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VCLS Covid-19 Update

We are closely monitoring the impact of COVID-19 on our industry and aim to bring you the very latest news from the Regulatory Agencies around the world.  This page will be updated as soon as these updates are announced.

April 1, 2020:

FDA updated the Guidance on Conduct of Clinical Trials of Medicinal Products during COVID-19 Pandemic on March 27, 2020 with an informative Q&A Appendix on clinical trial conduct, including questions and answers such as:

  • What are some of the key factors that a sponsor should consider when deciding whether to suspend or continue an ongoing study or to initiate a new study during the COVID-19 pandemic?
  • What key factors should sponsors consider when deciding whether to continue administering or using an investigational product that appears to be providing benefit to the trial participant during the COVID-19 pandemic?
  • How should a sponsor submit a change in protocol that results from challenges related to the COVID-19 pandemic?

FDA has also created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible. There is no equivalence in EU yet, but some countries such as the ANSM proposed some dedicated pathways to expedite new treatment against COVID-19.

March 30, 2020:

FDA has released a FAQ document (March 24th) regarding the investigational use of COVID-19 Convalescent Plasma in emergency INDs. From the FDA website:

“One investigational treatment being explored for COVID-19 involves the use of convalescent plasma collected from recovered COVID-19 patients. It is possible that convalescent plasma that contains antibodies to SARS-CoV-2 (the virus that causes COVID-19) might be effective against the infection.”

“FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications (eINDs) for Individual patients under 21 CFR 312.310.”

Learn more about our Regulatory solutions.

Impact on ongoing clinical trials

If you are currently conducting clinical trials in the EU, please be informed that the EMA, in collaboration with the Clinical Trials Expert Group (CTEG) of the European Commission, the Clinical Trials Facilitation and Coordination Group (CTFG)  and the GCP Inspectors’ Working Group, has published a harmonized guidance document on how to manage clinical trials during the COVID-19 pandemic, available here. In addition to this guidance document, Competent Authorities have already published specific instructions on how to conduct clinical trials in their countries during this time. In some cases, these national guidelines will take priority over the European harmonized recommendations.

Several Competent Authorities are asking sponsors to perform a risk assessment and prepare a mitigation plan for their ongoing studies, taking into consideration the following points:

  • Initiation of new clinical trials or inclusion of new patients in ongoing clinical trials should be critically assessed
  • Changes to the shipment of the IMP: shipment to the patient’s home when possible and allowed by national legislation and data protection regulations
  • Changes to the treatment administration and study assessments
  • Changes to monitoring: postponing source data verification, remote monitoring if no additional burden to the sites, etc.
  • Temporary suspension of recruitment or treatment (when the sites are closed due to the quarantine measures, for instance).
  • Discontinuation of study subjects, if they cannot complete the key evaluations or adhere to critical mitigation steps etc.
  • Protocol deviations (which may occur more often in this period) should be thoroughly documented: some authorities have asked for a summary report on all deviations that occurred during the COVID-19 pandemic
  • The circumstances in which the implementation of an Urgent Safety Measure may be deemed necessary.

Delays should be expected in the review timelines of initial applications and amendments not related to COVID-19 (which do not impact the safety of the subjects) due to the staff limitations in most of the Competent Authorities and Ethics Committees. Furthermore, some of them have started to accept and encourage electronic submissions in the context of the COVID-19 pandemic.

As the situation is evolving rapidly, VCLS is keeping an up-to-date list of the Competent Authorities and Ethics Committees having published specific recommendations both in Europe (EU and non-EU countries) and worldwide (USA, Canada, Israel, South-Africa, etc.). Most of these guidelines have been issued without prior public consultation, therefore some specific issues encountered by sponsors may not be covered. Our team at VCLS is ready to take a close look at your needs and create tailored solutions for preserving patient safety and data integrity on your studies in these challenging circumstances.

Learn more about our Clinical Submission and Operation capabilities.

Call for new treatments for COVID-19

At the same time, many authorities worldwide have emphasized the need to prioritize the development of new treatments against this public health threat, advising on including COVID-19 related endpoints to ongoing clinical trials or pooling research resources into large multi-center, multi-arm clinical trials to generate sound evidence (see EMA call here).

Some of the Competent Authorities and Ethics Committees are proposing a rapid assessment of clinical trial applications related to the prevention of the infection or to the management of COVID-19 patients.

Our experts are here to help you guide the planning, design, conduct and reporting of clinical trials in order to accelerate the development of potential COVID-19 treatments.

