What advantages do global data standardization bring to clinical research and the patients it serves? Learn how fine-tuning regulatory submissions and improving policymaking are expected to help ensure the meaningful exchange of trial data in this Applied Clinical Trials article co-authored by Rebecca Kush, Ph.D., scientific innovation officer at Elligo Health Research.
The Wall Street Journal interviewed John Potthoff, Ph.D., CEO at Elligo Health Research, about Elligo’s model that makes it easier for physician practices to participate in clinical research. Elligo is one of several startups mentioned that are working in significant ways to improve clinical research.
John Potthoff, Ph.D., CEO at Elligo Health Research, was interviewed for The Silicon Review’s “50 Innovative Companies to Watch 2018.” In his interview, Potthoff explained how Elligo’s work to streamline patient-oriented research is helping improve clinical research outcomes and close the gap between research and health care.
What role does patient centricity play in enrolling patients for clinical trials? Chad Moore, explains how addressing the patient directly and involving a trusted care provider can improve trial recruitment in this ACRP editorial.
Elligo’s president, Chad Moore, weighs in on the challenge of patient participation in clinical research and the impact clinical research as care can have on trial participation. Read the full article from the July issue of The CenterWatch Monthly.
Elligo’s scientific innovation officer, Rebecca Kush, PhD, was interviewed by Bloomberg Law based on her experience on clinical data and medical research as a follow up to Seema Verma, administrator of the centers for Medicare & Medicaid services, recent announcement to revamp the meaningful requirements. Read the full interview on Bloomberg Law.
Rebecca Kush, PhD, Scientific Innovation Officer, Elligo Health Research
The U.S. Food and Drug Administration encourages the use of new technologies, including electronic health records (EHR), for regulated clinical research. At a conference several years ago, one FDA representative spoke about the FDA guidance documents and initiatives related to this topic and asked, “What is it going to take?”
EHR data has been used to assess protocol feasibility, identify patients for research and seek safety signals for pharmacovigilance. EHRs have also directly auto-populated research forms in post-marketing studies and for safety reporting.
The ASTER (Adverse Drug Event Spontaneous Triggered Event Reporting) project, conducted by Pfizer with Harvard, demonstrated that drug-related adverse events could be reported in less than one minute, as compared to the typical ~35 minutes it took to complete a MedWatch form to fax to the FDA.
A recent study by Duke, using an EHR as an electronic source (eSource) to auto-populate electronic case report forms (eCRFs), resulted in time savings of 37 percent for data capture. Quality improved measurably, in terms of reducing transcription errors from 9 percent to 0.
Thus, the use of EHR for prospective clinical research and safety reporting has demonstrated time and cost savings; the ROI is apparent. The technical capabilities to conduct a clinical research study using EHRs have been available for years; the list of benefits is long, and they seem to outweigh risks. But, challenges obviously remain.
Current challenges to conducting studies using EHRs include concerns regarding:
- Lack of awareness and/or adoption of available technologies and standards
- Being ‘first’; fear of regulatory repercussions (e.g., FDA non-acceptance of data)
- Variations among EHR implementations/systems, health care data and standards
- Changing existing processes and roles
In addition, there are issues related to patient privacy, security and ethics, which in turn drive the generation of data use agreements and other legal documents that take time to develop and execute.
The challenges and how to overcome them will be discussed by a panel of experts at the Bridging Clinical Research & Clinical Health Care Collaborative on April 4–5. At this strategic forum, FDA representatives will present the latest on FDA guidance on the use of EHRs, mobile devices and real-world data in clinical research, as well as other innovative uses of technology and standards to streamline the way we conduct research today. Anyone interested in the potential benefits these opportunities will bring to patients and how to get involved should participate.
Elligo’s chief operating officer, Deirdre BeVard, speaks to her experience on the importance of connectivity as it is the foundation that unifies the entire clinical research industry. Read the full interview in Society for Clinical Research Sites’ December issue of InFocus.
Elligo’s Mary Costello, vice president of clinic development and patient advocacy speaks to the importance of proactively developing solutions that will overcome the challenges to research resistance. Learn more from Costello at BioSpace’s blog.
Elligo Health Research’s Keith Fern, chief commercial officer, discusses a solution to address low patient and physician participation in clinical trials. Rethinking recruitment, the Elligo Goes Direct® approach mobilizes community clinics and turns them into research-enabled sites that enroll eligible patients who already populate their practices, expanding the pool of participating patients and clinicians. Read the article about bringing research to the clinic at Applied Clinical Trials.