European Medicines Agency raises trial transparency bar for the next pandemic

A new regulation gives the European Medicines Agency an expanded role during future public health emergencies, coupled with new transparency rules for clinical trials and measures to reduce research waste.

NEW TRANSPARENCY MEASURES

During the next pandemic, the agency will (temporarily) adopt additional transparency measures.

These are set out in Article 17 of the new regulation:

• Trial protocols. Protocols of drug trials must be made public on the European trial registry “at the start of each trial… that examine[s] medicinal products which have the potential to address the public health emergency”

• Summary results. EMA will set a timeline for accelerated results publication on the registry. This timeline must be shorter than the 12 months after trial completion set out by current transparency rules.

• Regulatory documents. EMA will publish European Public Assessment Reports “as soon as possible and, where possible, within seven days of the marketing authorisation.”

• Clinical study reports. [CORRECTION] EMA will release “the clinical data submitted to the Agency in support of the application, where possible within two months of the marketing authorisation”. EMA “shall anonymise all personal data and redact commercially confidential information.” [see correction below]

Correction 11 February 2022

The original blog mistakenly stated that “the clinical data submitted to the Agency in support of the application" mentioned in Article 17 referred to individual patient data (IPD). In fact, it refers to clinical study reports (CSRs). TranspariMED today received the following clarification from EMA:

The clinical data publication referred to in article 17, point c) of the Regulation puts on a permanent footing one of the exceptional transparency measures put into place by EMA in the context of the pandemic, i.e., in the context of a public health emergency, the proactive publication of the clinical data submitted to EMA by companies in support of the marketing authorisation applications of their products, as well as the additional data submitted after major changes to the authorisation.

The type of data submitted is as per our publication approach described in EMA’s Policy 0070, which is explained here: Clinical data publication | European Medicines Agency (europa.eu). Note that the clinical data published concerns essentially clinical study reports. For COVID-19 treatments and vaccines, EMA broadened the initial scope of the publication of clinical data by publishing clinical data submitted to the Agency as part of any regulatory procedure.

I would invite you to check out the data available for COVID-19 products on EMA's clinical data website.

PREVENTING RESEARCH WASTE

The document also diplomatically notes Covid research waste experiences:

“Experience with clinical trials during the COVID-19 pandemic revealed a tremendous amount of duplication of investigations on the same interventions, a high number of small trials, under-representation of important population subgroups, based on gender, age, ethnicity or medical comorbidities, and a lack of collaboration, leading to a risk that research will be wasted.”

“International regulators pointed out the need to improve the clinical research agenda in order to generate robust evidence on quality, safety and efficacy of medicinal products. The main way of obtaining reliable evidence is through coordinated, well-designed, and adequately powered large randomised controlled trials.”

To prevent a recurrence of research waste:

“The Emergency Task Force should provide advice on clinical trial protocols and to developers of clinical trials that are conducted in the Union, providing guidance on clinically relevant endpoints and targets for vaccines and treatments in order to facilitate clinical trial design meeting the criteria for effective public health interventions.”

BUT... WHAT ABOUT 'NORMAL' PATIENTS?

TranspariMED strongly welcomes these plans.

At the same time, it should be noted that the ethical rationale for temporary transparency measures that are only applied during pandemics is questionable:

• If more transparency benefits patients, why are such measures restricted to pandemic patients?

• Why should patients who are ill with a pandemic virus enjoy greater access to information on their medicines than cancer patients do during ‘normal’ times?

For the full text, see Regulation 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices.