (eCRFs) and help desk support for clinical sites.  Additionally, P&G would have to invest in training and change management to roll out the EDC to ensure sponsors, data entry specialists, and all others involved in the trial process would learn the new process.  It may take a longer period of time to adapt to the EDC given potential resistance to change, but in the long run, I would recommend that P&G implement the EDC as it will provide a wider range of benefits which will address the issue at hand which is the need to reduce the length of time it takes to data lock.