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Clinical Trial Integrity with ADLT™

clinical trial integrity

Over the last year, we have spoken to many different organizations about their vision for using ADLT™.  In many cases, their challenges lie around bridging systems that don’t easily communicate with each other and data security/integrity.

The challenges for the management of clinical trials are the same.

One of the first challenges those coordinating clinical trials described is quicker access to data that is being added to the EHRs at the different study sites with the organization’s centralized clinical trial system. Currently, downloads are not on a daily basis and there is no traceability or monitoring of the data that is coming from the EHRs.  ADLT™ is an ideal solution. It not only can serve as a bridge between the systems ensuring that data moves more fluidly and on a schedule that meets the sponsor’s needs, but it also ensures the integrity of the data. Any changes in data would be recorded as it is entered into the EHR and placed on our ADLT™ platform. This would provide the sponsor of the clinical trial the assurance that if data was changed or updated there would be a point of comparison and provenance of that data trail.

The other issue of concern is around patient integrity. Patient integrity involves the assurance that the patient that signed up for the trial is the one participating and to ensure that the patient is not involved in other trials at the same time or has just recently completed a trial. There are professional clinical trial patients and many organizations have confirmed that this is a major concern. At least one organization told us that they were aware of a trial that did not achieve positive results as some patients, unbeknownst to the sponsor, were participating in another trial simultaneously. ADLT™ can serve as a registry of all patients that are currently or have participated in a study along with assigning them a digital id that they would need to use in each trial they participated in. This coupled with a biometric identifier could ensure that all trusted participants could validate the identification of the patient and generate a history of their involvement in clinical studies.

As with other areas that have been explored in previous blogs, ADLT™ provides the opportunity to bridge systems and provide data security, integrity, and provenance to any organization that requires it.  If you have any questions about ADLT™ or the BlockRx Project, contact us:  info@blockrx.com or info@isolve.io .

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