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.
A new study has been registered on clinicaltrials.gov. However, the registration doesn't imply the trial's commencement. The FDA mandates the registration of clinical trials beyond Phase 1 for drugs and biologic products. Despite this, organizations frequently register voluntarily, driven by motives like recruitment, showcasing pipeline activities, or ensuring transparency in drug development. Notably, many trials are registered post their start date. If registered beforehand, the first patient typically enrolls about five months later.
This marks an organization's inaugural registration of a study on clinicaltrials.gov as its lead sponsor. Lead sponsors, spanning companies, governmental agencies, and academic institutions, bear the responsibility for the trial's oversight and liaising with the FDA. Remarkably, since 2018, there's an annual average of over 25,200 new trial registrations, with industry-sponsored ones accounting for 22%.
An official announcement indicates the onset of a trial, marking the enrollment or dosing of the initial patient. Companies frequently broadcast such updates to demonstrate their progress, reveal investment in innovative programs, or delineate their patient demographics to facilitate enrollment. Such announcements constitute 11% of all clinical press releases tracked by AppliedXL. On average, trial enrollments span 2.3 years, but industry-sponsored trials tend to be swifter, averaging 1.8 years – a notable 22% faster than other organizational types.
This announcement heralds a partnership between multiple sponsors for a trial or drug development venture. Collaborative efforts vary, from minimal undertakings like feasibility studies to significant initiatives like joint research or drug commercialization agreements. Collaborative press releases comprise around 8% of clinical announcements monitored by AppliedXL.
A sponsor has attained Investigational New Drug (IND) approval, greenlighting them to initiate a clinical trial involving human participants. IND endorsements are pivotal for administering investigational products to humans and transporting interventions interstate. Such announcements might indicate a drug's green light for use in an unregistered clinical program or hint at a novel application. However, IND-related announcements are relatively infrequent, representing under 2% of clinical press releases identified by AppliedXL.
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.
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.
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.
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.