The last year has meant many changes for all of us in so many areas of life – home working, home schooling, home based holidays, etc. We all know that there have been many changes in how we’ve conducting clinical trials this last year too. There’s been a general acknowledgement that the situation has expedited several innovations which have been in development but not yet implemented on a widespread basis. Suddenly we were forced to look at remote and centralised options as the only way we could continue to run trials. The question that is now being asked is what will happen next? There is a danger that we go back to the old, tried and tested ways, rather than pressing ahead with the changes which have potential to change the way clinical trials are run forever.
Personally I’d really like to think that most of the changes are here to stay, as much of it makes so much sense, but we also need to be careful to assess on a case by case basis and also to consult those who may be affected either positively or negatively. Some of the specifics are discussed below, but I think generally there is a need to:
- simplify protocols (I’ve been saying this for years and MHRA included this in recent guidance)
- make our trials and procedures more flexible and agile
- really get to grips with ongoing risk assessment and management
Remote Patient Visits
We may assume that participants will be happier to spend less time at investigational sites and so home visits or local testing will automatically be well received. That may be true, but we need to consider the alternative. Patients may be uncomfortable allowing people into their home, or may feel they are not getting the attention they need if they don’t get to go to the hospital for their assessments. The only way to find out what patients think or want is to ask them – so improving public and patient involvement continues to be critical.
This includes the possibility of remote consent and regulators such as FDA have already issued guidance on this. Consent is a particular concern of mine, my main bugbear currently being that the way consent is managed today is more about protecting the sponsor than the participant. I’m all for eConsent, but not if it is just an electronic copy of a 30 page, black and white document written in incomprehensible language. If we are going to use eConsent we have to take the opportunity to improve the “informed” part of the Informed Consent PROCESS. Use colour, pictures, diagrams, audio, video – make it understandable. All this can be done pretty much for free with a bit of creativity!
Remote Monitoring and SDV
Remote monitoring and Source Data Verification may be more convenient for the sponsor, and may (or may not) be cheaper too, but what is the cost of that? Does it impact on the relationship between the sponsor and the sites, and thus motivation to recruit participants? Some tasks can’t easily be done remotely – for example drug accountability checks, informed consent review. I would argue that there is a strong case to continue onsite monitoring as part of a hybrid monitoring plan for most clinical trials. Also it’s worth commenting that remote SDV will not be permitted in some countries post Covid, so in person SDV will be the only option in these cases.
The idea of sending IMP directly to patients is appealing, in the same way as remote participant visits and, again, I’m all for this as long as the logistics are managed correctly and the risks assessed and mitigated.
In summary I think the Covid-19 crisis accelerated many great changes and gives us an opportunity to keep those changes for the better in the long term, but we must do so with the principles of GCP firmly at the forefront of our minds – Protecting Participants and Assuring Data Quality.
Please let me know what you think in the comments below!
1 thought on “Clinical Trials Post-Covid – will there be a “new normal”?”
Good points thanks Jo. I agree, we cannot take away that on site relationship, it’s invaluable for the sponsor, site staff, and monitor. I do believe and agree with you that we can move forward and continue to conduct certain aspects of trials remotely based on identified and calculated risks. Remote auditing for example, for us QA professionals, has worked really well. However, remote site audits are limited as we do still need to see the source data to ensure the protocol has been followed. It’s unfortunate that so few sites in the UK and Europe have implemented validated electronic health records.