What are the regulatory authorities doing in response to Covid-19?

What should you do if you are about to start a clinical trial? Or when it comes to ongoing trials? Marie Gårdmark, CEO of Regsmart, provides an update from the authorities.

What are the regulatory authorities doing in response to the COVID-19 pandemic?

Although clinical trials are a national issue, the Medical Products Agency cooperates with sister authorities in the EU to ensure, as far as possible, a common understanding of how clinical trials should be managed in the current circumstances. The authorities understand the impact of the pandemic on clinical trials and have published a number of guidelines to support the industry (see EMA and LV websites). Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemicis recommended. Keep checking for updates as the situation is constantly changing.

What should you do if you are about to start a trial?

A risk assessment must be carried out. The measures needed depend on the type of trial: a Phase 1 trial conducted in a separate out-of-hospital clinic where clinical data from previous trials are already available is less affected. If it is a hospital-based trial, the risk assessment is different and the start of the trial is likely to be delayed at this stage. It is important to include in the protocol a discussion of the risk to patients/subjects and the risk minimization measures that are intended to be taken.

What is the approach to ongoing trials?

Both FDA, EMA and national authorities have published guidance on the management of ongoing trials. The sponsor needs to make a risk assessment for each individual study and decide on the appropriate measures. This may involve, for example, temporarily pausing the study, reducing the rate of recruitment or extending the duration of the study. If the changes are such that the evaluability changes significantly, it may be appropriate to contact the relevant national authority(ies) for advice. Although the EU aims for a similar approach, the situation may be different in different countries and contact with the national authority is recommended. However, I want to stress the importance of carefully assessing whether the change is of such a nature that it needs to be assessed by an authority.

What is happening in terms of drug development for COVID-19?

Pharmaceutical authorities at national and European level have ongoing discussions with companies about the possibility of starting clinical trials and generating data that could inform regulatory decisions. This applies to both preventive and palliative treatments. The regulatory system understands the need for speed and the EMA offers ‘fast-track’ advice and a reduced fee. In a situation like this, the benefits of the well-established contacts and processes of the European Medicines Agency are clear.

Read more: COVID-19 and your ongoing or planned clinical trials

Here you will find SwedenBIO’s information page related to Covid-19: