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After years of pilot trials, the pharmaceutical industry still sees EDC as something new. Here are two approaches toward making EDC into business as usual.
Pharmaceutical companies have been running electronic data capture (EDC) pilot studies for some years now. In the early days, sponsors focused on making the technology work. Unreliable computers, poor data communications, and a computer-challenged scientific staff provided major challenges to making EDC studies work smoothly and presented barriers to the scale-up of EDC throughout a company. Studies were successfully completed, but they were typically restricted to special one-off or pilot projects.
The clinical trials industry has been slow to adopt EDC as a commonplace technology. Propagating the benefits of EDC throughout the industry will require sponsors to change the way that they view their technology investments. The most successful companies will be those that not only embrace EDC, but also develop a relationship with clinical trial stakeholders that will facilitate the adoption of technologies beyond EDC.
History of pilot projects
A typical pilot project was very different from business as usual. Staff at the pharmaceutical company and at the investigative sites were often hand-picked for these pilot studies. Essential participant requirements were usually seen as an openness to process change, enthusiasm for EDC, and strong computer literacyqualities not possessed by the majority of employees at pharmaceutical companies or at investigative sites. In addition, staff numbers on these early EDC projects were usually higher than for a comparative paper study. No expense was spared in making sure the pilot EDC project was a success. Studies were completed successfully, but study metrics always presented a poor return on investment against the technology. Because the pilot projects required such heroic efforts, scaling them up was seldom considered.
Even with handpicked staff, pharmaceutical companies soon learned there was more to understand than simply collecting clinical data electronically. The EDC trial required new skills by all staff involved. Personnel involved in programming, designing, and building an electronic case report form (eCRF) now needed a much greater understanding of how the scientific staff actually worked at the investigator site. Monitors had to become evangelists of EDC to help persuade site staff to make the change from paper to electronic data entry. This role mandated complete confidence and familiarity in the use of the new EDC system and also focused attention onto the monitors information technology (IT) support services and training. Meanwhile staff had to learn about and interpret the new 21 CFR 11 that now affected the way everyone went about their work.
As time passed, many of these concerns subsided. Hardware technology has become more reliable and more available. The Internet has become more widely accepted with much greater bandwidths. Clinical trials professionals have become more IT literate and generally proficient in using Web-based systems. Even the implications of the 21 CFR 11 ruling are now more widely understood as consensus has been reached on interpretation.
Despite these changes, the EDC pilots continue. While many of these pilots have clearly highlighted the potential for EDC within clinical trials, companies still struggle to make a significant, large-scale shift from paper to EDC. In 2001 EDC accounted for approximately 5% of new clinical trial starts, with paper dominating the remaining 95%. It is widely predicted within the industry that 2002 will see only about 8% of trials being run in EDC.
Obstacles to scale-up
With all the experience the industry has gained in EDC, why hasnt this technology been more widely adopted? Two main problems hold back any major industry change from EDC in pilot mode to EDC in business as usual.
The first of these is the clinical trial process itself. Most EDC studies have made little or no attempt to change the processes developed by the industry that are meant to handle paper-based trials. These paper processes have been developed, modified, and improved over a number of years and now provide a low risk, well-understood, and regimented way to successful completion of a clinical trial and regulatory approval. Modifying these processes to accommodate new EDC technology is not a low-risk business process, and pharmaceutical companies have avoided it. This has resulted in expensive old processes, because EDC adds expensive technology on top of the paper-based methodology. With a return on investment (ROI) that appears very poor, the scale-up of EDC does not present a sound economic option.
The second issue concerns the people involved in running a clinical trial. Years of process improvement within paper clinical trials have led to a workforce with specific tasks and clearly divided responsibilities. Many of these roles have been defined and delineated by natural divisions of task and responsibility within the paper process. EDC opens up a whole new set of process improvements, but to take advantage of some of these, many of the historic delineations of job role and responsibility need to change. This means changing peoples job descriptions, skill requirements, and possibly their compensation. These are never easy changes to make, and people often try to avoid them rather than tackle them head-on wherever possible. The requirements for personnel changes therefore add another obstacle preventing the momentum needed for the successful scale-up of EDC.
Some pharmaceutical companies realize that the implementation of EDC can never deliver on the promise of improved clinical trials without the requisite process and personnel changes. They have coined the term eClinical to identify EDC technology combined with process and personnel changes that deliver the reduced costs, improved quality, and improved speed that the industry is struggling to achieve from EDC.So how should companies go about making the change? What will drive people to change from EDC pilot studies to eClinical business as usual?
To date there appear to be two different approaches attempted to provoke the neccessary change in attitude. Time will tell if either approach works in the long term or is superseded by another, but each approach has its own strengths and weaknesses.
The strong management approach
At least two large pharmaceutical companies are attempting the strong management approach (to date, successfully). In these companies, senior management has taken the view that the EDC promise is already sufficient to cause their company to change the way it does business without the need for a full return on investment. While many issues must be addressed to fully realize the EDC promise, the belief is that these issues will only be sorted out by running real studies, learning, and evolving the process. Management have therefore given a strong message to staff that EDC will become the norm for business in their company. Any paper-based studies require special permission to proceed. This is a complete reversal of the EDC pilot situation, where it is the EDC studies that require special permission. The balance has been instantly tipped towards EDC, and scale-up will be the end result. Staff are focused to make this happen through corporate goals and objectives.
