Dr. Behfar Ehdaie

I've already determined eligibility. And so everything gets scrutinized. Everything that's an exclusionary eligibility criteria, remember, a research study system has to sit there with a checkbox. with every patient and make sure those things don't fit in those criteria. So we've now really emphasized, eliminate things that are not necessary.

There's no reason if you're doing a clinical trial of hernia repair to include liver function tests as an exclusionary criteria or checking an INR. Those things are done routinely for every prostatectomy. If a patient's a prostatectomy candidate, those steps have already been passed. So we sort of think two steps ahead and say,

There's no reason if you're doing a clinical trial of hernia repair to include liver function tests as an exclusionary criteria or checking an INR. Those things are done routinely for every prostatectomy. If a patient's a prostatectomy candidate, those steps have already been passed. So we sort of think two steps ahead and say,

There's no reason if you're doing a clinical trial of hernia repair to include liver function tests as an exclusionary criteria or checking an INR. Those things are done routinely for every prostatectomy. If a patient's a prostatectomy candidate, those steps have already been passed. So we sort of think two steps ahead and say,

If we're integrating our trials, let's integrate how we manage these patients and how we select patients.

If we're integrating our trials, let's integrate how we manage these patients and how we select patients.

If we're integrating our trials, let's integrate how we manage these patients and how we select patients.

So there's always a purpose behind every regulatory action or sort of dogma. But I think what we've learned over time is we need to challenge dogma because things have changed in time. Clinical records and assessment of electronic medical records has changed. We now, at the tip of our fingertips, know what everyone's allergies are. We know what past medical history they have.

So there's always a purpose behind every regulatory action or sort of dogma. But I think what we've learned over time is we need to challenge dogma because things have changed in time. Clinical records and assessment of electronic medical records has changed. We now, at the tip of our fingertips, know what everyone's allergies are. We know what past medical history they have.

So there's always a purpose behind every regulatory action or sort of dogma. But I think what we've learned over time is we need to challenge dogma because things have changed in time. Clinical records and assessment of electronic medical records has changed. We now, at the tip of our fingertips, know what everyone's allergies are. We know what past medical history they have.

We don't need to re-interview every patient at their follow-up appointment because we know their previous note is in the chart. So I do agree that there needs to be thought put in, and there always is, about adding or subtracting any inclusion or exclusionary criteria.

We don't need to re-interview every patient at their follow-up appointment because we know their previous note is in the chart. So I do agree that there needs to be thought put in, and there always is, about adding or subtracting any inclusion or exclusionary criteria.

We don't need to re-interview every patient at their follow-up appointment because we know their previous note is in the chart. So I do agree that there needs to be thought put in, and there always is, about adding or subtracting any inclusion or exclusionary criteria.

But if we start from the baseline, less is more, I think we can, even if you reduce it 10%, the list of items that you put on that inclusion or exclusionary criteria is critical. Oftentimes, even though the Research Council spends time on that section, investigators cut and paste probably from other trials and just add those things as routine.

But if we start from the baseline, less is more, I think we can, even if you reduce it 10%, the list of items that you put on that inclusion or exclusionary criteria is critical. Oftentimes, even though the Research Council spends time on that section, investigators cut and paste probably from other trials and just add those things as routine.

But if we start from the baseline, less is more, I think we can, even if you reduce it 10%, the list of items that you put on that inclusion or exclusionary criteria is critical. Oftentimes, even though the Research Council spends time on that section, investigators cut and paste probably from other trials and just add those things as routine.

So if you've done that, take a minute, because even though the inclusion, exclusion criteria may not be important up front to you as you write your trial, It will be a time and administrative burden in the future because every one of those criteria has its own paperwork that needs to be signed off and checked off from a regulatory perspective for every single patient.

So if you've done that, take a minute, because even though the inclusion, exclusion criteria may not be important up front to you as you write your trial, It will be a time and administrative burden in the future because every one of those criteria has its own paperwork that needs to be signed off and checked off from a regulatory perspective for every single patient.

So if you've done that, take a minute, because even though the inclusion, exclusion criteria may not be important up front to you as you write your trial, It will be a time and administrative burden in the future because every one of those criteria has its own paperwork that needs to be signed off and checked off from a regulatory perspective for every single patient.

So by reducing those, you've reduced paperwork, you've reduced administrative burden. But the other aspect of this is the burden on our patients. We transitioned from clinical integrated trials to this concept of two-stage consent. And the idea behind that was really when we sit there as our traditional consent in a randomized trial, we say, this is this new idea. It's really cool.