Of the many factors involved in choosing a clinical trials provider, start-up times are pushing the top of the list. Clinical trials are complicated and highly regulated and these factors alone contribute to lengthy clinical trial commencement times. Like all complex processes, attention to other details can keep delays in start up to a minimum.
‘Australia has a reputation for rapid ethics and governance approval thanks to the convenience and speed of the CTN scheme and competitive HREC turnaround times,’ says Dr Tina Soulis, General Manager of Neuroscience Trials Australia. ‘This is particularly true for private sites and high volume sites such as oncology,’ says Soulis, ‘but maintaining our reputation and extending it to other specialties can be achieved by following a few simple procedures.’
Communication and participant buy-in is key. ‘We routinely produce feasibility reports on site availability, potential recruitment and local treatment standards,’ says Soulis. ‘We also make sure the site trials team is aware of the study and how it will impact on their other study commitments, that the designated PI and study coordinator are confidant of trials success, and that any regulatory or legislative changes won’t derail the project,’ she says.
‘Traceability and study responsibilities are also important. Each study has a primary point of contact, the designated project manager, who ensures milestones are reached and timelines met. This responsibility begins before the trial starts and includes rigorous document control so that key documents – protocol, investigator’s brochure, research agreement – are appropriately identified, circulated in a traceable manner and correctly authorised before start up,’ she says.
‘Finally, and perhaps most importantly,’ Soulis says, ‘we regard competence as key to minimising trial start up times. While a feasibility study might predict trial success, we make certain our individual team members have the competencies and support necessary to guarantee a successful outcome. All our clinical staff are GCP certified and we have a structured mentoring program for less experienced staff members, particularly new research coordinators and first time PIs.’