Presentations covered everything from protocol design and improving access to patients via traditional ads and social media tools to the pros and cons of various recruiter payment models, but time and again the need for more openness and clarity were the central themes.
CRO and PRO attendees called for pharmaceutical sponsors to provide more detailed information on their study recruitment goals during the contracting process to allow for the development of appropriate recruitment strategies.
In response sponsors, which included representative from Shire, H Lundbeck, Otsuka, Millennium, Johnson & Johnson, Roche, said service providers and trial sites need to be more open and realistic about the number of patients they can reach.
Rikke Winther, divisional director, outsourcing management at H. Lundbeck, was one speaker who made this point, explaining that when sponsors and CROs are transparent with and share knowledge and patient recruitment is more effective, but implementing this idea is challenging.
“The fact is we're not one company”, Winther said, adding that sponsors and CROs have different goals but by engaging vendors and discussing the clinical trial better results can be achieved.
Joe Kim, director of clinical operations at Shire and pioneer of evidence-based protocol development, also stressed the benefits of better Pharma-CRO communication.
In addition to advocating the use of evidence, Kim said drug companies and contractors need to collaborate at the earliest possible stage to create protocols that are more attractive to patients, citing increasing complexity as a having a real impact on participation rates.
The debate continued during a discussion led by Robert Loll, VP of business development and strategic planning at Praxis. Delegates examined ways of balancing the needs of all stakeholders in patient recruitment and concluded that transparency and information exchange was key.
Patient communication
Speakers and delegates also agreed that improving communication with patients – from making them aware a trial is taking place to providing support throughout the trial process – can have an impact on recruitment rates.
John Needham from Patient Recruitment Strategy focused on patient attitudes to clinical research during his presentation, stressing that planning and research is key to successful recruitment strategies and cautioning against making assumptions about patients.
He also said that assessing the viability of recruitment and enrolment strategies is critical and went on to advocate a ‘patient-centric’ approach.
GlobalCare Clinical Trials CEO Gail Adinamis explored a similar theme in a presentation that examined the benefits of innovations in protocol development.
She cited Pfizer’s recently initiated REMOTE study – see the Outsourcing-pharma.com video from DIA – as well as her own firm’s centrally-managed ambulant care service model as some of the most interesting innovations in the field.