Clinical trials today would be all but unrecognizable to yesterday’s researchers. With evolution in trial design, technology, regulation, and other areas, the industry is seeing a lot more complexity than it did just a few years ago. And out of these changes has risen a trend with major implications for organizations across clinical research: clinical trial outsourcing and the rise of the Contract Research Organization or CRO.
For anyone looking at the data, it’s pretty clear that CROs have reason to be in high spirits – and optimistic about the future. From 2013 to 2017, the CRO industry saw its share of the total clinical trials market grow from 37% to 45%1 as more and more sponsors turned to clinical trial outsourcing. Looking ahead, things look even brighter for CROs, with experts predicting that half of all clinical trials will be conducted by CROs by 2020. With demand from sponsors high and rising, the CRO industry is of course evolving as well, with specialized organizations carving out niches within the growing market.
The driving forces of clinical trial outsourcing
So what’s behind the trend toward clinical trial outsourcing? Why are sponsors increasingly scaling down their in-house clinical trial operations in favor of CROs? The answer is multifaceted, but ultimately comes down to the expertise that CROs have in several key areas – and that position them to successfully navigate today’s complicated and fast-moving clinical trial landscape.
- Globalization – Like many other industries, clinical research is globalizing, with more and more trials spanning international – and even continental – borders. It can be difficult for sponsor organizations, especially smaller ones, to manage challenging tasks like patient recruitment and site management in multiple widely dispersed locations. CROs, however, are increasingly likely to possess the experience and resources to handle these tasks.
- Going digital – Technology is flooding clinical research. EDC has become standard, and eSource eClinical advancements like direct data capture and eConsent software are heading the same way. mHealth and wearables are gaining traction – as well as attention from regulators. But as exciting as this is, it has also complicated matters like data security, compliance, and finding personnel with technology-oriented skill sets – all issues that CROs are well-equipped to handle.
- Personalized medicine – With personalized medicine and development of orphan drugs on the rise – a record number of personalized medicines were approved by the FDA in 2017 – clinical trial designs and regulatory requirements are becoming more complex. Many sponsors are finding it wiser to let CROs take the lead on these matters so that they can direct their focus toward drug development.
What eClinical success looks like for CROs
With increased clinical trial outsourcing, it’s boom time for CROs. But the trend could also create more competition as more CROs enter the market to meet the heightened demand. What’s the right eClinical technology approach for organizations looking to successfully navigate this landscape?
There’s more sponsor business to be had than ever before, and success for CROs means claiming as much of that business as they can. That means, in part, implementing eClinical resources focused on facilitating this goal. EDC platforms that require extensive training and implementation will be of little use to organizations looking to get up and running and conducting trials quickly. The same goes for solutions that require extensive back-and-forth with programming vendors, occupying valuable time that organizations could otherwise spend expanding their portfolio. But the right platform – one that streamlines processes without adding unnecessary steps – can enable CROs to stand out from the competition at this exciting time. That’s why, as clinical trial outsourcing continues to rise, eClinical vendor selection becomes more important than ever.
1 CRO Industry Primer, Credit Suisse Securities Research & Analytics, 20 June 2016