With growing pricing demands, increased regulatory scrutiny, patent expirations, and generic competition, it’s crucial that R&D departments are able to utilize digital technologies to ensure high-quality clinical trials. The industry is excited about virtual clinical trials, but the adoption curve is still light. As your organization prepares to apply novel technologies to clinical trials, whether they are fully-virtual or hybrid, it’s important to take into consideration how operational activities will perform when the trial is conducted virtually as opposed to a standard brick-and-mortar model.
Conceptualizing virtual trials not simply as a standard study, but as a way of doing things differently, is essential to a successful outcome. Join us to examine how the industry is navigating different models of remote trials and gain best practices for preparing or improving internal infrastructure to support a remote study.
As we move through 2020, the industry will continue to incorporate digital health technologies into clinical study design. Leveraging technologies can improve recruitment, retention and give patients a choice of participating from home or site. Creating a more patient-friendly system is a process the industry is still attempting to solve. This session will discuss opportunities for improvements to virtual studies and examine how organizations are beginning to execute virtual designs.
- Discuss how the industry is combining conventional strategies with virtual trials
- Discuss when it can be more cost-effective to run a virtual clinical trial
- Restructuring internal processes in order to implement a virtual trial
- Investigate the digital health tools that can be utilized to move a virtual trial forward
- Reginald HooksOncolytics BiotechAssociate Director, Clinical Operations
- Kelly (Johnston) McKeeVertex PharmaceuticalsHead, Patient Recruitment
- Josh RoseIQVIA Virtual TrialsVP & Global Head
- T.J. SharpeTJSharpe.comPatient Advocate
- Hassan KadhimBRISTOL MYERS SQUIBBDirector, Global Head of Clinical Trial Business Capabilities and Clinical Innovation
- John ReitesTHREADCEO
Creating an experience that is less burdensome for patients is a top priority for the industry. Virtual trials can improve convenience for participants giving them broader options. This session will dive into a patient's experience with a virtual clinical trial, let’s discuss the burdens participants are still facing.
- Explore the ease of using apps and devices in everyday life
- Examine why the patient perspective is important in virtual trial design
- Discuss what being monitored continuously is like through the patient perspective
- What does data privacy mean to pharma vs. patients? Lack of provider engagement
- Christoph Paul Vincent HornikDuke Clinical Research InstituteAssociate Professor of Pediatrics, Chief, Division of Quantitative Sciences
- Shelly BarnesUCB BiosciencesGlobal Clinical Innovations
- Jen HoronjeffSAVVY COOPERTIVEPatient Advocate, Founder and CEO
- Craig LipsetCLINICAL INNOVATION PARTNERSFounder
Virtual clinical trials are not appropriate for every kind of clinical study. If a study requires complicated health measurements that require a trip to a clinic, a virtual study may not be a good option. How do you determine a good option for a virtual study and what companies are pushing forward with virtual trials? Explore trial selection and discover the best options for virtual studies.
- Explore trial selection and discover the best options for virtual studies
- Discover trials where capturing accurate and timely data through devices has been successful
- Discuss patient needs and how much face-to-face interaction in necessary
- Discuss new study designs (such as basket trials, adaptive trials, etc) and if they are amenable to virtual
- Penny RandallIQVIAVP & Head, Central Nervous System (CNS) Center of Excellence
- Jim KremidasAssociation of Clinical Research ProfessionalsExecutive Director
- Alicia StaleyMedidata, a Dassault Systèmes companySenior Director, Patient Engagement
- Alka ShaunikCSL BEHRINGGlobal Therapy Area Head, Cardiovascular & Metabolism, Medical Affairs
- Craig LipsetCLINICAL INNOVATION PARTNERSFounder
Implementing new methods and technologies isn’t as easy as it sounds, new methods also bring new challenges. This talk will review successful case studies for evaluating new procedures and help bridge the gaps between conventional and virtual trials.
- Review how companies are preparing to explore new digital solutions
- Recognize strengths across different models and learn how teams are building their capabilities to align with new methods
- Developing digital health strategy for using sensor technology in virtual trials
- Understanding the value of incentivized strategies for patient engagement when using wearables and healthcare apps
When faced with tight regulation and balancing the adoption of new technology with patients’ best interests, it can be nerve-racking to push forward with virtual trial designs. This session will explore some of the big challenges that arise when considering new technology in clinical studies and how to overcome challenges to ensure the desired outcome.
- Address concerns over data accuracy
- Ensuring technology required works as it should
- Discuss how organizations are being too conservative with their approach to virtual trials
- Examine social and cultural barriers
- Jacob LaPorteNovartis Pharmaceutical CorporationCo-Founder & Global Head of The Novartis Biome, Chief Digital Office
- Glynn Dennis Jr.AstraZenecaSr. Director, Data Science
- Nagaraja SrivatsanIQVIASenior Vice President and Chief Digital Officer, Research and Development Solutions
- Amir LahavIndividual Digital Medicine Consultant Former Head of Digital Innovation for Rare Diseases Pfizer Executive Director and Head of Digital Medicine Karyopharm Therapeutics Healthcare Intelligence Consultant Mitsubishi Tanabe Pharma America
- Karen BeyersJohnson & JohnsonDirector, Clinical Project Scientists
- Sarah KrugHEALTH COLLABORATORY; CANCER 101Founder; CEO
- Tufts CSDD studies have shown that complex protocols have a higher number of procedures associated with supplementary secondary, tertiary, and exploratory endpoints.
- The results of the 2018 pilot study showed statistically significant associations observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit.
- The study results also suggest a new and viable approach to optimize protocol design and improve patient engagement.
- Discuss the organizational shift that sponsors need to make to support virtual clinical trials
- Becoming more knowledgeable on how virtual trials are conducted and what data is most important to collect
- Training employees on new topics and technologies
- What skills sets must employees have?