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Safety Watch

Quanticate selects Oracle Argus Safety for pharmacovigilance database.

By Kevin Davies

May 18, 2010 | Quanticate has selected Oracle Argus Safety as its safety database to offer comprehensive global adverse event management and reporting for its customers.

“The key to pharmacovigilance is the collection of high-quality, accurate data,” says Alison Bond, Quanticate’s new head of pharmacovigilance. It’s about collating reports of adverse events during clinical trials and post-marketing, she says, as well as looking at the way that data are managed, analyzed and evaluated.

A third-party pharmacovigilance database is not always essential, but it is almost always required when dealing with large volumes of data. Quanticate’s selection came down to three of the leading validated databases. In the end, Oracle edged the other two providers.

“The web-based user interface will allow instant and continuous access by any Quanticate team member, whatever their location, in addition to being able to offer customers immediate access to their safety data,” says Bond. “There is also the potential for future growth with the use of other applications in the Oracle Argus Safety suite of drug safety and risk management solutions” and Oracle Clinical, the clinical data management system.

Bond started working on pharmacovigilance ten years ago while working at Parexel, managing the set up of pharmacovigilance systems for various pharma and biotech clients. She then worked as an independent consultant before joining Quanticate in January 2010.

The international systems that are currently in place for the detection, evaluation, understanding and prevention of adverse effects of drugs can be traced back to the 1960s and the thalidomide tragedy, says Bond. “It became apparent that more stringent measures were required, more structured processes for the collection of safety data to pick up as soon as possible any potential risks of drugs,” she says. “The whole idea is to put in place systems to collect and evaluate the risks of drugs and also to get the benefits. Any drug has to have a positive benefit risk profile in order to be on the market and ethical to treat a patient. It’s about balancing whether the benefit of the drug outweighs those risks.”

Life Cycle

Pharmacovigilance covers the whole product life cycle. “There is much more recognition that there needs to be proactive safety surveillance right through the product life cycle,” says Bond.

Data on a patient’s side effects is sent to the company running the trial and entered first into the clinical trial database (a separate entity from the safety database). “Those have come a long way in recent years to meet the regulatory requirements,” she says. Although generally separate from EDC, they are now starting to tie in.

All adverse events feed into the clinical trial database, and those that are serious go to the safety department and database. Most every drug in the clinic will have an associated safety database of some sort. The sponsor transfers the data to the regulatory authorities, the FDA or EMEA databases. That can be done directly from the sponsor’s own safety database to a gateway system or via the web. All cases of serious and unexpected adverse events suspected to be related to the study medication would be reported, as companies are keen to maintain compliance.

Bond says the technology behind safety data collection hasn’t changed much in recent years, but where she does see changes is in how the data are analyzed and interpreted, looking for safety signals and events early on. “When you do a marketing authorization application now, there’s a requirement in most cases to do a detailed risk management plan, which highlights identified or potential risks. So there could be risk with potential based on pharmacological property of the drug or preclinical work, and then you put in place systems to monitor that or mitigate any risks.”

Bond says there are potential advantages “in harmonizing where the data are kept” and searching for ways to improve signal detection and data analysis. “If you’ve got clinical, adverse events, and safety databases, you can have consistency in the way events are coded and make sure it’s reconciled. It can be a relatively small thing to find out a small signal in a huge database.”

The benefits of collecting pharmacovigilance data are much more subtle than merely making a go/no-go decision on a drug. “The idea would be you wouldn’t get a no-go decision,” says Bond. “The idea is to identify the risks and then manage that.” For example, if a trial revealed serious events in certain patients taking a drug, then it could lead to adapting the drug label “to make sure it’s given to the most patients that will benefit and reduce risks by not giving to patients that are not suitable.”

Ongoing cases are reported to the regulatory authorities and (in blinded fashion) to investigators running the trial. Early detection goes on through the trial, and could result in a protocol amendment to restrict patients or introduce other changes in the trial (even the trial being stopped).

Bond says she will be consulting with clients to see that they set up pharmacovigilance systems that are appropriate to their requirements and product. Quanticate also offers in-house medical writing expertise as part of the pharmacovigilance service offering, helping to produce periodic safety reports during clinical trials and once the drug is marketed. •

This article also appeared in the May-June 2010 issue of Bio-IT World Magazine.
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