The Trends and Challenges of Clinical Outsourcing
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With over 20 years’ experience in the industry, Professor Kenneth Getz, Director of Sponsored Programs and associate professor at the Tufts Center for the Study of Drug Development, is internationally known for his expertise on clinical trial management and outsourcing. Recently he spoke to Partnerships in Clinical Trials Europe about the trends and challenges in clinical research today.
AB: What do you see as the biggest trends in drug development and clinical research today?
KG: ‘There are a number of key trends that are redefining the drug development landscape. The first is the ongoing movement towards precision medicine and the targeting of patient sub-populations. The other area is patient centricity, where the clinical research enterprise has expressed a very keen interest in engaging patients as well as healthcare provider and payer communities as partners in the clinical research process.
Additionally, there are a number of challenges that have been around for a very, very long time and continue to plague the industry. There is the ongoing trend towards rising drug development costs, declining success rate of our programmes in development, and the difficulties we've had in accelerating drug development timelines.’
AB: Why are these challenges getting more difficult?
KG: ‘Our research during the past 15 years has shown that protocol design complexity is one of the fundamental causes. The complexity of our designs is increasing and complexity leads to longer cycle times, difficulty recruiting and retaining study volunteers, and increased numbers of unplanned, unbudgeted and highly disruptive protocol amendments.
Protocol complexity will likely continue to increase given growing pressures to more fully demonstrate the safety, efficacy, economic value and comparative effectiveness of new drug candidates and as we target smaller patient sub-populations. Protocol complexity is a reality of today’s drug development operating environment. What we can do, however, is manage complexity more prudently and effectively.’
AB: How are these trends impacting the outsourcing strategy of pharma companies?
KG: ‘Over more than three decades, CROs have become an increasingly integral partner in drug development. And yet, despite the CROs' high level of involvement and engagement in the research process and the sponsor companies' heavy reliance on CROs, we continue to see long cycle times, high and rising costs and low success rates. We have not seen improvements in drug development performance.
This begs the question: what about the sponsor-CRO relationship is not leveraging the value and impact of the CROs?’
AB: Why are there still such big challenges with sponsor-CRO partnerships?
KG: ‘Generally speaking, sponsor companies have really under-invested in some of the most critical aspects of their relationships with CROs. CROs are not typically involved in the up-front planning or in protocol design. They typically don't have a voice in this process and as a result they are often asked to execute on a protocol that is less feasible and more challenging. The CRO's own performance is then held to this specific protocol despite having very limited or no input into the design of the research effort.
For a variety of reasons, some of them cultural, sponsors have always mixed and matched different CRO strategies simultaneously and they're not very consistent in the strategies that they utilise. As a result, sponsors are typically not leveraging a single CRO model and they're not giving their CRO partners a chance to thrive because it tends to be a fragmented and poorly integrated relationship.’
AB: What strategies can CROs use to stand-out?
KG: We see the patient centricity movement as a critical opportunity for CROs to establish a competitive advantage and some are already doing so. They are looking at ways to improve their relationship by leveraging their ability to engage patients and the patient support community more effectively.
Some CROs have purchased investigative sites so that they can influence that part of the process and provide even greater support to the site, thereby ensuring that the patient has a better experience.
Others are trying to get closer to real-world data and big data in order to better inform the identification of study volunteers and investigative site partners to improve recruitment and retention of volunteers.
Additionally, a lot of technologies, like wearable devices, social media and internet based approaches - electronic informed consent for example, are being tested and applied to clinical research. In some cases the CRO is better positioned to experiment and pilot these initiatives on behalf of their sponsors. That gives the CRO greater leverage and the good news is that since both the sponsor and CRO are looking to build higher levels of patient engagement, there is momentum and the ability to create more of a shared set of objectives from which the sponsor and CRO can work more collaboratively.’
Professor Getz is speaking on the major trends in the drug development and CRO landscape at Partnerships in Clinical Trials Europe in Vienna. Join over 1000 clinical trial professionals from 450+ companies at the conference on the 16-17 November 2016 - find out more here.