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We explore the remote trial and hybrid models in clinical trial patient centricity with Hassan Kadhim, an executive at Boehringer Ingelheim.
Our series on patient centricity continues, as we delve deeper into the biopharmaceutical perspective. Hassan recently spoke about patient centric models at PanAgora’s Patient Experience Summit. In this interview, we will explore the remote trial and hybrid models in clinical trial patient centricity with Hassan Kadhim, an executive at Boehringer Ingelheim - Business Consultant of RDM Clinical Operations. There will be more discussion on the topic at PanAgora’s Mobile Innovations Summit.
Moe Alsumidaie: What does patient centricity mean to you?
Hassan Kadhim: Patient centricity has become very popular over the past five years, especially in clinical research, although it's not a new concept. It gained more ground with the Affordable Care Act in 2010. In the context of clinical research, patient centricity is about putting the patient at the center of every thought process in designing clinical trials. For a clinical trial, it’s about designing a trial that is comfortable for the patient and minimizes the burden on them.
I have been specifically focusing on remote trials when thinking about patient centricity. A remote trial by definition is a trial design focused on using one central coordinating site, and allowing patients to join a study from several locations within the country, which removes distance limitations, so that patients can join a study without having to be geographically co-located with a site. In my graduate research, I have focused on defining a remote trial for the United States; for example, the remote trial would consist of one central site and patients joining into it from several states.
MA: Can you elaborate on the 5 components of a remote trial?HK: Patient Recruitment: The first component of a remote trial is patient recruitment. Since the site is not necessarily located in the same geographic location as the prospective subject, we would need a strategy for recruiting patients remotely. This includes utilizing today’s digital opportunities, such as social networks, dedicated disease social networks, and patient matching tools. This component also includes utilizing electronic health records to target specific patients across the country that could be a potential match for the trial.
eConsent: If patients have been pre-screened and are eligible for the trial, they can go through the second component of the remote trial, which is the electronic informed consent, taking place remotely. Patients would have access to a device, like a computer screen or a tablet, and go through the educational portion of the informed consent process remotely. Then they would have an interaction with the site (remotely) but via telemedicine so that site staff are able to answer all of the patient’s questions and ensure that the patient is informed. If the patient is still interested in joining the trial, they sign the informed consent documents electronically. The physician or site staff cosigns, and then the patient is officially enrolled in the trial. During this process, you also have to screen the patient to ensure they are eligible for the study. Screening procedures can be done remotely by sending a qualified staff member (i.e., remote nurse) to the patient's home or allowing the patient to get screened at a nearby clinic. Alternatively, depending on the protocol, some screening procedures can be made remotely at the patient’s home using specific digital devices. After the patient is enrolled in the study, the device and study drugs are shipped to them, likely via the central coordinating site.
Remote Data Collection: The third component of a remote trial is remote data collection using electronic patient reported outcomes or validated sensors and wearable devices. Remote data capture would be done electronically at the source (eSource) and we need to figure out a way to upload this data into an electronic data capture system (EDC). A good trial candidate fitting the remote trial model should have an outcome that is measurable remotely via a sensor, or could be a patient reported outcome like quality of life questionnaires. Therefore, it is clear that not all therapeutic indications would be suitable for this model.
eMonitoring: The fourth component of a remote trial is monitoring. We call it eMonitoring, and it consists of a robust risk-based monitoring approach, telemedicine to replace the in-clinic visit schedule with an e-visit schedule and some form of remote drug adherence monitoring, powered by digital tools, to ensure patients are compliant with the treatment regimen.
Patient Engagement: The last component of a remote trial is patient engagement which consists of making sure that the patient is always engaged with the treatment and with the trial through reminders and notifications; this could be an app or a website where the patient has all the necessary information they need at their fingertips. We feel this is an essential component of success for the remote trial, as patients may feel distanced from the clinical experience if they don’t have regular engagement cues while they are part of a remote trial.
MA: Can you tell me about the Hybrid Model?HK: There are additional considerations that need to be taken before jumping into a remote trial and it may be overwhelming for a sponsor. This is where the idea of the hybrid remote trial model comes in. The hybrid trial does not eliminate all of the sites; for example, if you are conducting a trial that needs 10 sites across the United States, you would still keep those ten sites, but you would minimize the number of visits per patient. You could have an initial screening visit and a last visit at the clinical site, but everything in between is done via telemedicine. Data would be collected remotely via remote data collection or eSource, so the patient does not have to come in for a physical visit at the site. There would still be an RBM strategy and a remote drug adherence monitoring strategy. Patients can be recruited online if it's deemed useful, but can also be recruited at the site. Informed consent can happen at the site, regardless of whether it will be in an electronic or paper form. The hybrid aspect of the model also allows patients the flexibility to access and visit the study site whenever they want. The hybrid model also allows sponsors to move forward towards an eventual remote trial in the future by first applying and learning how to implement these new methods and approaches, in a robust manner within an interventional clinical trial.
MA: How are regulatory agencies changing to accept this sort of innovation?
HK: Regulators have taken steps in making clinical research more patient centric; they have released draft guidance and sought input from trial sponsors on improving patient centricity in clinical research including the use of technology, as many sponsors responded to a 2015 Federal Register Docket on creative use for technologies in conducting clinical investigations. The FDA is quite open to innovation to drive patient centricity and reduce patient burden in clinical research. For regulators and pharmaceutical sponsors, keeping patient safety and security in mind is of the utmost importance, while continuing to drive innovation to enhance the patient experience in clinical trials.
MA: What are the driving forces behind the biopharmaceutical industry to initiate patient centric initiatives?HK: The patients of today and the patients of the future. If you think of the millennial generation, they have grown up to expect a certain way of interacting with any industry because of the influence of the internet and modern digital tools and how these have made the world so small. Millennials come to expect a certain level of interaction with the different industries that they deal with. The patient of the future expect similarities in convenience and remoteness from the biopharmaceutical industry if they want to be engaged in a clinical trial. The other example is that it is becoming increasingly challenging for the pharmaceutical industry to engage and find treatment naïve patients to recruit into clinical trials, and our research suggests that we need to design and execute studies in a more patient centric way to make sure patients are not only motivated, but also do not feel burdened for being a study participant.
If sponsor companies resist this change, we will reach an era where the companies in the industry that have evolved towards a more patient centric approach will have a competitive edge over those that have not. The companies that have innovated and evolved towards a more patient centric approach will be able to not only recruit patients more effectively but also collect data more efficiently, and potentially reduce their cycle times and overall development costs. We are moving into the Pharma 3.0 era where it's not just about the drug, but also everything else that is provided with the drug. The seamless integration of the experience of being in a clinical trial with the patients’ daily lives will make advancing clinical research much more compelling for patients of the future. This is not simply a pharma industry trend; it is a trend of the 21st century, the digitization of all industries. Throughout the course of my work, I was motivated by the motto: “Making more health for generations to come”, and I think the industry needs to put the patient of the future in their strategy to efficiently address and tackle the rising challenges of the near future.
Hassan Kadhim wrote a research thesis paper on the Remote Trial concept – entitled: “The Remote Trial Concept to Drive Patient Centricity” – available for download at: http://bit.ly/RemoteTrialsThesisPaperHK. Follow Hassan on Twitter @mrhskadhim
Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.