The right technology, at the right time

The growing popularity of Electronic Data Capture (EDC) is indicative of a broad recognition that EDC as a method of data capture offers significant realisable benefits. Developers of drugs that use EDC within their clinical research processes will have a significant competitive advantage, bringing new drugs and therapies to market faster and cheaper.

The transition to EDC is the single biggest technological advancement the clinical trials industry has seen to date. But what must companies do to ensure that this method of data capture can and will deliver maximum benefits? The key is in considering EDC as more than just a technological advancement. Selecting the most appropriate EDC solution is a strategic business decision, not just an IT application decision. Adoption of EDC requires change management at every level of the business and the implementation of such a system should only go ahead with a clear set of objectives and supporting business plan.

Choosing the right technology

With the range of vendors offering EDC systems companies looking to implement EDC must be prepared before going shopping. The plethora of system functionality, costing and licensing propositions will confuse the selection process unless the right questions are asked. Along with identifying user needs and requirements for system use, including concerns and questions relating to EDC implementation, there are a number of key ‘show me’ and ‘need to know’ questions each vendor should be expected to answer.

• How do remote users connect to the application? This should include internet access requirements such as the type of browser/version, speed of connection, firewall restraints and expected page-turn performance
• How does the application protect privacy on the internet? Including encryption details, whether or not cookies are left (which touches upon privacy and data protection issues) and user access processes within the application itself
• How does the application handle workflow within the study? Including, for example, how many clicks it would take a site to find a query for the patient and how it relates to the patient record in terms of location. It should also address specific needs for various global locations for handling protocol amendments and other changes throughout the study duration
• How are eCRF screens developed, and what is the connection of this development to the actual database? Are there any resulting synchronisation issues?
• What are the standard reporting capabilities ‘out of the box’, including who sees what based on access/security permissions? What type of filters can a user apply? In addition, what advanced reporting capabilities may be available that will combine both the clinical and meta data, at what cost and their ease-of-use?

This list goes on, based on the company size, global flexibility and study phase experience. The key is to know what your organisation needs and is prepared to embrace.

From our experience the best approach is to select the top 3-5 systems that meet your needs; schedule time to see them, touch them, test them and try to break them. Bring in users from all functional groups that will need to work with them for input and evaluation as part of the decision-making process. Too many companies see EDC as a system for their data management department and overlook the far-reaching impact EDC has on the day-to-day clinical processes – so include all appropriate departments in the evaluation process.

There are currently two leading EDC applications, Medidata Solution’s Rave™ and Phase Forward’s Inform™, that are beginning to dominate the market place. Both are comparable in many ways, yet each application has its own unique style, features and functions that differentiate one from the other. Either vendor will offer enterprise-type solutions along with knowledge and or technology transfers so you will have a choice of using the system in the ASP mode or you can internalise the system (eCRF development and hosting).

The bottom line is each company must decide what the key decision points will be when making a vendor selection. Look at the experience, the history and financial performance of the vendor, their track record and their future development and research cycles. Consider the regulatory issues along with any branding issues multi-national companies may face and flexibility provided by a given system. Consider your vendor team and the vendor’s compatibility with your company’s culture and process flow.

Selecting the right vendor and system is, however, only part of the challenge; the impact on a company and its internal processes is as much a part of the implementation decision as is the selection of the EDC vendor/application itself.

Organisational roll-out strategy

The most critical factor to be considered when rolling out an EDC application for a pharmaceutical company or a CRO is that the significance of the new technology must be appreciated at all levels of the organisation. All of the successful early adaptors cite senior management buy-in and support as one of the primary factors influencing their success. At an operational level, having a system champion who can drive change on the ground in the face of resistance is key and such individuals should be identified early and nurtured. It is critical that the impact of this new technology on all departments and all operating procedures be considered but it is also key that traditional divisions in roles and responsibilities be carefully reviewed. The line between CRA and data manager is becoming ever finer and it is essential that all departments are flexible in the face of necessary change.

