Regulatory compliance is about to get more challenging in the E.U.
Last year, the European Union (E.U.) adopted new clinical trial regulation, E.U. CTR 536/2014, which is intended to clarify and standardize rules for conducting clinical trials across the region. The new regulation, scheduled to take effect in May 2016, repeals a directive issued by the European Parliament in 2001. It is unclear if the effect of the new rules will match their intent.
The E.U. has for a long time attempted to harmonize the regulation and conduct of clinical trials throughout Europe in order to facilitate drug research. The 2001 directive set forth clear rules for interventional trials on everything from adverse event reporting and safety monitoring to the type of information to be submitted to regulatory bodies and ethics committee.
While the directive did a good job of clarifying the rules for conducting clinical trials in Europe, it made it more complicated for companies wishing to conduct non-interventional studies. How these studies should be conducted was left up to each of the 28 European countries to define and codify. Some countries, for example, saw a blood draw as reason for classifying research as a clinical trial while other nations did not. What evolved was a tapestry of differing legal requirements that could cause a single research study to be classified in multiple ways depending on where it was conducted.
Ironically, the 2001 directive actually contributed to a decline in the percentage of global clinical research conducted in the E.U.
It may seem that regulators now are addressing problems with the 2001 directive, but will the new law solve them without creating a whole new set of challenges? So far experts don’t think so. The new rule is expected to cause confusion around non-interventional trials, also referred to as observational studies. Vague regulatory language and the need for every E.U. country to review and alter existing national regulations have created anxiety for many folks in the industry.
E.U. CTR 536/2014 increases the scope of what is considered a clinical trial, creating an entirely new category of trial that no one has tried to implement before.
Starting in May 2016, there will be three categories of research: clinical trials, non-interventional studies and a new third category called low-interventional clinical trials. A low-interventional clinical trial is a non-interventional style by design but one that includes some form of additional diagnostic or monitoring procedures that carry minimal risk or impact on patients, such as a study-specific blood draw.
These low-interventional clinical trials will cost sponsors far more than the standard non-interventional study. In addition, how a study is classified directly and significantly impacts which regulations must be followed. Consequently, getting a study classified correctly is essential for research sponsors, from both a financial and legal perspective. Expanding the definition of a clinical trial will have an enormous impact on companies wishing to conduct non-interventional studies.
All this confusion is playing out at a time when real-world data from non-interventional studies has never been more important. Such data obtained from patients in real life conditions now is essential for building the evidence required by regulators for payment and reimbursement decisions.
Typically we think of clinical research in terms of randomized trials of a specific medical intervention. But post-commercialization drug research and surveillance is just as important because it contributes to our understanding of how safe and effective a drug is in actual clinical practice. Non-interventional studies can uncover valuable insights that may not be seen within the constraints of clinical trials.
As the deadline for implementation of the new regulation approaches, individual companies must stay current with the changing landscape, take measures to mitigate risk and find partners for navigating the shifting seas of European regulation. Over the next few years, national laws across Europe will be under review to assure compliance with the E.U. regulation and companies must stay abreast of these country-specific changes.
Meanwhile, the uncertainty that has plagued sponsors since the 2001 rules may only be getting worse. The rules and regulations governing clinical trials have not been changed for a decade, but globally, rules, regulations and guidelines governing non-interventional studies change roughly every six months.
Companies that expect and prepare for a regulatory environment in flux will be better positioned to marshal their resources, call in their experts and be aware of the specific, potential pitfalls to be avoided.
Matthew Howes is senior vice president, marketing innovation for PALIO, an inVentiv Health company. A leader in digital strategy, he has provided the fuel for digital businesses visited by over 100 million people every month.
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