Although technology is advancing, clinical trials have changed little over the past 20 years. Using traditional methods to collect and track data, visibility into the information may take not only weeks but sometimes months, resulting in lack of insight into early data and reduced ability to decrease our risk. When we make decisions, we are basing them on data that is way too old. Business as usual is getting stale and not moving us forward. Hey guys, we are in the 21st century! We have a different way of thinking and doing business at Otsuka Pharmaceutical Development and Commercialization. Innovative tools and technologies are readily available for us to use in the clinical trials today. Let's review some of the new technologies and put them to use:
- We can now obtain informed consent via a tablet with immediate visualization. Leveraging eConsent will enhance patient understanding and hopefully improve overall consent compliance. This information is easily included into the final study electronic datasets.
- Direct entry of data into a tablet, thus creating an eSource, can substitute for both site source documents and Electronic Data Capture (EDC). Bye, bye EDC. Making this shift to eSource will not only increase transparency which is definitely welcome by sponsors, but also reduce site workload which is definitely welcome by site personnel.
- Another tool that we can use is called eSupply (i.e., scanning). Implementing electronic management of clinical supplies will help reduce risks, decrease errors, and increase visibility. Conservative estimates from one small Otsuka study indicate we saved over 100 hours of site and sponsor time in reconciling trial supplies. This translates into savings for everyone.
- Digital medicine is coming and we all need to get on this bandwagon. We can now take a medication, embed an ingestible sensor into it at the point of manufacturing, and record the ingestion event via a wearable sensor. Voila, we can now measure ingestion at the pill level and aggregate the data over time. In addition, the wearable sensor has the potential to collect other physiological data including heart rate, temperature, activity level, and even able to measure rest. The patient has access to all data collected on their smartphone. With appropriate patient consent, summary data may be shared with their physician, treatment team, and even their caregiver via web-based applications. The beauty of the system is that the patient controls the flow of all data and who is able to see it. We believe this will provide greater insight into patient behavior which we have ever had to date. Most importantly, we will now know if a patient takes their medication or not!
Now, how do we bring this all together? We are developing novel combinations of cloud computing and storage capabilities to provide adequate and secure data management of multiple types of data streams (i.e., eConsent, eSource, eSupply, and digital medicine). A secure, cloud-based, scalable and flexible data processing/analytics platform has been constructed to collect structured, semistructured, and unstructured data simultaneously. This platform utilizes unique combinations of readily available computing tools to provide information in a readable format that can be accessed by any tool that has Hadoop/Impala interface capability or can be mapped to this interface. Our group is currently utilizing business intelligence tools and analytics engines to interface with the data and is now developing interfaces with traditional drug development statistical packages. Thus, digital versions of data collection are available for all phases of clinical trial conduct. These technology resources will allow faster access to the data for both the sponsor and sites alike. Bottom line: Faster access leads to the data will lead to appropriate insights and hopefully improved decisions in the drug development process.
All in all, generation, collection, and processing of data are changing dramatically with improvements in information technology, accessibility and bandwidth. Together, we can improve the clinical trial process by combining technologies and digital health solutions while providing timely data to authorized end users. Otsuka Pharmaceutical Development and Commercialization is collaborating and partnering with patients, clinical investigators, clinical research organizations, and innovative companies in an effort to integrate insights, operations, and digital medicine into complex CNS clinical trials.
eTools will enable us to have almost immediate access to data. This is definitely a new world which will require new business tactics. We can combine cloud-based technologies with open source processing applications to have near-time or real-time access to study data in a single dashboard view. Access to clinical data in hours and days rather than in weeks and months now allows for earlier decision-making and troubleshooting by all stakeholders in the trial process. We can possibly even recognize and mitigate the risks before they ever occur. And finally, the ability to provide integrated and streamlined analytics greatly improves the potential for breakthroughs and insights into complex CNS disorders which our patients are struggling with every day. This is the whole "raison d'etre" anyway.
*Timothy Peters-Strickland, MD, is the Senior Director of Global Clinical Development at Otsuka Pharmaceutical Development and Commercialization