A need for training and communication

Training begins with awareness and one of the most critical aspects of this technological transition is keeping all levels of the organisation aware of the system implementation developments as they occur. Communication is key and it is important that all levels of the organisation get to look at and ‘feel’ the system long before they have to use it in production. New technologies enable remote or user-led Web demonstration of the system but it is our experience that nothing can replace an instructor-led demonstration followed by an opportunity to ‘play with’ the system in a sandbox environment. Once you proceed towards roll-out a comprehensive training strategy must be in place. The challenges here are greater than ever before. For the first time, users for whom computers are not usually a primary component of their job will be interacting with your CDMS and such users will most likely be geographically dispersed. Success is dependent on how well the training is targeted to the specific user population. The focus of training for data managers, clinical staff and site personnel will be different and so too might the mechanism of delivery. While Web-based self-training may work well for your data management personnel, site training is best delivered by those who work with and understand the needs of site personnel. It is also important to measure the effectiveness of training and to be ready to provide refresher training as soon as the need becomes apparent.

Consider the integration issues

One of the biggest challenges facing adopters of EDC systems is integrating the system with the many disparate technologies and data sources being used within the clinical research industry. Those who have the infrastructure and ability to quickly integrate all the required information will succeed in bringing their drug to market fastest. Integration, however, often comes at a heavy price as no single system has managed to successfully integrate all the required information sources. Attempts to exchange and integrate data often get bogged down in considerable validation effort or compromised system performance.

Take advantage of on-line solutions

The reliability of the Internet and its global availability has made previously difficult locations as accessible as the high-tech countries that have been key targets for EDC penetration. It is also now allowing EDC applications to offer streamlined and effective on-line solutions that require minimal, if not zero, provisioning. This, coupled with a single on-line data repository as the underlying database, also makes the administration of such systems more efficient and effective.

The global nature of the Internet in addition to the ability to use on-line solutions has also facilitated the recent shift toward truly global studies. Countries such as China and India are becoming popular locations for clinical studies due to the large numbers of patients, especially the large numbers of treatment naïve patients. Since the medicine in these countries is mainly administered via large, often newly equipped hospitals, in many cases the IT infrastructure is better than that found in some ‘high tech’ countries. The ability to rely on and use Internet-based solutions reduces the need for ‘off-line’ EDC systems in these countries.

However, with connectivity comes risk – loss of data, downtime, security breaches etc. Fortunately, many of these risks have already been addressed within other industries such as internet banking. Billions of dollars are moved around the internet securely every day and the same technology is being used to electronically transport clinical data. Pharmaceutical organisations must ensure that they employ this technology to its fullest and many are choosing to bolster their security by outsourcing the hosting and maintenance and support of their hardware to an external provider. With the right system, the risk of downtime should be minimal and the organisation must determine at a study or even site level how to best mitigate this risk. An example of such mitigation might be the provision of paper CRFs as back-up to sites that see persistent connectivity problems.

Ensuring top class eCRF designs

The success of EDC implementation also depends on the quality of the processes defined and the quality of the eCRF designs employed (including point-of-entry edit checks). We are now seeing eCRF designs that are truly first-class, offering better quality EDC than ever before. The more user-friendly the eCRF, the stronger the acceptance within the user community and the corollary to strong acceptance is higher quality data.

Understand EDC’s potential role in electronic health records

While EDC technology will continue to change the shape of the clinical research industry the true revolution will be seen when EDC systems become fully interoperable with electronic health records providing wider access to higher volumes of data and providing a single interface for the physician. Organisations such as CDISC and Health Level 7 are working hard to define data standards that will facilitate such interoperability but there are many obstacles, both technological and political, to overcome before such integration can be realised.

Summary

EDC can offer many benefits to the data collection process, helping organisations accelerate clinical studies, increasing efficiency and the quality of results. While to many the process may seem like a huge shift from paper-based trials, confidence in EDC systems is increasing and the next generation of technology savvy professionals are looking to accelerate the adoption of EDC in the future.

EDC offers the greatest single potential to reduce the cost of clinical drug development, and provides the ability to more closely monitor patient activity as part of the drug development process. EDC provides the previously unavailable ability for adaptive study design by enabling study managers to adapt to results as soon as they occur and roll out immediate changes within the study design.

The industry has made numerous attempts in the past to use the various EDC applications available however, save for some of the larger pharmaceutical organisations most companies scarcely progressed beyond running one trial in each of the available technologies. Today however we are seeing multiple trials in the same technology; this is the largest single indicator that EDC is finally here to stay and becoming the common technology of the drug development process.