Direct-to-Patient and Virtual Clinical Trials – A Digital Experience
DAY 1|9th July 2020
1:00 pm OPENING KEYNOTE: Adapting to new clinical trial models in the wake of COVID-19
- Making your physical trial virtual: overcoming obstacles in order to keep your trial going in the face of social distancing measures
- Crisis management and designing a clinical trial with decentralized and remote models in mind
- Lessons learnt during the COVID-19 pandemic: how will clinical trials be impacted moving forwards?
1:20 pm Live Q&A with presenter
1:30 pm Uncovering how decentralized trials are unlocking the potential of technologies by enhancing patient-centricity, resource management and accuracy of data
- Examining the use of predictive modelling and AI in machine learning to learn from data without removing it from its stored location
- Identifying how this disruptive approach ensures the study is built around the patient rather than a centralized site
- Outlining how building trials around patient homes and the community through remote visits enhances retention
- Establishing virtual site contracts and managing relationships by focusing on patient-physician interaction
1:50 pm Live Q&A with presenter
2:00 pm Developing a patient-centric approach: why is direct-to-patient important for clinical trials and what is needed for its successful implementation?
- How can DTP equally benefit sponsors, sites and patients?
- Access: how DTP helps reach patient populations who would otherwise struggle to participate and comply with clinical trials
- DTP as a way to increase patient recruitment and retention
- The importance of clear, direct communication, flexibility, and agility in clinical studies involving DTP
2:20 pm Live Q&A with presenter
2:30 pm Remote monitoring and telemedicine in virtual clinical trials
- How to put into place an effective strategy for remote monitoring during a virtual clinical trial
- Using wearables, monitoring technology and the Internet of Things to collect data during virtual trials
- Balancing remote monitoring and patient communication: how often do you need physical contact during a clinical trial and how much can be replaced with remote monitoring and telemedicine?
2:50 pm Live Q&A with presenter
3:00 pm CASE STUDY: Using data effectively in a virtual clinical trial
- Ensuring data quality and integrity when a trial is conducted remotely
- Transitioning from analogue methods of data collection to digital methods: how quickly can this be done without compromising quality?
- Collecting real world data: how can you utilise this effectively and what additional data points should you be collecting?
- AI and Machine Learning as tools to support patient engagement
- Data and ethics: obtaining patient consent and validating data collection from a scientific point of view
- What are the best solutions available for effective remote data capture and analysis?
Head of Virtual Trials
3:20 pm Live Q&A with presenter
3:30 pm Reducing bias: blinding challenges in remote clinical trials
- What additional obstacles does conducting a clinical trial virtually create for effective blinding?
- Developing an effective blinding mechanism that will work for a remote trial
- Patient confidentiality and working with couriers to ensure data is truly blinded
- Incorporating Interactive Response Technology systems into your DTP model
3:50 pm Live Q&A with presenter
4:00 pm What is best practice in terms of patient engagement in decentralized trials
- Recruiting for a virtual trial: what additional challenges are there and how can you overcome these?
- Engaging older populations: is it necessarily the case that an older population is harder to engage through digital channels? What alternatives are there?
- Technology as a tool for engagement: how can you determine what is best for each individual patient?
- Maintaining patient communication and crucial role of behavioural science in engaging patients during a remote or virtual trial
- How data and technology feed into patient behaviour, engagement and retention during a remote or virtual trial
4:20 pm Live Q&A with presenter
4:30 pm Temperature maintenance and quality assurance in both direct-to-patient and direct-from-patient shipments
- Temperature maintenance: how can you confirm drug shipments avoided temperature excursions with patients unfamiliar with processes?
- Reducing the risk of temperature excursions when shipping biologics
- Ensuring accuracy and clarity of temperature-related information for patients
4:50 pm Live Q&A with presenter
5:00 pm Implementing risk based quality management into your virtual clinical trial
- Using data and technology effectively to identify, monitor and mitigate risk
- Risk based monitoring as a cost-effective strategy to improve efficiency in studies without compromising quality or integrity
- How to employ risk based monitoring while ensuring compliance with regulatory bodies
- Regulatory guidance to help sponsors better manage, monitor and report data
5:20 pm Live Q&A with presenter
5:30 pm Leveraging technology and data to create patient-centric medical device clinical trials
- Exploring registered nursing options for home-based trials
- Real-world example of virtual reality trials and a summary of the pitfalls and successes of this new concept in clinical practice
- Identifying key products and software available to facilitate remote studies
- How lowering the burden on participants can reduce patient-dropout rate
5:50 pm Live Q&A with presenter
6:00 pm Preparing for a virtual clinical trial: what do you need to think about from a regulatory perspective?
- What guidelines and regulations do you need to be thinking about in your virtual trial strategy?
- Filing amendments for protocols in clinical trials affected by the COVID-19 pandemic
- Maintaining patient data in compliance with data protection legislation, particularly where clinical studies involve blinding
- An overview of new guidelines for clinical trials during the COVID-19 pandemic
- Cross-border direct-to-patient shipping and challenges in compliance with international regulations
6:20 pm Live Q&A with presenter
6:30 pm ‘The new normal’: will decentralized trials be the future for clinical trials?
- Weighing up remote vs traditional models: with the former now in place, will we ever return to the latter?
- Planning for future clinical trials with crisis management strategies in mind: incorporating remote options into protocols for future trials
- How likely is the industry to go back to fully in-person trials: should we be looking at hybrid models instead?
- Will the sudden spike in virtual clinical trials be a durable change?
6:50 pm Live Q&A with presenter
7:00 pm Closing remarks
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