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International Clinical Trials

Integration in Action

Jim DeSanti of PharmaVigilant assesses the future of clinical data management, focusing on ways to integrate disparate clinical systems

The future of clinical data management will be defined not by industry pundits proselytising controlled transition, but by the commercial factors facing our industry. In order to meet the future needs of both drug development and the individuals that invest in those companies, the commercialisation of R&D is necessary, now more than ever. The industry has always been a business; however due to the recent economic downturn, the industry is seeing a narrowing of typically exuberant margins, leading to tighter budgets and greater expectations for trials to be completed on time. Due to this growing scrutiny, R&D will be held increasingly to different standards. As the current process is clearly not providing the desired pipeline or results to achieve those standards, they will have to accelerate the transformation of how they conduct drug development significantly. Moving forward, commercial reality will supersede intellectual optimism.

A known accelerant to increase productivity in all industries is technology. It has driven productivity gains made by the US for decades and continues to fuel the country’s economic engine. As an industry, however, pharmaceutical and biotech companies have not integrated technology as quickly as other sectors, resulting in a redefined definition of ‘slow’. Unfortunately, as a result of this slow integration, the technology issues are starting to stack up within our industry:

  • The adoption of electronic data capture (EDC) systems
  • The integration of multiple complex systems
  • The convergence of electronic medical records (EMR) systems and EDC

The increased pressure on our industry to continually do more with fewer human resources will facilitate the acceleration of technology adoption. Increasingly, we will segment efforts into: value added; non-value added but necessary; and nonvalue added. It will be important to apply resources and technology to the first two items, and re-evaluate the need for the third at all. In order to redirect necessary resources, standard operating procedures (SOPs) will have to be re-evaluated, with casualties an anticipated side effect.


When we think of technology, many gravitate to EDC; however, EDC is just one piece of a complex puzzle – a puzzle that requires integration in order to provide effectiveness. The industry has invested heavily in integration for decades, but with minimal results. Based on these investments, they have proven that they can expend enough time and money to integrate hundreds of systems; however, the return on investment (ROI) of these integrations remain elusive, exposing a need for change.

Perception is not always reality, and although there is awareness, the integration of EDC into clinical development has been slow. Many individuals and companies believe that their adoption of technology is greater than it actually is. Pat Huminara stated that: “In 1997, the FDA produced the regulations that would guide the industry through this transition (CFR Title 21 Part 11). Still, six years hence, recent analyst research has identified that only 30 per cent of ongoing clinical trials are conducted using EDC” (1). Anne Neure et al argued that, by 2010, “it has gained a firm foothold in the clinical trials market, with estimates for new trials starting with EDC in the 50 per cent range” (2). Although there is a slow improvement in integration of this highly effective platform, over a decade after these regulations were set in place there still has not been complete industry adoption.

For years, individuals have tried to segment the use of EDC technology based on the trial. Larger companies understood its value as a platform and standardised it years ago, across all Phases, just as they transitioned their companies to email in the 1990s. However, other companies initially implemented the platform for large, logistically challenging trials, with a greater chance of implementation for a Phase IV trial as EDC reduced many of its risk issues. Shortly after, EDC integration gravitated to Phase II-III trials; however, the adoption on Phase I was slow due to the perceived high price points.


The future of EDC in clinical data management will be strong growth, approaching 100 per cent. Although the industry will have trials conducted in remote locations requiring alternative approaches, this number will continue to decline dramatically. Given the FDA’s strong view of electronic submissions, it is only logical that the industry should and will align with the regulatory agency that approves its products. Companies need to realise that EDC is not a product; it is a platform, just as paper is, and moving forward the industry will standardise one platform for its increased speed, accuracy and cost reductions. In the end, it comes down to the commercialisation of this segment.

The path of integrating disparate clinical systems within our industry is a well-travelled road paved in gold. The results, however, have been disappointing commercially, with “more than half, 52 per cent reporting that their systems integrate only somewhat well with external data sources” (2). The industry has pursued many different paths, be it best in class with massive internal integration, or settling for multi-function systems that provided bantam weight systems that were marginally integrated. For such a risk-adverse industry, change is difficult; however, based on the proven ineffectiveness of these past integrations, it is logical that the next step for the industry is to a complete adaptation of EDC.

As the commercialisation process continues within R&D, the industry will demand that the vendors share in the financial burden of producing integrated products and stand up to a greater accountability for their trials. The vendor community will have to provide platforms with larger integrated footprints. This transference of costs to the vendor community will be the cost of entry for competing for future clinical development projects. The rationale for this is that at the heart of integration is standardisation. This is elusive in an industry controlled by guidance and not standards, so it will take greater accountability from vendors to ensure that these platforms are integrated.

