Medidata Solutions is a global provider of cloud-based technology and data analytics for clinical research. They work with a variety of life sciences clients who conduct studies to gather, store and analyze data to help assess the safety and efficacy of their products before bringing them to market. Amassing and securely storing the enormous amounts of data generated in clinical research can be challenging, as can handling and analyzing these datasets. Medidata aims to provide a platform to help streamline this process and overcome regulatory hurdles. One focus for the company is helping sponsors who are interested in leveraging wearable devices in their clinical R&D programs, which are becoming more popular. However, there are still some challenges to overcome before the trend is fully adopted.
Medgadget had the opportunity to ask Medidata’s Managing Director of Mobile Health (mHealth), Kara Dennis, some questions about their business and how the organization is helping move clinical research forward through the use of wearable devices.
Conn Hastings, Medgadget: What is Medidata’s role in alleviating some of the frustrations that come with collecting large amounts of data from clinical research, particularly when it comes to wearables?
Kara Dennis, Medidata Solutions: The heart of Medidata’s business is improving the way clinical research is designed, conducted and analyzed through integrated technologies and data analytics. The emergence of mobile health is enabling sponsors to capture a richer, more complete dataset directly from patients, gain unprecedented visibility into the patient journey, and provide researchers with a more objective, nuanced picture of a therapy’s safety and efficacy. However, working in mobile health often means ingesting large amounts of data from high-frequency devices, such as wearables. This can include sensors that are collecting hundreds of data points per second, and if you have patients who are wearing devices for long periods of time, the data sets get extremely large and can be difficult to sort and analyze.
That’s why we tell our clients to leave the data operations to us. Our data capturing system allows us to gather, process and store large volumes of data all within our single, unified platform. Medidata then organizes the raw data into tangible numbers for customers to glean insight—from easy-to-interpret dashboards to summary metrics in their clinical records. This eliminates worry about how the data got there or the quality of the results.
Medgadget: Are you concerned about data security, particularly when it comes to sensitive patient health information, considering Medidata’s cloud-based platform? How does Medidata address this?
Kara Dennis: At Medidata, we are highly cognizant of the importance of protecting patient information and customer data in our field. Bringing data relevant to clinical development together in a regulatory-compliant way is not only one of our core competencies—it’s ingrained in our DNA. Medidata has been operating in the cloud for more than 15 years, investing heavily in best-in-class processes and building our systems to adhere to global regulatory standards.
In the growing era of digital health, Medidata is committed to lowering the barrier of entry to mHealth, making it easier for life science companies to conduct studies that leverage the best possible tools for collecting diverse, rich sets of data—all within the secure, scientific and regulatory-compliant environment of clinical research. Many companies capture and aggregate data from wearables, but data used for regulatory submissions must answer to a higher scientific standard.
The capture and storage of patient data for research must adhere to a strict set of regulatory requirements that are engineered into the Medidata Clinical Cloud. Our platform ingests mHealth data, creates a regulatory-compliant audit trail, and aggregates and transforms the data to extend to the clinical record. Medidata uses a well-defined framework of standard operating procedures (SOPs) in accordance with our Quality Systems program overseen by our Quality & Regulatory Affairs organization. Medidata takes every step possible to protect privacy, which is why our platform is GCP-compliant and adheres to standards for confidentiality of subject data, fit-for-purpose and security.
Medgadget: How does Medidata Solutions help medical device developers to test their technology? What are the specific challenges and factors in clinically testing medical devices, including wearables?
Kara Dennis: Medidata’s life blood is helping life sciences companies leverage technology to better understand therapeutic response in patients. Whether we’re working with a biopharma or medical device sponsor, the nature of our collaboration is to test the efficacy of a new therapy—from drug compounds and biologics to surgical implants, such as heart stents. Wearables, both medical grade and consumer, are playing an increasingly larger role in that process. For example, companies may use sensors to evaluate range of motion or recovery after surgery, or overall quality of life based on the proxy of movement or steps walked. Medidata helps the life sciences community better understand their patient population, the nature of their illness and ultimately create a better course of care for the patient.
Medgadget: How does the Medidata platform, coupled with internet-enabled devices, improve the experience of test subjects in clinical trials? Can data from individual medical devices be directly and automatically uploaded to the cloud, meaning that people don’t have to attend a clinic as often during a trial?
