The goal of any clinical trial or post marketing surveillance effort (Phase IV studies) is to collect patient level data to evaluate a drug’s effectiveness while protecting the identity of the patient from those researcher evaluating the results of the trail.
The challenge in this age of readily accessible personal data is to identify ways to further protect a person’s identity for traditional clinical trials while preparing to leverage new technologies like IoMT and data collection apps to pro-actively collect Phase IV clinical data.
ADLT™ provides the solution to this challenge. By assigning patients a digital key that masks their identity, the biopharma industry can strengthen the blinding for traditional trials (as only some individuals removed from the research group would have access to unmasked data) and allow anonymity for anyone participating in Phase IV data collection. As only authorized individuals would have the right key to unlock the identity of Clinical Trial participants and Phase IV data could only potentially be unlocked with patient consent, there would be a record of who accessed data, when they accessed it, and what they did with that data. This would bring a new security model to the collection and protection of patient level data.
HIPAA and its global equivalents rightly demand that we protect patient level data from groups or individuals that should not have access to it. The advancement of research and discovery into new treatments requires that we have access to that sensitive data. ADLT™ is the bridge that connects both of these objectives with a layer of security that collects data and protects its integrity and source simultaneously. The results are the creation of better and more lifesaving medications coming to the global market while ensuring that those already approved are achieving positive patient outcomes and any unexpected side effects are detected sooner rather than later.