Frictionless Data for Clinical Innovation: “The Patient Is the Source”

Wednesday, September 2, 2020, 2:00pm – 2:45pm

Moderator: Temitope Keyes – VP, Business Development, Adaptive Clinical Systems

Dannelle M. Palmer, MBA, PMP, Vice President, Clinical Operations, OncoBay Clinical
Jennifer Gaskin CCRP, CMQ-OE,  Senior Director, Quality, Centrexion Corp 

Part Two Addresses: 
Frictionless Data for Clinical Innovation: “The Patient Is the Source”

In today’s new environment, the Patient has become the central focus and challenge  for clinical trials. Dramatic change is underway across the continuum of clinical development as sponsors adapt and adopt strategies for implementing decentralized trials (DCT).  The goal of this webinar is to discuss the approaches for implementing this new patient-centric model.

  • What does it take to recruit, retain, and engage with patients while remote?
  • How to sustain and manage valuable research site relationships?
  • Why we need to adopt new digital tools like EMR/EHR, eSource, mHealth/wearables?
  • What clinical and data operations changes are needed to successfully implement DCT that will facilitate fast data acquisition and enable the automation of data flows to gain real-time insights and holistic reporting?

Poll Question #1 :Attendees

Poll Question #2

Here’s what our panelist believe how COVID-19 changed clinical trials that were already underway. 

“The impact and fundamental issue of getting data by going to physical sites is a challenge to patient recruitment and engagement – that’s the most pressing changes that are happening. I believe it’s here to stay – I just don’t think we can go backwards. Transparencies and changes in our culture will need to change.”   

“People have been waiting for this opportunity. We envision this as drag racing and green lights and we hit the final light and it’s all a go. Can’t get bogged down now.” 

Barriers to Digital Innovation in the COVID Era

“Barriers are coming from leadership from larger companies… the mindset of “tried and true” that has always worked. It’s hard to argue it won’t stay; the industry needs to make the shift and a lot of things need to be worked out like source data – to do remote monitoring in the right way.  Getting those documents from a remote process is the barrier but we are going in the right direction.”

“Keep in mind 10 years or 20 years of progress happened in one week in March.  Remember it’s not a hurricane that comes and go. This is such a broad pandemic that it’s impacting people in a broad way, but pharma doesn’t work that fast.” 

What is “frictionless” clinical data? Why is it important?

“When we look at source data capture – it’s siloed. Think about EDC, e-Source, EMR, EHR – how do we break those barriers? We can’t engage patients at the site and pay them….this is a radical shift.  Will we go ahead or stay with the things we know.  We are the most regulated in the industry – making data fluid by breaking down those silos and making it more efficient….I think we will have the permanence of these changes.” 

“I agree with the individual silos – we tend to think that frictionless data occurs if all data is in one database but there are new strides in the industry – new tools that access all the data regardless of where the data resides. These new tools will help us get to where we need to be.” 

“Measuring frictionless data – is it quantifiable?  It’s a matter of time from bucket of activity to bucket of activity….starting with planning, and I mean thoughtful planning for data flow seamlessly from end to end.  Well thought out plans of moving data from the right person at the right time is plan heavy and data centric.” 

“Larger organizations will drive the changes….big pharma has to lead the way.  They are very active but they still have a lot of legacy systems they can’t abandon too quickly but they can be the stumbling block for moving forward.  Now is the time to be looking at more end-to-end strategies.  COVID has allowed people to move quickly on COVID trials….we know it can be done…so let’s get out of our own way to move forward.” 

How about CROs? Can they impact frictionless data?  

“Thinking has been changed that smaller companies can take more risks and able to quick change course because they don’t have the larger legacy system.  We will need a greater trust in our partners.  We can’t work out the bugs until we take on a new partner and work out the bugs together. We need to shift that paradigm to be willing to take risks together and respect each other’s vulnerabilities.”

“The bigger challenge for sponsors becomes a small thing – they have the scale issue to deal with.  So while they want to drive standardization and tools, it makes sense to explore and use technologies and expand to larger sets of studies.”

As sponsors design trials for the “new normal,” what will they need to emphasize? We are still in the first wave….is there a new normal? 

“We are changing the way we think about trials….the patient centricity era is here. Now we start with the patient first, what data are collecting, what data do we give back, and what analysis has to be done?”

“The regulatory barriers are there but if we shift the focus to the patient – the patient is the source.  We need a framework to directly engage with the patient.  The regulatory body needs to catch up with the technology.”

“We need a much more flexible with the regulatory authorities – it motivates large pharma and smaller organizations to be more agile.” 

“We have an opportunity to have influence. Even prior to COVID, regulators gave some guidance to follow, but we know it’s time to switch gears in terms of oversight and monitoring.  The gloves are off now.” 

Poll Question #3

“Patient is the source. If we’re talking about collective efforts for patient centricity, this is our moment.  

“Biometrics team is where it starts: we need to determine the data and where the data is coming from. We need to scrutinize our protocols.” 

What new data sources and endpoints will we see?

“We should be able to ask any question and get the data we need.  It starts with the patient – tee it up in the beginning and patient as a source and patient as a destination – meaning  what do we give back to the patient?

“One of the things we are seeing are more tech savvy things like Alexa will need to be considered. Data integration has been talked about in our industry using excel spreadsheet but now in a multi-source and bi-directional manner.  Take virtual reality, for example, to have a site visit and giving back to the patient a full experience.” 

“Data sources are changing dramatically.”

[Question from the audience] Do we think sponsors will limit to essential data?

“It will be reduced somewhat but I think there’s always going to be a need for getting more out of your trials…exploratory … not so much to answer the question at hand. We collect a ton of redundant and unnecessary data today.  A lot of that will be filtered out.” 

“With the volume of data (like my shopping preferences) we will get new data because we are going save some dollars (saving on patient sites and expenses attributable to that) using analytics platforms, but I think we will collect more data than less.” 

[Question from the audience] “What’s the role of wearables and AI – what’s the impact?”

“Everything we collect from a patient in a thoughtful way, must go into the planning up front, and if we’re collecting it rapidly, we need AI.  They go hand in hand.” 

“We have to be smart about the application of these, but AI is good at large volumes of data. We must have a baseline that you measure on top of…AI is good at prediction and forecasting.  But if you’re in Phase 1, you don’t need it.”  

Key Topics In This Webinar Discussion:
• Trial types – what model will ensure the highest quality data, patient engagement, and site performance?
• Data sources – what modalities (e.g. mHealth) will best enable the capture and reporting of relevant endpoints, critical safety data, and defined KPIs/KRIs
• Technological innovations – what novel tools and platforms can be deployed to facilitate the speed, adaptability, and visibility required when sites, patients, and systems are diffuse?

The landscape of clinical development has likely been permanently altered by the global pandemic. Concepts like decentralized trials (DCT), adaptive designs, and mHealth are moving from possibility to necessity. Concurrently, the regulatory landscape is shifting as new guidance, ICH E6 (R3) and E8 (R1), are putting technology at the core of best practices to address the ever increasing complexity of developing new treatments globally. That means all stakeholders – patients, sponsors, providers, sites, involved in study conduct are now expecting to use built for purpose tools that rapidly capture, analyze, and deliver data. Dynamic data is frictionless. It is seamlessly aggregated, integrated, and interoperable so trials can be designed and conducted with maximum flexibility.