Media Coverage

P&GP's Progressive eClinical Integration

P&GP's Progressive eClinical Integration

Adapted from Procter & Gamble Pharmaceuticals' Best Practices entry

Bio IT World

March 14,, 2005

Leading pharmaceutical and biotech companies constantly look for ways to manage clinical processes efficiently and to conduct trials rapidly and cost-effectively. To meet this demand, many new technologies introduced to the clinical trial arena simplify processes and reduce the time required to run trials. With recent advancements, trial sponsors and site staff continue to seek ways to increase their return on investment.

One way to reap added benefits from clinical technologies is to recognize that many processes often 'touch' the same data points. This overlap in technology and processes takes place with data points such as randomization codes, patient status, and stratification factors. When technologies are not integrated, however, study personnel must repeatedly enter common data points into various systems.

 

Integrating eClinical Systems

Organization & Project:

Procter & Gamble Pharmaceuticals' eClinical Data Integration

Vendors and Tools:

Phase Forward's InForm software for electronic data capture; ClinPhone's interactive voice response systems for randomization, patient diaries, and medication management.

Key Benefits Realized:

Site coordinators have less data entry to perform.

  • The P&GP data management group do not have to check for discrepancies between common data points in the IVR and EDC systems.
  • Possible queries from discrepancies between the two systems are eliminated, thereby saving time and effort for the data management group and the sites.
  • Patients are assisted in keeping up with their diary entries.
  • Investigators have immediate access to the IVR patient diary data via the EDC system thereby complying with regulatory guidelines. Such access to diaries may also improve patient care.
  • The reduction in data entry, potential discrepancies, and number of queries results in a more efficient workflow and an accelerated time to database lock.

Faced with these inefficiencies, Procter & Gamble Pharmaceuticals (P&GP) realized an opportunity to optimize the capabilities of ClinPhone's Interactive Voice Response (IVR) platform and Phase Forward's InForm Electronic Data Capture (EDC) platform with an integrated solution. With this solution, P&GP has been able to maximize features of each system to shorten IVR calls, simplify EDC entry, and pass IVR patient diary data into EDC case report forms. Some key benefits of this integration are near-real-time accurate data acquisition, streamlined and accelerated workflows and prevention of costly, time-consuming data reconciliation activities on common data points.

 

Project Details

Procter & Gamble Pharmaceuticals' data management staff process clinical trial information for multiple clinical studies in various phases of clinical development every year. These efforts are managed by working in collaboration with clinical investigators and study sites around the world.

For each of these trials, it is critical to clean, load, and process all the data as quickly as possible in order to lock the clinical database for statistical analysis and decision-making. Industry estimates report that each day that a clinical trial runs over costs over $40,000 on average. Of course, the greater cost is incurred when a drug is late to market because of delays and industry estimates of $1 million are common. Thus, P&GP data management is focused on constantly improving the workflow of clinical trials in order to clean and lock databases as quickly as possible.

It is imperative that all solutions introduced to clinical trial participants are practical, easy to use, and compliant with good clinical practice (GCP) guidelines and regulatory standards. With these principles in mind, P&GP has taken deliberate steps to analyze the flow of data from clinical sites through to the final database to identify redundant or inefficient tasks. In this analysis, it was observed that clinicians sometimes use several systems to enter and track the same data points. For example, on any given study, a clinical coordinator might enter patient demographics into multiple systems. On the surface, this seems like a small inefficiency that only requires a few extra minutes of the coordinator's time for each patient. However, the costs run much deeper.

Whenever data items are entered into two systems, it is possible that the values in each database may not agree. As a result, the sponsor must have a process in place to look for discrepancies - and this takes time, even if it is an automated check. Next, any discrepancies must be reviewed and, typically, these lead to queries. In turn, these queries must be sent to the site, thereby taking up their valuable time. Finally, the query is returned to data management for data cleaning. Current industry estimates place the cost of each query at over $100, but again, the true cost is in the overall delays in locking in a clean database. To eliminate such inefficiencies, the data management team designed an improved workflow that would remove redundant data entry for some of the most commonly used technologies, namely EDC and IVR systems.

In addition to designing efficient workflows, P&GP also had to ensure that the tools and partners they selected would be able to implement their designs. They had extensive experience using Phase Forward's InForm software for EDC and were already taking advantage of the accelerated data entry and query cycles the tool offers. They also had experience working with ClinPhone's IVR systems to perform patient screening and randomization, emergency unblinding, and to manage the medication supply chain. Further, the data management team performed due diligence to determine that these partner companies had the capability to integrate data in real time in a secure fashion. The two companies also had support teams available 24x7x365 and could integrate their help desk procedures for the integrated studies - an essential requirement for the success of these projects. Finally, each of these vendors has successfully completed more trials than any other companies in their respective class.

P&GP also decided to introduce improvements in the workflow progressively and systematically to help the clinical study teams and sites adjust to the new methodologies gradually. They planned to begin by implementing one-way, real-time data flows from the IVR system to the EDC software as a proof of concept. This was put into practice in a complex study involving approximately 60 sites globally. Randomization was to occur within six hours of screening a patient and data entry via EDC would be completed shortly thereafter. Thus, the study design dictated that the patient demographics entered into the IVR along with the randomization information would flow immediately into the EDC system. This was successfully implemented, and the key study stakeholders realized the benefits of eliminating redundant data entry and extra data reconciliation.

From the successful results of the first study, the team planned to increase the number of data elements that would be integrated in the next project. A study using IVR to collect daily patient diaries was selected. The design stipulated that once a patient diary record is entered in the ClinPhone system, it would be sent immediately to Phase Forward's servers, allowing site users to view the patient-entered data in the InForm software.

P&GP's creative approach to collecting and reviewing patient self-reported data has several advantages. First, current regulatory guidelines state that diaries are part of the complete casebook and, as such, investigators have responsibility for these records. The integrated solution places the diary entries in the hands of the investigators almost instantly. Second, the fact that the IVR diary records are captured in real time allows patient compliance to be monitored on a constant basis. Automated reports are provided to the investigative staff to identify those patients who have missed entries. In turn, the sites contact these patients to remind them of the importance of entering their diary records.

In a climate in which many companies are still finding their footing with e-clinical technologies, P&GP is creatively implementing ways to optimize the use of such systems. The team is convinced that taking such practical steps will make clinical trial procedures faster and simpler for all key stakeholders and, ultimately, will save time and resources and will significantly cut costs. Based on the success of the first two integrated studies, the P&GP team was able to design two-way data exchanges. Thus, a very deliberate and systematic approach to improving clinical workflow has been implemented. The Phase Forward - ClinPhone integration has now been successfully implemented in several clinical trials and has benefited as many stakeholders.