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Improving the productivity of sponsors’ clinical development processes will continue to be a primary driver of outsourcing in 2018, writes Nuala Murphy.
Improving the productivity of sponsors’ clinical development processes will continue to be a primary driver of outsourcing in 2018 and beyond. Sponsors will persist in their drive for new ways to help them improve cycle times and reduce costs. We expect this will increase interest in specialist capabilities such as risk based monitoring, adaptive trial designs and flexible delivery models.
Sponsors will also be looking to leverage the investments that CROs have made in new capabilities that address key development challenges such as big data partnerships to improve site identification, patient recruitment, health economics and outcomes research.
We expect there will also be demand for services in the areas of orphan and rare disease drug development as sponsors look for specialist therapeutic knowledge and global site relationships to help them design smarter trials and recruit patients faster in these complex areas.
Sponsors need to increasingly generate outcomes data both as part of the product approval submission and as part of post-approval research programs. This requirement to be able to demonstrate the economic value of new treatments will present a growth opportunity for CROs who can offer support in developing and interpreting outcomes data. There will also be the expectation that CROs can keep up to date with evolving regulatory requirements and collaborate with organisations such as International Consortium for Health Outcomes Measurement (ICHOM), that are setting the standards in benchmarking and systems for data collation.
Improving patients’ lives will always be the priority in drug development. In clinical trials, this means everything from defining outcomes that make the most difference in patient’s lives, making trials more accessible to patients who are identified through EMRs in their physicians’ office, to minimizing control arms using advanced statistical methods and providing study results as soon as they are available.
Patient recruitment persists as the key driver of cost in clinical development and will remain a focus for the years to come. Industry sources estimate that it can account for over 30% of a trials budget, but it is still often the delay factor in studies. According to Tufts 11% of sites fail to recruit a single patient and over 37% underperform in recruitment target.
CROs will continue to look for new ways to approach this challenge, whether that is decreasing the burden on patients to make clinical trials a care option, putting site networks in place to make the process and outcomes more predictable, supporting sites more fully in the training and tools they need or the automated data collection and analytics of electronic medical records (EMR).
Innovation is playing an increasingly important role in helping to support more efficient drug development. Sponsors and CROs are engaging in discussions in how new approaches coupled with existing, tested technologies and sophisticated analytics can substantially reduce the risk and cost of clinical drug development. It will be important that CROs are able to streamline these solutions and reduce the number of systems involved to deliver a standardized environment on a unified, centralized platform.
CROs will continue to collaborate with sponsors in the deployment of cutting edge technology for example the emerging role of wearables and sensors in clinical trials, which sponsors can adopt to drive additional value in their development programs.
Adaptive design is no longer a new, unproven concept. However, each adaptive trial provides insight on how to best design and execute the next study. The lessons, and responses to them, will enable CROs to consistently and efficiently design and execute effective, complex adaptive clinical trials. The next step will be to create scientific machinery that further saves resources, optimises development, and enhances knowledge about the effects of drugs and devices.
ICON is partnering to lead this effort and is applying quantum computing to machine learning models to predict clinical trial outcomes. Such initiatives will redefine how sponsors use data and adaptive design to accelerate development opening the way to more widespread adoption. We estimate that optimal use of adaptive trials across a portfolio, which is encouraged by regulatory agencies in Europe and the US, could reduce trial costs, by 25 percent.
Nuala Murphy is President, Clinical Research Services, ICON Plc.