Data management in clinical trials

How health analytics solutions help researchers leverage historical data

The healthcare sector collects vast amounts of clinical data, much of which is ideally suited to clinical trials and research. However, historically, leveraging this data was challenging due to the fragmented nature of healthcare databases and the diverse array of data owners.

Arranging, conducting and managing data in a clinical trial is a complex process, requiring multiple approvals, significant funding and considerable time investment. In some instances, researchers progress through the process without knowing whether good data is available for research purposes.

An innovative digital health analytics solution, Omda Research is transforming how clinical researchers access and utilise historical healthcare data, making trials and research easier to conduct and removing obstacles that previously slowed progress. In this article, we explore the various ways health analytics solutions help researchers incorporate historical data into their studies and how Omda Research maximises the value of this data.

Larger and more valuable data sets

Previously, clinical trial data was compartmentalised, siloed and difficult to access. Individual trials stored data in independent databases, creating a fragmented data environment that forced researchers to either collect fresh data or painstakingly piece it together from various sources.

Omda Research is transforming the clinical trial data management landscape by centralising data, making it more accessible and enabling healthcare professionals to leverage historical data for cutting-edge research. This occurs in unique ways in different markets. For instance, in Sweden, quality registries serve as the primary mechanism for collecting and collating historical data. In the UK, there is a trend towards merging databases from related research areas. This creates larger and more valuable data sets, which researchers can leverage for future clinical trials.

AdobeStock 842307488 WP Full Width

Making the most of consolidated data

While consolidating and centralising healthcare data theoretically allows for quicker, more efficient and more cost-effective clinical trials, there is more to it. Clinical researchers also require a mechanism for extracting relevant data from these databases.

Referencing study protocols, Omda Research manages data retrieval from all available sources, collecting relevant data and depositing it in a unique database for analysis in clinical trials. The approach provides clinical researchers with a sizable, tailored data set that they can model and analyse in myriad ways, supporting their work and generating valuable insights.  By creating databases tailored to specific research initiatives, Omda Research streamlines the collection of valuable data, reducing costs and the time required to run trials.

To achieve this, the Omda Research solution is highly configurable. Clinical trials do not follow a one-size-fits-all approach. They measure and emphasise distinct variables and utilise unique study protocols. Omda Research accommodates this diversity and is tailored to the needs of clinical researchers, enabling them to conduct their trial in the most effective, efficient and scientifically rigorous way. In contrast, off-the-shelf solutions lack configurability, leading to compromises in how the clinical trial is conducted.

Support from Omda data scientists

During the process of conducting a clinical study, researchers often generate new findings and ideas that can shift the trial’s focus, leading to changes in data analysis approaches. This can result in clinical trial data management challenges, and ensuring the validity and comparability of data requires specialist expertise. While Omda Research facilitates these changes, researchers also benefit from working with Omda data scientists who can advise on the implications of these changes and their potential impact on the study.

While clinical researchers have the required expertise to analyse clinical data, they often need support with the technical aspects of data management in clinical trials. Many doctors may only perform one or two clinical trials in their career. Omda, which has managed numerous trials and has considerable healthcare experience, can provide the necessary technical expertise, ensuring that the complexities of clinical trial data management do not negatively influence the trial. This experience in data management is invaluable in clinical research and ensures effective checks and balances to prevent errors.

youre as fit as a fiddle shot of a dentist and a 2022 09 30 23 02 03 utc WP Full Width

Feature-rich clinical trial solutions

Omda Research also empowers clinical researchers by integrating features that make data management in clinical trials that much easier. In doing so, it also ensures compliance with study protocols and simplifies data handling.

For instance, in clinical trials, randomisation is an essential technique for avoiding selection bias, balancing confounding variables and ensuring the ethical distribution of participants. It enhances the validity and credibility of clinical studies and their findings. With this in mind, Omda Research incorporates features that allow for randomisation in historic data sets.

When collecting new data, monitoring and display tools enable researchers to view and analyse that information, making it easier to identify anomalies or deviations from protocols and enhancing data integrity. Visualisation tools simplify data interpretation and encourage informed, data-driven decision-making. Greater oversight of data improves transparency and accountability, creating a digital audit trail that researchers can use to demonstrate compliance with regulations and trial protocols.

Additionally, health analytics solutions must accommodate the various roles healthcare professionals perform in clinical trials. These roles often affect data visibility, determining what information is available to individuals conducting the trial. For instance, in blinded and double-blinded studies, some information needs to be withheld from participating researchers. The study protocol will determine these access requirements. Omda Research supports distinct user roles and complex access management.

As well as ensuring compliance with study protocols, user management features also support ethical research, ensuring only data that is of significant scientific interest is made available to researchers.

International collaboration

Data from international clinical studies is utilised in various healthcare areas. However, it is particularly valuable in trials focused on rare diseases and orphan drugs, where the low number of potential participants means data has to be drawn from multiple sources. In these cases, the ability to quickly perform visibility tests and create databases that are compatible and comparable with those from other nations is extremely valuable.

However, this is challenging without well-managed data. Omda is the largest private player in managing quality registries in Sweden. These registries often contain significant historical health data and are maintained to meet the evolving standards that have been established in recent years. The depth and quality of these datasets make them well-suited for inclusion in international trials and facilitate the alignment and combination of data from various countries. As a result, these quality registries are particularly attractive to global pharmaceutical companies seeking to leverage the richness of Swedish health data.

Omda’s Health Analytics solutions

With innovative digital health analytics solutions, Omda provides researchers with the data, tools, and support required to conduct effective clinical trials. With access to some of Sweden’s highly respected quality registries and considerable experience from consolidating and ensuring access to well-managed data in other markets, Omda helps researchers identify and extract relevant data and guides them on how best to manage that information from a technical perspective. The solutions improve data management in clinical trials at all stages of the trial process.

Visit the Omda Health Analytics page to learn more about our solutions. Alternatively, contact the Omda team directly with any enquiries.

Roger Weman
Business Area Manager, Health Analytics
Categories

Related News

G-Cloud 14 Approval for Omda’s Health Analytics Solutions
Read More
Interoperability in Healthcare – Helping Systems Connect & Work Together
Read More
Data management in clinical trials
Read More
Data analytics is the beating heart of progress in medical science
Read More

Get in touch

Please enable JavaScript in your browser to complete this form.
Name
Helen Døcker
Chief Marketing & Communications Officer
helen.docker@omda.com
She is based in the company’s headquarters in Oslo, Norway.

Join our conversation to build a safer and healthier world.