The new offerings come one year before the complexity of the regulatory landscape in Europe will shift. Beginning next May, the EU will implement a new regulation governing clinical trials, which was adopted last year and which replaces a previous EU Directive.
inVentiv claims that the new regulation could “spark confusion” around the conducting of non-interventional trials, which are also known as observational studies.
Stuart McCully, global regulatory expert at inVentiv, told us that the regulation “initially says quite clearly that it does not apply to non-interventional studies. But then it does,” and that’s where the complications arise.
In Europe there has been “continuing, unresolved debate” over what constitutes a non-interventional study, and in an effort to help resolve that debate, the new regulation creates a new category of research, called the “low intervention clinical trial,” McCully said.
But the definition of a “low intervention clinical trial” in the new regulation “is exactly the same as the definition of a non-interventional study -- with one difference… ‘additional diagnostic or monitoring procedures (that) do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member state concerned.’”
However, according to McCully, there is no consensus among EU countries on what “additional diagnostic or monitoring procedures” means. “In one country, a request for a detailed questionnaire or a single additional blood draw may be considered an unacceptable additional burden and cause an NIS to suddenly become a ‘low intervention clinical trial.’ In a neighboring country, that same blood draw might not be considered burdensome at all – and so the research is classified as an NIS,” he added.
As far as what companies need to do to prepare for the changes in the new regulation, McCully said: “First, they need to be aware of the changes coming and the implications for the studies they have planned. Organizations that expect and prepare for a regulatory environment in flux are more likely to marshal their resources, call in experts and be aware of the specific, potential pitfalls to be avoided. Companies also should be lobbying for greater clarity from the EU because non-interventional studies have never been more important to the success of a drug or manufacturer. Payers around the world are looking to drug companies for real-world data to aid in their approval and reimbursement decisions.”
Clients of the new inVentiv services will also have access to an NIS Regulatory Intelligence Database, the first of its kind.
“inVentiv Health’s NIS Regulatory Intelligence Database gives biopharmaceutical clients instant access to real-time data on significant changes in regulation governing non-interventional (observational) studies. This database is the first of its kind and contains links to all regulations and guidelines, submission document templates, data on regulatory bodies, as well as visual process maps and a great deal more essential information for 52 countries,” McCully added.