Bryan Clayton, Vice President, Strategic Solutions
Last week was my seventh consecutive year of attending CBI’s IRT conference. It’s great to reconnect with colleagues and see familiar faces at each event. While accustomed to hearing common themes each year, which have recently focused on data standards, inspection readiness, new technology and protocol complexity, I’m always curious to know what we’ve done with these insights and emerging trends as an industry. This year, I was pleased to hear progressive updates on these topics and candid discussion on areas that need more work. Paul Hughes of Pfizer opened and closed the conference by declaring “the solutions are in this room.” I, too firmly believe we can address the challenges in the IRT space through the diversity of organizations and roles involved with IRT implementations.
Key themes and strident calls to action included:
- Data standards are more important to implement now than ever, especially to take advantage of the efficiencies newer technologies such as machine learning, natural language processing and blockchain have to offer. We heard about structured protocol authoring and machine learning for improved supply forecast algorithms. Virtual trials will rely heavily on standards for technology logistics support. Barry Moore of GSK discussed the progress of GS1 label standards, and explained how further adoption of GS1 standards will simplify integration between IRT, depots and other supply chain systems. To support 50 plus trials per year, Prasann Mehta of Merck discussed how data standards and technology are essential pieces to promote better quality and efficiencies throughout their end-to-end operating model.
- Data Integration and Interoperability, also part of the data standards discussion, was a recurring theme of many other presentations. eClinical technologies that grew up in silos need unified solutions for a single source of truth, and to avoid the unintended consequences of change on other functional areas. Point-to-point is the industry’s defacto standard, but limits data integrity and efficiency.
- The two areas that represent the biggest transformative value require collaboration on a new scale. Barry Moore of GSK and Imran Shakur of Biogen reminded us of the urgent need for alignment and agreement to effectively deploy blockchain for end-to-end visibility through the clinical supply chain. Describing the progress of the Blockchain Working Group, a consensus-based model is essential to working in a distributed ledger. Additionally, we learned that the successful deployment of master protocols involves coordination across many groups, as well as recognition that there’s no one department more important than the other. Master protocols offer an array of benefits to patients, notably the increased probability of inclusion in a trial targeted to their mutation. Lastly, Craig Mooney of BMS and Imran Shakur of Biogen reinforced this when talking about the need to think beyond transactional outsourcing.
- Relationships and domain expertise are more important that system capabilities when it comes to vendor selection. Most of the advisory panel have served in provider and sponsor roles, and have participated in various governance models. There was general agreement on the structural elements to success, as well as the softer areas of relationship management. Across vendors, Craig surmised that the technical issues are the same, but the responsiveness makes the difference, and people matter more than technology.
- Flexibility and agility are more important than simplicity when it comes to system capabilities. As drug development moves closer to personalized medicine, the ability to turn functionality on and off on the fly are replacing traditional methods. IRT system capabilities need to support flexible supply strategies, and different versions of protocols. Protocol amendments, “never-ending studies”, and master protocols are critically dependent on configurable IRT. Paul Hughes admitted that “At least once a month I see something I’ve never seen before, and that requires flexible solutions.”
- Regulatory readiness continues as a major theme. The number of regulatory inspections appears to be on the rise, as is on-demand IRT data. Audit trail reporting needs to be human-readable and reflect sponsor requirements, instead of system capabilities. Overall, while not everyone has these capabilities, the industry is moving in a direction where it’s imperative to review data at ongoing intervals during a study, and actively look for data issues. Data reviewers need to know how to connect disparate data, identify risk and take immediate action. Manual data changes need clear context on the who, why, when. Most important, sponsors need to be able to explain their processes to regulators. This is an opportunity for vendors to ease regulatory preparedness with advanced, logical audit trail reporting, vs. the traditional data dump.
As an industry, We know we’re not going to solve challenges around operational efficiencies, data silos and integrations overnight, but we also know that complex study designs will only increase, as will the volume of data that flows through a trial. IRT functionality, system performance, domain expertise and creative solutions will have to keep pace. I look forward to reporting on industry progress here.