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. Last Updated: 07/27/2016

Stricter Regulations Sought for Drug Trials

Health officials said Monday that they wanted to introduce tougher rules for clinical drug trials after a scandal involving vaccine tests by GlaxoSmithKline earlier this year.

Doctors warned that the change would put drug research at risk. But the Health and Social Development Ministry, which helped draft the bill, noted that the legislation would also for the first time allow any clinic to participate in trials.

The bill, which is expected to be submitted for reading to the State Duma shortly, would give any clinic the right to carry out a trial as along as it secures permission first, said Maxim Lakomkin, a spokesman for the Federal Health and Social Development Inspection Service, which drafted the bill with the Health and Social Development Ministry. Currently, only specially accredited clinics can participate in trials.

Volgograd prosecutors opened a criminal investigation into a clinic in February, accusing it, among other things, of not being on the list of accredited clinics. Parents had complained that the clinic was administering a chicken pox, measles and rubella vaccine made by British pharmaceuticals giant GlaxoSmithKline on their babies without telling them it was part of a clinical trial.

But the proposed bill would also introduce midterm checks at specific stages of each trial, which could cause the permission to be revoked.

"The idea is to develop the practice of clinical trials in Russia, yet, protect its citizens," Lakomkin said.

The proposed checks, however, would interfere with international research projects, said Mikhail Lichinitser, deputy director of the Russian Cancer Research Center. "Our research has always been part of joint international projects into new drugs and subject only to international checks," he said.

Regis Lhomme, head of Pfizer International's Moscow office, said research is usually carried out concurrently in multiple countries, a practice that would be impossible to continue if each country had its own regulations.

More importantly, he said, his company rarely has midterm checks so as to preserve the purity of the clinical results. Most research, he explained, is done by the so-called blind method, when neither doctors nor patients know whether they are using the real medicine or a placebo.

"The checks would demand that the codes of the medicines be revealed. That would be very bad for the final result," Lhomme said.

Lichinitser said, however, that midterm checks could help bring domestic trials on vaccines and medicines up to international standards.