Clinical Trials for Medical Devices 2021- Virtual Conference

FDA response to COVID-19 related challenges – lessons learned during the first year of the pandemic

• FDA Organizational leadership changes
• OEIO’s involvement in the supply chain for Covid-19 vaccines, PPE and test kits

Lessons learned from the Covid-19 pandemic from the FDA ORA perspective

A primer and roadmap to implement emerging technologies for device and diagnostic trials

• The rise of TeleHealth & Remote Trials
• How to integrate your device or diagnostic via API
• Two case studies that highlight DCT methodologies that you can incorporate into your DCT strategy

Innovative approaches to building winning relationships and trust with patients, research sites and CROs in a post COVID-19 world 

• Engaging with patients to understand their needs and preferences to develop insights that will result in better therapeutic experiences
• Partnering together with sites to design relevant clinical trial protocols and optimize study execution – lessons learned

• Handling quality assurance in a complex environment where standards and access to care differ globally – can CROs help in navigating a complex regulatory landscape?

• Top tips to building a partnership-oriented sponsor-CRO relationship to deliver a robust performance and optimized trial execution

The already challenging task of recruiting patients for clinical trials was exacerbated by the global COVID19 pandemic. Yet the “current reality” that is emerging brings with it a new creativity and diligence on trial design that will ultimately benefit the industry. This presentation explores a greater awareness and sensitivity towards the patient journey during both recruitment and site engagement for a trial, a pragmatic approach to global site selection, and the customization of site engagement during the life cycle of trials that embrace a wide range of technologies, alongside a necessary change in stakeholder mind set, to successfully execute and collaborate in order for successful outcomes to be achieved in global locations.

• Site considerations
• Patient journey
• Operational execution

• What to expect from an ADCOM panel – understanding the process
• Determining who needs to be involved and advice for preparing your team in advance
• The importance of the transparency of communication at all stages of the advisory panel process
• Issues that we raised during the panel and how they were overcome

• Unique aspects of a device study
• Stakeholder engagement
• Technology solutions to address study specifics

• Latest developments in EU legislation with respect to medical devices – a yearlong delay in launch due to the global pandemic
• An update on how US medical device industry is dealing with the transition to the European Medical Device Regulation
• Looking at the immediate and long-term implications on different medical device products and how the regulation affects global operations for trial sponsors
• Highlighting changes to the revised standards, such as ISO14155, the impact of changes, and the greater need for clinical data in general as a result of MDR

• Provide an overview of global monitoring expectations post COVID
• Discuss inoperative monitoring strategies going forward
• Practical Tips for Optimizing Monitoring visits

• Navigating the complexity of study designs and assessing the volume and method of data being collected. Deciding which regions are best for US trial sponsors?
• Discovering the key success factors of a high quality clinical investigational plan – patient populations and local expertise
• How to incorporate site input into the protocol development process? Facilitating open dialogue between industry sponsors and investigators to decrease number of procedures needed to be done within a study and decrease number of protocol amendments in the future
• Hear lessons learned from working in US versus international sites and key tips for moving forward

• Why are virtual delivery models ideal for medical device trials and what does it take to run them?
• What are the benefits and challenges?
• Fad or fate? What does the future hold?
• How to access free support for medical device trials in the UK.

• Analyzing the magnitude of the impact COVID-19 had on clinical development in terms of trial activity, across geographies and therapeutic areas
• Managing disruption and overcoming challenges such as delays in patient enrollment and study initiation or inability of patients or sites to comply with scheduled visits
• Exploring effective ways to address statistical implications from missed patient visits, tests, and increased protocol deviations
• An overview of successful strategies to advance decentralized trials and remote monitoring
• COVID-19 as a catalyst for change – encouraging protocol amendments innovation and flexibility in patient engagement
• What does the future hold for the post-COVID-19 clinical research in medical devices?

• Understand the foundations/bedrock of a GCP/FDA compliant clinical study
• Evaluate when to outsource versus keep functions in house
• Explore the integration of auxiliary expertise for successful study execution (e.g. Reimbursement, Healthcare Economics, Healthcare Compliance)

• How to overcome the product development funding challenge as investors tend to wait to invest until a device achieves sufficient safety and efficacy evidence, or until regulatory approval and reimbursement have been secured
• Working collaboratively with industry participants to find new sources of funding – the power of networking
• Locating sites that possess the capacity and willingness to properly execute medical device trial

• Leveraging FDA Guidance documents
• Understanding FDA Review policies
• Utilizing the Q-Submission process

• Educating principal investigators and site staff about the importance of including women in trials
• How do you promote recruitment and retention of women? Understanding the main participation barriers for women
• Tackling the gender gap in health research and education – key considerations when planning, developing and implementing new processes and protocols
• Exploring how virtual and remote trial models can benefit women’s health trials and how Covid-19 has accelerated this shift

• COVID-19 and its impact on the adoption of technologies already available to improve patient outcomes
• Accelerating the development of new device-specific technologies to optimize patient care
• Maintaining essential data collection to meet study endpoints, the global clinical trial challenge
• How effective data management can help to accelerate progress toward the aim of improving the patient experience

• Redefining digital clinical trials from the point of view of patients, sites, sponsors and regulators
• How do you ensure accurate data collection and reporting by patients – best practice
• How can you get more out of clinical trial data and obtain more comprehensive, consistent and reliable outcomes from clinical trials?
• Debating the true potential of digitization in reducing the number of participants and lowering the cost of bringing device to market

COVID-19 has been an inflection point for clinical trial innovation and it is transforming how we generate evidence.  Innovation can be delivered through different channels.  

• Through study design with the use of novel data sources and methods to generate real world evidence
• Through study operations with a shift to patient centric data collection approaches
• Through technologies with data integration, curation and analytics to gain novel real world insights

Learn more about these emerging approaches and as we emerge from COVID-19, what innovations will continue to evolve and how will be using real world evidence as part of a learning healthcare ecosystem.

• Patient’s view – what information is critical to support the participation decision-making process from the patient’s point of view?
• An overview of powerful enrolment strategies
• Diversifying clinical trials – how to engage women and minorities in clinical trials
• Patient-driven clinical trials – diminishing the burden of participation by making the participant journey as convenient and pleasant as possible
• A case of overcoming challenging consent and – using effective enrollment aids

• Conducting usability testing remotely – what can we learn about safety and efficacy from thousands of miles away
• The regulatory agency’s response to remote testing
• Human factors and usability research – what digital tools can we use to effectively gather information about usability but also subjective feedback on device improvement

• How hybrid and decentralized trials have altered traditional clinical pathways
• Top tips to implementing a digitally-enabled research
• Discovering the benefits to patients, such as improved access to research and a more positive trial experience
• Exploring the new ways in which sponsors, sites and patients must navigate as a result of the COVID-19 pandemic

• AI as an enabler to drive down the costs of clinical trials whilst ensuring patient safety and improved timeliness
• Applying advanced machine-learning techniques to objectively measure symptoms and quantify the impact of therapies – lessons learned from the pharmaceutical industry
• Exploring the potential of AI in gathering more objective evidence by automatically collecting consistent, unbiased data
• Effective ways to capture new kinds of data from clinical trials subjects using sensors, wearables, smartphone apps, and other devices – an overview of solutions available on the market

• Diving into the latest technology trends for digitally streamlining medical device trials
• A hybrid area: exploring how digital health tools can power successful medical device trials and conversely the connected and wearable MedTech products offering solutions for pharmaceutical clinical trials
• Assessing the future of telehealth and telemedicine in shaping patient monitoring norms
• Hear updates on the regulatory environment for digital health and the FDA’s stance on this market