InVentiv Health is cautioning its customers about the potential for confusion that could result from the European Union’s first major regulatory change for clinical trials in 15 years.
The new regulations, set to take effect in May 2016, will cover new clinical research, but the biggest change is the E.U.’s plan to implement a new category of trials—non-interventional studies (NIS)—with its own compliance rules.
InVentiv recently expanded its business to provide compliance products and services to assist global biopharmaceutical companies conducting non-interventional studies—also known as observational studies and which observe the “normal” usage of already approved medicines. The CRO’s entry into the post-approval area of research and new services to clients in Europe include access to its NIS Regulatory Intelligence Database.
The regulations, which also overhaul existing clinical trial regulation for approvals of new medicines, are expected to override the current rules, which have been criticized for having excessive bureaucracy and increased administrative and regulatory burden. The new rules are aimed at streamlining trial authorization and harmonization requirements for trials in Europe. Additionally, all trials must be registered, with applicants submitting a single electronic application via an online E.U. portal.
“Our focus on the observational or non-interventional studies comes as countries in Europe and the rest of the world have started asking real-world questions about the use and cost of new medications to help them make better decisions about effectiveness and reimbursement,” said Lynn Okamoto, executive vice president of late stage, inVentiv Health Clinical Division.
Okamoto’s research showed in 2013, sponsors spent a total of $3.5 billion globally on observational studies, and that total is projected to reach $4 billion in 2017 as real-world data from patients using newly-approved medications builds the evidence required by payers for payment and reimbursement decisions.
“In the next three to four years, countries will re-examine their own observational regulations and bring them into compliance with the new E.U. regulations to avoid delays in starting new studies,” said Okamoto, adding that unlike the harmonized rules for clinical trials, there is no such harmonization for global observational studies.
For the 28 nations that comprise the E.U., each has specific rules covering observational studies likely to cause considerable confusion because of vague regulatory language, inVentiv warned. Those country-specific requirements are necessary for study approval and will, in the coming years, be reviewed by each country and altered to assure alignment with E.U. regulations, the company said.
“The complexity of the regulatory landscape in Europe over the next few years requires that companies take measures now to prepare,” inVentiv said in its announcement. “Organizations that expect and prepare for a regulatory environment in flux will be more likely to marshal their resources, call in experts and be aware of the specific potential pitfalls to be avoided.”
For observational studies, Okamoto said inVentiv’s new services, including the NIS Regulatory Intelligence Database, will link to all of the regulations and guidelines, as well as submission document templates, data on regulatory bodies and visual process maps.
InVentiv also will provide e-learning modules to assist companies with training by country about which regulations have changed or are changing, regulatory classification, regulatory framework/applicable legislation and guidelines, plus approval requirements. InVentiv said key users of its new service will be biopharma company executives in regulatory affairs, medical affairs, quality assurance auditing, project management and pharmacovigilance.
“Confusion over new regulations makes it increasingly difficult to satisfy the first order of regulatory compliance: knowing the rules with which you need to comply,” Stuart McCully, vice president, late stage support services, inVentiv Health Clinical Division, said in a statement. “How a study is classified directly and significantly impacts which regulations must be followed, so getting this right is essential for research sponsors, financially and legally.”
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