Patient recruitment timeframes are one of the most important parts of the clinical trial process to consider as the recruitment period often extends past recruitment goals and in turn exceeds anticipated costs. This is an important element to consider as part of due diligence in the planning and budgeting stage to ensure confidence that you will meet your patient recruitment goals.
Patient recruitment takes 30% of the trial process, longer than any other step of the trial. Recruitment of patients remains a challenge for the industry and it is an issue which must be tackled in order to speed up time to market and maximise sales of a potential therapy.
Generally, patient recruitment takes up 30% of the duration of the trial process, longer than any other step of the trial. Because of this, pharmaceutical companies seek strategies that decrease clinical trial times. The rising costs of R&D are predominantly a result of the increasing number of procedures in trial protocols, which have risen by 6% a year over the last 10 years. It has been shown that the growing complexity of clinical trial protocols has resulted in patient recruitment rates dropping from 75% in 1999–2002 to 59% in 2002–06, while volunteer retention rates fell from 69% to 48%. The complexity of clinical trial protocols is likely to increase in the future, coupled with the need to have larger sample sizes and studies of longer duration. Although this data reflects US trends it is still indicative of our local markets within Australasia.
So, why should this be important to you? Investigator sites frequently over estimate their ability to recruit and although this optimism is welcome it does not necessarily guarantee a positive result. Realistically evaluate your sites strengths and weaknesses, identifying threats and opportunities associated with the specifics of the study. Only when you are aware of the potential risks in the patient recruitment process can you move forward to identify solutions that will keep your study on track within agreed timelines. This is of particular importance with competitive studies. Sites that understand their limitations with patient recruitment and prepare strategies in advance to formulate solutions will undoubtedly have better outcomes than sites that are deficient in planning and preparation with their patient recruitment.
For CRO’s and sponsors it is equally important to understand that some sites perform better than others with certain studies. You can use historical data to identify the sites that are most likely to provide the best result for your study. Alternatively you can manage the patient recruitment process where its management is centralised to maximise advertising effectiveness and minimise cost whilst providing a consistent message and a reliable screening process for subjects who may wish to participate.
However you choose to manage your study, the most important aspect in the process is to understand the need to plan and conduct a thorough risk assessment of the patient recruitment phase of the study.
Information source: Datamonitor – Optimizing the clinical trial process