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.
Clinical trial sites play a crucial role in research, but are often overlooked. Higher site engagement can boost study performance. Involving sites early, seeking their input, and establishing site relationship teams can improve collaboration and motivation. Treating sites as valuable team members, not subordinates, benefits the entire trial. This approach ultimately leads to better study enrollment.
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.
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.
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.
A significant factor in recruitment for participants and conduct of clinical trials is Principal Investigator / Site motivation. A motivated investigator can motivate study staff and increase recruitment potential for a trial and decrease site related issues. Conversely, an Investigator or clinical trial site that is not motivated or loses motivation during a trial can result in recruitment slowing or completely halting. It is not uncommon for sites to silently quit studies they were once excited about. This series of articles will examine the 4 I’s of Investigator / site motivation and unpack what can be done to optimize clinical trial conditions.
Clinical Research 