Mitotech is working to do everything reasonably possible to minimize disruption to patients participating in its clinical trials and to meet their needs during this uncertain time. This page is intended as a resource to gather relevant links and information in one place.
It is critically important for patients and caregivers to contact your physician with specific questions and to stay up to date on your local health authority’s updated guidance.
Questions about clinical trials
How will Mitotech deal with challenges to clinical trial data collection?
Mitotech is closely monitoring its studies and working to mitigate disruption and delay in both dosing or follow-up visits. We are working in accordance with guidance issued by regulatory bodies, such as US FDA, who have provided direction and flexibility on clinical trial conduct during the pandemic. Mitotech is working closely with each site to adhere to this guidance to minimize risks to trial integrity and, most importantly, ensure that patient safety remains our top priority. We are evaluating options such as where we can adapt trial protocols to allow for virtual interactions and reduce risk to patients, while remaining fully compliant with Good Clinical Practice, and continuing to advance these important investigational treatments.
Does Mitotech have enough supply for current trials?
Mitotech continues to provide an uninterrupted supply of its therapies to patients and the company developed a contingency plan with its suppliers to avoid disruption to patients.
What kind of change may occur in procedures at a clinical site?
Individuals involved in clinical trials are encouraged to keep in contact with their clinical trial sites to discuss any issues that may cause an interruption in the trial experience. We are quickly working to develop alternate methods of visit conduct where possible. These changes are being communicated to your clinical trial investigator.
Community Resources and Support
General Guidance and Statistics on the COVID-19 Pandemic
U.S. Centers for Disease Control and Prevention
World Health Organization
U.S. Federal Emergency Management Agency