By Dan Schell, Chief Editor, Clinical Leader
How Do You Define EDC? Does It Start With An eCRF, Or Can It Start With A Physical CRF?
Patrick Hughes: Each sponsor looks at it differently. Historically, you start with what is done on paper and see how it gets converted to an eCRF (electronic case report form). Today, most companies are starting with the electronic media. The only catch is that they often install the EDC system in parallel with a CRF as a failsafe measure.
Andrew Schachter: To some extent, EDC is misunderstood. To Axiom, it really is a process of taking a study and converting it to an electronic medium. Ideally, considerations are made at the beginning of the process regarding how to implement the study, what technology to use, and what impact that technology may have. Therefore, to us, it starts with the protocol, the vendor selection, and the operation of the study. We define EDC as the process of moving the very laborious paper-based process of clinical research to the Web. This means everything from the electronic case report form to the roles of monitors and data management.
Martin Young: Broadly, EDC is any system that automates the collection and validation of clinical trial data in-stream to explore the efficacy and safety of a drug under study. The rise of the Internet and the decoupling of EDC from hardware, combined with the globalization of the clinical development industry, have established EDC as the standard method to manage clinical trial data and the only practical solution to conduct the increasing number of complex, global studies.
In Your Opinion, What Is The Biggest Impediment To Widespread EDC Adoption?
Hughes: The biggest stumbling block is the conservative nature of the industry. You often need an ROI assessment to get approval for one of these solutions, and sponsors have a hard time quantifying the internal costs of some of their activities. They need to get better at this, but they often don’t have the bandwidth or time to do so. The fear of the technology letting them down is a big obstacle.
Schachter: Poorly designed and implemented technology and lack of high quality service. Too many companies in the space have technology that fails to deliver on the promise of what technology can bring to any problem or situation. While there are several competent vendors that deliver solid solutions, many are too focused on the technology spin and spend too little time ensuring the solution works for the right end user.
Young: Widespread EDC adoption is already here. Well over half of all new clinical trials are expected to use EDC this year, and that number should continue to grow rapidly. Really, there are few obstacles remaining to overcome. In fact, trials are already starting to move beyond EDC and are looking for integrated systems that not only include EDC, but incorporate patient-reported outcomes, randomization capabilities, and trial supply management. These advanced needs and the ubiquity of the technology have spawned increasingly sophisticated EDC users, and the greatest challenge is not convincing them to use the technology, but redesigning the technology to work appropriately for them in this new user paradigm.
Going from a manual data collection system to an EDC obviously involves a significant amount of change management. What’s usually the biggest problem? Database creation? Retraining staff to collect data in a different way? Integrating the new EDC system with other auxiliary systems (e.g. IVR, CTMS, etc.)?
Hughes: For those companies that have already dabbled in EDC, it’s very difficult to switch to a new provider because of the additional training and retraining that is involved. For those companies implementing EDC for the first time, they need to redefine the roles and responsibilities of their staff and remember that EDC doesn’t always lead to a reduction in headcount, but more often, it creates a better allocation of resources. Integration with other auxiliary systems usually isn’t much of a technical issue because the vendors have taken care of this step already.
Schachter: There are many facets that are part of the process of moving from paper-based research to an electronic clinical research environment. In the end, though, it should not be a problem-filled exercise if it is well planned. The key elements that will require the most time are the following:
- creation and development of new operating procedures
- determination of updated roles and responsibilities for clinical researchpersonnel
- motivating the team to be open to coming forward with new ideas
- embracing change — the movement to EDC should be a collaborative process for everyone involved. It’s key that a leader needs to be part of the decisionmaking process.
The technology and associated database creation should not represent the biggest challenges in the change. The technology partner should make sure that it is a smooth implementation throughout the life cycle of the conversion and launch of Web-based clinical research.
Young: We find the greatest challenge to be managing the process change. When an organization moves from paper to EDC, the world speeds up considerably. Clinical operations personnel and monitors, in particular, find a very different environment in which to perform their jobs. Once an EDC system is implemented, site-monitoring can occur 24/7 — for example, data can be reviewed and a query can be issued within half an hour of data being inputted, when previously it could have taken weeks. What was once a fairly opaque and cumbersome batch process is now highly efficient and transparent.
How Can A Company That Has No EDC Prepare For The Implementation Of Such A System?
