Procter & Gamble Case Study

Proctor & Gamble

Electronic Data Capture and Clinical Trial Management

The clinical data management in Procter & Gamble Healthcare department faces the challenge of reducing the length of time it takes to complete clinical trials for its prescription drugs. The delay in introducing the new drug in the market costs roughly $1M dollar per day in lost sales.

The clinical data management team introduced the usage of Web-enabled Electronic Data Capture (EDC). This technology enables the collection of trial data from investigator sites via internet.

Issue Description:

The clinical trial data collection and verification takes a long time to process. The Clinical Research Associate (CRA) collects the clinical trial data and performs the cursory observation to check for obvious errors in Case Report Forms (CRFs). This data is then entered into the back-end database by two different individuals. These two entries are compared and verified for any discrepancies and if any errors are found, then a third individual re-enters the data to remove the discrepancy.

Locking of final database involves many steps. In order to reduce this time lapse there are three alternatives for improving the current process.

Paper-based Process:

This is a conventional method that involves manual data entry from CRFs into the data management system. Few adjustments can be done to improve paper based process such as using express delivery to mail CRFs from the sites on a daily basis and increasing staff members to perform site monitoring and source data verification more rapidly. But conventional method of paper-based process usually takes longer any way.

Evaluation:

Since the data entry and verification is entered manually by individuals, there is little guarantee the data is 100% free of errors.

By using this method company needs to acquire more resources which is ultimately going to increase the cost along with nominal effect of time constraint.

Digital Imaging:

International Record Imaging System (IRIS) is another alternative for the improvement of the process. In this method the investigator sites fax the completed CRFs to a processing site at the sponsor. Faxes are digitally received and stored by the system. Clerks reconcile data in the same manner as in paper-based process by using a split screen with the document on one side and the data entry form on the other side.

Evaluation:

This method does not do much to reduce delay and workload. The delay occurs as the investigator sites let CRFs pile up before faxing them into the system. This method also requires significant investments in data storage facilities as there are a lot of images to store.  Reviewing the data takes same amount of time as in the paper-based process.

Web-enabled EDC:

The usage of Electronic Data Capture (EDC) is the third alternative. This method allows data to be entered into the data management system directly by investigative sites.

Evaluation:

This method is far more accurate and faster since data is entered directly at the investigative sites and error-prone paper-based forms are eliminated. Predefined data validation rules are applied to each record to avoid potential errors during initial data entry. These records are immediately available to the sponsors for monitoring the trial and conducting preliminary analysis on blinded data.

Presentation:

If I were the consultant of P & G, I would present the case through PowerPoint slides, Visio flow-charts, tables and graphs. I would calculate the cost of all three alternatives, weigh their pros and cons and would use the alternative with the best cost-to-profit ratio. I would also provide training and technical support to the investigator sites in order to facilitate the new system in the company.

Reflection:

Consultants presented their case to us and described the benefits and weaknesses of each method. After discussing with C- level members and thoroughly evaluating these methods, we concluded that EDC benefits outweigh its weaknesses and it is faster, more cost effective and more accurate than other methods. The conventional Paper based process had worked in P & G for years and employees are already familiar with this process and do not require any training. On the other hand, this method takes much longer to validate data and resolve errors.

In comparison, EDC rectified the errors and reduced operating costs. CRAs needed to make fewer visits to sites for the verification of data. Software does not need on-site support as it does not reside at investigative site. The resistance to use web interface is low because it resembles the paper-based forms and most of the employees are already familiar with using the internet and would not require extensive training. The data entry cost was $6-$9 per CFR page entered manually but EDC reduced it to $3-$4 per page. The cost of purchasing laptops ($1200 each) for participating sites is offset by the profit earned through deduction in data entry costs as well as by introducing the new drug in the market sooner than its competitors. It generated $1M dollar sales per day on average and results in increased profits. Being the first one to implement this method, it will boost the company image in front of shareholders. The stock price P & G rose to 20 percent from 2000 to 2001 after using EDC.