Procrastination or necessary gestation?
If you’ve been following the comments on my previous post “Secret Squirrel” then this will be somewhat of a repeat of some of what is contained in there.
In February the following tweet appeared on Dr Parnia’s feed:
Given that the study was supposed to complete recruitment by May of this year, one’s first reaction might be to groan “oh no, not another delay”. However, the comments that people have made regarding this announcement have probably best captured how I feel about this, namely that extending the study duration is a positive sign. Combined with the previous information that surfaced about the new drive for recruitment, this suggests just how serious the AWARE study team are about completing this ambitious study and recruiting sufficient numbers to have statistically, clinically and scientifically meaningful result.
There has also been the suggestion that they may already have one hit, and that this is providing the extra impetus, or belief in what they are doing. This is obviously pure speculation, but not without a strong rationale. When I was involved in HIV research, the organization I worked for was running a study on women, a notoriously difficult population to recruit into HIV trials, and they had fallen well behind the planned recruitment numbers. However, those who had access to the raw data, were confident the study was well powered and would produce the intended result if completed. On the basis of this, the company went ahead and extended the duration, and increased the number of recruitment sites, interestingly adding Canada, my current home. It appears that Parnia is also targeting Canada.
The AWARE II team have behaved exactly as any study team would if they believed they were pursuing an achievable objective:
1. Incentivized existing sites to recruit more patients.
2. Recruited additional study sites.
3. Increased the duration of the study.
As I’ve said before, my gut feeling is that they do indeed have at least one hit, and that the immediate drive is intended to get at least one more. If that were to occur, I would expect Parnia to go public before 2020, possibly following the route he did before and publish a new book. Personally, I think it would be more beneficial if he were to announce any development like this as an interim analysis at a scientific meeting, or via some other means as this would not only serve the wider community better, but would improve recruitment of new sites.
We will see, but I doubt that we will have to wait till July 2020 before we hear more about this.