The release of the ICH E6 R2 guidance, which outlines a new approach to clinical trials operations, will have a major impact on the industry, writes Patrick Hughes.
The release of the ICH E6 R2 guidance, which outlines a new approach to clinical trials operations, will have a major impact on the industry. In response, and to better understand the perception of the new guidance by pharmaceutical companies, Tufts, CluePoints, and PWC organized a roundtable, which included senior executives from top tier pharmaceutical organizations that have responsibility for facilitating the changes required by the new guidance. The roundtable sought to highlight the main aspects of the guidelines, how organizations are responding to it, and the challenges they now face in an effort to achieve a common level of understanding across the organizations.
Generally, the roundtable highlighted a positive attitude towards the guidelines, with executives seeing the introduction as an opportunity to make significant changes to the industry. Clinical trials are becoming more complex and costly, and still rely on the same processes that have been in place for decades. As this process becomes unsustainable, change must be made in the way clinical trials operate to ensure the industry continues to move forward. The introduction of the new guidance enables key decision-makers to accelerate adoption of technology to ultimately improve resource efficiency, data quality, and study timelines.
All of the organizations represented at the roundtable have already discussed and made plans to accommodate the guidelines, and most have made progress into the types of activities that are recommended. Prior to the guidance being introduced, most organizations had already recognized that a risk-based monitoring approach is the way forward, with a general consensus that this approach must be adopted in every study to become the norm. The ICH E6 R2 states that organizations should develop a systematic, prioritized, risk-based approach to monitoring clinical trials, which has given organizations the momentum they have needed to start implementing this type of approach.
Although the new guidelines have only recently come into effect in Europe with other regions to follow soon, and it is still early days for the industry, representatives at the roundtable highlighted what will likely be the main challenges in implementing this change. The reorganization of processes which have been imbedded for years will take time and effort, and staff members will have to be trained to properly incorporate new technology into the organization. Additionally, each organization currently has a different approach, and will have to adapt the changes needed to the processes they already have in place. For example, the most variable decision highlighted at the roundtable is how organizations are going to monitor clinical trials, and whether to take a centralized or decentralized approach, or a mixture of both.
The roundtable has shown that the pharma industry is ready to embrace more efficient approaches to trial design. Rather than a hurdle, many organizations are seeing it as an opportunity for more efficient clinical research; however, there will be more challenges ahead as organizations start to implement the necessary changes.
For more information on how companies are responding to the addendum, and the challenges the industry now faces, please download a full report from the roundtable discussion here:
Patrick Hughes is Chief Commercial Officer,
