Results Release

Clinical trial results, either interim or final, from the trial are now accessible or will be presented soon. Critical indicators of a trial's success include the mention of statistical significance and attainment of primary endpoints. Effective press releases about results detail the study's structure and implementation, the patient count, and the endpoints (both primary and secondary). Additionally, the division of patients included in the statistical analysis is vital; results rooted in subgroup or responder analyses might be deceptive. This type of announcement is prevalent, constituting 30% of all clinical releases monitored by AppliedXL.

Publication Announcement

Data pertinent to the trial has been featured in a scientific journal. To assess this type of update, consider factors like the journal's reputation, the methods and results section, and the primary outcome's statistical significance. Trials sponsored by the industry account for 24% of those published in scientific journals.

Journal Publication

An article about the clinical trial has been published in a medical journal and is listed on PubMed. The publication typically contains detailed insights regarding the study's design, execution, and findings. Often, preliminary results might already be disclosed through other channels such as press releases or academic conferences. Key evaluation elements include the methodology, results, especially the primary outcome's statistical significance, and the journal's reputation. Research institution-sponsored trials represent 69% of trials mentioned in scientific journals, while industry-sponsored trials stand at 24%.

Results Available on Registry

Summary findings of this trial are now listed on clinicaltrials.gov. As per the Food and Drug Administration Amendments Act (FDAAA) of 2007 and the Final Rule (2017), it's mandatory for trials (excluding Phase 1) of both unapproved and approved products that meet certain standards to disclose results within a year post-completion. This listing might precede, succeed, or replace results reporting in other platforms (like publications or press releases). When evaluating these results, the Outcome Measures section, which details the items under comparison and their statistical significance, is vital. The Participant Flow offers a glimpse into any significant patient deviations from the initial design, crucial for results assessment. Notably, only 42% of industry-backed trials that were due for result posting have complied. However, this figure surpasses the 14.5% rate of trials funded by research institutions.