Clinical Trial Design Agenda
All times are in GMT
12:25 pm - 12:30 pm
PHARMA IQ WELCOME
12:30 pm - 1:30 pm
PANEL DISCUSSION: VIRTUAL, DECENTRALISED AND HYBRID CLINICAL TRIALS IN LIGHT OF THE CURRENT PANDEMIC
Kim Hawkins -
Global Head CSO Project Leaders,
Sanofi
Musaddiq Khan - Director, Clinical Program Operations, Eli Lilly
Fiona Maini BSc. MSc. - Principal Global Compliance and Strategy, Medidata Solutions a Dassault Systèmes Company
Rosamund Round - Vice President, Patient Innovation Center and Decentralized Trials, Parexel
- How is the industry reacting to this shift in leveraging remote strategies?
- How do we balance key factors such as patient centricity, data, regulation, compliance and cost, and should flexibility be the greatest priority?
- What impact is this having on the regulators and how they operate?
- Will remote trials affect data endpoints and to what extent?
- What impact do virtual, decentralised and hybrid trials have on patients and how can we reduce potential burdens?
- How is this influencing patient engagement strategies?
Fiona Maini BSc. MSc.
Principal Global Compliance and StrategyMedidata Solutions a Dassault Systèmes Company
1:30 pm - 2:10 pm
VIRTUALISATION AND PATIENT CENTRED DESIGN: TECHNOLOGY AND THE FUTURE OF CLINICAL TRIALS
Paul O’Donohoe -
Scientific Lead, eCOA and Mobile Health,
Medidata Solutions a Dassault Systèmes Company
- While clinical trials are getting ever more complex, the use of technology such as eCOA, wearables and “virtualisation” allows us to capture increasingly accurate data while mitigating the burden on patients
- Putting patients at the heart of how we design clinical technologies ensures we’re building solution that work for patients and captures the data needed to demonstrate safety and efficacy
- The impact of the Covid-19 pandemic will accelerate trends that have been developing for years
Paul O’Donohoe
Scientific Lead, eCOA and Mobile HealthMedidata Solutions a Dassault Systèmes Company
2:10 pm - 2:50 pm
CREATING A PATIENT-CENTRIC APPROACH THROUGH DIGITAL INNOVATION
Terttu Haring -
Global Head for Clinical Digital Innovation,
Sanofi
- How to leverage digital innovations for strategy, operations and patient engagement of your compound development plans
- What questions to ask and answer at which time-points in your planning,
- How to assess the impact on productivity, pace and patient centricity with your digital innovation
2:50 pm - 3:20 pm
CONTENT BREAK
3:20 pm - 4:00 pm
MATCHING THE RIGHT PATIENTS TO THE RIGHT TRIALS
Gareth Powell -
Business Development Officer and Patient Engagement Project Lead,
NIHR Clinical Research Network
- Ensuring the patient voice is heard throughout the lifecycle of a trial to guarantee better study delivery for patient benefit
- Leveraging AI to improve patient recruitment and enabling real-time clinical trial matching based clinical data at the point of care
- How is the ongoing pandemic affecting patient relations and patient diversity?
Gareth Powell
Business Development Officer and Patient Engagement Project LeadNIHR Clinical Research Network
4:00 pm - 5:00 pm
THE DOMINO EFFECT: ALIGNING ELIGIBILITY, RECRUITMENT AND DIVERSITY
Elizabeth George -
Director, Clinical Trials Diversity,
GSK
Keri Mcdonough - Lead, Advocacy and Patient Relations, Syneos Health Communications
Poonam Pattni - Senior Associate, Global Clinical Trial Disclosure, Eisai
- A brief history of barriers and the current state of diversity in clinical trials
- Inclusive Design: Are your trials reflective of the patient population they aim to serve?
- How can trials be more reflective of populations with disease?
- How can we increase education and awareness to avoid patient bias and improve recruitment?
- What are some other approaches to overcome barriers and extend the reach of trials to more diverse participants?
