Looking over the horizon: 2018 and beyond

In the US we see an FDA that under Commissioner Scott Gottlieb appears to be genuinely invested in modernizing clinical trials and committed to encouraging innovative trial designs, like adaptive and seamless trials, and to streamlining the path to market for innovative products in areas like regenerative and digital medicine.

We anticipate greater acceptance by the agency of real-world evidence to supplement clinical trial data, initially for label extension and other post-market trials but eventually as a meaningful part of a new product application. We also see an expectation of much greater patient participation in the development process, from design through execution, and real efforts to increase inclusion of minority and other under-represented populations. Dr. Gottlieb has even spoken of the potential for conditional product approvals, which would represent a genuine departure from current policy.

In Europe, meanwhile, CROs and their biopharma partners are rapidly gearing up for the extensive new regulatory and contractual requirements, including changes to processes for ensuring consent, of the General Data Protection Regulation (GDPR) which is scheduled to take effect in May 2018, as well as the Clinical Trial Regulation that will be implemented in 2019.

Throw in the uncertain effects of the UK’s planned 2019 departure (Brexit) from the European Union, which could impact everything from the movement of clinical trial supplies and personnel to ethics committee reviews, and it is clear that clinical research in Europe will be anything but business as usual in the next few years.

If we see a Europe in some turmoil, it is notable that the regulatory environment in China for drug development has changed dramatically in the past two years, with study initiation approval for NCEs roughly halved, and more or less in alignment with US FDA standards.

Approval times for trials of biologics remain long, however, and the movement of biological samples and human genetic resources out of China requires a separate and fairly lengthy approval process. All in all, though, we expect China to be increasingly receptive to industry-sponsored clinical research in the coming years.

Something else that will be increasingly important in 2018 and beyond is collaboration – in non-competitive spaces – between and across biopharma companies and CROs. From collaborative clinical trials to the development of best practices for risk-based monitoring and the implementation of common protocol templates, the sharing of ideas and expertise aimed at improving trial efficiencies and decreasing non-productive burdens on investigators will be key to making real progress toward reducing the still too-long and too-expensive product development pathway.  

 Finally, in regard to the business environment for US-headquartered CROs and biopharmaceutical companies, the availability of greater capital as a result of the lowered corporate tax rate and opportunity to repatriate ex-US earnings proposed in current tax reform negotiations could well fuel further merger and acquisition activity.

In 2018 and beyond the regulatory and business environments will increasingly expect innovation in clinical research – innovation in trial design and execution, including the use of big data and predictive analytics to identify and recruit patients, to give just one example – and CROs, especially full-service, global CROs,  will be well-positioned to reap the rewards. There will be some bumps along the way, surely, but it is future that looks bright for the industry and for the patients whose lives we aim to improve.