Euro Roundup: MHRA revises guidance on remote clinical trial monitoring, EHR access

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on remote access to electronic health records (EHRs) by monitors and the off-site oversight of clinical trial sites during the COVID-19 pandemic.
 
Last year, MHRA published two guidance documents on the topics. The guidance on access to EHRs by sponsor representatives in clinical trials lacked a discussion of remote direct access to the records. Similarly, guidance on how to manage clinical trials during the COVID-19 pandemic only featured a short section on remote monitoring of studies. The section voiced support for remote monitoring in some circumstances but lacked a detailed description of the risks and how to mitigate them.
 
MHRA has now filled in the gaps in the documents. The EHR guidance has undergone a significant expansion, with MHRA adding seven sections that describe remote direct access, the use of online document sharing portals, system security and other matters essential to the compliant review of health records by off-site representatives of study sponsors.
 
The guidance expresses a preference for enabling monitors and auditors to log into the EHR system remotely, rather than requiring them to be onsite or granted access via video calls, as it puts less of a burden on site staff. Sites can upload scanned or electronic copies of source documents to a secure portal, but MHRA will only consider the approach to be direct access if the entire EHR is uploaded. The guidance details the privacy and study site workload implications of document uploads.
 
“There should be acceptance that in some cases, the investigator/institution may not be able to support Upload Access, particularly when on-site direct access is available. The sponsor should also accept that on-site visit limitations may be necessary,” the guidance states. 
 
Another section covers the five pieces of EHR system functionality that are needed for login access. MHRA wants EHR systems to support read-only access, two-factor authentication, automatic time-out, restrictions on extracting information and time-restricted access for monitors. EHR systems should have the features in normal circumstances, but MHRA acknowledges that in the pandemic sites may need short-term mitigations to enable remote access.  
 
The updated COVID-19 guidance details the short-term mitigations. When the system lacks the ability to grant read-only access, MHRA is advising sites to check for inappropriate changes after a monitor has been in the EHR. MHRA is proposing sites confirm the identity of the monitor by video call if the system lacks two-factor authentication. The mitigations typically require more active involvement of site staff but will enable remote monitoring to happen until new features are added to EHR systems.
 
MHRA Guidance, More
 
EMA starts reviewing Pfizer COVID-19 booster jab amid doubts over need
 
The European Medicines Agency (EMA) has begun reviewing an application for approval of a booster dose of the Pfizer-BioNTech COVID-19 vaccine. EMA revealed the review days after its public health counterpart said there is no urgent need for people to receive a third dose of COVID-19 vaccines.
 
Pfizer-BioNTech is seeking authorization of a third dose through an accelerated assessment of data from an ongoing clinical trial that has given a booster shot to around 300 healthy adults six months after they completed their original two-jab regimen. Other studies have shown a booster dose raises antibody levels to a new high, leading some people to suggest three shots may be optimal.
 
European authorities currently have doubts about the need for a third dose. A technical report from the European Centre for Disease Prevention and Control (ECDC) found, “There is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population” because two shots are providing protection from hospitalization, severe disease and death.
 
Even so, EMA is evaluating the Pfizer-BioNTech application “to ensure evidence is available to support further doses as necessary.” EMA is also assessing data on the effects of third doses of mRNA vaccines on people with weakened immune systems. ECDC supports considering third doses in some immunocompromised individuals.
 
EMA Notice, More
 
Swissmedic updates Project Orbis guidance after Israel joins the program
 
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its Project Orbis guidance and forms in response to changes including the addition of the Israeli regulatory agency to the program.
 
Israel joined the US-led oncology drug assessment collaboration over the summer. In response, the Swiss regulator updated its Project Orbis paperwork to reflect the inclusion of its Israeli counterpart and make other changes to the documents.
 
Swissmedic’s guidance now features a flowchart that walks companies through the process of seeking approval through Project Orbis. The flowchart explains the role the US regulator plays early in the process, and the various types of Swissmedic review of Project Orbis filings. Swissmedic’s approach is dictated by the length of the lag between submissions in the US and Switzerland.
 
Swissmedic Notice, More
 
EMA warns pharma industry about phishing attempts using its name
 
EMA has advised its customers to be vigilant about phishing attempts. The warning mentions the risk of scammers sending emails pretending to be from EMA to extract information from companies.
 
Biopharma companies are popular targets for phishing attacks, with companies including Immunocore being targeted and fraudsters seeking to obtain the passwords of executives to access confidential information. The US Food and Drug Administration has warned of scammers using its identity, and EMA was the victim of a cyberattack late last year.
 
EMA’s latest notice lacked information about what prompted its phishing warning. The brief addition to the “How to pay” page of EMA’s website simply advises customers to be vigilant and contact its accounts team to verify the authenticity of correspondence.
 
EMA Notice
 
France starts requiring some manufacturers to hold 2 months of drug supplies
 
France has begun requiring manufacturers of products of major therapeutic interest to hold two months of supplies to reduce the risk of shortages. The change follows a year in which stock-outs rose by 63% amid the disruption caused by the COVID-19 pandemic.
 
Last year, the French National Agency for Medicines and Health Products Safety (ANSM) received 2,446 reports of stock-outs. The jump in cases came in a year in which ANSM pushed for early reports of supply risks and new financial penalties took effect. ANSM needed to act to reduce the impact of the supply disruption in 5% to 10% of cases.
 
The requirement for manufacturers of certain drugs to hold two months of stock stems from a decree published in March. ANSM provided guidance on the implications of the decree for medicine manufacturers over the summer. In some cases, ANSM may require companies to hold four months of stock. ANSM will give manufacturers six months to comply with the request.
 
ANSM Notice (French)
 
Other News:
 
The UK National Institute for Health and Care Excellence (NICE) has begun collaborating with Cochrane to keep guideline recommendations up to date. Cochrane, an independent assessor of health data, already works with NICE. The new agreement is intended to enable NICE to make better use of Cochrane reviews to accelerate the guideline update process. NICE Notice, More
 
Swissmedic has published a new form for clinical trial applications in anticipation of the switch to a paperless submission procedure. Swissmedic Notice