Hughes: Working with someone who has experience in EDC implementations can be very important during these implementations. What works well is that the EDC vendor takes on the responsibility for the implementation and works with the service provider. Start small, and work up to many more sites. Don’t try to grow too much too fast. And remember, not all vendors provide the support that is needed. You need a service provider — not just a software provider.
Schachter: Ideally, it makes the most sense to partner with an EDC vendor that really can assist in the transition to EDC. The technology partner should be in a position to play a key role in helping the client adapt its operating procedures and internal work guidelines to transition to the new operating medium of EDC. Sponsors should pursue courses at industry seminars when possible to enhance their knowledge base and awareness of the EDC process. In addition, it is best to take a broad view on implementing EDC.
Young: Creating a pilot program to establish trials in an application service provider (ASP) mode, which puts design, server hosting, and help-desk functions in the hands of the EDC provider, is a sound strategy. The sponsor immediately gains the benefit of the solution without having to worry about maintaining the necessary technical infrastructure and support system — after all, getting the benefits is the reason why they are investing in EDC! This strategy, however, is only as strong as the EDC provider. An experienced provider will have a wealth of practical knowledge to convey best practice strategies and outline critical success factors.
How Can A Company That Wants To Change Its EDC Prepare For The Transition?
Schachter: First of all, if a company is considering transitioning to a new EDC vendor, then it should consider the core reasons for the switch. Did the current EDC system fail? Was it a personnel performance issue? Too complicated to use? It’s really important to identify the reasons for the transition. A checklist of needs and wants is crucial to making the change. No EDC system will do everything that a company might be looking for though. Therefore, assessments will help in the decision-making process.
In addition to determining needs, it would be wise to consider the circumstances ofthe change: rescue situation, poor service, limited reporting tools, etc.
Young: It is important to work with the EDC provider to jointly perform detailed start-up planning and training. Trying to impose former processes on a new system won’t work. As outlined above, the ASP model is a good path to follow and gives the sponsor the quickest results.
What Are The Pros And Cons Of Choosing A Single-Source Provider Of EDC And Its Related Programs (e.g. CTMS, IVR, ePro) Or A Best-Of-Breed Solution? Which Is More Popular?
Hughes: Historically, best-of-breed solutions have been more popular. This industry has a complex process with multiple stakeholders (i.e. people impacted by the EDC system). Only some of the largest companies have one person who is in charge of all of those responsibilities. In those instances, a single-source provider might be more appealing.
Schachter: I believe the choice has more to do with the needs of the organization. Some larger companies want a single point of contact for all of their EDC requirements and related technologies. Small-to-midsize clinical research firms generally benefit from seeking out best-of-breed solutions to meet their technology needs. Often, EDC companies can bring additional components, such as integrated randomization to the table. While integrated technology is a huge buzzword, many companies will fail to benefit from the extended technologies that they will pay for but not necessarily use.
Young: We believe the industry is moving toward single-source providers of what we call an Integrated Clinical Research Suite (ICRS), which provides sponsors a single source of accountability and delivery for EDC and its related applications. With trials becoming more complex and greater in scope, trial sponsors want to simplify their vendor portfolios and make things easier for their investigative sites. However, a single-source provider and best-of-breed solution should not be mutually exclusive. Clients really need both — an ICRS with best-of-breed technology.
Is The Promise Of Real-Time Transactional Data Possible With MOST EDC Implementations, Or Is This The “Holy Grail” Of This Technology?
Hughes: As Electronic Health Records (EHRs) become more prevalent, it will be easier for data to be captured once and then transferred into the EDC system seamlessly. This will certainly drive real-time data acquisition, but it will likely be a few more years until this model persists.
Schachter: We believe that the entire purpose to EDC technology is to make clinical research real-time. If the EDC system someone is using isn’t accomplishing that goal, then something is missing from the solution. One of the key elements to realtime transactional data is access to core reporting tools that paint a clear picture of the status of the project’s enrollment, clinical research, site activity, and overall metrics.
Young: Near real-time transactional data is already possible today with most EDC implementations that have closely integrated software. In most instances, the few minutes it takes for data to refresh will suffice to allow for appropriate decisions. To get more accurate results quicker, sponsors should seek out EDC systems that accommodate the sophisticated EDC with user interfaces that group information in more meaningful ways and streamline workflow.
Used with permission from Life Science Leader magazine.