everythingpossible - Fotolia
Cloud-based pharmacovigilance systems help prevent lethal mistakes in clinical drug trials and other medication programs and can be used by provider systems and pharma companies.
Pharmacovigilance software is a key technology within pharmaceutical organizations that helps keep watch over drug trials and other medication programs to improve safety and avoid potentially lethal errors.
Now, new pharmacovigilance software analytics systems use cloud-based data science technology to improve safety programs, and predictive signal management -- the ability to sift through drug trials and catch errors or unknown side effects before they become dangerous.
Pharmacovigilance software analytics systems have become increasingly important in light of tighter regulation of the life sciences industry and incidents such as a recent French clinical trial in which a person died and five were hospitalized.
French regulators concluded that the clinical research organization Biotrial failed to properly manage the testing, according to Stat, The Boston Globe's online source for pharma, bioscience and health IT news. Biotrial criticized the authorities' findings and blamed the medicine, a brain enzyme being developed as a treatment for cancer pain.
In this SearchHealth IT podcast, Glenn Carroll, a principal in Deloitte Consulting LLP's life sciences practice and a pharmacovigilance software subject matter expert, says pharmacovigilance analytics "can provide huge amounts of data when a product is in clinical [drug trials]."
Carroll says that pharmacovigilance software analytics systems can come into play during clinical trials involving 50 to 4,000 patients trying one or more drugs, and also after the product is launched for public use.
"If you can have access to that data and you can mine that data using analytics, you can sort of drive additional insights about ... how the product may be taken in the marketplace," Carroll says. "You'll understand how the product will interact with other products. You can use that information to essentially ask different questions of your product."
Pharmacovigilance software systems can identify safer ways to administer the product and also additional benefits to the medication, Carroll says in the podcast.
Carroll also discusses how pharmacovigilance software analytics systems can keep pharma companies, clinical trial organizations and health systems abreast of the quickly evolving regulatory climate.
Transcript - Pharmacovigilance software helps detect lethal drug trial errors
So what is pharmacovigilance software and why has it become so important recently?
Glenn Carroll: Vigilance is essentially a function that exists within pharmaceutical organizations. That function is to understand the safety profile of the products that they're marketing in the marketplace, and basically ensure that pharmaceutical companies are operating in a compliant manner and they're really protecting patient safety.
How does pharmacovigilance software use analytics to help life science organizations improve safety in clinical drug trials and other venues?
Carroll: It helps in a significant way, enabling an understanding of what's going on in the marketplace from a patient safety perspective can provide huge amounts of data as it relates to clinical. When you think about it, when a product is in clinical, depending on the phase of trial, the exposure can be anything from 50 people to, say 4,000 people. When the drug is essentially launched, then that patient exposure can increase significantly. You get exposure to different patient populations, different demographics. And within that, you will also get exposure to patients that are taking one drug, or may be taking several other drugs.
If you have access to that data and can mine that data using analytics, you can drive additional insight into how the product may be taken in the marketplace. You will understand how the product will interact with this other product. As you continue your clinical research, you can essentially use that information to ask different questions of your product in the clinic and so thereby identifying either more safe ways to actually administer the product, or you can also identify additional benefits from using the product.
Can you talk a little bit about the shift from operations to outcomes using pharmacovigilance software?
Carroll: This certainly relates to pharmacovigilance [software]. I would say it probably relates even more so to medical sellers and how medical sellers' organizations are thinking about patient outcome. Essentially, what pharma is trying to do, and this is driven by sort of different tests of regulations, either government regulations or other, is really demonstrate the value of the product. And the value of the product can be seen either through reduced risk or improved efficacy or benefits.
When pharmaceutical companies are now thinking about the value they provide, they're thinking about it much more so from an outcomes perspective. And when we're talking about outcomes it's obviously, not only the risks that are exposed, that patients are exposed to the actual product, but also how they use the product, and what does that mean in terms of at the care pathway, what that means in terms of overall quality of life. And they're using that information, the patients' outcome, to communicate that value to various stakeholders, whether they be sort of providers, large hospital systems or even insurance companies. Insurance companies are starting to make decisions based on outcomes as opposed to just the product itself.
In what other areas and for what other users other than pharmaceutical companies and their clinical trials can pharmacovigilance software prove useful? What kinds of companies and industries can use the technology?
Carroll: There's a whole host of stakeholders that are now involved in formulary decisions, in reimbursement decisions. Having the data and being able to draw insight out of the massive amounts of data that are now being created essentially enables being able to share those insights and perspectives.
The true value of the benefit that the patient is getting is critically important. Those stakeholders can be anything or anybody from a primary care physician to much larger providers and hospital systems. Also pharmacists and PBMs are getting a much better perspective on the actual patient outcomes. Because there're so many different stakeholders now involved in making decisions around patient treatment and what treatments get reimbursed, having access to this data and information and being able to share it is extremely important. It's massively influencing kind of the overall marketing of products.
How does the evolving regulatory environment affect the use of pharmacovigilance software technology? And how can pharmacovigilance software help organizations comply with new safety and other regulations?
Carroll: With the increase in regulatory scrutiny, this is continuing to have an impact on pharmacovigilance and capabilities that sit within pharmacovigilance. The regulations are continuing to evolve and formalize and become far more stringent. And that's particularly seen in some of the emerging countries that essentially have new regulatory environments that are being put in place.
So it's a critical part of how pharmacovigilance helps companies maintain their license to operate. Pharmacovigilance organizations need to continually understand the changing regulatory landscape. Typically, pharmacovigilance organizations will have a business or safety intelligence function that will do that. That needs to be a global function because they need to understand the regulations where they market their products around the globe.
Once they have a good handle on that, they need to understand if they're going to have a response to these emerging regulations. How do we operationalize them? How do we bring those regulations we didn't have to make sure that the pharmaceutical company is maintaining its license to operate? Typically, the questions include what sort of assessments are needed to understand the regulatory environment, and do we have the processing in-house? Or do we need to find or redefine some existing processes? Do we have the people, the skill sets, the roles, and responsibilities that can help enable execution of those processes? And do we have the supporting technology that can drive productivity within the organization that essentially can help us execute these processes in a more efficient manner?
There's a tremendous amount of complexity that goes into helping pharmacovigilance organizations, support the broader pharmaceutical company and essentially help protect patients. Pharmaceutical companies and executives realize the importance of staying on top of this. They will invest quite substantially in the area of pharmacovigilance to make sure that there's overall compliance within the company.
That was a stimulating discussion. Thanks for being with SearchHealthIT today, Glenn. And listeners, please check out this podcast and others at SearchHealthIT.com.
Carroll: Great. It was an absolute pleasure to talk with you today. Thank you.
FDA support for clinical research using EHRs and data capture systems
Clinical trials driving life sciences market growth