Mobile Devices And RBM Expected To Drive Trial Efficiencies In 2016

By Ed Miseta, Chief Editor, Clinical Leader

Jonathan Zung has logged over 20 years in the pharma industry, and holds a resume that includes executive positions with both Bristol-Myers Squibb and Pfizer. He is currently the VP, Head of Global Clinical Sciences & Operations for UCB and serves as Chair of the TransCelerate BioPharma Operations Committee.

Zung’s specialties are currently in global operations management, with experience in merger and acquisition integration, strategic planning, organizational design and restructuring, and project management. I recently spoke with Zung about the trends that he believes have the greatest potential to impact clinical trials in 2016.

Ed Miseta: There is a big push now for a greater focus on patients, and mobile/wearable devices will play a role in that. Will the Apple watch play a role?

Jonathan Zung: There will definitely be a focus on how to provide services on the clinical side that will make it easier for patients to enter a trial and remain in it for the duration.  The Apple watch has some niche indications and what Apple is doing will clearly get everyone to think bigger. I suspect we are going to see breakthrough and disruptive technologies that will be far more advanced than the Apple Watch.

I also see more companies trying to understand how to best implement different types of devices and sensors into trials so as to get data in real time. Whether it’s the Apple watch or a device that can monitor blood pressure or detect a seizure before it occurs, we are going to see more and more of these devices used in clinical trials. We still seem to be on the forefront of that. There are more disruptive technologies and devices that will hopefully be available in the next three to four years, which are currently still in the prototype stage. The challenge will be figuring out how we can quickly incorporate these technologies into clinical trials to evaluate their utility.

Miseta: What can be done to help with recruitment and retention?

Zung:  There is no simple solution around enhancing recruitment effectiveness, although there is much work occurring in this area.  I often talk about the clinical trial of the future.   The trial of the future will be more patient centric.  It will utilize technologies and approaches that will minimize the burden for patients.  This means fewer visits to the clinic. Ideally for some studies, this could mean patients can enroll right from their home, and have their vital signs or other key measurements taken by a device that will transmit the information to central database or EDC system. It may also involve a patient going to a convenient location near their house, corner pharmacy with a walk-in clinic where a nurse practitioner or a PA can take their vital measurements, or going to a nearby lab to have blood drawn versus traveling to the clinical site. There has to be much more of a focus on how we can minimize the inconvenience for patients so they really want to participate in a trial.  In terms of enrollment, being able to effectively mine EMR and other key databases will allow for a better understanding of where potential patients and physicians are.  We must become more efficient as an industry in engaging the appropriate patients and ensuring diversity in clinical trials.

Miseta: Why are new technologies that can enable this still so slow to take off?

Zung: That’s a good question and it is something that every company struggles with. Companies often worry about how to successfully implement these technologies and how the health authorities are going to view the tools. At some point companies just need to move forward with a pilot, look at the results, make adjustments, and move forward with the next iteration. If we spend too much time focused on perfecting all of the details, we will talk ourselves out of piloting the technology in a study and the next technology or approach will arrive a displace  what we have been looking at. I always tell people in my organization that we need to run the experiment, get the answer, and then make a decision based on that. If it fails, then like any entrepreneur or innovator we go back, make the appropriate changes, and run another experiment. There will be failures; however, this is part of the development process  

A good example is the virtual trial that Pfizer ran a few years ago. It may not have been a positive outcome for them, but there were a lot of learnings that came out of that for the rest of us in the industry. We were able to see what worked, what didn’t, and what could be done differently. If we want to innovate, we are going to have to experiment.

Miseta: Will TransCelerate play a role?

