When you think about clinical data these days, it’s easy to focus on data integrity and compliance over anything else. This is likely due to the increased attention these have received lately, and it makes sense when you think about the consequences of not being compliant with current oversight regulations. But what if we start to think beyond compliance alone, and start to put that data to work?
There’s Gold in Them Thar Hills
If we’re going to all the trouble of collecting and reporting clinical data, isn’t there more we can get in return? To really conquer that mountain, perhaps we need to think about what’s under it as much as what’s on it. To maximize the return on our efforts, maybe we should view the collection and reporting of clinical data not only as a necessary step in meeting regulatory requirements, but also as a vital step toward mining for the potential gold inside.
Clinical research has evolved significantly since the first randomized controlled trial of streptomycin in 1946. The advent of computers ushered in the digital world, which not only spurred on this evolution, but paved the way for incredible advances and efficiencies.
Over subsequent decades, the biopharmaceutical industry continued to expand its use of digital capabilities, resulting in an explosive growth of collected data, which we’ve only recently started thinking about sorting and understanding. But mining this data for value requires new tools, new approaches, and new thinking.
Advances in the Digital World
This has resulted in the application of artificial intelligence (AI), data analytics, and other methods to extract useful information from the vast array of new data being collected as well as data already available. Researchers are using AI and machine learning to discern patterns in data that were not visible before the advent of these new tools. They are applying these insights into the design and development of novel therapeutics for a range of complex diseases, including cancers, neurological disorders, immune disorders, and more.
Data scientists are using AI and other data mining tools to look for previously unseen biomarkers and develop new algorithmic models for understanding disease. They are also using these tools to generate new genetic insights and expand their understanding of the human immune system in order to deliver the next generation of medical breakthroughs and, in some cases, cures for specific diseases. It’s an exciting time to be in clinical research.
But beyond the complex intricacies of genomic data mining, biomarker matching, and algorithm development, the clinical testing of drugs produces vast amounts of data that can be used in a range of applications beneficial to the industry and its constituents.
Transparency and Integrity Benefit All
The results of clinical trials can be used by physicians, patients, and policy makers worldwide to make informed decisions regarding the benefits and safety of new therapeutics. ClinicalTrials.gov was launched in 1999 to expand public access to information on new therapies in development and to maintain sponsor compliance with FDA guidelines for electronic submissions. Sponsors of certain clinical trials are required by law to register their trials on ClinicalTrials.gov and to submit summary results.
Registering clinical trials when they begin, providing timely updates, submitting summary results, and making this information publicly available fulfills a number of purposes and benefits a variety of people. For example, patients, along with their physicians and families, can search for actively recruiting studies that they may be able to participate in, or to learn about new treatments that are being considered for a particular ailment. Researchers can search the database to stay up to date on developments in their field, to find collaborators, and to identify unmet needs for investigation.
ClinicalTrials.gov is a both a registry and results database of privately and publicly funded clinical studies conducted around the world.
As a global registry, it helps:
fulfill ethical obligations to participants and the research community
provide information to potential participants and referring clinicians
reduce publication bias
help editors and others understand the context of study results
promote more efficient allocation of research funds
help institutional review boards (IRBs) determine the appropriateness of a particular research study
As a trial results database, it helps:
provide a public record of basic study results in a standardized format
fulfill ethical obligations to participants and promote the overall contribution of research results to medical knowledge
reduce publication and outcome reporting biases
facilitate systematic reviews and other analyses of the research literature
Despite this trend toward transparency, however, consumer trust in the pharmaceutical industry hit an all-time low in 2018. This dramatic drop was driven by a number of high profile cases in the news as well as a growing climate of questioning medical authority. On the heels of this public trust crisis, patients, payers, and politicians demanded more rigorous oversight of the industry. As a result, regulatory bodies are setting out to enforce even greater transparency into clinical trial design and outcomes, as well as pricing and prescribing information.
In September 2018, the FDA released a draft guidance introducing monetary penalties for sponsors and other responsible parties that fail to register clinical trial data in a timely fashion. But there’s more than just compliance at play here; there’s also further insight and opportunity to be gained.
What This Means for Your Business
There are currently tens of millions of clinical trial datapoints available to the public for free, and the amount of data keeps growing. The advantage to those working in clinical trials lies in making this data meaningful. With the right tools in place, strategic mining of clinical trial data can provide intelligence to:
gain new insights into industry trends
collect contact information for sponsors and investigators
monitor competitor trial activity
draw out vital enrollment information on trial sites around the globe
use data to support client and investor presentations
In the end, it’s not just the data we collect, but what we do with the data that will ultimately drive innovation and opportunity. As we move toward personalized medicine and curing disease, the application of insights from the data we collect will be invaluable. But first, we have to shift our thinking.
Industry teams use BrackenData Analytics to create tables and visuals of clinical trial data. Signup to get a personal demonstration of our tools and dashboards: