German Regulators: 1,300 Trials Imperiled by “Hard” Brexit

Some 1,300 trials in the UK may have to stop their work if the UK leaves the EU without some kind of new regulatory regime in place, officials at Germany’s Federal Institute for Drugs and Medical Devices say in a new advisory published last week.

German regulators are warning trial sponsors that changing a representative requires “substantial amendments” to a trial’s regulatory regime. Sponsors should file a single amendment focused on their post-Brexit move to the continent and let any other regulatory questions lie for now. It will probably take 20-35 days, on average, to process the new filings, the institute says.

If sponsors are only changing their legal representative, “it is possible to submit this amendment for several clinical trials of one single sponsor by way of a collective amendment,” the advisory says.

Read the regulatory update here: https://bit.ly/2txx3Ri.

FDA Reopens Real-World Evidence Docket

The FDA is giving the public an extra 60 days to weigh in on the agency’s proposed plans for real-world evidence in drug trials.

The comment period originally closed in February, but regulators worried that the 35-day government shutdown might have disrupted the flow of comments (CenterWatch Weekly, February 19, 2019).

The new deadline for comments is April 16.

Electronic comments can be filed here: https://bit.ly/2GFITl2.

EMA Releases New Guidelines on Data Requirements for Advanced Therapy Trials

A new guideline from the European Medicines Agency outlines clinical trial data requirements for applications to conduct exploratory studies of gene, cell and tissue-based therapies.

Focusing on risk, the 53-page guideline says sponsors proposing first-in-human trials can conduct an initial risk analysis at the beginning of a treatment’s development “based on existing knowledge of the type of product and its intended use.”

A risk-based approach can help sponsors stay in compliance with trial regulations, but it doesn’t “obviate the applicant’s obligation to demonstrate the quality and safety of the product to enable the generation of reliable efficacy data” and it doesn’t “replace appropriate communications with the authorities,” the EMA was quick to add.

The deadline for comments on the guideline is Aug. 1.

Read the EMA’s guideline here: https://bit.ly/2Ve2D2h.

FDA Issues Guidance on Nicotine Replacement Product Trials

The FDA has released draft guidance containing new endpoints for drugmakers to assist them in the clinical development of nicotine replacement therapy (NRT) drugs intended for smoking cessation and related indications.

Acceptable endpoints include “the proportion of subjects who are abstinent from cigarette use over the entire efficacy ascertainment period,” reduction in risk of relapse, reduction in urge to smoke and relief of withdrawal symptoms not associated with attempts to quit.

The agency recommends that sponsors compare their investigational NRT drug to placebo in a randomized, double-blind superiority clinical trial design, with the placebo being identical in all meaningful ways, such as in appearance, taste and texture.

Generally, Phase III trials should study active smokers 18 years of age and older who wish to quit smoking, including ones with comorbidities similar to those of the target population.

Sponsors can, in some instances, require that participants smoke a minimum number of cigarettes per day — for example, if the investigational drug gives a nicotine dose higher than the amount delivered by light smoking (10 or fewer cigarettes per day).

Read the full guidance here: https://bit.ly/2SU3OHm.