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European Pharmaceutical Contractor

Performance Enhancement


More efficient incorporation of electronic data capture technology can streamline processes and improve patients’ experiences in even the most complex clinical trials.

The question facing innovative clinical technology companies who operate in the fastest-growing therapeutic area in the industry is how to make the most of technology to enhance the clinical trial process in oncology.

As those involved in clinical research increasingly have to consider pharmacoeconomics, working within a cash-strapped economy, the race is on to find ways to pursue clinical objectives faster, more efficiently and for less money – while maintaining scientific integrity. While technology can help to make those goals a reality, some potential obstacles will need to be overcome in ensuring a comfort level is established with the technology-driven future.

Mapping Technology onto a Complex Trial

As protocols for oncology studies become increasingly complex, finding ways to seamlessly incorporate technology into challenging trials – while navigating the regulatory landscape – has become a priority. As a result of organisations trying to save money, companies are now bringing two ‘phases’ into one protocol. For example, whereas phases were traditionally represented in distinct protocols, they may now be combined into a single protocol; for example, combining Phase 2b and 3. As a result, the technology must now be flexible enough to cope with the equivalent of examining two collections or reservoirs of data in a single study.

The main challenge is the psychology of the people involved. For too long, automation has been the preferred approach because the perception was that it eliminated the complications that the human element brought. The incorporation of technology for studies in oncology and other therapeutic areas is supposed to make trials easier, faster, more collaborative and more efficient. Yet for the end user, the realisation of those goals can be difficult to envision. Instead of feeling empowered by the technology, the user often feels overwhelmed.

With the majority of studies now using some measure of electronic data capture (EDC), end user disillusionment with technology has to be addressed. That is why expectation management has gained such a vital role in the adoption of technology into clinical trials, both straightforward and complex. The right form of management, combined with the right of amount of training, can turn a bulky process into an efficient one.

Navigating the Regulatory Landscape

Though we are in a digital age of sharing and transparency, the pharmaceutical industry as a whole is a slow technology adopter, by nature of its conservative, traditional mindset. As a result, regulatory challenges ranging from data privacy to site IT infrastructure can dramatically hinder the ability of technology to alter the way clinical trials are conducted.

To many observers, regulatory guidance is not black and white, making it more and more open to interpretation. So for better or worse, most companies sit back and wait until Big Pharma interprets a regulation a certain way. As a result, most organisations have been overly cautious, ramping up the complexity of protocols and slow down the process dramatically. Instead of analysing the guideline in terms of risks and boundaries, companies are forced to go to extreme lengths to prepare for every eventuality. However, times are changing as ulators work to embrace a more risk-based approach and encourage the industry to embrace technology. The FDA’s eSource draft guideline is an example of this.

Additionally, the pharmaceutical industry has traditionally been extremely reliant on paper. Due to the confidence of having a wet-ink signature on a tangible piece of paper, there is resistance to electronic-only processes. As a result, the approach usually involves transcribing source data onto paper and then entering it into an EDC system, a cumbersome process that can have adverse effects on data quality.

While many feel these issues could be addressed through electronic health records, there are ongoing concerns about the compatibility and compliance of hospitals. In addition, there are ownership issues at play; if data is taken out of an electronic record and placed in an EDC system, who actually owns the data?

When faced with such obstacles and concerns, the industry usually ends up talking itself out of the bold new ideas. The result is less willing acceptance of regulations, and more wariness of and overcompensation for them.

Accepting Technology as a Facilitator of Better Research

The reality is that technology can ramp up the pace, efficiency and collaboration of studies. Helping study staff see that the road to trial happiness is paved with technology is the worthy challenge awaiting EDC providers everywhere. Technology has the power to make trials easier, safer, quicker, more efficient and more collaborative – with cleaner data and a faster database lock. The empowerment behind all of these improved variables leads to happier sites, sponsors and investigators.

