Earlier this year I wrote to you about US FDA March 2020 issuance of a new guidance for industry, Investigators, and Institutional Review Boards regarding the conduct of clinical trials during the COVID-19 pandemic.
This time, I am writing to you regarding FDA’s recent (September 2020) update1 to this guidance. With this update comes an addition of further discussion points and a section on industry questions and answers about conducting clinical trials during the COVID-19 public health emergency. Many informative topics are discussed by the agency in this guidance update. Some Q&A highlights include managing protocol deviations and amendments, conducting remote (virtual) clinic visits, alternative monitoring approaches, use of video conferencing for trial visits, and my personal favorite topic, deciding whether to suspend or continue an ongoing study, or initiate a new trial during the pandemic.
The reason that the discussion topic of deciding whether to suspend, continue, or initiate trials is of most interest to me is because FDA emphasizes the importance of Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), and Data and Safety Monitoring Boards (DSMBs). ProPharma Group’s Clinical Services provides these essential DSMB and Medical Monitoring consulting services and have been navigating the challenges that the pandemic has presented over the past several months for conducting clinical trials, such as quarantines, site closures, meeting protocol-specified procedures (e.g. administering the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing).
FDA views the Medical Monitoring and DSMB’s involvement in a study as crucial, especially as Sponsors and investigator sites respond to the disruptions brought on by the pandemic. Medical Monitors and DSMBs provide medical expertise, ethical support, and assessments that determine whether trials continue per protocol, if investigative sites remain open, and how limitations imposed by COVID-19 may impact a trial, all while assessing and ensuring the safety of trial subjects and ensuring the validity of the trial.
It is interesting to think that the DSMB’s involvement in trials has been somewhat unknown to individuals outside of clinical circles. That is, until this year when their importance has been spotlighted by news media with respect to their impactful decisions on COVID-19 treatments and vaccines. We have seen news stories describing the go-no-go decisions on trials sponsored by large and small pharma all aiming for COVID-19 therapies and cures.
A great deal of hope rests on the success of trials, hope for the benefit that the drug or product will bring to patients and their loved ones, improvement of world health, and desire for company financial success that can be applied to future pipeline therapies. Independent of all of this, the DSMB must weigh the efficacy and safety of the trial against the data that is collected and make the difficult decision to continue with the protocol as written or not. ProPharma Group is grateful to be able to assist in delivering services with such high importance to the progression of patient health.
Clinical trial Sponsors already have a lot at stake: investor money, the race to outperform competitors, and most importantly, assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity. In addition, we have all witnessed how quickly the world can change during a global crisis, such as the current pandemic.
ProPharma Group has the capabilities and experience to coordinate and manage the DSMB and provide the independent medical reviewers through our extensive pool of physicians. As with each of our clinical services projects, a dedicated Clinical Services Project Administrator is assigned to serve as point person and act as the conduit between the client and the project members. To expedite our services, ProPharma Group maintains established procedures that may be used to facilitate the creation of many of the essential documents, such as confidentiality agreements, conflict of interest statements (or lack thereof), DSMB charters, Medical Monitoring plans, and safety management plans. This administrative support provided by ProPharma Group allows for the client to focus on executing successful study protocol and activities at the investigator sites.
To connect with our clinical services experts, contact our team today!
1 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency
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