By Leandro Moreira, SVP, Corporate Development, Yourway
The COVID-19 pandemic has led to widespread embrace across the industry of decentralized clinical trials models, including direct-to-patient (DTP) and direct-from-patient (DFP) supply and healthcare services. However, the pandemic has also introduced novel challenges and complications with DTP and DFP logistics.
A specific new challenge the industry is facing due to the implementation of DTP trials is quality-by-inspection instead of quality-by-design. Quality-by-inspection relies on identifying quality issues after they have occurred, while quality-by-design emphasizes product and process understanding, as well as control and a risk management approach to predict quality issues before they arise. Quality-by-inspection can hinder innovation because it requires constant change when something new arises.
The pandemic has also made patient enrollment a bigger challenge. Almost 85% of clinical trials fail to maintain viability because of inability to retain enough patients. Furthermore, patients who are immunocompromised have unique challenges since any travel at all may place them at unnecessary risk, especially during the pandemic. Virtual patient management, including DTP care, decentralization, and telemedicine have expanded the capabilities of ongoing trials.