The importance of recruiting competent clinical trial investigators is not only judged on quality of experimental results but also results achieved under time constraints. Indeed, pharmaceutical companies have estimated that it costs $35 million (€29 million) for every day that the product is not on the market.
The process of identifying clinical investigators varies with companies relying heavily on database searches and epidemiological data. Other companies turn to their Clinical Research Associates (CRAs), sales force or marketing departments for investigator leads.
Analysts identified several areas, which distinguished high-performing clinical operations units and in which pharmaceutical companies and contract research organisations (CROs) could substantially gain.
By aligning structures and communication systems that ensure accountability internally and impact externally with investigators, companies could align incentives and responsibilities to ensure employees were directly accountable for successful investigator recruitment. The report identified companies would then empower those employees to make the decisions necessary to deliver on investigator recruitment goals.
However, successful companies also understood the need to balance clinical operations requirements for investigators against those of other internal stakeholders.
The report also identified the need for successful companies not to be tied to any one trial during the process of recruiting investigators to participate in clinical trials. It must be an ongoing aspect of clinical operations.
Data revealed that the majority of companies surveyed (80 per cent) began the process of identifying and recruiting investigators at least four months before the start of any clinical trial.
Furthermore, as companies planned for specific trials, they created recruitment strategies, set goals and fully leverage internal resources to speed up the process
The report also commented that process approaches would need to be standardised to ensure quality and impact of work with CROs, partners and investigators.
Veteran clinical operations executives identify common productivity frontiers, developing defined work activities across clinical projects, studies, teams and therapeutic areas. However, clinical trials tend to be organised as large but discrete projects characterised by low-volume activities that are not repeated frequently.
Consequently, such work processes are not articulated for high impact or high productivity. Yet, study sponsors continue to carry out these activities across scores of projects and programs. Unfortunately they often fail to benefit from process-oriented continuous improvement and standards of excellence across projects
The study revealed that most pharmaceutical companies consult a broad spectrum of internal groups when identifying investigators revealing that 24 per cent of pharmaceutical companies involved marketing in clinical investigator identification.
In addition, 29 per cent used medical affairs during the recruitment process and 14 per cent of pharmaceutical companies used medical liaisons.
Interestingly, there was near unanimous agreement that soft skills were as highly valued as the technical skills. 61 per cent of pharmaceutical companies and CROs specifically identified communication and interpersonal relationship building as some of the most in-demand soft skills that need to be identified in the recruiting process
The report, entitled: "Clinical Trial Excellence: The Science and Art of Winning Investigators in a Competitive Marketplace," is available from pharmaceutical research firm Best Practices, LLC.