AccessCT enables greater enrollment rates to pivotal studies in shorter periods of time, speeding up the time it takes to publish studies and get new drugs approved and on the market.
For the first time in the medical and pharmaceutical industries, the ability to scale large Multi-Center clinical trials on a national level is now available by way of AccessCT, an EHR-integrated service and the latest of an expanding suite of physician documentation software offered by medical informatics company Hiteks Solutions. Leveraging conductivity within Electronic Health Records (EHR) systems, Hiteks offers a seamless E-Screening based solution for data access to patient records that enables physicians to more effectively and efficiently identify potentially eligible patients for sponsored trials.
How It Works
AccessCT determines whether patients qualify as participants for medical based studies by interpreting the studies’ inclusion and exclusion criteria. These criteria are programmed against a real-time data feed from the EHR of structured and narrative patient records. The Hiteks clinical Natural Language Processing and Artificial Intelligence engine (the fastest and most accurate in the industry) then processes the data instantaneously (within one second) and uses its findings to identify whether there is a match between the patient data and the study.
For patient records that match with enough criteria, physicians receive a highly predictive alert with the option to refer the patient to the study’s Research Coordinator, who can then conduct a more rigorous screening of lab tests and patient history and obtain patient consent before the decision is made on formal enrollment. Once selected, the small percentage of prospective patient participants who qualify for a trial can now gain the opportunity to choose to participate based on the national and international footprint of various EHR system hospitals and physician practices.
The provider controls the authorization to refer a patient, the decision of which he or she bases on the real-time recommendations of AccessCT. Providers can elect to refer their patients into trials either locally, through a regional study site, or through virtually implemented methods if made available by the sponsor. Providers who are interested in leveraging AccessCT simply need to turn on the connection within their EHR, which shares data securely with Hiteks. Pharmaceutical companies can also leverage this platform by communicating their study protocols with Hiteks, who will then process the trial’s inclusion/exclusion criteria and develop a budget with the Development team.
Why AccessCT Defies Its Predecessors
Patient participant selection for clinical studies by way of manual chart reviews is a very laborious and expensive process, whereby overly complex and time-consuming selective methods of identifying trial sites cause most patients throughout the nation to not even be considered for studies. AccessCT simplifies and streamlines this process by utilizing EHR connectivity and workflow processing to conduct E-Screening.
Studies show that E-Screening is a far more resourceful and proficient mechanism for generating such identifications when compared to manual chart reviews because it bypasses the need for costly and time-consuming manual feasibility and site selection [1]. Pilots of EHR E-Screening have shown that when an institution uses EHR data to identify patients, researchers can double or even triple their participant enrollment rate [2].
There is no cost to physicians since the costs are paid for by the Pharmaceutical Sponsors or existing Investigator Trial Budgets, who gain the ability to get their study data submitted to the FDA faster, and publish studies from their trial data sooner. In addition, those hospitals and physicians who are already participating or will soon participate in clinical studies can elect to have their recruitment handled through the use of AccessCT. As a result, trial sites can become more competitive financially and reduce their own costs of trial participation.
To learn more about AccessCT and the other solutions in the Hiteks’ Insight suite that are transforming the medical industry, you can reach them online at www.hiteks.com, via email at info@hiteks.com or by phone at 212-920-0929.
References:
[2] Kleczko, J et al. Using EPIC electronic health record system to assist with screening patients for cancer clinical trials, results from a pilot study in the MPD Program. Tisch Cancer Institute at Mount Sinai Health System.