The updated Good Clinical Practice (GCP) guidelines from the International Council for Harmonization (ICH), known as ICH-GCP E6 (R2), has now been approved, and implementation has begun across the globe. This second revision of the GCP guidelines in over 20 years has already been adopted by Health Canada with an implementation target date of April 1, 2018.
If your organization – whether you work for a pharmaceutical, biotechnology, a research site, or a contract research organization – has not yet kept abreast of these changes to GCP guidelines, you need to begin today as it brings major implications for all clinical development stakeholders worldwide.
ICH-GCP E6 (R2) reflects the drug development industry’s growing emphasis on risk-based quality management and monitoring, highlighting the increasing complexity of clinical research and how the ongoing evolution and emergence of new technologies create opportunities for realizing greater efficiencies in quality management.
The updated guidelines specifically describe quality management as a versatile process, with an emphasis on re-thinking protocol design to minimize its complexity, eliminating unnecessary procedures and refining data collection tools and methods. Ultimately, it provides us with a key to better decision-making to ensure we focus on relevant activities to bring about faster, less costly studies while maintaining high levels of quality and safety for trial participants. As an excerpt from E6 (R2) states:
“When the original ICH E6(R1) text was prepared, clinical trials were performed in a largely paper-based process. Advances in the use of electronic data recording and reporting facilitate implementation of other approaches. For example, centralized monitoring can now offer a greater advantage, to a broader range of trials than is suggested in the original text. Therefore, this guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.” (1)
In essence, what ICH has done is force the drug development industry to take a hard look at itself after 20 years of complacency, and implement changes to systems and processes in order to achieve more innovative approaches to the whole life cycle of developing new therapies.
As Arkadi Kuhlmann, the chairman and CEO of ING Direct USA, wrote in the Ivey Business Journal in 2010, “For all the talk about the importance of innovation, very few companies have figured out how to make it happen in a sustained way. Many businesses come up with one big idea, but that’s not enough… The key to long-term success is to make innovation happen continuously. That’s where companies fall down. Intentionally or not, they become complacent.” (2)
Most people think that innovation equates to new inventions, gadgets, or start-up businesses, however, true innovation is when we begin creating organizational cultures that continually renew, change and improve the way we work and live. By proposing the following changes to GCP guidelines, ICH has given us not only an interesting challenge, but a wonderful opportunity to do better.
Interestingly enough, and rightly so, ICH still leaves enough ambiguity and room for interpretation even within the new updates to E6. Most clinical research professionals would find this frustrating since we often demand straightforward answers to issues we might encounter while conducting research studies.
However, ICH has recognized the fact that leaving room for interpretation and providing more of a guide rather than a recipe book will foster out-of-the-box thinking. This also allows the new guidelines to have more flexibility in a fast-changing world of evolving technologies.
Again, many of us would probably be outright disappointed to see that after 20 years of no changes, ICH provides us updates that certainly clarify lots of contentious issues (such as use of e-records, certified copies, investigator oversight responsibilities, validation of computer systems, etc), yet still falls somewhat short of leaving zero doubt in other areas of interest. One particular section of the new updates, number 5.0, Quality Management, shines a much-needed light on a topic that has, for many years, baffled even some of the most experienced of us all.
During one particular conference a year ago, the author probed audience members during a presentation on Quality by Design and asked, “What is your definition of Quality Management?”
Ten people raised their hands and provided 10 very different answers.
Indeed, ICH recognizes that “one-size-does-not-fit-all” when it comes to Quality Management (QM) systems, but provides a well thought-out generalized roadmap for organizations to get started with setting-up a solid QM foundation that promotes principles of continuous process improvement strategies throughout the lifecycle of a clinical trial. This is when true innovation is achieved.
You cannot attain or even begin to claim that your organization is “innovative” without fostering a culture of innovation, and it all begins with hiring the right type of people. It starts at the interview process.
At Vantage BioTrials – an innovative Canadian CRO – they have learned to hire individuals that do not fit a perfect mold. The best people are found in unusual places. For example, one of their clinical project managers with an M.BA and a history of entrepreneurial ventures proved to be one of their most valuable team players, not to mention a marketing guru with effective patient recruitment ideas; another employee, a highly-motivated drug discovery scientist with over 10 years of lab research experience became one of their most valued clinical monitors, who could easily discuss scientific concepts with principal investigators.
These are just some examples of how creating a diverse, engaged and open-minded workforce helps bring about the necessary cultural shift towards innovation. Vantage BioTrials also uses the diverse backgrounds and experiences of their staff in their protocol optimization process, where they carefully and meticulously scrutinize study designs, protocol procedures, and scientific concepts in order to realize best outcomes for their Sponsor clients and ultimately remain compliant with ICH GCP E6 (R2).
Because of innovations that have increased the value and power of data in trials today, clinical trials of the future are already becoming smaller, faster, and involve fewer participants. With more patient involvement and input and continued progress in the areas of technology platforms, recruitment strategies, and building partnerships, we expect to see more responsive and flexible trial designs, making it possible for studies to make adjustments to protocols in response to trial data and refine and improve outcomes in the midst of a trial.
Reaching this ideal state and realizing all of the potentials for future clinical trials requires more than just innovation amongst industry stakeholders, and we now finally see international policies aligning with industry efforts through ICH’s amended guidelines. Ultimately, this is what is needed to get life-saving treatments to patients, and in the drug development world, it is the only thing that should truly matter.
Vatche Bartekian is president of Vantage BioTrials Inc.
- ICH Harmonized Guideline; Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2), Current Step 4 version dated 9 November 2016.
- Ivey Business Journal; Reinventing Innovation, by Arkadi Kuhlmann, May/June 2010 issue
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