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A word on Corona

Well, we are living in the time of the Corona pandemic.  Coming from the pharmaceutical world, I find it interesting now that everyone from the public, academe and governments are looking to the pharmaceutical industry to 1) make and supply lots of masks, 2) make and supply lots of respirators 3) find better and faster tests for Corona including bedside PCR and fast serology 4) find a treatment/cure for Corona and a vaccine to prevent the infection in the first place.

Gone is the talk of evil drug companies, predatory pricing, capitalist profiteers etc. None of this is surprising.  The industry, not just for the good of humanity, but also to save their own lives and profits are indeed rushing to do this.  After all, the government doesn’t have factories to make masks or respirators. It is highly likely the industry will respond and do it well. Governments are already relaxing some standards and requirements for approval to get these products to the people asap.  Still, it may take many months and many lives but it will happen and a “new normal” will be reached.  Then the harping will start again about drug pricing, corporate greed etc. This is the human condition. This certainly does exist but the bottom line is that the pharma industry is a net contributor to the world.

Clinical Trials FDA

The FDA and MHRA (and others) have issued two documents on clinical trials now underway for non-Corona related clinical trials.  First the FDA issued a guidance entitled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards  (See https://www.fda.gov/media/136238/download for the pdf).

The point of this guidance is to “assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.”  Because of the emergency, no public comment was sought in advance but comments are still welcome.  FDA reminds readers that this is a guidance and is not obligatory.

The agency realizes issues may arise in clinical trials from quarantines, site closures, travel limitations, supply chain problems with drug product and COVID-19 infection in trial staff and/or subjects etc.  FDA realizes there will be protocol deviations and changes to protocols.  Several points are made:

On-going trials

Trials where policies and procedures are not yet in place

Clinical study report

Comments: All of this is very reasonable and understandable.  FDA is indicating it will be flexible and that changes to trials will be necessary and will alter analyses and conclusions.  How FDA will respond at NDA approval time regarding “weakened” studies remains to be seen.

Clinical Trials MHRA

On its blog, the MHRA on March 3, 2020 gave its advice.  It noted initially, similar to FDA above, that changes will be necessary due to Corona.  See:    https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/ .   They note:

Comments: This is quite similar to FDA’s requirements.  Pragmatism on everyone’s part is either clearly stated or implied.  The goal is to preserve the integrity at the study where possible but the subjects’ health is paramount and must not be risked to maintain the trial.

Obviously, lots of judgment calls here.  Hopefully one has good rapport and relationships with the agencies, IRBs and investigators.  Be transparent, keep everyone informed. Document everything.  Repeat: Document everything. Protect the subjects.  Repeat: Protect the subjects.

REMS

FDA released a guidance on REMS  and Corona.  See: https://www.fda.gov/media/136317/download

FDA notes that “For a limited number of drugs that are subject to a REMS with ETASU, the REMS requires laboratory testing (e.g., liver enzyme testing) or imaging studies (e.g., magnetic resonance imaging).”

FDA recognizes that getting these tests done may not be possible if patients are sequestered or at risk by going to labs or imaging facilities.

For these situations, health care prescribers and dispensers “should consider whether there are compelling reasons not to complete these tests or studies during the PHE, and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies. Health care providers should also communicate with their patients regarding these judgments, including the risks associated with it.”

Comments: Here too the FDA is indicating there is flexibility.  Sponsors and prescribers, dispensers and patients should consult and come to reasonable agreements on how each situation or even each patient should be handled.  Everything should be well documented and it is advisable to periodically let FDA know what is being done.

Overall Comments

Obviously, lots of judgment calls here.  Hopefully one has good rapport and relationships with the agencies, IRBs and investigators.  Be transparent, keep everyone informed. Document everything.  Repeat: Document everything. Protect the subjects.  Repeat: Protect the subjects.

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