You’ve just been handed a protocol and asked to build it out in your EDC...
Researchers worldwide are working to find reliable and effective Covid-19 treatments. OpenClinica, a leading clinical research software company, is conducting an extensive adaptive platform trial alongside Quantum Leap Healthcare Collaborative for patients hardest hit by Covid-19. In December 2020, the trial’s significant life-saving potential drove a major contract to Quantum Leap Healthcare to expand and accelerate their efforts. The investment is being used to scale the phase 2 clinical trial, boost patient recruitment, and accelerate data collection by extending the trial into non-academic hospitals and non-research centres.
“We initially built a relationship with Quantum Leap Healthcare when our clinical trial software supported their signature breast cancer adaptive trial,” explains OpenClinica CEO Cal Collins. “When the Covid-19 crisis hit, their leadership team identified that a similar adaptive platform trial design could quickly and efficiently find effective Covid-19 treatments.”
Although adaptive platform trials are not a new paradigm, their advantages are on full display in this particular trial application due to the Covid-19 public health crisis. This study design approach allows multiple therapies to be trialled at once, with new treatments continually added as they become available. Once sufficient data is gathered on treatment or it is deemed ineffective, it is retired from the trial. Amending the trial to incorporate new treatments—rather than setting up a parallel trial—radically decreases time to get new treatments incorporated by streamlining IRB approvals, study protocols, staff training, and site approvals. “It is a really efficient way to trial multiple indications and medications in one study,” says Collins.
The initial trial began in the summer of 2020. All trial participants are seriously ill with Covid-19 respiratory symptoms, with most in ICU on supplemental oxygen, intubated, or ventilated. The funding provided through the partnership will allow the trial to continue and collect data on potentially up to 1,500 patients throughout the US.
An innovative aspect of the trial is its targeted integration and interoperability with electronic medical records. Integrated data will soon be possible at the patient’s bedside for this trial via mobile devices that link EMRs and the research system. Covid-19 is proving the impetus and urgency to integrate research and care processes using technology in order to find effective treatments at a faster pace. “It’s crucial that we move past old ways of doing research, and harness technology to move faster and reach more patients,” says Collins.
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