Clinical Trials: Patient Centricity and Wearables

Mana Chandhok:
Hi everyone. Welcome to this pod cast from Cambridge Health Tech Institute for the SCOPE Summit, which runs January 24th to the 26th, in Miami, Florida. I am Mana Chandhok, an Associate Producer. We have with us today one of our speakers from the Clinical Technology and Innovation conference, Jaydev Thakkar, a Director of Information Systems at Amgen. Jaydev, thank you for joining us.

Jaydev Thakkar:
My pleasure.

Mana Chandhok:
Clinical trials are constantly innovating, and the latest change is the viewpoint towards patients. How are these patient centric trials different from traditional clinical trials from the data management point of view?

Jaydev Thakkar:
While some companies have already made good strides in bringing patients in the limelight and the focus of clinical development phase, I think the industry in general as a whole, we are now realizing how critical the patient is part of this clinical development phase. I think some of the early focus has been around how to reduce patient's burden and keep the patient more engaged throughout the clinical trial phase. I see our industry starting out with designing clinical trials with some patient focus, patient panels, and patient conversations helping in the design phase, and then going into throughout the course of study conduct, how can we keep the patient more engaged.

By doing this, essentially we are starting out and telling the patient that we appreciate you taking part and anything we can do to reduce the burden is a big part of this conversation. In traditional clinical trials, patients typically consent for clinical trials upfront and are not aware of what data points are being collected. With patient centric trials, we are getting feedback from patients up front in the design process. In particular, for outcome focused or value based trials, earlier patient engagement can aid in making the determination of what data points are really needed for trial to meet its objective.

The fact that the patient is engaged earlier on, they will be more motivated throughout the trial journey, increasing the patient retention and lowering the probability of missing data points. From a data management perspective, the biggest change may come from trials that are looking to reduce patient burden of clinical trial visits by requiring data more remotely through avenues like TeleMedicine, or MHealth Technologies, or sourced directly from EHR. eSource data can be more richer than higher quality requiring significantly reduced effort for data planning activity while more effort in analyzing the data side and generating some insight from the real-time stream of data. This may mean data management function would be dealing with fairly different sets of challenges for the future of these trials.

Mana Chandhok:
Wearables have taken over not only everyday devices, but healthcare as well. How do you envision wearables changing the future of clinical trials?

Jaydev Thakkar:
That's a good question. I see wearables still in the early days, but I've seen two distinct ways where this could become a likely game changer. One from a patient experience standpoint, and the other one from the value of the product. We now have access to remove data that we are collecting, possibly from patient using wearables and sensors, thus potentially eliminating a site visit for patient to go to a clinical trial site. Now, data is collected at the comfort of their home and that's probably going to make patients more easily readily be available for taking part in a clinical trial that might in terms expedite their recruitment.

From a product value standpoint, I think wearables have opened up an opportunity to tap into possibly novel endpoints such as sleep patterns, or activity tracking, or even heart rate. The data streams are continuous and are providing us an objective measurement. That in turn can help us justify the value of the product. These novel end points can be a big differentiator for companies to showcase both to the regulators as well as to the payors.

Mana Chandhok:
We are very much looking forward to the SCOPE Summit in general and the Clinical Data Strategy and Analytics Conference in particular. As a speaker and an attendee, what are your goals and expectations for the meeting?

Jaydev Thakkar:
I'm looking forward to share with the rest of the community what we have been doing in the innovative space of future clinical trials, and then get the feedback and engage in a Q&A while I'm being a speaker there. I'm also very much keen to engage with the peers and the discussions, and various networking opportunities, to learn more about what they are doing, how they are embracing this new wave of clinical trials, learn how they are dealing with various challenges associated with this wearables, sensors and mHealth technologies and see how we can leverage potentially common ways, common approaches, as an industry to solve some of these upcoming challenges.

Mana Chandhok:
Jaydev, thank you for your time and insights today.

Jaydev Thakkar:
My pleasure. Thank you for giving me an opportunity to have this discussion.

Mana Chandhok:
That was Jaydev Thakkar of Amgen. He will be speaking at the Clinical Technology and Innovation Conference at the upcoming SCOPE Summit taking place January 24th to the 26th, in sunny Miami Florida. If you'd like to hear from him in person, please go to www.scopesummit.com for registration information and enter the keycode podcast. I'm Mana Chandhok. Thank you for listening.