Ochsner Health System and Pfizer partner to develop innovative models for clinical trials

PfizerNEW ORLEANS & Ochsner Health System, Louisiana's largest non-profit academic healthcare system, and Pfizer Inc (NYSE:PFE) have entered into a multi-year strategic alliance to develop innovative models for clinical trials. Through this partnership, Pfizer and Ochsner - through its innovation lab, innovationOchsner (iO), in partnership with Ochsner Research - will explore ways to enhance the clinical trial experience and ease participation in clinical research for both patients and healthcare professionals.

The alliance aims to create faster, improved access and connectivity to clinical trials for patients, with the ultimate goal of better experiences and outcomes. Participating patients will have the opportunity to test out new digital tools designed to make the clinical trial experience more inclusive and enjoyable. Participating clinicians will benefit from reduced manual data entry as a result of direct data system integration and automated study conduct tools, freeing up time and work to allow them to offer clinical research as an option to a broader range of patients. And research groups will experience efficiencies from interoperability that may lower costs while increasing capacity. These projects are designed to ensure that all data collected is secure and will only be used with patient consent, as in any clinical trial.

"As a national leader in healthcare, Ochsner is delivering on its mission to bring the most innovative ideas to our patients. We are relentless about using the latest breakthroughs in science and technology to solve some of the toughest healthcare challenges," said Dr. Richard Milani, Ochsner's Chief Clinical Transformation Officer and Medical Director of iO. "Partnering with Pfizer allows us to transform medicine by creating a digital clinical trial experience that improves patient participation, integration, communication and accessibility."

The strategic alliance's first project began with a "proof of value" phase in which researchers successfully transferred mock data (e.g. no actual patient data was used or shared) from Ochsner's EHR system to Pfizer's electronic data capture system used in Pfizer clinical trials. The experiment aimed at understanding the gaps and variances between data collected in electronic health records and patient-reported data from clinical trials.

Since the inception of electronic health records (EHRs), integrating EHR data into clinical trial databases has been a goal of research institutions, industry and regulators. Such integration would reduce the burden of manual data entry, save time, decrease cost and accelerate clinical trials. The ongoing challenge has been exchanging data between healthcare systems and clinical trial systems, because each uses different technology platforms and data standards. In recent years, Fast Healthcare Interoperability Resources, or FHIR®, a standard developed by the nonprofit organization Health Level Seven International (HL7), has been introduced as a secure and open solution for healthcare data exchange to accelerate information sharing. Most health apps use FHIR data standards, but FHIR has yet to be adopted for data exchange in industry-sponsored clinical trials. As one of the first health systems to implement FHIR, Ochsner has continuously explored opportunities to use the standards in other applications, including clinical trials. The Ochsner-Pfizer alliance project aims to build a model for applying FHIR standards so that high-quality clinical trial data may be collected consistently, reliably and securely within hospital and clinic electronic systems.

"We're pleased that we succeeded in transferring core data types collected in healthcare provider electronic health records to Pfizer's clinical trial data capture system using FHIR standards. To the best of our knowledge, this is a first for our industry," explains Rob Goodwin, Vice President, Operations Center of Excellence, Global Product Development at Pfizer. "There is more work ahead, but this is a significant step forward in simplifying data capture for clinical trials, and the first of many pioneering solutions we hope to develop through our partnership with Ochsner."

During the next phase, Pfizer and Ochsner will continue to develop new ways to digitize the patient and clinician experience in clinical trials, with attention to patient preferences on access to and use of their health data and with an overarching goal of enhancing the quality and value of clinical research interactions for all participants.

About Ochsner Health System

Ochsner Health System is Louisiana's largest non-profit, academic, healthcare system. Driven by a mission to Serve, Heal, Lead, Educate and Innovate, coordinated clinical and hospital patient care is provided across the region by Ochsner's 40 owned, managed and affiliated hospitals and specialty hospitals, and more than 100 health centers and urgent care centers. Ochsner is the only Louisiana hospital recognized by U.S. News & World Report as a "Best Hospital" across three specialty categories caring for patients from all 50 states and more than 70 countries worldwide each year. Ochsner employs nearly 25,000 employees and over 4,500 employed and affiliated physicians in over 90 medical specialties and subspecialties, and conducts more than 700 clinical research studies. Ochsner Health System is proud to be a tobacco-free environment.

About innovationOchsner

innovationOchsner (iO) is an innovation lab launched by Ochsner Health System to solve healthcare's most pressing problems and reimagine and revolutionize the delivery and experience of healthcare. iO is developing new ways to empower patients to take an active role in monitoring, maintaining and enhancing their own health and for providers to dramatically improve the quality of care by managing patient conditions more effectively and efficiently.

About Pfizer Inc: Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

FHIR® is the registered trademark of HL7 and is used with the permission of HL7.

Most Popular Now

New target for COVID-19 vaccines identified

Next generation vaccines for COVID-19 should aim to induce an immune response against 'replication proteins', essential for the very earliest stages of the viral cycle, c...

Safety concerns raised for neuroblastoma candidate…

St. Jude Children's Research Hospital scientists looking for drugs to improve survival of children with high-risk neuroblastoma found a promising candidate in CX-5461. Th...

Johnson & Johnson COVID-19 vaccine named one o…

The editors of Time announced that the Johnson & Johnson COVID-19 vaccine has been selected as one of Time's Best Inventions of 2021. The vaccine, for which Johnson & ...

Pfizer's novel COVID-19 oral antiviral treatment c…

Pfizer Inc. (NYSE: PFE) today announced its investigational novel COVID-19 oral antiviral candidate,PAXLOVID™, significantly reduced hospitalization and death, based on a...

Researchers reveal a strategy for next-generation …

A study led by the Garvan Institute of Medical Research has revealed a guide to developing COVID-19 vaccines that both prevent the coronavirus from infecting human cells ...

A commonly found parasite could treat certain type…

Scientists have discovered that a deadly parasite, known to cause ill health in pregnant women and immunocompromised patients, could potentially be used to treat various ...

'Dancing molecules' successfully repair severe spi…

Northwestern University researchers have developed a new injectable therapy that harnesses “dancing molecules” to reverse paralysis and repair tissue after severe spinal ...

A target for potential cancer drugs may, in fact, …

In recent years, much scientific effort and funding has focused on developing drugs that target an enzyme with the unwieldy name of Src homology 2-containing protein tyro...

Abbott launches new initiative to drive diversity …

Abbott (NYSE: ABT) today announced the launch of a new initiative designed to help create a more inclusive clinical trial ecosystem through new approaches to training, ed...

Needle-free COVID-19 vaccine shows promise

A needle-free COVID-19 vaccination could be possible, with University of Queensland scientists successfully protecting mice from the virus by administering a US-developed...

Cleveland Clinic launches first-of-its kind preven…

Cleveland Clinic researchers have opened a novel study for a vaccine aimed at eventually preventing triple-negative breast cancer, the most aggressive and lethal form of ...

Novartis to sell its Roche stake in a bilateral tr…

Novartis has agreed to sell 53.3 million (approximately 33%) Roche bearer shares in a bilateral transaction to Roche for a total consideration of USD 20.7 billion. Vas...