P&G…Upgrading for the Better?

Procter & Gamble (P&G) loses millions of dollars each day a prescription drug is delayed to enter the market. In order for a new prescription drug to enter the market it must pass IV Phase trials, cost a company over $125 million and be approved by the FDA. During each of those phases, there is an average percentage of drugs that are tested and do not follow through to the next phase. For example, only 30% of the drugs that enter Phase II move onto Phase III. As anyone can imagine the other 70% of drugs that cannot move on to the next phase cause the company to lose roughly $15 million. With large dollar amounts like that, it is no wonder why P&G is looking for a solution to reduce the length of time it takes for their company to complete clinical trials for prescription drugs.

P&G currently manages their procedure through a typical paper-based trial that involves three phases: trial preparation, data collection and verification and data management and review. The scope of this procedure is that it works for P&G as they are accustomed to this process and know their financial budget for this method. However, with this process the lead times are excessive, causing the company to suffer in delays of introducing a new drug. P&G can turn to three respectable alternatives that will prevent delays in completing clinical trials for new prescription drugs. The important factor for P&G is to solve their problem by finding an alternative that will ultimately reduce the length of time it takes to complete clinical trials. For starters, P&G can improve their familiar paper-based system by speeding up the data management process. This alternative would entail an increase of staff and express mail shipments. Seeing as P&G currently has an extended process in site monitoring and source-data verification, added staff would decrease the time allowed for these two stages. Express mail shipments would also reduce the length of time during the paper-based process by delivering at a fast speed. Although, these two improvements would hurry the familiar system P&G uses they would still have to rely on the other stages of the paper-based process that create delays. A second alternative for P&G is the use of digital imaging, which follows the same procedure of the paper-based system except when transmitting data from investigator sites to the pharmaceutical sponsors. This method like the first alternative reduces the length of time but does not provide a significant decrease because delays occur in several stages of the process before and after the digital imaging period. For instance, investigative sites allow for CRF’s to pile up before faxing them into the system. Also, the time it takes to review the CRF images still create delays in the process. A third alternative for P&G is the use of Web-enabled EDC. This process truly diminishes the time it takes to complete a clinical trial as data is entered into the data management system, records are immediately applied, potential errors are identified during the entry process and all the data is available to sponsors immediately. With this option, there are fewer visits to the sites are required to perform source data verification. This reduction will help decrease the delays caused in the paper-based process. As Ray D’Alonzo, Associate Director for Clinical Data Management at Proctor & Gamble explains in the case study, Procter & Gamble: Electronic Data Capture and Clinical Trial Management the Web-enabled EDC is “a no-brainer.” This solution could speed up the process of clinical trials and allow the company to advance their methods through the latest technology.

This third alternative is allows the company to challenge their time constraints and complete clinical trials at a faster speed but are they considering costs? How much will the Web-enabled EDC system cost for P&G and will it pay itself off in the future? This is an important question to ask since technology is improving and changing every day. Will this system be outdated in a few years? Technology is constantly changing and asking these types of questions can really help P&G find the best option for reducing the time it takes for clinical trials. One can see that P&G’s paper-based system is certainly obsolete and improving this system will still leave the company behind in today’s digital era, making this not the most logical alternative. Also, the cost perspective for this alternative would result in higher expenses when hiring additional staff and paying for express shipment. Digital imaging is not a rational choice for P&G either as it still relies on their old school paper-based process to complete clinical trials and it will affect the company’s overhead. Web-enabled EDC is allowing P&G to enter a more technological stage by advancing their equipment. New technology does not come free and usually has high price tags but it will truly be worth P&G’s investments. Staying current with technology is significant to a company like P&G because any new products delivered today are already ancient history tomorrow due to new advancements being made in such a tech based world. Alternative three is certainly staying current and allows P&G to enter the digital era by using Web-enabled EDC. This option answers P&G’s problem of reducing the time it takes to complete clinical trials. It also allows for extra benefits that include less visits to sites, potential errors being identified and up to date records.