UK clinical research implications for stakeholder groups

Prof Jacky Swan returned to the survey data that opened the conference, to discuss some of the implications for different stakeholder groups.

Looking at knowledge and skills, the survey highlighted a shortage of experienced trials managers and monitors and these personnel prove difficult to recruit and retain. However, these are the people who know how to make the systems work in practice. Smaller commercial and non-commercial organisations also lack resources to employ and train specialists in non-science areas such as legal/regulatory, project management, business and finance. Different types of organisation face different skills gaps, and geography and an organisation’s status also play a significant role in attracting staff. The ABPI have described this skills gap as a “tipping point”.

Jacky then presented a chart of perceived impediments in setting up clinical trials. This showed that cost, time and R&D approval were considered major impediments, above contract negotiation and patient recruitment. However, the non-commercial sector viewed funding and team expertise more severely than other stakeholders, while biotechs/device companies saw engaging clinical sites and recruiting patients as more important than their pharma and academic colleagues.

As retaining an experienced team is seen as vital to project success, Jacky looked at the motivations and incentives for individuals. While many diverse motivations exist, the lack of a formal career path was highlighted by research nurses.

Different stakeholders have differing perceptions regarding studies, and these play out in differing strategic imperatives. These include the profit imperative for commercial organisations and affordability of medicines from a wider health service perspective. Similarly, expertise and prestige are increasingly needed to justify funding in the non-commecial and academic sectors. Some research models are more likely to get funding (eg, rare conditions), but these are often more difficult to manage.

Concluding with a look at research governance, Jacky discussed the mixed effect of the EU Directive. This brings a higher level of bureaucracy and cost, but this is more standardised and clearer to adhere to. Government has made much of “bureaucracy busting”, and many have high expectations, but so far this has had mixed impact, so Jacky warned of a potential backlash if these expectations are not met. Earlier in the day, we had discussed the öne size fits all” model for regulatory, ethics and R&D approvals, but Jacky commented that this presents greater challenges for non-standard or innovative trials.

Jacky closed with discussion of the suggested 2010 review of the EU Clinical Trials Directive and concerns expressed by many that this could lead to increased uncertainty and possible even tighter, more counterproductive controls.