A recent report carried out by the Avoca Group explored both sponsor and provider views on innovation in outsourced clinical development. This article will examine the results of the survey and the outlook from the industry on innovating clinical trial processes. The aim of the study was to understand how innovation is being utilized, from both the sponsor and vendor perspective, and the extent to which it is helping enhance R&D efficiency and effectiveness.
How do sponsors & vendors shape up?
From an internal perspective, it was clear that providers are more advanced in taking innovative approaches, with nearly three-quarters of providers considering themselves to be above average in innovation, whereas only 40% of sponsor companies felt they were pushing forward in this space.
The results from the survey clearly show that providers perceive themselves to be more committed to pursuing modernization than sponsors along various dimensions. Providers believe they are more likely to recognize and adopt innovative approaches that are shown to be successful as well as being more willing to try and fail in the pursuit of novel approaches to clinical development. Accordingly, providers are more willing to invest appropriate amounts of money and resource into developing new pioneering strategies. Sponsors on the other hand seem to have a much more lacklustre approach to innovation, especially when it comes to investing in this area.
It is also interesting to note the perceived role of partnerships in the development of these kind of approaches. According to the survey, 89% of providers believe they have introduced innovative strategies to their sponsor partners, whereas only 43% of sponsors believe their CRO has introduced this to their trial. This begs the questions: why this disparity in perception between sponsors and vendors? There is clearly a lack in communication between vendors and sponsors on this matter; either CROs are providing these revolutionary approaches and they are being ignored by the sponsor (perhaps due to cost fears), CROs are providing ideas but the sponsor does not deem them ‘innovative’ or sponsors are unaware of the CRO’s proposed strategies.
Where is innovation coming from?
While respondents specifically named the largest companies most frequently as contributors to innovation, when asked to evaluate the innovative abilities of various types of organizations, small/virtual companies (both within sponsor and provider categories) received higher average ratings than large organizations. Smaller companies are seen to have a more innovative culture with a higher aptitude for risk and are able to avoid the time consuming bureaucratic approach found in larger companies, these agile start-up companies are also somewhat required to take more risks to succeed with smaller pipelines.
When it comes to funding innovation, three-quarters of participating sponsors reported that costs are embedded within study budgets, while providers are more likely to have a centralized budget and in terms of measuring ROI associated with innovation relatively few sponsors indicated that they have metrics in place, while nearly half of providers reported having these metrics.
Why are companies innovating?
Within the survey, both sponsors and providers confirmed that various goals are important in their pursuit of innovative approaches to clinical development. Most importantly, companies are trying to take a revolutionary approach to reducing timelines and cost. In general, providers view themselves as more successful in achieving these goals than sponsors.
What barriers are companies facing?
Across sponsors and providers alike, the main challenge is to change company mindset. Higher management have a preference to stay with current measures instead of taking risks on novel approaches to clinical development. Things without a proven success rate are hard to get implemented, and employees need to be able to show the potential ROI of new strategies. It is not only the higher management that needs to be persuaded to take these chances; providers have also expressed frustration with obtaining sponsor ‘buy-in’ for novel projects. Issues stemming from poor relationships between sponsor and provider can have a massive impact on innovation. This is backed up by survey results showing that deeper ‘partnership/alliance’ relationships are seen have the most positive impact on innovation from both sides of the relationship.
In terms of regulatory barriers, the US FDA and EMA are perceived as having a positive impact on the use/adoption of innovative approaches, whereas the regulatory authorities in Japan and China are viewed as having a negative impact. This positive impact from the FDA will be in part due the formation of the Clinical Trial Transformation Task Force within the FDA. This task force has allowed for more flexibility within regulatory frameworks to allow sponsors and vendors to be more proactive towards innovative approaches.
What does the future hold?
With new clinical innovation teams being developed in mid-sized to big biopharma companies on a global scale, it is clear that the trend of innovation will only continue. Three-quarters of survey participants agreed that organizations involved in the biopharma industry will create and adopt innovative approaches that will significantly improve the way clinical development is conducted over the next five years. Opinion is certainly divided on how this will take place and there is plenty of commentary on different options that both sponsors and provider will take.
More information on the report can be found on the Avoca Group website following the link below: http://www2.theavocagroup.com/2015-avoca-report