Only the vendors that produce the systems can control the level of standardisation that they integrate into their systems. The challenge will be achieving a balance with the flexibility that the industry will continue to demand. The future will be the birth of massive databases, incorporating disparate data types – for example data, images and video – that are parsed out, enabling the right user to access the right data at the right time. The key to this pathway is to embed robust control systems that are validated and auditable, ensuring that data integrity and privacy is maintained. Only then can the scale necessary to drive costs and human capital from the equation be achieved.


The prospect of the integration of EDC and EMR systems looms on the horizon of the future of clinical development. It is logical that many parties would benefit from this integration – sites, sponsors and so on – and it would drive down the costs within the industry. However, it is important to look at the current implementation levels in order to predict future adoption. “In 2008, it was reported that just four per cent of physicians had an extensive, fully functional electronic records system, and 13 per cent reported having a basic system. More recently, it was reported in 2009 that only 1.5 per cent of US hospitals have a comprehensive electronic records system (that is present in all clinical units), and only an additional 7.6 per cent have a basic system (present in at least one clinical unit)” (3). An important thing to note is that these numbers are specific to the US, and as this is the traditional starting point for technology adoption, it is safe to assume that there is even less adaptation globally.

Although technology adoption is accelerating, it is important to remember that, 13 years after the first guidances were issued, EDC is only at 50 per cent adoption. The industry continues its optimism, however, according to an online survey, “70 per cent of total responders (375) agreed strongly that EDC and EHR will merge within the next five years” (4).

There are several issues that plague this initiative, including the fact that “most of the existing EHR systems cannot be used directly as a source for clinical research data. There are two main reasons for that: the variability of systems and data documentation, and the fact that most of the EHR are not in line with the existing clinical research regulation – for example, FED regulation 21 CFR Part 11 (4). These issues are complete showstoppers commercially.

The variability of the systems and data documentation equates to a lack of standardisation on the EMR side of the equation. However, the major issue is that most of these EHR’s are not in line with current regulations. Again, the reason that these issues will not be addressed nor corrected by the vendors that supply these systems is commercial. The deployment EMR systems in the US alone will be measured in the tens of thousands. The cost of documentation and validation of regulatory compliant systems across so many potential sites would be financially impractical, with no identifiable party willing to bear the cost – be it pharmaceutical vendors, sites or the government. Hospitals and other institutions have not provided links into their current EMR systems for fear of lack of controls and potential litigation – again, for commercial reasons. The intellectual desire to integrate these two systems, although logically correct, will be once again trumped by commercial constraints. Even though the governments will aid in the adoption of EMR systems in the US, the linkage between EDC and EMR systems will not happen due to costs.


Commercialisation of R&D will be more of an ever-present guidance in the strategy and tactical decisions made within the industry. “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” (5). The industry will demand that the vendors drive the future of integrated products. Massive databases consisting of integrated trial master files, case report forms, lab data, images and so on., will be integrated and accessible via a single login; however, with this power comes the need for improved controls to ensure data security. As we reach for increased transparency, data quality and accuracy, the information becomes more portable. The controls necessary to instil confidence will not be insignificant. Patient databases such as EMR will not be merged with clinical data bases due to standardisation, validation and cost issues, regardless of our desire. The costs are too high, with no party or group of parties even willing to entertain the expense, especially in an environment dedicated to reducing costs. It is time to face reality head-on and the vendors to step up. Overall, the current clinical trial landscape is ever-evolving and a dramatic increase overall in standards, procedures and processes is likely moving forward as the industry looks to commercialise R&D.


1. Tuminaro P, Electronic Data Capture... Then and Now,, accessed 21 May 2010

2. Neuer A, Warnock N and Slezinger E, The Upfront Cost Hurdle of EDC, Applied Clinical Trials 19(4): pp52-58, April 2010

3. Mitchel J, Kim Y, Choi J, Park G, Suciu L and Horn M, The Final eFrontier, Applied Clinical Trials Online, 2010

4. Jahn E and Prove J, CRAs Rate EDC, Applied Clinical Trials: pp46-52, May 2008

5. Bunn G, Scaling up EDC: How to Move Away from Paper Trials, Applied Clinical Trial Online 2, 2002

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As CEO and Founder of PharmaVigilant, James DeSanti has over 25 years’ experience in the pharmaceutical and software industries with extensive experience, starting and managing companies globally. He started his career at Johnson and Johnson, involved in Sales & Marketing (product development and launches). He was later named President of Walsh Americas, with operations in the US, Canada, and Brazil. He has been actively involved in over 400 clinical trials and nine clinical technology transfers in the pharmaceutical, biotech and medical device industries.
James DeSanti
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