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While the biopharmaceutical industry faces challenges in regulation, standardization, and change, CROs are often in the middle of the change.
While the biopharmaceutical industry faces challenges in regulation, standardization and change, CROs are often in the middle of the change. ACRO provides the voice for the industry to address these challenges. While at the 2014 Partnerships in Clinical Trials Conference, I had the opportunity to interview John Lewis from The Association of Clinical Research Organizations (ACRO), who spoke about the challenges facing the CRO industry.
Moe Alsumidaie:Can you elaborate on data transparency initiatives with CROs? Are they allowed to share data, considering legislation that is forcing biopharmaceutical enterprises to make their data publicly available?
John Lewis: While CROs have access to a lot of clinical trial data, they are not the owners of this data, and cannot participate in such initiatives. As such, CROs are mostly focused on the operational impact of such transparency initiatives, like ensuring informed consent forms are appropriate and that patient privacy is protected. While greater transparency may be a worthy goal, this is not as easy to achieve, operationally, as some would have you believe.
MA: Will the clinical trial approval system standardize across the EU?
JL: In collaboration with The European Federation of Pharmaceutical Industries and Associations (EFPIA) we support this proposed regulation by the EU authorities to standardize the clinical trial approval process, so that an approval within the EU will be applicable across all EU nations. This universal approval would help maintain Europe’s competitive position for clinical research. We are also advocating for shorter approval timelines and for privacy policies that encourage research while protecting patient information.
MA: How involved is ACRO with Transcelerate Biopharma?
JL: ACRO continues to engage with Transcelerate to find areas of cooperation to improve the drug development process. We are trying to find synergies to solve issues facing the biopharmaceutical industry, such as Risk-Based Monitoring, and improving the relationships among Sponsors, CROs and study sites. ACRO members are actively engaged with Transcelerate members in a number of projects looking at innovative approaches to the development process.
MA:Can you elaborate on global legislative priorities on tax reform? How is this affecting the CRO industry?
JL: As the US Congress begins to entertain tax reform, ACRO is focusing on changes to the Research & Development tax credit that would help CROs and level the playing field between the US and other countries. Currently, if a sponsor outsources its R&D, it may only claim 65% of the eligible R&D expenses for the tax credit, rather than 100% if it does the work in house. The other 35% simply disappears. In other countries, like France, the UK, Canada and others, CROs are eligible for the R&D credit because we are the ones employing the researchers and actually conducting the research. While the US will remain a hub of clinical research, and there are many reasons to conduct research globally, we believe this small change would help keep the US competitive and encourage high-paying research jobs in the states.
MA: Aren’t there too many non-profit organizations focusing on solving the same problems?
JL: There are dozens of initiatives focused on improving elements of the drug development process, many of them with overlapping agendas. From an association perspective, there is a limit to how many we can support and be involved in. We first ask, “What problem are you trying to solve?” What is the business case for your project?” We do not need initiatives that, while well-intentioned, would add increased complexity and barriers to research. Site accreditation, for instance, could be an example. Our focus is on projects that can be executed quickly and that have an immediate impact on improving the efficiency of the clinical research process. ACRO is very supportive, for instance, of common data standards and are looking at a core set of metrics for evaluating research sites. Our members also believe that a competitive market ultimately drives innovation.