Kristin Brooks, Contract Pharma06.02.15
The CRO industry plays an ever increasing role in the development of new medicines globally and legislative and regulatory policy can have a tremendous impact on clinical research. ACRO, the Association of Clinical Research Organizations, and its members advocate on a global basis for safe, ethical, high-quality medical research and engages with national and global agencies on important issues affecting drug development. The legislative, business and regulatory environment for clinical research play an imperative role in promoting the development of new medicines.
According to ACRO, about half of clinical trials take place in the U.S.—more than any other nation in the world. ACRO’s legislative agenda in the U.S. is focused on promoting policies that foster innovation in the drug development process and ensure that the U.S. remains a competitive venue for clinical trials—in addition to advocating for a better-funded, scientifically-advanced FDA. Its current legislative priorities include: lobbying to advance tax policies that recognize the critical role CROs play in research & development and ensure that the U.S. remain globally competitive; and working to integrate research applications into electronic health records (EHRs) to facilitate outcomes research and patient recruitment for clinical trials.
With nearly 30% of all clinical trials taking place in EU, it is critical to ensure regulatory structures and research quality standards are in place to support the advancement of clinical research in Europe as well. Today, ACRO is working to support the European Medicines Agency in its efforts to advance Good Clinical Practice (GCP) compliance and enhance international inspection efforts, and responding to public consultations impacting the CRO industry. This includes supporting and responding to the European Commission in its development of legislation, and working with European officials to strengthen and refine the Clinical Trials Directive in Europe, as well as to promote appropriate privacy and data protection regimes to facilitate research.
Globally, the issues can be a bit more complex. For example in India and China, where, despite exponential market growth, complications around regulatory issues can bring R&D to a grinding halt.
In and interview, John Lewis, senior vice president, Policy & Public Affairs at ACRO, reveals CRO industry trends in drug development and Sponsor/CRO relationships, as well as provides insights into the organizations current regulatory and legislative priorities on a global basis. –KB
Contract Pharma: What are some of the latest drug development trends and how are they impacting CROs?
John Lewis: We are continuing to see large pharma divesting parts of their of their R&D infrastructure, which bodes well for outsourcing in general. So CROs are seeing annual growth in the range of approximately 10% in terms of revenues and employment. This also presents an opportunity for CROs to hire very skilled clinical researchers who have worked in the pharma industry. This was unheard of a few years ago. Now, according to the Tufts Center for the Study of Drug Development, our members have more clinical research staff than the pharma industry. So we have seen a real shift not only in terms of numbers but also in expertise and innovation.
CP: What efforts are being made to streamline drug development within Sponsor/CRO partnership models?
JL: There are many examples within these partnerships, most of which, of course, are not public. In a broader sense, ACRO has launched a CRO Forum – open to all CROs – for the specific purpose of providing CRO input into the work of TransCelerate Biopharma Inc. We are currently providing input into four TransCelerate workstreams: risk-based monitoring, where our members have been the leaders in innovation; site qualification and training, quality management system; and development of a common protocol template. We expect to be involved in additional workstreams as they gain momentum within TransCelerate and our input becomes necessary.
CP: In what geographic markets do you see the most growth and investment?
JL: Most recently, Asia-Pacific, the Middle East and Africa. But our members do clinical trial in 142 countries so there is room for growth everywhere.
CP: With respect to establishing global standards (i.e. site accreditation and standards for sustainability and best practices), what progress is being made?
JL: As mentioned, we are working with TransCelerate on the site training and qualification project to make sure that sites are adequately trained to protect patients and to provide high-quality data. We are also working with the Society for Clinical Research Sites on a variety of projects to improve the interaction, communication and efficiency between CROs and sites. We expect to work with both SCRS and TransCelerate on a project to develop a standard site contract.
CP: What are ACRO’s current regulatory and legislative priorities, globally?
JL: In India, the regulatory system has been in disarray for a couple of years, which has brought clinical trial activity to a virtual stop. Therefore, our top priority in India is predictability and certainty. We are seeing some signs of improvement.
In China, we are seeing some progress on the time needed to get a new clinical trial approved.
In EU, we are focusing on the implementation of the Clinical Trial Regulation and also attempting to address some issues around data protection and privacy. Beyond the EMA, we are focused on building relationships with several key national authorities – UK, Germany, France, Spain, Sweden and Italy. We are also working very closely in Europe with colleague associations like EFPIA, IPPC and Europa Bio.
And in the U.S., in addition to our FDA agenda, we are working very closely with Congress on the 21st Century Cures initiative. We are especially interested in the provisions around enhancing data sharing, speeding up IRB reviews and improving clinicaltrials.gov, but several other parts of the legislation as well. We are also working to make CROs eligible for the R&D tax credit in the U.S. as they are in many other countries. This would drive U.S. innovation and employment in the research sector. Additionally, we are always looking at ways to incentivize greater clinical trial participation by patients and investigators.
