DUBLIN, Feb. 12, 2020 /PRNewswire/ — The “Global Clinical Trials Connect 2020” conference has been added to ResearchAndMarkets.com’s offering.
The 4th Annual Global Clinical Trials Connect 2020 will provide a platform to discuss on the futuristic advancements in clinical trials and clinical research. This multidisciplinary program involves broad participation of people from clinical trials community from around the globe who are focused on learning more about clinical research, clinical trials planning and management.
The Pharma and Bio-Tech companies are consistently evolving and new clinical studies, technologies and advancements in care and treatments have augmented the efficiency and at the same time, the complexity of clinical trials has increased, with tests being carried out in a highly structured and closely coordinated manner. It is high time that we look into innovative strategies, new technologies, effective and quality collaborations to address these issues, which can cater to the needs of the patient and the industry.
This conference intends to focus on the global health and clinical trials around the world. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based monitoring, clinical auditing & financial planning and other significant topics that play a key role in clinical trials will be addressed along with innovative sessions on new technologies, effective and quality collaborations.
This program will certainly educate health care scientists on trial design, operations, organizing trials, research computing, regulatory aspects, report on clinical trials and gain a better knowledge of the implications of clinical trials in prevention, diagnosis, clinical trial-related ethics and disease treatments.
The summit will facilitate an invaluable networking opportunities with decision-makers and focus on real case studies, insightful presentations and round tables.
Key Highlights
- Patient Recruitment and Site selection
- Innovative trial designs
- Partnership & Collaboration – Sponsors, CROs, Sites and External Vendors
- Patient-centric clinical trials
- Making Patient Engagement a Reality
- New innovations in Patient Recruitment planning and execution on a clinical trial
- Outsourcing strategies and models
- Electronic Clinical Outcome Assessment and Electronic Patient Reported Outcome
- Streamlined IRT development process
- Pharmacovigilance & Clinical Trials
- Post-Clinical Trial closed communities
- How to future proof your clinical operations
- Implementing Risk-Based Monitoring
- Streamlining R&D and lower costs in clinical trials
- Adaptive Trial Model
- Clinical Trial Auditing
- Real-World Clinical Trial Strategies
- Data Quality & Technology
- Clinical Data Strategy & Analytics
- Clinical Technology and Driving Innovation
- M-Health, Wearable and Consumer Technology
- Big-Data, IoT and Artificial Intelligence in Clinical trials
- Blockchain technology for improving clinical research quality
Agenda
DAY 1
08:30 – Registration & Refreshments
09:20 – Chairperson’s opening remarks
09:30 – Strategies for globalization in clinical trials
- Connecting the developed and the developing nations
- Dealing with differences owing to culture and ethnicity
- Role of CROs and third-party stakeholders
10:00 – Innovative trial designs to save time and cost without compromising on the efficiency
- Strategies & Methods for flexible design trials
- The Adoption and Impact of Adaptive Trial Designs
- Preclinical environment and trial designs Opportunities and Limitations
10:30 – Morning Coffee/Tea & Networking
10:50 – Case Study: The role of surrogate markers in (cardiovascular) drug development
The session will highlight the importance of surrogate markers in general for drug development and in the field of cardiovascular research in particular. Following aspects will be covered in the presentation:
- Inform/de-risk phase III
- Proof of Concept
- Enrich patient population
- Label enhancement
Patient Recruitment & Site Selection
11:20 – Efficient and Effective clinical trial recruitment planning
- New approach to strategic recruitment planning
- Co-operation with all relevant stakeholders
- Data-driven approach to maximize engagement and support
- Recruitment performance monitoring and evaluation plan
- Patient-Centric Enrolments Planning and Engagement
11:50 – Monitoring and Quality Assurance in site selection and patient recruitment to optimize clinical trials
- Site pre-assessment and selection
- Ensure patient protection and to deliver high quality data
- Quality assurance can at times be difficult as regulatory requirements, standards and access to care differ globally – How are we going to handle this?
12:20 – Networking & Luncheon
13:10 – Sponsor centric to Patient centric framework – Improving patient recruitment & enhancing their involvement
- Patient recruitment and engagement tools
- Challenges and Barriers – How to overcome it?
- New models will have to emerge to support data sharing while protecting patient privacy
- How to tackle the lack of regulatory guidance?
13:40 – Effective patient recruitment and retention in clinical trials
- What will persuade and impact the patient?
- Is there anything pharma can provide for a trial member that will increase the value of participation?
- The aim of patient-driven clinical trials is to diminish the burden of participation by making the participant journey as convenient and pleasant as possible
- Utilize fitting procedures and techniques to limit dropouts without, in any capacity, constraining a patient to remain in the study
14:10 – Panel discussion: Novel approaches to streamline site selection and reduce delay in recruitment to ensure success
- Discover sites with a demonstrated track record of good execution in trials
- Study and site staff with solid certifications to expand the likelihood of powerful enrolment and an effective trial.
