CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week writer Barbara M. Bolten spoke with Patrick Hughes, Chief Commercial Officer at CluePoints. Hughes is responsible for all sales and marketing strategy for CluePoints, and has worked in driving industry change through enabling technologies throughout his twenty year career history.

Q: What was the purpose of the executive roundtable discussion of the ICH E6 addendum, and what were the main findings from the roundtable?

A: Following the release of the updated ICH E6 guidelines, CluePoints worked with the Tufts CSDD to facilitate a roundtable of R&D leaders from major pharmaceutical companies. It was an opportunity to understand the operational process changes needed and the technologies that can help drive more efficient processes.

The overwhelming consensus was that the new ICH E6 R2 guidance provides the industry with a catalyst for long overdue change to make operational processes more efficient. The regulators have mandated new practices to enable companies to change.

The way clinical trials are managed now is unsustainable because of their rising complexity and the rising costs of tasks, such as 100% source data verification (SDV). In some larger studies, 30% of the overall clinical trial budget is spent on monitoring, and 15% is spent on SDV. The risk-based approach advocated by the addendum is a huge opportunity to accelerate efforts to re-engineer clinical operations processes and harness the power of technology to focus on data quality and patient safety.

The roundtable found that most large pharmaceutical companies have already started looking at risk-based approaches and establishing processes. The guidance—which came into effect in Europe in June—has enabled them to accelerate adoption so they can start to see benefits in cost and resource efficiency, and improvements in data quality and study timelines. The addendum has provided an impetus to say: We can’t just dip our toe in the water. We’ve got to fully embrace it.

Q: How have companies responded to the addendum?

A: Most of the companies at the roundtable have already made inroads into the methods the guidance is advocating. The response to the guidance has been an accelerated adoption cycle. Most companies recognize that risk-based monitoring (RBM), for example, is the way forward, and have taken steps to prove the concept, but the guidance puts it front and center. The overwhelming conclusion was that we not only need to plan for change, we actually have to do it—rather than carrying out endless pilots trying to prove that this is right for the organization.

The insistence by regulators has provided the impetus to drive more progressive change. Some organizations are on a run-plot to using risk-based approaches in, say, twenty studies in the first year, a hundred studies the next year and two hundred studies the year after. We can’t afford, as an industry, to wait 10 or 15 years for adoption—which has been the case in the technology realm in the past. Electronic data capture (EDC), electronic patient reported outcomes, interactive response technologies (IRT), and electronic clinical outcome assessments (eCOA), for example, have all taken a long time to become standard in clinical trials. That’s not going to happen here. Making the changes advocated by the guidelines will probably require a three-to-five year process.

This is a new undertaking for the industry in general. The early majority adopters see the benefits and start to adopt. After that first wave of activity, the late majority comes in. We are now at an inflection point where the early majority is not just looking at proof-of-concept, but implementing risk-based approaches in higher percentages of clinical studies.

Q: What are the key challenges for companies implementing the guidelines?

A: Companies have embedded processes that they really need to challenge. They need to be more revolutionary, which is inevitably uncomfortable for some of them. The biggest hurdle is sorting out internal enablement processes in tandem with bringing in technologies that can increase efficiency. For example, we’ve been involved with an organization where people from different functional areas come to the table and work out the blueprint for how the process is going to look tomorrow. There are a lot of moving parts in that effort because clinical trials are very large, complex, sophisticated beasts. Tinkering with that process, making sure the changes give improvement across data quality, patient safety, cost efficiency and resource efficiency—and still give the right results—is a big effort with many people involved.

Change is inevitable in the way that people do their work, so it’s absolutely essential that people are open-minded. The fear factor is that people’s jobs are at risk. I don’t think that should be a worry. People’s jobs will change in terms of the way that data is explored and interrogated and how decisions are made, but that’s part of the advancement. Advances in technology deliver greater levels of automation which, combined with new analysis techniques such as central statistical monitoring (CSM), can enable organizations to significantly improve output quality, maximize resource productivity and deliver their products earlier to market than by using traditional methods. Companies need to be enabled to take advantage of these new techniques so that everybody gets better at their jobs and becomes more efficient. 

This article was reprinted from Volume 21, Issue 31, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »