Osteoarthritis Trials: The Role of Imaging for Subject Selection

Life Sciences, Clinical Trials, Patient Recruitment & Retention, Biomarkers,
  • Wednesday, July 28, 2021 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

The combination of an aging population and gains in longevity increases the significance and societal burden of osteoarthritis (OA). Bioclinica has worked actively in the application of imaging for OA clinical trials for more than 20 years, but a safe and effective disease-modifying therapy remains elusive. Nevertheless, interest in this disease remains high and pharmaceutical and biotech companies continue to discover and test new candidate therapies in hopes of solving this unmet medical need.

While a regulatory approval has not been achieved, advances in trial design and methods of evaluating biomarkers of interest have occurred, providing new confidence in running effective and efficient trials. One of the first challenges in designing an OA trial is selecting the right patient population to study. Clear clinical and imaging criteria have been established to diagnose the patient suffering from osteoarthritis. However, a successful trial will depend on more than that. Based on the candidate drug’s therapeutic target and method of action, the study population must also meet the endotype/phenotype requirements to maximize the chance to see a therapeutic effect. In addition, given the slowly evolving nature of this disease, careful subject selection can help shorten trial duration facilitating go/no-go and dose selection decisions.

It is now standard to use both radiography and MRI to select study participants who meet the baseline characteristics required by the trial design while excluding subjects with confounding conditions and other pathology. Moreover, imaging is shown to be useful for identifying an enriched cohort with increased risk of progression (e.g. radiographic joint space narrowing or cartilage loss).

Register for this webinar to explore the role of imaging in determining subject eligibility in OA trials. Topics to be covered will include:

  • The complementary roles of radiography and MRI for subject selection and when to use each
  • Specific selection criteria to target the right OA patients
  • Workflow strategies for efficient screening
  • The current status of prognostic imaging biomarkers for disease progression

Speakers

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Thomas Fuerst, PhD, Chief Science Officer, Bioclinica, Inc.

Dr. Thomas Fuerst leads the design and scientific oversight of musculoskeletal clinical trials for Bioclinica. Dr. Fuerst received his Ph.D. in medical physics from the University of Wisconsin at Madison and has more than 25 years of clinical trial experience in musculoskeletal, immunology and inflammation, metabolic disorders, women’s health and rare diseases. Prior to joining Bioclinica, he was a faculty member of the University of California, San Francisco, where he served as Associate Director of the Osteoporosis and Arthritis Research Group (OARG). Dr. Fuerst is also a co-founder of the imaging core lab Synarc, where he served as Scientific Director before its merger with Bioclinica in 2014.

Message Presenter

Ali Guermazi, MD, Professor of Radiology & Medicine, Boston University School of Medicine; President, Boston Imaging Core Lab

Dr. Guermazi is a Professor of Radiology & Medicine at Boston University School of Medicine. His research focuses on imaging the musculoskeletal system, especially in characterizing the magnetic resonance imaging (MRI) and X-ray changes that occur in osteoarthritis (OA). His work also focuses on imaging in sports medicine and especially the role of MRI in preventing sports injuries and predicting return to play.

He is the founder and Director of the Quantitative Imaging Center (QIC) within the Department of Radiology at Boston University School of Medicine, Boston, MA, a research group focusing on Musculoskeletal Radiology and especially MRI that provides radiological analysis services for industry, foundation or NIH-sponsored trials.

Professor Guermazi was the Deputy Editor of the musculoskeletal imaging section for the RADIOLOGY journal from 2013-2019. He has authored or co-authored more than 590 peer-reviewed papers and made numerous scientific presentations at national and international osteoarthritis, rheumatology and radiology meetings.

Message Presenter

Who Should Attend?

  • Medical monitors, clinical scientists and trial managers designing and running OA clinical trials
  • Biostatisticians responsible for analysis of OA imaging data
  • Academic researchers in OA

What You Will Learn

In this webinar, participants will learn about:

  • The complementary roles of radiography and MRI for subject selection and when to use each
  • Specific selection criteria to target the right OA patients
  • Workflow strategies for efficient screening
  • The current status of prognostic imaging biomarkers for disease progression

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Bioclinica

Bioclinica is a global, life-science provider that utilizes science and technology to reduce risk of clinical trials – helping companies to develop new, life-improving therapies more efficiently and safely. The company’s offerings include medical imaging and cardiac safety services; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site and patient payments and budget forecasting; pharmacovigilance, and trial management.

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