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How FDA’s Guidance on RWE Impacts the Life Sciences and Influences Oracle Health Sciences

If you haven’t yet, please navigate to this link to read this exciting new guidance on Real World Evidence (RWE) released by the FDA in early December 2018!  The guidance document is riveting to read, and it is an exciting element of Oracle Health Sciences’ current strategy to disrupt clinical research with our new Oracle Health Sciences Clinical One platform, Oracle Health Sciences Data Management Workbench (DMW), and Oracle Health Sciences mHealth Cloud Connector Service.  Read on to find out how! First, in the guidance document, the FDA makes clear that coupled with the 21st Century Cures Act, RWE is a critical pillar in the ongoing quest to get the approvals of new drugs and biologics to patients faster and at a lower cost.  This guidance is underscored by FDA Commissioner Scott Gottlieb’s quote, “As the breadth and reliability of RWE increases, so do the opportunities for FDA to make use of this information.” Additional critical points: The FDA’s RWE journey started years ago in the safety arena.  One manifestation that has been very successful is the Sentinel System. This system assesses EHRs and claims-real world data (RWD) sources to generate RWE for drug safety.  The Oracle Empirica Signal Suite is also a byproduct of the FDA’s safety journey. Years ago, the FDA served as an Oracle development partner to create the solution, and the agency continues to use the Empirica Signal Suite in its drug safety program today. Examples of RWE sources include data derived from: EHRs, medical claims and billing, product and disease registries, and patient generated data (including in-home settings) from mobile devices and sensors.  The good news for our customers is that Oracle Helath Sciences knows a lot about RWD sources.  With its healthcare business, Oracle has been successfully integrating EHR data for healthcare provider and government organizations for over 20 years.  Also, because Oracle’s mHealth Connector product supports patient generated data from mobile devices and sensors, electronic clinical outcome assessment (eCOA) and electronic patient reported outcomes (ePRO) data sources can be easily integrated with both Oracle Health Science InForm and Oracle DMW. In addition to using the above-mentioned real world data (RWD) sources to generate RWE, RWD can also be used to improve trial efficiency.  This means that a biopharmaceutical company’s clinical research budget can support exploring more potential targets, not only reducing time to market, but also increasing the number of therapies it can pursue simultaneously.  Examples include:     Generating hypotheses for testing in randomized controlled trials (RCTs) Identifying drug development tools, including biomarker identifiers Assessing trial feasibility by examining the impact of planned inclusion/exclusion criteria in a relevant population Informing prior probability distributions in Bayesian statistical models Identifying patient baseline characteristics for enrichment and/or stratification Assembling geographically distributed research cohorts (particularly for rare diseases and targeted therapeutics) Single-arm trials are a reality!  This development is extremely exciting.  It speaks to manyof the good things they enable, such as: Reducing the number of patients needed for a trial.  Since there isn’t a need to conduct a dual arm trial, a single-arm trial can reduce the number of patients needed by up to 50 percent (50%).  Patient enrollment is the Number One problem with running clinical trials, as only three percent (3%) of patients volunteer to participate.  In addition, the overhead of finding the best sites that can help a sponsor get to the right level of patient enrollment, including getting all the patient data and paperwork required for the regulatory process, adds tremendous time to a successful study startup. (See how our recent goBalto acquisition streamlines this!) Alleviating ethical dilemmas.  For deadly diseases, it’s very difficult, ethically, to have a control group who does not receive the prescribed trial treatment.  In a single-arm trial, the sponsor can mine RWD sources for patients with that disease who have not taken the therapy in past and compare those historic patients to the current studied patient group.​ Speeding the Drug Approval Process. Using RWE, Blincyto, a treatment for acute lymphoblastic leukemia, was approved under the FDA’s accelerated approval process.  The response rate in a clinical trial for Blincyto was compared to historical data from 694 patients. The historical data was extracted from over 2,000 patient records at US and EU clinical study and treatment sites.  Enabling an adaptable learning health system. A dose-response-aspirin-trial compared two common doses (81mg and 325mg) across 20,000 randomized patients who had a history of myocardial infarction (aka heart attack).  This was a long-running trial integrated into regular patient care with minimal inclusion/exclusion criteria and no additional treatment protocol beyond the aspirin regimen.  Primary trial end points such as death, another heart attack, stroke, etc. and secondary endpoints, such as coronary procedures, hospitalization, etc. were captured from electronic health records (EHRs) and claims-data sources.  Arguably, this trial was an example of integrating trials/research directly into patient care processes and/or an instance of the learning health system. Of course, there are many, many more important elements of the FDA’s RWE framework strategy in the document, so please read it! From all of this, it’s easy to see how Oracle Health Sciences’ fundamental Clinical One strategy is really going to advance and re-envision clinical trials. Most critically, the next module for Clinical One is not called EDC (for electronic data capture).   It’s named Data Capture.  Why? Because the game is different now.  Our new data capture capacity isn’t just to get data from one site.  It’s performed to enable data to be captured from all required data sources -- including RWD sources -- in real-time for the trial.  Clinical One allows users to make this fundamental, streamlining, yet disruptive, change to the clinical research process easily. Are you re-thinking your RWE strategy? Take a look at the progress of our Clinical One vision and contact us for a conversation!  

If you haven’t yet, please navigate to this link to read this exciting new guidance on Real World Evidence (RWE) released by the FDA in early December 2018!  The guidance document is riveting to read,...