Clinical Trials: A De-Centralized Response
I recently wrote about my experiences at the SCRS Site Solutions Summit back in October 2019, and one of the topics I discussed was decentralized trials and how it felt like they were progressing fairly slowly. Data at the Summit suggested that less than 15% of sites had experience with trials that had some component of virtualization. My guess is that at the 2020 Summit (hopefully, in a post-quarantine world), that number will be significantly higher.
The shifting landscape of clinical trials
Among the many amazing responses and reactions I have seen the Pharma industry initiate in the wake of the global pandemic is the acceleration of home health services, telemedicine, and remote data collection to address and enable social distancing for the safety of patients and site personnel. It's unfortunate that the use case had to present itself in such a catastrophic manner; however, it is exciting to see Pharma companies, sites, and technology/service vendors rally to the call.
As they say, necessity is the mother of invention. Some of the inventions I have seen get off the ground in a (very!) short time include:
- Discovering ways to deliver investigational product directly to patients in their homes
- Deploying mobile nurses (with the appropriate PPE) to patients’ homes to help with drug administration
- Lab sample collection
- Safety monitoring
I have seen site personnel risk, or offer to risk, their own safety for the benefit of their patients by traveling to homes to deliver medicine and supplies. I have even seen technology and service companies offer their services pro bono in order to support mitigation efforts. These are amazing stories of amazing people who have their hearts in the right place and their heads fully in the game during a difficult time. I am grateful for those around me who have looked to shine a little light on a terrible situation.
As we work toward a post-pandemic world, I am interested to see how these responses accelerate the implementation of decentralized trials and sustain the momentum created in these difficult times. I expect there will be a lot of lasting effects - hopefully more positive than not. The quick adoption and scaling of decentralized trials will be one of the positive outcomes of having to look at the world of clinical trials in a different way.
One final note: If you read my previous post, you may remember something I quoted from one of the patient representatives. She said, "Clinical research has to fit into your life." I think that statement takes on a whole new meaning as life as we know it has been turned upside down. Decentralized trials are meeting that challenge at a rapid pace.