Kara Dennis: There is potential for the use of wearable sensors to reduce the number of clinic visits or the number of procedures required as part of the study protocol. Medidata is excited about this paradigm shift and expects to see this type of technology evolve and multiply in the near future. While the idea that patients can skip the clinic entirely remains a bit aspirational, the use of technology to provide more information to the user—and to make the wearable experience simpler and more seamless—exists today.
The industry is still exploring the potential to reduce the number of times individuals see a physician during their trial, but that is the goal and it holds great promise. At Medidata, we are focused on ensuring that patients who are wearing a sensor, or using mobile app technology, have a better study experience. We recently added an electronic consent (eConsent) tool to our portfolio of mHealth solutions, which helps better explain to a patient what they should expect throughout the course of the trial.
As far as reducing clinic visits, there are a few hurdles that still need to be cleared for both Medidata and the life sciences industry to get there. Today, our clients are exploring the use of sensor data, and trying to determine if can replace in-person visits completely. Subjects continue to attend traditional doctor appointments while simultaneously wearing sensors. As such, we are still learning from such devices—the research and analysis is still ongoing.
Medgadget: What is your take on wearable medical devices? Are there improvements we could make to existing technologies?
Kara Dennis: There are degrees of quality within the mHealth space and we are learning a lot about what characteristics make up an “excellent wearable.” At Medidata we believe there are two key components of a medical wearable device: one is user experience and the other is data quality. This is the criteria we use to evaluate each device. User experience ensures the sensors are easy to wear, light, waterproof, have a long battery life, etc. Those components are a big deal from a UX and compliance standpoint, and can determine whether or not the study is successful. Data quality is just as important—the ability to sync data easily, provide access to raw data, apprehensiveness, liability, accuracy and so forth.
We believe there are always going to be improvements that can be made to existing wearable technologies. There are some devices that lack maturity at this point, and are simultaneously preventing greater adoption in the industry. If you take a look at big pharma companies, they are slower to adopt wearable devices, which may be attributed to a lack of industry guidance. Big companies are looking for validation from regulatory bodies. We believe that the FDA is very open to taking on this initiative, but they seem to be waiting for more evidence—i.e., results that show a direct comparison between wearable device data and whether or not the user’s quality of life and health is improving. At Medidata, we provide the technology and analytical insight to pave the way for such evidence to grow. Clients are exploring, experimenting, gathering data and using our technology to discover new digital biomarkers, study endpoints and ways to improve the patient experience. We’re excited to be playing a foundational role in helping the industry get to this point.
Medgadget: What should we expect from the wearables industry over the next decade?
Kara Dennis: We expect to see a lot of changes and advancements from the wearable industry over the next decade. We predict a set of manufacturers will emerge that will specifically target their wearable devices toward use in clinical development. These devices will include components unique to clinical R&D—for example, they might need to blind some of the data that patients can access in order to avoid bias. In the early days of wearables, there were very few companies that met all of the regulatory, data and patient needs, and we think, increasingly, there are cohorts of manufacturers that are primarily focused on bringing wearables to market. We predict in the next decade the number of manufacturers dedicated to this will only increase.
At Medidata, we are finding that much of what is happening on the consumer side of wearables is driving change in the devices used for clinical research. This may not be intuitive, but the physical attributes of the device are directly related to the success of the study. We have interviewed patients in the past who said they don’t want to wear something that is clunky or not waterproof—this makes a big difference in whether or not a user keeps the device on. We find that as the products get sleeker, lighter, non-obtrusive and more durable, clinical studies become more precise. Every time something “new” makes a big splash in the wearable device industry, we find there is an uptick in the volume of people who are interested in wearing a sensor, or volunteering as a participant for a study. Over the next decade, we expect a lot of “splashes.”
Medgadget: Are there any specific issues or perceptions regarding wearable devices or clinical devices that should be addressed in future?
Kara Dennis: One of the biggest misperceptions in the space is that sponsors may think regulatory agencies could be an obstacle for them to conduct a trial or exploratory work in the space. However, the FDA has spoken publicly on several occasions to share their interest in collaborating with big pharma companies on how to move forward with novel technologies in clinical trials. We think the FDA’s interest in collaborating is extremely powerful, but often unknown or overlooked.
Link: Medidata Solutions…