Kristin Brooks has been Associate Editor at Contract Pharma since 2004.
According to ACRO, about half of clinical trials take place in the U.S.—more than any other nation in the world. ACRO’s legislative agenda in the U.S. is focused on promoting policies that foster innovation in the drug development process and ensure that the U.S. remains a competitive venue for clinical trials—in addition to advocating for a better-funded, scientifically-advanced FDA. Its current legislative priorities include: lobbying to advance tax policies that recognize the critical role CROs play in research & development and ensure that the U.S. remain globally competitive; and working to integrate research applications into electronic health records (EHRs) to facilitate outcomes research and patient recruitment for clinical trials.
With nearly 30% of all clinical trials taking place in EU, it is critical to ensure regulatory structures and research quality standards are in place to support the advancement of clinical research in Europe as well. Today, ACRO is working to support the European Medicines Agency in its efforts to advance Good Clinical Practice (GCP) compliance and enhance international inspection efforts, and responding to public consultations impacting the CRO industry. This includes supporting and responding to the European Commission in its development of legislation, and working with European officials to strengthen and refine the Clinical Trials Directive in Europe, as well as to promote appropriate privacy and data protection regimes to facilitate research.
Globally, the issues can be a bit more complex. For example in India and China, where, despite exponential market growth, complications around regulatory issues can bring R&D to a grinding halt.
In and interview, John Lewis, senior vice president, Policy & Public Affairs at ACRO, reveals CRO industry trends in drug development and Sponsor/CRO relationships, as well as provides insights into the organizations current regulatory and legislative priorities on a global basis. –KB
Contract Pharma: What are some of the latest drug development trends and how are they impacting CROs?
John Lewis: We are continuing to see large pharma divesting parts of their of their R&D infrastructure, which bodes well for outsourcing in general. So CROs are seeing annual growth in the range of approximately 10% in terms of revenues and employment. This also presents an opportunity for CROs to hire very skilled clinical researchers who have worked in the pharma industry. This was unheard of a few years ago. Now, according to the Tufts Center for the Study of Drug Development, our members have more clinical research staff than the pharma industry. So we have seen a real shift not only in terms of numbers but also in expertise and innovation.
CP: What efforts are being made to streamline drug development within Sponsor/CRO partnership models?
JL: There are many examples within these partnerships, most of which, of course, are not public. In a broader sense, ACRO has launched a CRO Forum – open to all CROs – for the specific purpose of providing CRO input into the work of TransCelerate Biopharma Inc. We are currently providing input into four TransCelerate workstreams: risk-based monitoring, where our members have been the leaders in innovation; site qualification and training, quality management system; and development of a common protocol template. We expect to be involved in additional workstreams as they gain momentum within TransCelerate and our input becomes necessary.
CP: In what geographic markets do you see the most growth and investment?
JL: Most recently, Asia-Pacific, the Middle East and Africa. But our members do clinical trial in 142 countries so there is room for growth everywhere.
CP: With respect to establishing global standards (i.e. site accreditation and standards for sustainability and best practices), what progress is being made?
JL: As mentioned, we are working with TransCelerate on the site training and qualification project to make sure that sites are adequately trained to protect patients and to provide high-quality data. We are also working with the Society for Clinical Research Sites on a variety of projects to improve the interaction, communication and efficiency between CROs and sites. We expect to work with both SCRS and TransCelerate on a project to develop a standard site contract.
CP: What are ACRO’s current regulatory and legislative priorities, globally?
JL: In India, the regulatory system has been in disarray for a couple of years, which has brought clinical trial activity to a virtual stop. Therefore, our top priority in India is predictability and certainty. We are seeing some signs of improvement.
In China, we are seeing some progress on the time needed to get a new clinical trial approved.
In EU, we are focusing on the implementation of the Clinical Trial Regulation and also attempting to address some issues around data protection and privacy. Beyond the EMA, we are focused on building relationships with several key national authorities – UK, Germany, France, Spain, Sweden and Italy. We are also working very closely in Europe with colleague associations like EFPIA, IPPC and Europa Bio.
And in the U.S., in addition to our FDA agenda, we are working very closely with Congress on the 21st Century Cures initiative. We are especially interested in the provisions around enhancing data sharing, speeding up IRB reviews and improving clinicaltrials.gov, but several other parts of the legislation as well. We are also working to make CROs eligible for the R&D tax credit in the U.S. as they are in many other countries. This would drive U.S. innovation and employment in the research sector. Additionally, we are always looking at ways to incentivize greater clinical trial participation by patients and investigators.
Kristin Brooks has been Associate Editor at Contract Pharma since 2004.
