Clinical trials site recruitment optimisation: Guidance from Clinical Trials: Impact and Quality.

BACKGROUND/AIMS: Participants are integral to the success of any clinical research study, yet participant recruitment into clinical trials poses ongoing and complex challenges. It is widely accepted and recognised that clinical trial sites often find it difficult to meet recruitment goals, both in terms of accrual targets and timelines. This can impact the validity of trials or cause major delays for research. There are very few frameworks available to clinical trial sites to improve recruitment. The GREET project (Guidance to Recruitment: Examining Experiences at clinical Trial sites) sought to identify barriers to recruitment and produce formal guidance to optimise recruitment outcomes. METHODS: Clinical Trials: Impact and Quality, a collaborative of sector stakeholders, convened a project team with comprehensive knowledge of the Australian clinical trials sector to undertake the GREET project. The project scope included exploration of recruitment issues at a site level across all phases of clinical trials and all types of trial sites. The scope excluded upstream issues such as protocol design and general public clinical trial awareness, participant retention and elements of recruitment outside a site's capacity to directly influence or control. The project team's extensive knowledge and experience conducting clinical trials in Australia was used to collaboratively identify a list of 24 key barriers and 12 enablers to site recruitment which formed the basis of the project. Key stakeholder groups were surveyed to challenge project team assumptions. A national and international environmental scan and literature review was conducted to identify best-practice recruitment solutions. RESULTS: A total of 343 people responded to a survey sent to sites, sponsors, and contract research organisations, and 162 people responded to a survey sent to consumers via consumer networks. The key barriers and enablers initially identified by the project team aligned with the key outcomes of the surveys, which in turn assisted in the development of best-practice recommendations in the form of a Clinical Trial Site Recruitment Guide. Recommendations were grouped into four key themes; conducting accurate study feasibility; proactive planning during start-up; selecting optimal recruitment methods; and participant involvement. Early intervention was identified as a key facilitator in maximising improved recruitment outcomes. The GREET Clinical Trial Site Recruitment Guide is publicly accessible on the Clinical Trials: Impact and Quality website. CONCLUSION: Participant recruitment challenges experienced at a site level are widespread and varied, and there is no universal recruitment solution. However, this project identified that there are interventions and assessments that can be proactively implemented and selectively applied to facilitate improved recruitment outcomes.

Enhanced recovery for fractured neck of femur: a report of 3 cases.

Enhanced recovery is now a standard model of care in most UK elective surgical units. For hip and knee arthroplasty this approach typically includes opioid-sparing anesthesia (OSA), local infiltration analgesia (LIA), and day of surgery mobilization. There is evidence that these interventions shorten hospital stay and improve outcomes, without increasing complications or readmissions. These interventions may also benefit patients undergoing surgery for femoral neck (hip) fractures. This group of patients are frail and elderly, and are at high risk from surgery, anesthesia, and opioid and bed rest-related complications. Hip fractures are also a major public health concern. They are common, expensive to treat, and associated with poor outcomes. Despite this there are no published descriptions of the use of OSA and LIA to enable day of surgery mobilization in patients with hip fractures. We present 3 patients who underwent hip fracture surgery according to an enhanced recovery protocol that incorporated all 3 interventions. In each case day of surgery mobilization was achieved safely and comfortably, without requirement for strong opioids postoperatively. The cases demonstrate that these interventions can be well tolerated by patients with hip fracture, including those with impaired mobility or cognitive function. The protocol is compatible with all common operations for hip fracture, and with spinal or general anesthesia. It is inexpensive and requires minimal expertise. It may have the potential to improve care and shorten hospital stay, while reducing cost. Further investigation is required.