- Factors such as disease prevalence rates, treatment practices, regulatory requirements and statistical considerations must be considered
- Access to subject population with the required eligibility criteria
- Network within industries
Patient Centricity & Patient Engagement
14:40 – Making Patient Engagement a Reality
- Current trends & challenges
- Understanding of the patient and the trial journey
- Improving data quality and ensure safety & efficacy
- Engaging and retaining existing patients
- Improving patient centricity of the trials
- Integrating technology and communication to enhance transparency
15:10 – Afternoon Tea/Coffee
15:30 – Case study: Embedding a patient-centric approach to clinical trial design
- Examine learning points from multiple studies engaging patients at the protocol design stage
- Understand the importance of the independent intermediary
- Analyse the outcomes – evidencing the impact of earlier involvement
16:00 – Aspects of Informed Consent and Vulnerable Patients in Clinical Trials in the Digital Age
16:30 – Gain Insight to PatientCentric Remote Trial Conduct
- Patient-centric remote trials trial setting
- Customization of clinical trials
- Simplify trial participation.
- Modern technology for collecting clinical data
- Direct Data Capture (DDC)
- Experiences from current trials, challenges and benefits
17:00 – Interactive Breakout Discussions:
All the participants will have a great opportunity to discuss and explore a selection of most interesting topics discussed during the conference in small groups with their industry colleagues in an informal setting.
Each table will nominate a head who will summarise the discussion and questions posed. The group members are given equal rights to share and learn from each other’s experiences to discover an actionable solution on the discussed topic.
- Round Table 1: Innovation in Clinical Trials – Digital Approaches
- Round Table 2: Patient Centricity
- Round Table 3: Globalization and Country Specifics
- Round Table 4: Recruitment Challenges – Patients and Sites
- Round Table 5: Changing Clinical Trials – What needs to be addressed
- Round Table 6: Patient Retention
17:30 – Chairperson’s closing remarks
17:40 – Networking Drinks Session
DAY 2
08:30 – Registration & Refreshments
08:50 – Chairperson’s opening remarks
Outsourcing and Partnerships in Clinical Trials
09:00 – Weighing and evaluating the outsourcing approach that is right for you
- Flexible, and easy to implement model
- Creating an effective strategy to decide when to outsource
- Analysing the key risk factors your CRO might bring and how to tackle them
09:30 – Establishing quality partnerships between sponsors and CROs
- Having a shared vision in sponsor-vendor relationships
- Involving the CRO in the project design and planning
- Decide on the Quality Agreement and CRO Oversight Plan upfront
10:00 – Efficient means of vendor oversight when it comes to metrics, deliverables and quality
- Monitoring outsourced clinical trials
- Managing Continuous & Real-Time Collaboration
- Both sponsor and CRO must invest time in defining goals, anticipating issues and measuring results.
10:30 – Morning Coffee/Tea & Discussion
10:50 – Establishing quality partnerships between sponsor and CROs
11:20 – A key factor in vendor Selection – The role of the CRO in advancing patient-centric clinical trial approaches
11:50 – Panel Discussion – A collaborative clinical ecosystem: How to effectively manage partnerships with all Stakeholders including Patients, Sites, CROs, Sponsors and Regulators.
- Managing continuous & real-time collaboration
- How transparency will lead to industrywide collaboration
- Both sponsor and CRO must invest time in defining goals, anticipating issues and measuring results.
- Considering what patient centricity factors your CRO brings in
12:20 – Networking & Luncheon
Quality, Compliance and Risk Management
13:10 – Adapting QA to ensure that we move quality to the front of all processes using auditing and internal compliance management
13:40 – Inspection readiness, inspections and audits preparation and CAPA management
14:10 – Implementing risk proportionate approaches in clinical trials – moving towards risk-based monitoring
- Observing exercises and methodologies ought to be chosen to be proportionate to the risks identified within a trial.
- Risk-based monitoring needs an effective and adaptable technology platform with analytics, which are combined with monitoring to assess, manage and mitigate risk.
Clinical Data and Tech-Driven Trials
14:40 – Advances in Predictive Analytic Modelling of Clinical Trails Operations
- Innovative trial designs
- Patient Recruitment and Site selection
- Implementing Risk-Based Monitoring
15:10 – Afternoon Tea/Coffee
15:30 – Interpretation and Impact of Real-World Clinical Data
- Strategies for better decision-making
- High-level models and simulations compelled by data will allow the elimination of risky trials
- The potential of real-world data in clinical research goes past patient identification and patient recruitment
16:00 – Clinical trials in the era of digitization – the impact of smart innovations in clinical research
- Rethinking the R&D Clinical Process
- Patient-Centred Innovation in Clinical Trials
- New trial designs and analysis methods
- Discovering and validating sequential, personalized decision-making strategies
- An Integrated Business Model – Using technology to streamline processes
16:30 – Describing the landscape in the pharma and healthcare settings, exploring the areas where Blockchain could be used and presenting two detailed use cases
- Patient Data Access/Transparency) to support future development and implementation for an upcoming proof of concept.
- Drug Supply Chain using Smart Contracts
17:00 – Novel techniques- Tech-driven clinical trials
- Effectively using technology is enabling patient centricity
- How to implement mobile technology and make it work in clinical trials
- Does consumer technology devices used in clinical trials?
- IoT in digital transformation of clinical trials