Position Health's technology enables automatic, real-time detection and notification of significant adverse events that, without our technology, are reported with weeks of delay or go completely unreported.
In the sections that follow, we describe how significant adverse events are detected today and show the value proposition for automatic, real-time detection and notification of these events for trial participants and sponsors.
What Happens Today
Today, significant adverse events are manually detected:
When participants go to their clinic appointment and inform the trial team.
When participants self-report hospital visitations.
Automatic detection of significant adverse events can only occur if participants go to an emergency department attached to the primary investigator. Typical appointment intervals for clinic visits during trials are 6 weeks. This means that trial teams could learn about a medical facility visit, potentially caused by the clinical trial compound, up to 6 weeks after the visit occurred. Furthermore, due to the limitations of self-reporting and high dropout rates for clinical trials, trial teams might never learn about a participant’s medical facility visit.
Benefits of detecting significant adverse events in real-time
Increased safety for trial participants.
Increased efficiency of drug development pipeline - detect bad compounds sooner.
Complete audit trail of participants' medical facility visits throughout trial duration.
Eliminate the possibility of patients not self-reporting medical facility visits, which can lead to inaccurate trial results.
Increased safety for trial participants
Increased trial safety cannot be quantified monetarily but has great value for participants and, from an ethical and reputational perspective, for trial sponsors.
Increased efficiency of drug development pipeline
Position Health's technology can produce upwards of $550k in savings (per trial) by allowing a clinical trial to be halted once adverse effects are discovered. Potential savings are calculated based on the following assumptions:
Average time between a medical facility visit and when this visit is detected by the trial team of 3 weeks.
Clinical trial cost of $15,000,000.
Clinical trial length of 18 months (78 weeks)
Per week cost for the clinical trial of $15,000,000 / 78 = $192,308.
Based on a per-week cost for a typical clinical trial of $192,308, the ability to detect significant adverse events on average 3 weeks sooner than today, can produce a cost savings of $576,923 for the trial sponsor if the detection leads to the trial being cut short.
Complete audit trail of participants’ medical facility visits throughout trial duration
Position Health’s automatic detection of medical facility visits creates a complete audit trail of participant utilization, which eliminates audit data gaps that exist today due to self-reporting.
In addition, event tracking via Position Health is in real-time, which increases the accuracy and value of the participant medical facility visit data sponsors collect during trials.
Lastly, as clinical trials evolve towards virtual configurations, automatic detection, notification and audit trail generation for medical facility visits becomes mandatory.
Position Health’s technology provides participants with increased safety. Furthermore, it provides trial sponsors with the ability to automatically detect significant adverse events in real-time, without relying on participant self-reporting. This creates more accurate and complete trial audit data. Lastly, automatic real-time detection can allow sponsors to more quickly suspend trials for unsafe compounds, enabling them to repurpose valuable dollars to other drugs.