Virtual clinical trials could soon be an option for pharma biotech companies
Conducting clinical trials – or partnering to do so – under budget constraints and tight regulatory watch can be one of the most demanding and challenging processes for a medical device startup or biotechnology or pharmaceutical company. But as the industry morphs under the influence of a new wave of e-patients, clinical trials may follow.
Pfizer Inc. is testing a new, virtual model for clinical trials of its drug Detrol LA for overactive bladder. In this “Partnerships in Clinical Trials” podcast, Craig Lipset, the head of clinical innovation for worldwide research and development at Pfizer, talks about how virtual trials will enable participants to self-report results via the Web.
If Pfizer is able to get reliable results and engage in productive conversations with regulators during the pilot program, the virtual trial could become a more effective option for young companies to consider. The most likely candidates for a virtual clinical trial would be therapeutics for conditions that are largely self-reported already, Lipset said.
“The virtual trial is about really putting the patients at the center of the clinical trial and embracing them as a real participant in clinical research,” he said.
Virtual trials remove the geographic barrier historically associated with clinical trials, allowing for more diverse participants and better patient engagement.
However, it may be a challenge to convince outside partners that this type of disruptive change can be implemented while maintaining ethical and legal standards and obtaining reliable data from patients. Plus, Lipset said, companies may lose some referrals from physicians once the geographic barriers are removed.
By early next year, Pfizer should have some results that will help the industry better understand how virtual trial models can work in this digital health environment.