Did you know that less than 10% of clinical studies are completed on time? In fact, 94% of trials are delayed by over one month. Although this doesn’t sound like a significant delay, it has been estimated that for each day a clinical trial is delayed, it costs a trial sponsor between $600,000 and $8 million, per day.
The top reason for clinical trial delays is poor patient recruitment and retention. Up to 20% of Principal Investigators (PIs) fail to enrol a single subject and over 30% under-enrol in any given trial.
Planning is therefore essential and the following need to be considered carefully before starting a clinical trial:
It is vital to define the correct primary endpoints within clinical trials and to simplify their designs as much as possible. Protocol designs also need to marry clinical research requirements with ‘real-world’ clinical practice.
Disease related differences such as incidence, genetic and phenotypic variations, along with cultural differences also need consideration. Types of medical care will also be different between regions, thus making region selection important.
Feasibility needs to be undertaken for all studies. Is study disease epidemiology data available at the targeted clinical trial sites? Why would sites be motivated to enrol? What are the study barriers (travel / multiple clinic visits / etc)?
Before the final selection of trial sites, it also needs to be determined if they have done similar trials before. How is their recruitment history? Are facilities adequate and do they have the available resources? Do inter-disciplinary relationships between departments exist to aid subject referrals?
Site Specific Strategies
Tools should be created to help identify, approach, enrol and retain trial subjects. Problems need to be anticipated and quick action taken when recruitment falls behind schedule to pinpoint the problem.
Getting the first two R’s – ‘Recruitment’ and ‘Retention’ – right, will go a long way to providing the third R – that being the ‘Reward’ of on-time clinical trial completion.
Our team of consultants are available to support effective planning and design to help you achieve the 3R’s of clinical trials. Call us on +61 3 9251 0777 now.
This article was written by Ric DeGaris from our Clinical Development team.