The Association of Clinical Research Organizations (ACRO) and its members advocate on a global basis for safe, ethical, high-quality medical research so patients can benefit from the development of new treatments and therapies. Its members are dedicated to helping their clients bring efficiency, innovation and value to the clinical research process.
John J. Lewis, senior vice president, policy and public affairs at ACRO discusses outsourcing trends, opportunities and challenges, and global markets, as well as what we can expect from CROs in the future.
Contract Pharma: What pharma/biopharma trends are you seeing and how are they impacting CROs and services?
John Lewis: The science is advancing very quickly, especially in areas like immuno-oncology and genetics research. This is very exciting for researchers but also presents challenges to rethink the way clinical trials are being done in some areas. Outside of the science, some of the emerging trends are new trial designs like collaborative trials, more emphasis on real world evidence, including data from EHRs and patient registries, and the incorporation of new technologies into clinical trials, from the use of social media to wearables. These trends impact biopharma and CRO services, and pose new challenges for the FDA and other regulators.
CP: Where do you think the biggest opportunities lie?
JL: We have some new research coming out shortly on the use of new technologies in clinical research. Those areas where we see the most benefit and the highest adoption include: risk-based monitoring, eConsent, wearables, use of social media for patient recruitment, and near real-time trial data analytics. In some of these areas, additional regulatory guidance would be welcome.
CP: What efforts are being made to streamline drug development within sponsor/CRO partnership models?
JL: Many of the efforts to streamline development are being done within specific Sponsor/CRO partnerships where there is a great deal of experimentation going on that is not necessarily in the public view yet. At a higher level, ACRO launched the CRO Forum last year to provide a CRO perspective on various TransCelerate projects. This relationship continues to evolve and we are making good progress in some areas of common interest, like risk-based monitoring, site qualification and training and, coming up, eConsent.
CP: What are some of the challenges CROs face in today market?
JL: The biggest challenge is always patient recruitment. We must have willing and appropriately consented patients for clinical trials. We also must have well-trained and enthusiastic investigators. We are seeing a lot of progress being made in the area of patient engagement leading to more patient-focused drug development. The patients are being involved from the early stages of research, like protocol design, all the way through the risk/benefit analysis for approval. Social media is enabling more direct-to-patient interaction and engagement. And, we are certainly seeing the CRO industry collectively and individual CROs working more collaboratively with research sites and investigators.
CP: What will CROs need to do to prepare for the future of regulatory over-site and transparency?
JL: On the regulatory front, the biggest issues for our members are consistency and predictability. We need to be confident that the regulatory pronouncements from the senior people in regulatory agencies penetrate down to all levels so there is predictability. The science and the clinical trial designs and technologies are advancing so quickly that it is difficult for the regulators to keep up. To the extent to which sponsors and CROs are concerned about regulatory uncertainty in regard to new technologies and trial methodologies, innovation will be slowed. This is a major challenge.
CP: With respect to global trials, are you seeing a return to established markets?
JL: The U.S. and Europe continue to be the leading markets but we are beginning to see much more activity in the Asia-Pacific region and, to a lesser extent, Latin America.
CP: Are CROs/sponsors pulling out of some countries? What’s working domestically/ globally and what’s not?
JL: We are finally getting some positive signs that the regulatory and political situation in India has stabilized after several years of uncertainty and a near complete cessation of clinical trials in the country. India represents the biggest single opportunity if we can get some confidence restored to that market.
CP: What do you anticipate for the CRO model of the future? What expertise will be needed?
JL: We think the ACRO members, the larger global CROs, have a model that is working and will continue to work. We are seeing partnerships emerge between CROs and entities like IBM Watson, Google, Apple, Patients Like Me, 23andMe and other disrupters and technology providers. But as we know, as in other industries, technology by itself cannot solve problems without context and expertise. No one has more expertise in running clinical trials than our members.