Roche’s Clinical Development Programme Statement re: Coronavirus (COVID-19) Outbreak

13 March 2020

What Roche says:

"Roche will not exclude patients from SMA clinical studies based on travel restrictions due to the Coronavirus (COVID-19) and will ensure to maintain supply where possible amid the outbreak.

We advise patients and families participating in clinical studies to follow the advice provided by the site and site team members and abide by any travel restrictions issued by the local authorities.

If local regulations and recommendations allow, patients should come to the site for all protocol assessments. If, however, a specific country has implemented special entry and exit restrictions for their territory, patients must not travel to the site.

In the case where a patient cannot attend the site for the protocol assessments, the advice for the investigators or delegate is be in regular contact with the patient/the patient's caregiver over telephone to monitor the general health of the patient, discuss any potential adverse events and any other issues the patient may have during this time. No doses should be missed as long as the patient is in an appropriate condition and unless instructed otherwise by a physician.

Should any patients become affected by coronavirus, the patient should ensure to let the physician know that they are participating in a clinical trial.

We recommend that anyone concerned, contact their respective study sites to discuss the individual circumstances with them."