“The safety of clinical trial patients and staff is paramount. We are working with our clients in pharma and CROs to assess each trial to see if it needs to be suspended, delayed or if it can carry on in a way that is safe both for the clinicians and participants” commented Stuart Young CEO of Panthera the independent SMO.
Stuart continued, “the major regulatory bodies across the world – FDA, MHRA and EMA - have given clear guidelines with safety being the number one consideration. I have outlined below how we are proceeding.”
- Panthera is working with sponsors who need to press ahead with trials which can be done safely.
- Trials involving patients who are in the high-risk categories will be managed with extreme caution and Panthera will work with sponsors on appropriate measures and recruitment pauses as needed.
- Panthera already has remote patient visit protocols in place including using phone or video links. These links could also be used for monitoring and site inspections.
- During this pandemic any visit by a patient has been mapped out so that there is a greatly reduced risk of contamination. Patients are asked to remain in their vehicles until the healthcare professional is ready for them. A thorough hygiene regime is also in place.
- With new sites coming on line Panthera can be very nimble and has the ability to adapt to the sponsor’s needs.
- Because some of Panthera’s sites are isolated Panthera is able to help on existing studies where enrolled patients can be moved – protocol permitting – from hospitals and GP practices which may well be unsafe in this current environment.
Panthera which has sites in Manchester and Preston has only just opened a new site in North Manchester. The North Manchester site which is a standalone building with its own car park has seven consulting rooms and all the technical facilities required to run a professional clinical trial site. The GCP trained staff will manage trials on conditions served by primary care.
The Panthera Preston site will be expanding next year when it moves into a purpose-built super-practice which is presently under construction.
Panthera plans to open a network of sites across the UK. It is also in advanced discussions in providing specialist secondary care sites for trials in Neurology and Oncology.