Zung: looking forward, I believe we are going to see TransCelerate and other forums continue to put out recommendations and white papers on how to implement different approaches or share best practices to simplify the execution of a clinical or trial or add value in the clinical development paradigm.  There are also several vendors working on innovative approaches, and I believe their efforts will make a significant difference in the next couple of years. While TransCelerate is not working on any mobile-specific guidance, it is trying to understand what role it can play to help make the effort easier for companies much like it did with the white papers and recommendations around Risk Based Monitoring (RBM). In the case of RBM, TransCelerate developed a model approach for risk based monitoring of clinical trials.  The methodology, manuscripts and initiative updates have been openly shared both with member companies and non-member companies via the TransCelerate website, publications and presentations. 

Miseta: Are you seeing any uptick in the use of RBM?

Zung: With the volume of trials being run in many companies there are certainly meaningful efficiencies that can be realized using RBM. If you can look at data in real time and find trends in the data, there is long-term value to that, especially when running many studies per year and the desire to ensure trials are run on both an effective and high quality manner.  CROs are also implementing and leveraging their RBM capabilities both for large pharma and smaller biotechs.

Miseta: The guidance produced by TransCelerate seems to have been instrumental in getting companies on board.

Zung: I may be biased as a TransCelerate member but I think you’re right. Since its inception in 2012, TransCelerate has focused on its core mission “to collaborate across the global biopharmaceutical research and development community to identify, prioritize and facilitate the implementation of solutions designed to drive the efficient, effective and high quality of medicines.”    This has been and continues to be done through five strategic priorities: (1) improve the site investigator experience, (2) facilitate the sharing of information, (3) enable the harmonization of clinical trial processes, (4) enhance sponsor efficiencies and (5) improve the patient experience. 

TransCelerate is also a good example of pharmaceutical companies coming together in a consortium in the pre-competitive space to work on common challenges in order to simplify the trial process and offer common solutions. It is impressive to see the amount of work TransCelerate has delivered in just a few short years. Today there are 20 member companies. The industry is to the point where it needs to become more efficient, and getting companies to work with one another, in the pre-competitive space is one way to gain those efficiencies.   

Miseta: EHR seems to be the next frontier for greater patient recruitment. Will the EHR language issues be a problem for the industry?

Zung: EHR is clearly an untapped area.  More and more healthcare organizations, pharma companies and technology companies are working to develop approaches to search and mine EHRs.  There is no doubt that being able to  mine the EHRs will help identity a larger pool of patient patients for clinical trials or would could benefit from specific treatments.  Getting EHRs to speak to one another is something that has and continues to be worked on.  Great improvements have been made. I expect to see greater efforts being made in 2016 and 2017. While I don’t expect this problem to be totally solved in the next two years, I think we will see enough progress that three or four years from now there, communicating between EHRs will be more common and mining data the norm.

Miseta: What new technologies do you think will help pharma increase the efficiency of trials?

Zung: I believe mobile technologies and approaches like eConsent will be examples of where technology can be used to enhance the efficiency of clinical trials and hopefully the patient experience.   Today when a patient gets consented for a clinical trial, it is usually a lengthy paper document, which at times can be challenging for the patient given its length and complexity. eConsent approaches use technologies that simplify the consent process by putting the information into a simple, animated video that the patient can watch. There are points in the video where questions are asked to ensure patients understand the intent of the study and the risks associated with it. Not every sponsor or country has adopted it, but I see eConsent as a way to simplify how we work. 

Miseta: Some in the industry seem to be questioning the value of strategic partnerships. Any thoughts?  

Zung: This is a topic that will continue be debated as there is no one size that fits all.  I have worked in both strategic partnerships and in the functional service provider (FSP) model. There are pros and cons to each; however, I believe we will see more companies revert back to the FSP model since it can provide greater flexibility. The FSP model, when done in thoughtful way allows one to leverage the benefits of being able to pick the right partner for a particular study, or one particular aspect of a study.    I don’t expect to see strategic partnerships go away but I do believe sponsors will be spending more time deciding what is core to a strategic partnership and what can be done more efficiently through an FSP model.  In either model it will be important for the sponsor and CRO to measure the effectiveness of the partnering relationship with meaning performance metrics.