When the concept of using technology in clinical trials was first introduced, large organisations moved quickly to jump aboard. These companies essentially dumped new technology onto the sites for them to parse and figure out, which created a culture of bad feelings between sites and sponsors for many. And while that attitude has dissipated over the years, the mindset of leaving the sites to fend for themselves in terms of understanding new technology has remained for some.

As a result, sites crave an approach that includes collaboration and training when it comes to incorporating EDC into studies. In addition, while initial attempts often involved forcing the protocol into the technology, many feel the path to success is to take the opposite approach: using the technology to make the protocol work optimally for the sites.

However, even the best technology is destined to fail if the sites are not entering data. Safety and compliance issues then arise, which puts pressure on everybody involved in the trial.

With a more collaborative relationship, sites, sponsors and investigators all become more invested in the process, which leads to happier users. As a result, sites aren’t being changed as often and users get the immediate, positive feedback that EDC allows.

Technology Can Change Study Roles for the Better

Along the way, technology providers need to overcome the natural resistance to change by helping new users see that EDC truly makes their jobs easier. Using EDC solutions can alter roles and responsibilities for those involved in oncology studies, so training and support is essential to show those involved that the technology is not overwhelming and that they can successfully work in concert with EDC. People are resistant to change, and can view technology as overwhelming and difficult, and complex clinical setting and data collection can raise expectations that technology won’t fit the study. But it is imperative that people enhance their roles to include technology – not stop doing what they were doing because of it.

Because the process has largely become automated, with edit checks built into both the front and back end, data managers have had to adjust to shifting roles. Previously, they would receive the paper CRF and examine the data to perform a sanity check. Now, that sanity check is bypassed in many cases due to automation, which leaves statisticians to do the questioning further down the line. And since edit checks are linear and unable to provide context, issues often make it all the way to statistics before they become apparent. In that sense, there are concerns that technology has made data managers forget – in some ways – to be data managers.

As we become more reliant on technology in so many aspects of our lives, it is healthy to examine how it has altered the way we think. In the case of technology and clinical studies, it needs to be emphasised that technology does not remove risk, and that while roles may have to shift, the challenges of data management and clinical research remain.

As Complex Protocols Become the Norm, Fiscal Concerns Will Drive Change

In the future, studies will be built straight from the protocol, and data standards will be addressed on the front and back ends. It will be incumbent upon leadership to assimilate technology seamlessly into new roles and responsibilities. Technology cannot be ignored or avoided – we just have to be careful about how it is adopted and how we work with it.

By incorporating risk assessment and management during study deployment, the risks associated with protocol are accounted for at the start. All parties should at least be aware of the importance of risk assessment and management, and be willing to have it as a topic of discussion upfront.

In an ideal world, the study of tomorrow would be completely integrated, allowing data to pass easily between systems and making patient information readily available. These trials would have the ability to guide users and be easy to interact with, with electronic sourcing and the flexibility to integrate with data. However, the pharma industry’s legacy of conservatism makes one wonder just how far into the future we must look in order to see that type of trial come to fruition.

For the pharma industry, becoming leaner and eliminating waste and redundancy are vital to the pursuit of this study of tomorrow. Leaders will be charged with asking the right questions at every step of the process: Is this adding value? Is it keeping the patient safe? And is it ensuring that we are delivering top-quality science?

The hope here is that the current global economic climate will force pharma down a leaner path. The days of Big Pharma being able to buy its way out of trouble are over; the companies that find a way to continue to do stellar jobs with a third of the money – partially by incorporating technology seamlessly into the process – will be the ones leading the way in the pursuit of the streamlined trial of the future.

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Emma Banks has a BSc in Pharmacology at University College London, then went on to earn a PhD in Pharmacology from the University of Liverpool. In her nine years at Datatrial, Emma has headed up the organisation’s growth in data management, statistics, business development, and operational and service delivery. Now, as Chief Executive Officer, she champions the role of customer engagement within the company, and has rolled out initiatives designed to integrate the company’s five values – tailored solutions, collaboration, efficiency, long-term relationships, and connecting promise and results – into everyday processes. Email: emma.banks@datatrial.com
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