2013 Predictions for Clinical Development

1. Sponsors will be forced to modernize – What has always worked in the past will not necessarily work in the future (in fact, it most certainly will not). In the year ahead, proliferation and adoption of powerful technology to not only make processes more efficient, but also provide clarity into what’s actually happening across a sponsor’s portfolio of trials. It will enable sponsors to expect more from their CROs, and force all companies to modernize.  This hasn’t been possible in the past, but now that EDC systems are commonplace, along with the power of the cloud, will enable companies to really take advantage of their data in ways previously impossible.

I’ve talked to several sponsors who are dropping partner CROs that they’ve worked with for years, because the old-fashioned CROs are unwilling to do things differently. For example, the sponsors want access to interim data, and the CROs are unwilling to do it because “this is the way we’ve always done it”. The sponsors, in response, are simply finding new CROs to work with.

In 2013, CROs will learn to adapt to the new requirements of their sponsors, or they will be forced to go out of business (or at least, downsize).

2. Trials will (finally) become more dynamic – We’re already starting to see new processes that allow for better reactions throughout a trial, like risk-based monitoring, centralized analysis, adaptive trials, and more specifically-targeted treatment for patients – but this will take off in the year ahead. Companies are vigorously pursuing adaptive clinical trials, and this trend will continue.

The FDA is continuing to work with various sponsors to refine risk-based approaches to monitoring. This will continue to evolve. They’re also exploring new ways to run and structure adaptive clinical trials, and this trend will continue en force.

In 2013, companies will continue to push the boundaries of adaptive clinical trials and risk-based monitoring, and successfully begin using these techniques to run more efficiently, and cheaper, than traditional methods.

3. Sponsors will take on more risk in R&D – Sponsors need to start targeting blockbuster drugs that will cure diseases ailing millions of people. Over the past few years, we’ve seen large pharma shy away from this, due to regulatory or litigation fears. However, the technology support infrastructure is in place to allow them to confidently pursue more common indications.

In 2013, several large companies, who have been focusing primarily on orphan drugs, will announce that they’re pursuing research and/or starting trials on potential blockbuster drugs.

4. R&D technologies will integrate– The massive buildup in the number of eClinical systems will continue, as companies continue to add additional data collection systems into the mix and new vendors spring up. The industry would love to start consolidating, but this will never be possible. Instead, they will start relying on technology that connects these systems instead of creating new silos.

In 2013, several new mergers will result in completely incompatible data collection systems. Several companies will realize that their sizable investments in data warehouses were wasted. Several companies will start using new, modern technology (shameless plug: like Comprehend), that will help them integrate their systems.

5. Only the strong survive – Now more than ever, pharmas are facing increased pressures from generics, regulator bodies and lawsuits. The long term impact will be that companies that can adjust and create scalable and agile businesses will succeed, those that cannot will disappear. Sponsors that embrace risk-based monitoring and adaptive clinical trials will be able to drastically cut costs, those that don’t will go out of business. CROs that embrace opening data and analytics to their customers will get new business, those that have done “what they’ve always done” will disappear.

In 2013, there will continue to be large cutbacks at companies that aren’t modernizing.