Mike Wilkinson, President & COO
Organizations like The Bill and Melinda Gates Foundation have helped medical research make great strides in recent years. The funds made available by such organizations have made it possible for the researchers to invent cures fordiseases that were once incurable. However, medical research is not solely dependent on laboratory experiments but also on human clinical trials which are often time-consuming and cost-intensive. More than 80 percent of clinical trials in the USA face significant delays and can cost over $30,000 for each wasted day. Spearheading a disruption in the way these trials are conducted is the patient medical record aggregator—Patient iP—and one of their new leaders is President and COO Mike Wilkinson.
The major cause for delays in clinical trials is the inability to easily identify qualified patients. Patient iP has access to over 16 million patient lives through their electronic medical records, aggregated from over 4,000 physician practices. The company has developed proprietary software—daTAscape—to consolidate, manage and interrogate this data. daTAscape is programmed to process search queries on this data and, using a trials’ inclusion-exclusion criteria, find eligible patients easily and quickly. Wilkinson says this analysis results in a patient and physician listing, that along with their protocol optimization services, can dramatically reduce the time and cost challenges associated with most clinical trials today.
Many pharmaceuticals outsource the process of clinical trials to Contract Research Organizations (CROs), making them and pharmaceutical companies the biggest client base for Patient iP. Traditionally CROs would send out surveys through their physician network, and doctors would estimate of the number of patients—eligible for clinical trials—under their care. Doctors usually do not have the time to manually search their records, thus leading to delays and discrepancies when it comes to actually enrolling patients.
As the company obtains detailed patient information first-hand, they can directly approach doctors and request them to allow eligible patients to join the trial. This allows CROs to prepare proposals and perform feasibility studies before the trial. Wilkinson and his team have a rich experience of working in clinical research, which gives them the prerequisite knowledge to comply with all FDA regulations. “With our rich experience, we can suggest possible modifications to the inclusion-exclusion criteria or to the operations plan to include a wider range of patients,” explains Wilkinson.
Other data companies in this industry only have access to de-identified data, providing CROs only high-level geographical indicators and not the names and locations of patients and their physicians. Patient iP obtains patient records directly from EMR companies, and after identifying eligible patients, they rely on the physician to re-identify the anonymous data through a unique patient-identifier. This is a win-win situation for everyone as it also enables the doctors to enroll their patients in the latest trials.
As the company obtains detailed patient information first-hand, they can directly approach doctors and request them to allow eligible patients to join the trial
Recollecting one of their success stories, Wilkinson says, “After a couple of companies failed to help an organization find patients for a trial, they approached us. We were able to locate quite a few patients within just two weeks.” They also set up an automated querying system for a large CRO that had recently acquired its own data network.
Patient iP will soon shift its business model from a service to a software-as-a-service (SaaS) model enabling clients to directly utilize their technology. The company further plans to disrupt the industry by establishing some unique partnerships. They envisage a day when patients will be identified first and clinical trials will be designed specifically for them.