What are some of the current critical issues facing the industry with regard to clinical trial data collection and analysis?
The first critical issue I’ll mention is the volume and variety of data that is now available. The industry has evolved into a digital, patientcentric environment that is producing massive amounts of patient and population data. Research data is no longer limited to clinical trial data. Now, it increasingly includes real-world patient data captured by clinicians, data generated by wearable sensors, patient reported outcomes, and even genomic data. While this is great for research, the challenge is figuring out what data is most valuable, where it exists, and how to ensure it is trustworthy.
A second, related, critical issue is figuring out how to derive meaning from all this data. Just as in most areas, looking at something in isolation introduces risk. To get a complete picture and take full advantage of all this data, researchers need to look at what it means in the context of other data. At Oracle, we are constantly hearing from biopharma, medtech and CRO about their struggles with data collection, aggregation and analysis.
The availability of all this data has great potential to positively impact clinical research, but only if we are able to access it, synthesize it, and use the insight gleaned from it to make better, faster decisions.
Can you tell us about some recent technological innovations that are helping pharmaceutical companies meet their clinical trial data collection and analysis requirements/goals?
Years ago, the themes were cloud and mobile. These innovations laid the groundwork for both the increase in data that we see today, as well as our improved ability to access it. Understanding the direction of this innovation, Oracle Health Sciences anticipated the need for a single platform that would aggregate, organize and clean data from multiple sources in a single location. Last year, Oracle Health Sciences launched its Data Management Workbench (DMW) Cloud Service. Our DMW platform enables pharmaceutical companies and CROs to integrate, reconcile and analyze data from any source and get valuable insight from the data. By automating data flow and standardizing data for review, clinical researchers can have real-time access to meaningful information for rapid clinical trial decision making to get drugs to market faster.
Another area of tech innovation that has tremendous potential to help pharmaceutical companies meet their clinical trial data collection and analysis requirements is artificial intelligence (AI) and machine learning. Other industries are already successfully using AI and machine learning to automate both simple and complex data review via algorithms based on human reasoning and judgement. It is a fascinating area of innovation. This technology is now being applied in areas of clinical research such as safety signal detection. At Oracle, we are very interested in exploring how to leverage this innovation to make our eClinical solutions even stronger.
When a pharmaceutical company is choosing a company for clinical trial data collection and analysis efforts, what questions should be asked? What qualities and expertise should a provider have to ensure that clinical trial data collection and analysis goals are met?
The new era of clinical outsourcing is built on data transparency, trust, and collaboration. To meet these demands and take advantage of new ways of conducting clinical trials, sponsors and CROs are looking to cloud-based technology solutions. Cloud-based, multi-tenant Softwareas-a-Service (SaaS) solutions are, inherently, built for collaboration. Such platforms are a single instance, so everyone is actually looking at the same data at the same time – no more walls, no more redundancy. This alone solves a lot of the problems study teams face as it relates to data transparency, trust and collaboration. In addition, cloud-based, single instance platforms also help with data quality and data governance. So, specifically looking for cloud-based solutions is important when evaluating data management solutions for clinical research.
In addition, as sponsors and CROs begin incorporating new data from various sources and in various formats, they will want to look for solutions that can handle this, and handle it well. Study teams will need a data management platform that can integrate, reconcile and analyze all of their clinical and healthcare data in a single place. Not only that, they will want a platform that automates data flow to streamline activity and speed delivery of insight to facilitate rapid decision making. By using an integrated workflow, data discrepancies can be closed faster, reducing clinical review cycle times and increasing overall data quality. So, automation is an important requirement, when evaluating solutions. Finally, as study teams are expected to respond quickly to new information and changes to the trial, sponsors and CROs should look for technology that is flexible, adaptable and user-friendly.
Some questions to ask software vendors, related to these requirements:
- What tools do you have available to help me clean and monitor data?
- How flexible are your reporting capabilities?
- Are you prepared to support my mid-study changes or amendments?
How has the globalization of the pharmaceutical industry affected clinical trial data collection and analysis?
Globalization has compelled the industry to seek solutions that are available around the clock to support study team members and sites, regardless of their location. To match the global nature of clinical trials and working with larger, more diverse populations, sponsors and CROs need to partner with vendors who also have a global presence and have demonstrated experience supporting a global customer base.
The most notable impact of globalization on clinical trial data collection and analysis is definitely its role as a catalyst in moving clinical research to the cloud. On-premise solutions are fading out and being replaced with light-weight cloud-based SaaS solutions. Cloud-based solutions are flexible and scalable, supporting adaptable trials and changing requirements. In addition, by design, cloud solutions are built to put control in the hands of the users. Simple and intuitive user interfaces and on-demand training mean study teams are up and running faster and require less reliance on vendors to make changes as their trial requirements change.
What future clinical trial data collection and analysis innovations do you foresee? How will they help pharma companies test and bring products to market?
The CRO-sponsor relationship is evolving from single task-based services towards more strategic services that align around science that, ultimately, optimizes clinical development. Creating an alliance between the sponsor, CRO, and technology vendor sets the stage to grow opportunities that combine the resources, processes, and tools of all stakeholders to compete successfully in the marketplace and add value to clinical development.
From a technology perspective, the industry is moving away from highly-customized, time-consuming solutions to those with the ability to be rapidly configured. There will be a focus on the interoperability of functions throughout trials, rather than an effort of building productized integrations between silo’ed point solutions. More tools will provide automation of data transformation and aggregation, saving the industry millions by removing manual work from clinical trial process.
Dr. MaryAnne Rizk globally leads the CRO Business Partnership strategy at Oracle Health Sciences. Prior to joining Oracle, MaryAnne was the Senior Director at Medidata’s CRO Partner program, leading the eClinical SaaS business through accredited CROs Channel partners. At Merck, MaryAnne had lead both global clinical and commercial technology initiatives, including the collaborative Merck & Schering Plough joint venture and the deployment of Merck’s global clinical trial portal for principle investigators, and managed clinical outsourcing activities to key stakeholders of CROs, SIs and technology vendors.
Dr. Rizk has received her Bachelor of Engineering and Masters in Management from Stevens Institute of Technology. She holds a PhD in Technology Management specializing her dissertation in Pharmaceutical Strategic Partnerships. Dr. Rizk is an active leader and speaker of Healthcare Innovation through chairing various board memberships and is a proud member of the following networks: Healthcare Businesswoman’s Association (HBA), New York Health Business Leaders (NYHBL), Drug Information Association (DIA). You can reach MaryAnne by email or follow her on Twitter @RizkManagement