Of course there is much more to senior management insistence that EDC will be the standard process going forward. Everyone in the company, from senior managers to junior staff, needs to believe that EDC is the correct investment for the company, and this belief must be backed up by policies and procedures to ensure compliance. Once the course is set, success requires a high degree of openness, innovation, learning, and refinement within the company. The staff must feel empowered to make changes and improvements to the people and clinical trials processes as necessary to take EDC towards the eClinical vision and realization of benefits. Through all this change, there will still be difficult studies (as there are difficult paper studies), and this will require a certain amount of doggedness and continued commitment to the eClinical cause.
The stakeholder approach
An alternative approach to the strong management EDC implementation, and one that is only just being fully understood, appreciated, and employed by a few pharmaceutical companies, is the stakeholder approach. Traditionally, pharmaceutical companies looking to implement EDC have focused on the benefits to their own company and then instructed (or forced) people involved in the trial to use the EDC system. These people do so because they are being paid by the pharmaceutical company to run the trial or are employees, but real commitment may often be low. This is especially true when process and job role changes are required, the management is weak, and resistance among the staff involved is strong. In these cases the required changes are never fully implemented and EDC scale-up is slow or nonexistent. In the stakeholder approach, however, companies focus on the business benefits of the EDC system to all of the stakeholders involvedespecially the end users. Although this may not provide such an immediately apparent quantum shift in balance towards EDC, when it is implemented correctly, staff become drivers of change, instead of resisting change.
Investigators and their site staff are the most difficult people to convince of the value of EDC scale-up. They must see systems that are easy to learn and use and that provide the functionality that they require to perform their everyday tasks effectively. When they have good experiences with these systems and see the answer to the question, Whats in it for me? these stakeholders may begin to demand EDC before agreeing to participate in a study. Indeed, if the competition for investigators is high because many pharmaceutical companies are simultaneously running similar therapeutic studies, motivated investigators have been known to switch to pharmaceutical companies that run their clinical trials with EDC. Instead of the pharmaceutical companies forcing investigators to use EDC systems, investigators reverse the situation and drive a paper-based pharmaceutical company towards EDC.
Currently a few investigators are talking to the industry about the functionality that they would like to see from an EDC system and how it would help them manage their clinical sites. It is time for the industry to listen to these stakeholders about their requirements. Pharmaceutical companies have traditionally been unsure about investigator attitude towards EDCnote the number of investigator surveys conducted in this area. And once shown good business incentives to make the change to EDC (answering the Whats in it for me? question), investigators are often willing to cooperate. Investigators love an 80% reduction in data queries, timely closing out of a study, the ability to manage their own part of the trial better, more informed clinical decisions, and ensuring they have been paid correctly.1 Many of these issues were previously beyond investigator control. But, when implemented with the stakeholder in mind, EDC can empower the investigator to run better clinical trials.
These two different approaches towards large-scale EDC implementation are clearly at opposite ends of the spectrum. The first makes use of policy and enforcement, while the second employs end-user empowerment to break from the mold of paper-based trials. Company philosophy, culture, and confidence are key within the strong management approach. The staff must be confident that management is leading the company in the right direction. Conversely, management must have confidence in their skilled and resourceful staff to find a way to make the eClinical initiative a reality. With the stakeholder approach, the ultimate success of the project lies in the ability to understand the different business priorities of the various stakeholders. Ultimately, both approaches need to focus on personnel and processes rather than data or technology, as has traditionally been the case with EDC studies.
Note that both approaches are also largely technologyvendor independent. It will be useful to select one or maybe two vendors and stick with a limited number of different EDC solutions. This will help staff to focus on the major issues without having to grapple with multiple new technologies. The chosen EDC solution must also clearly work in a satisfactory manner to avoid user frustration. But ultimately, success relates more to implementation (and the vendors implementation experience may be critical) rather than the actual technology being employed.
Continuing process improvement
Finally, it is worth looking to where the two approaches to EDC implementation may go in the near future. Given commitment and confidence, the strong management approach should result in a company that quickly moves from paper-based trials towards EDC scale-up. Because of the enforcement approach, however, it is then more likely to settle into a static EDC business-as-usual routine rather than continuing to focus on process improvement. The stakeholder approach, while it may take longer to execute, does present more opportunity for a company to maintain the focus on stakeholder benefits after a new system is implemented. Ultimately this should result in more openness to consider future impacts of EDC on people and processes. This will result in an increased ability to bring future technology on board, particularly in the upcoming areas of final eCRF delivery mechanismpersonal computer, personal digital assistant (PDA), and mobile phone. Pharmaceutical companies that maintain a focus on the benefits to the way investigators, site staff, monitors, and eventually subjects want to work will be the ones most likely to attract these scarce resources in the future. Providing a variety of delivery mechanisms that will allow users to incorporate EDC into their tool-set, and ultimately their way of life, will ensure maximum future benefits for all clinical trials stakeholders.
1. Clarifying the Investigators View and Perceptions of the Benefits, Pitfalls and Practicalities of EDC SystemsGetting the Balance Right (Thomas Fetch, Institute for Clinical Cardiovascular Research, 2002).