Here's how the clinical trial industry would approach baking the best bread. The bake shop owner would send out a job posting for a baker but wouldn’t tell them what type of bread they’d be baking. The fastest baker to respond would be hired. After they were hired, the baker would be informed that they... Continue Reading →
The perception of importance drives actions in clinical trials. Sponsors must work on creating positive perceptions by demonstrating site value and emphasizing study significance. A compelling story and direct sponsor-site connection elevate a study's importance. To engage sites effectively, consider involving them early, sharing the study's narrative, and treating them as valued partners.
The clinical trial industry struggles with enrollment due to a lack of curiosity and rushed judgments. The "Be Curious" approach is key to addressing enrollment challenges. Questioning and engaging with diverse sites prior to feasibility assessment is crucial. Understanding and addressing site-specific issues can optimize enrollment and study timelines.
Reminiscing about childhood vacations, where everything possible was packed to ensure nothing was lacking. This is not unlike sponsors' approach to clinical trial recruitment & enrollment. While many approaches are utilized, there are a number that remain as significant barriers to enrollment. A thorough overhaul is needed to improve enrollment.
Clinical trial sites are burdened by pass-through costs, which are not fully reimbursed, leading to financial strain. The process of invoicing for these costs is time-consuming and often results in delayed or unreceived payments, causing additional administrative and financing expenses for the site. This impacts the site's operations, staff resources, and overall financial well-being.
Effective clinical trial recruitment is marred by a lack of prioritization. Despite considerable investments, the pivotal steps often slip through the cracks. Fostering a culture that gives due diligence to connecting suitable candidates with study teams is essential.
Clinical trial invoicing can be optimized with early invoicing, adherence to contract specifications, building relationships, setting reminders, and persistence. Deviating from contract instructions can lead to delayed payments.
It's time for clinical trial sponsors and CROs to recognize that sites should be compensated for monitoring visits. Sites are increasingly asked to do more in clinical trials and the study budgets haven't increased with the additional responsibilities.
Recruitment in clinical trials is in crisis. Most trials don't meet their recruitment targets on time. One reason for this is the industry's short term approach to recruitment. Recruitment is only contemplated one study at a time when it should be approached as a long term plan.
The negotiation of a clinical trial budget should commence during the feasibility questionnaire review and continue through pre-study visits using planned communications.
Clinical Research 