Ashok Bhat, commercial operations director at Phase Forward, explains the reasons behind the industry's growing adoption of Electronic Data Capture to gather clinical trials data
Within the last year or so, the adoption of Electronic Data Capture (EDC) as a means of gathering the data generated within clinical trials has gone past the 'tipping point'. Rather than being seen as an interesting concept to evaluate, but avoid making a final decision about universal adoption, increasing pressure on pharmaceutical companies to raise their productivity has led to EDC becoming the method of choice for new trials. So what has driven this step change in its appeal?
In its early days, EDC was seen more as a tactical tool for data collection rather than a strategic pathway to increase data visibility, improve productivity and shorten overall study cycle times. This situation was compounded by the fact that the early decision makers regarding its adoption were often functional specialists who had little imperative to think more strategically. Furthermore, decisions were often made on a study-by-study basis, rather than being part of an overall strategy.
Despite their best efforts, in the early days vendors of EDC systems were seen as selling technology and gizmos. This made them appeal more to staff with a 'function and features' mindset, rather than those looking for options for a real strategic change of direction. Even when EDC systems were evaluated, the ensuing benefits were only seen at a micro level, and were rarely replicable or considered truly scalable across an entire organisation.
However, in recent years, various industry drivers, such as the need for increased productivity, higher regulatory hurdles to negotiate, heightened safety concerns, increasingly more complex clinical trials and a generally harsher pharmaceutical economic environment have pushed EDC and general improvement of the drug development process much further up the strategic agenda.
By taking a far more enterprise-wide, as opposed to piece-meal view of its potential, senior staff in an increasing number of companies began to realise that adopting EDC and automating a significant chunk of the development process across their whole portfolio was the only way to generate strategic benefits. Today, the majority of the larger pharmaceutical companies and Clinical Research Organisations are adopting EDC for the bulk of their studies, and this trend is moving throughout the industry. In fact, the last year or two can be seen as the inflexion point and EDC is fast becoming the standard way to run trials.
implementing the technology
Companies have finally realised that it is not difficult to implement EDC, as long as they make sure they take care of a few key fundamentals and adopt a model that meets their needs. These can range from comprehensive outsourcing - utilising an Application Service Provider (ASP) - at one end of the spectrum, to bringing all the technology and activities in house at the other, with various hybrid alternatives in between. Whichever is chosen, it is critical to ensure the following for success:
- Choose the right vendor - it is not just their technology, but their ability to leverage their experience, scalability and services strength to facilitate delivery of trials, train staff and facilitate the realisation of the strategic benefits. It can not be emphasised enough that for all options, it is critical to have the vendor provide experienced services staff
- Ensure there is a strategic mandate, senior management commitment and the vision is communicated across the organisation
- Focus on usage and user adoption - ensure training and processes are in place for fast adoption
- Prioritise site, clinical and data management workflow first
problem-free adoption
The adoption of EDC will be less successful if it is only IT and/or data management-driven, and it is imperative to secure 'buy in' from senior clinical staff in headquarters and monitors in the field. In addition, ensuring that the step change improvements in key metrics are shared with the operational teams ensures that change is driven by line management.
In the 'risk-averse' culture that still pervades the pharmaceutical industry, mitigating the likelihood of failure when adopting EDC will always be a prime concern. This means selecting a vendor who has adequate experience and back-up services to facilitate delivery of trials and realise benefits. Such a vendor is likely to be committed to library and standards development by utilising best practice to ensure standardisation and maximising the reuse of materials to minimise study set up time. They should also be able to advise on business process optimisation, bringing to bear genuine 'hands-on' experience gained from working with other players in the pharma industry. And, as EDC is similar to many other major IT projects, global support for user sites is vital.
Large scale site and clinical customer satisfaction surveys have shown that first call resolution problem solving is a major key to user adoption and buy-in. Pharmaceutical companies are reluctant to 'impose' technology on investigators unless they are happy to utilise it. When a clinical site has a question, they need an answer immediately - the ability of telephone support staff to resolve as many questions as possible at the first call is imperative. For these reasons, a 24 x 7, multi-lingual help desk team, trained to resolve the majority of questions in the first phone call, is a prerequisite for efficient EDC. Prompt resolution has a positive impact on data quality. Multi-lingual staff enhance communication, build the relationship between the site and the support team, and encourage confidence in EDC adoption at the site level.
the benefits
So, if EDC has gone past the tipping point, what benefits are pharmaceutical companies expecting to derive from their switch away from paper-based data collection systems? These can be grouped into five main categories: greater (earlier) visibility of results; reduced costs; increased capacity; greater speed; and improved quality.
Greater visibility and earlier access to results can have a major impact on subsequent decision making, for example in ensuring that sites minimise screen failures, manage safety issues, or to quickly stop an early phase study that is problematic. In terms of cost and capacity, checking data at the point of entry reduces the scope for errors, cuts queries and improves process efficiency by decreasing overall data management and monitoring costs. The ability to perform browser-side checks reduces queries and increases the inherent quality of the data. Furthermore, the inclusion of automatic checks (rules firing) leads to much faster query resolution and a massive reduction in manual queries. Finally, the ability to view data and manage source data verification allows reduced source data verification-related queries and significantly reduces monitoring costs.
With regard to speed, adoption of EDC should lead to a significant reduction in the time from last patient last visit to data base lock, and enables faster data entry (leading to earlier visibility of results), protocol amendment management and speed of query resolution - in the end leading to reduced time to submission.
In terms of quality, the improved integrity of the entered data should lead to increased investigator and site satisfaction - which can play a role in the successful recruitment and retention of patients.
A further benefit of switching to EDC is that it should not be too long before the benefits begin to be realised. By partnering with an experienced vendor and utilising best practices, the first studies can be up and running in a matter of weeks, giving immediate study-level benefits. As they scale up, users begin to see substantial strategic benefits. To give an idea of potential scale up rates, one large company scaled to over 100 trials live in little over a year, gaining very substantial benefits in the process. CROs can also realise major benefits, improve their competitiveness and ramp up customer satisfaction very quickly by switching to enterprise adoption of EDC. In addition, if the right vendor is chosen and appropriate support and training is provided to clinical sites, investigators and site staff become great advocates of the move to EDC and enjoy very high customer satisfaction. Patient recruitment, cost per patient and quality are all positively impacted, as is the desire by these sites to participate in future studies.
Finally, for both cost and access reasons more and more pharmaceutical companies are seeking patients outside of the developed Western countries. Given the ubiquitous nature of the internet, and the speed with which the related infrastructure has been adopted globally, EDC has facilitated the efficient and widespread use of sites in countries in the Far East, Latin America and Africa.
a new standard
To conclude, the use of EDC is fast becoming the standard for collecting data in clinical trials. This is because more and more pharmaceutical companies and CROs understand the strategic benefits which they can realise when adopting this technology for the majority of their studies: early visibility of data together with step-change improvements in productivity, cycle time and quality. In addition, it is important not to forget the investigators and sites as a key consideration in adopting the appropriate technology, as their experience will be a critical factor in the ongoing success of the adoption of EDC. Although widescale implementation of EDC is not difficult, choosing the right partner to ensure the realisation of its potential strategic benefits is crucial. Look for a vendor that has the experience, scalability and services strength to facilitate the company's success. Finally, given the fast-changing and challenging nature of the pharmaceutical environment, it is imperative that they have adequate financial strength, to be there for the long term, and possess a coherent product development strategy that recognises future industry requirements.