Track changes in recruitment statutes, actual versus targeted patient enrollment, and irregularities across 11 event variations so you can accurately assess the feasibility and timeline of any clinical trial.
The study is now handpicking patients from a set population determined by investigators. Enrollment is exclusive to invitees, often seen in open-label extensions of prior studies. This recruitment method is rare, used in less than 1% of interventional trials.
The study has transitioned to the active patient enrollment phase. The update might not reflect the exact recruitment start date but serves as a measure of the trial's recruitment duration and progress. This standard progression represents a quarter of all status change updates.
The trial is reverting to “Enrolling by invitation” from “Active, not recruiting”, deviating from its usual path. This change typically characterizes long-term extensions of completed trials exclusive to original participants. It's an atypical trajectory, accounting for about 2% of tracked status changes.
The study has completed its recruitment phase, with all patients enrolled. Though the trial continues, this standard progression is a benchmark for gauging trial health and progress. On average, trials take 2.3 years to finish enrolling, with industry-sponsored trials completing 22% faster.
The trial's recruitment strategy has shifted, either broadening its scope or becoming more selective. This change might indicate a revised study population or hint at a long-term extension. Such changes are rare, occurring in less than 1% of status updates.
The patient enrollment count or target has risen. These shifts can signify various developments, sometimes due to interim analyses re-estimations. Often, they align with primary completion date delays, especially during recruitment, leading to subsequent delays.
The study's patient enrollment or target has been reduced, usually as the actual count aligns with the initial target during the transition from recruitment to active phases. Such changes might suggest enrollment challenges or broader trial alterations. Notably, 59% of enrollment events involve reductions.
A considerable rise in patient enrollment or target has been noted. Major increases often coincide with primary completion date delays, leading to further postponements. Around 70% of such trials face subsequent delays, with 40% experiencing multiple ones.
The actual patient enrollment significantly lags behind the target. Falling short might challenge initial efficacy and design assumptions, potentially affecting the trial's outcomes. This pattern might suggest reaching the maximum dose in a dose escalation trial or a transition between trial phases. Notably, 53% of trials with a substantial enrollment decrease that have concluded were terminated early.
The trial is re-initiating recruitment, diverging from its expected path. Pauses can arise from planned seamless trials, regulatory holds, or external factors like the Covid-19 pandemic. Sometimes, this involves expanding the study or altering its hypothesis. This is an atypical trajectory, accounting for about 2% of status changes.
The study is regressing to the “Not yet recruiting” status. This deviation often impacts the projected completion timeline and might herald further trial disruptions. Such trajectories are exceedingly rare, occurring in less than 1% of status changes.
Get data readouts from dozens of trial registries, scientific publications, and sponsor announcements, including data that has yet to be presented publicly. All relevant information is packaged and organized for you so you can make sense of it quickly.
Monitor 45+ variations of roadblocks such as safety, futility, enrollment problems, and supply chain disruptions and preemptively manage risks to maintain the integrity of your own clinical trials.
Keep an eye on drug approvals, special designations, and clearances from governing authorities across the globe. With 8 variations of regulatory events tracked, you’ll see crucial milestones that directly impact a drug's development pathway and market viability.
Follow across 5 event types that highlight the latest innovations in clinical development, such as new trial registrations, partnership announcements, INDs, and first patients dosed. As new treatments, companies, and drugs enter the space, you’ll be the first to know.
Watch over setbacks and accelerations in trial completion dates with 6 event types that highlight the varying levels of risk or progression. Link each event type with associating factors like regulatory updates, recruitment activities, and more.
Know the current status and future trajectory of any study through our 8 event variations that cover a trial from beginning to end. Milestones like completing a phase or resuming after a suspension ensure that you’re always kept in the loop.