Continuing the execution of your clinical trial(s) during the coronavirus pandemic is just one daunting aspect of this global situation. Actually starting a new trial during lockdown is even more challenging. In the spirit of sharing good news and peer encouragement here we briefly illustrate some encouraging anecdotes from our customer base whose Clinical Operations have proved sufficiently resilient during the pandemic for them to both continue existing trials and start new ones.
This is not to say for a moment that these actions were easy or trivially achieved. While their use of the myClin Clinical Oversight Platform is a common theme much more important is the good human practice these teams are applying. There is an essential flexibility and innovative spirit in their approach that has been key to their success – a flexibility that has been matched by the regulatory responses they received.
So how can you execute a clinical trial when you can’t visit a site?
And the inability to visit your sites is likely to strike in the future too as various geographies might be forced into renewed “second wave” lockdowns. There are 2 main ways myClin has helped.
First, controlled and reliable communication between all study stakeholders. Suddenly the delivery of essential study information is a task your monitors cannot perform. So how do you deliver that important study update? More challenging, how do you train a site from scratch when starting a new study?
The myClin tool helps because:
- Readership of all study documents and communication is transparently reported and shared.
- A range of online training can be delivered efficiently.
- Receipt and acknowledgement of essential study documents is tracked.
- Users at sites and in your clinical team are led to the items that require their attention.
- Study management can quickly see which staff are paying good attention and those that need encouragement (myClin Compliance Score).
The second use case is support for remote SDV (source data verification). As a highly flexible storage tool for clinical documents, sites are uploading copies of source documentation into myClin. This content is suitably redacted by the site. The monitors are then able to review this source material alongside the eCRF data and continue to fulfil their SDV duties in a timely and targeted manner. All with the in-built audit trail and view tracking that is normal to myClin.
For the studies that were already underway this change of process has been discussed collaboratively with regulatory bodies. Those bodies have understandably been sympathetic to efforts to continue trial operations through the pandemic – patients still need treatment and care through all of this.
Good luck in your own efforts to continue study operations despite this unprecedented health crisis.
By Adam Wood, VP, Business Development at myClin