March 23, 2020:

Many of you may be concerned about the impact of COVID-19 in the testing for human cells, tissues, or cellular and tissue-based products (HCT/Ps). The FDA has released a Q&A document that can be beneficial to understand their recommendations at this time. At VCLS, we are monitoring the situation closely and we are providing recommendations to our clients based on our most recent experiences. We strongly advise following FDA’s recommendations on implementing screening measures as a precaution to patients and healthcare providers. Please see below the extracted information from the Agency:

Q: Can COVID-19 be transmitted through human cells, tissues, or cellular and tissue-based products (HCT/Ps)?

A: Respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of human cells, tissues, or cellular or tissue-based products (HCT/Ps). The potential for transmission of COVID-19 by HCT/Ps is unknown at this time. There have been no reported cases of transmission of COVID-19 via HCT/Ps.
Routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors.

Q: Is the FDA recommending that establishments implement screening measures for the deferral of HCT/P donors of who may be at risk of having COVID-19?

A: The HCT/P establishment’s responsible person must evaluate a prospective donor and determine eligibility (21 CFR 1271.50). Based on the limited information available at this time, establishments may wish to consider the following donor history in the 28 days prior to HCT/P recovery for persons who have:

  • traveled to areas with COVID-19 outbreaks, as defined by CDC
  • lived with individuals diagnosed with or suspected of having COVID-19 
  • been diagnosed with or suspected of having COVID-19

More details are available here: FDA emergency preparedness and response to COVID-19

March 19, 2020

The FDA released a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.

From the Clinical Trials perspective:

If you are currently conducting clinical trials in the EU and especially in the UK, Italy and the Netherlands, please be informed that Authorities have recently released communications on recommendations to follow in clinical trials’ submissions and conduct.

Please see links from MHRA and HRA in the UK, AIFA in Italy (English rough translation attached) and the CCMO in the Netherlands.

We recommend our clients to take consideration of putting the following measures in place, and in many cases will need to be reported/submitted to Competent Authorities/Ethics Committees in a timely manner:

  • IMP shipped to the patient’s home;
  • Administrations performed at home;
  • Visits/ assessments performed at home, including recording in source documentation;
  • Modifications in monitoring (potentially remote);
  • Temporary suspension of recruitment or treatment (e.g. if sites are entirely closed);
  • Discontinuation of study subjects, if they cannot complete key evaluations or adhere to critical mitigation steps; etc.

Competent Authorities and Ethics Committees are progressively sharing information on the conduct of clinical trials during this period, and which submissions are required for the exceptional measures put in place.

At VCLS, we are monitoring the situation daily, including communications from the Competent Authorities/Ethics Committees on this topic, and its potential impact on your ongoing activities.

Learn more about our Clinical Trial Operation capabilities.

March 18, 2020

From the EU perspective:

  • EMA has said as a precautionary measure, all EMA committee meetings and working parties will be held virtually until the end of April 2020. In addition, stakeholder events hosted by EMA which were planned to take place at the Agency’s premises in Amsterdam in March and April will either be held virtually or postponed until later in the year. Participants of these meetings will be informed directly about this decision.
  • EU Regulatory Stakeholders may also adjust their activity accordingly. Further country-specific information can be found via the country specific links.
  • Most EMA staffs are working remotely, and this is expected to last until the end of April. These measures do not impact EMA’s core activities so far. We shall keep you posted of any development on this front.

From the USA perspective:

  • The FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. The FDA based this decision on a number of factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. Government employees, Centers for Disease Control and Prevention travel recommendations, access restrictions being imposed on foreign visitors by certain countries, guidance from the Office of Personnel Management and the importance of the health and safety of its employees.
  • No one is traveling to the FDA for meetings. The meeting format was changed late last week to teleconferences call only. Our understanding is that most, if not all of FDA staff is working remotely. Our recent experience is that the FDA staff is calling from one line although they are all participating remotely. It gives them the possibility to conference call prior to calling the Sponsor and the option to put the Sponsor on hold, so they can have an internal discussion, if needed.

March 13, 2020

Current events around the spread of the COVID-19 virus and its impact on the global economy continue to evolve. Voisin Consulting Life Sciences (VCLS) would like to reassure you that we continue to provide the same high-quality service during this difficult period.

We are monitoring the situation closely and constantly take appropriate actions to protect our employees to ensure business continuity. Please keep us informed of any steps or business restrictions your company takes that will impact the way we work with you so that we can make any necessary adjustments to our plans to stay on track.

Our focus, dedication and support are unwavering and we hope you and your closed ones remain safe and healthy.

 

VCLS Solutions