As we begin a new year there’s a bit of a feeling of déjà vu about things. Last January we were excited that 2020 was done with and hope that 2021 might see life get back to normal, but we all know it didn’t quite work out that way. It kind of feels the same now, but we are more cautious about the future and whether 2022 will be any different, but from what I can see we are in a much better place generally in terms of the Covid-19 pandemic and I’m optimistic.
Whatever happens with Covid-19 we can be sure that change is coming for those of us working in clinical research. This is the year the EU Clinical Trials Regulation finally takes effect and also the updates to ICH GCP are on the horizon. There are a several important areas where we need to see change happening and so I’d like to spend a few lines reflecting on a few of these.
Decentralised Clinical Trials
The Pandemic has certainly accelerated adoption of remote capabilities for running clinical trials and this has to be a good thing. There are so many opportunities to make life easier for participants, sites and sponsors, but we need to be sure we get it right. I think there are some key considerations to bear in mind:
- What do patients/participants really want? We may assume they’d prefer to stay at home, but they may want the security of visiting the doctor, or they may feel uncomfortable having strangers in their home. We need to ask them and consider their views.
- Remote capabilities need to be built with security and privacy in mind. Data Protection is an important provision and we need to make sure we can meet the requirements of data protection legislation and data integrity.
- Managing relationships is key to running effective and efficient clinical trials and so communication must be at the heart of any clinical trial management system or process. This includes relationships between sponsors, vendors, sites and participants.
This issue was highlighted during the Covid Pandemic and the underrepresentation of ethnic groups, different age ranges and women, including trials in pregnancy has become one of our hot topics. There are many people working on this and much is being written, including FDA guidance on the subject.
This is something we probably should have addressed much earlier than this, but I’m glad it’s being addressed now. Some of the suggestions to improve the situation are:
- Increasing diversity in investigational sites and investigators
- Engaging and consulting with patients
- Providing cultural awareness training for clinical research staff
- Considering language and its impact, and offering alternatives
This is an issue, not just for clinical trials, but for medicine in general. How can we reduce the use of disposable and single use items while ensuring safety? How can we reduce the use of paper and plastic and our carbon footprint?
Decentralised clinical trials will help with this as we turn from paper to electronic information and signatures, and virtual participant visits and monitoring visits will reduce travel.
We also need to consider manufacturing and disposal of consumables such as medication and laboratory kits and this becomes more of a challenge when we think about sending these directly to patients rather than using them at investigational sites where proper equipment, facilities and processes can be put in place.
It will take a shift in thinking, creative approaches and lots of hard work, but we’ve shown that we can change and for the future of our planet we must do so again.