The right hand doesn't know what the left hand is doing: from investigator calls to taking back (almost) all the bad things I've ever said about New Jersey
This is definitely something solely on the bureaucratic side of the equation from the hospital. Many sites use shadow research charts and this is not clinical care.
You're familiar with a regular clinical chart (usually electronic, e.g., EPIC). However, as you've seen in more complicated cases, especially in oncology, these charts can be massive, and filled with a lot of information that is not necessarily needed for a clinical trial (unless it's something basic such as establishing prior lines of treatment, or start and stop dates of treatment). It sounds like your husband is relatively early in lines, but I've seen some Phase I trials have upwards of 6-8 prior lines of treatment, so imagine those charts!
A shadow chart is going to have all of the information that's in the clinical chart but pertains only to the research procedures and requirements itself. It's not used for official clinical care but is for the research procedures, investigators, study team, and the monitors as well. Getting a monitor access to an EMR is arduous and it can be easier to have that background chart to use.
Additionally, in some cases, you just go to a research center or institute rather than dealing with the barriers of the big institutions.
I'm a molecular biologist in a field directly related to cancer research. My both my best friend and my cousin died of CIC::DUX4, non-Ewing's sarcoma this year (in what is a freakish coincidence, like winning the worst lottery I can imagine).
I cried reading part 1 and 2, remembering the chaotic way I followed the same path as you, thinking naively that it must be a straightforward process and being absolutely beaten down by the reality that the system is impossible to understand, even with expertise like ours.
Ultimately, neither my cousin nor my best friend ended up joining any trials, partially because they did not have resources to travel. I'm holding out lots of hope for you and Jake that a trial will make all the difference and win you valuable life time together. I think with your expertise and Jake's willingness to fight, you have a great shot.
I’m so so sorry to hear about your friend and cousin. Sometimes, during this process, I thought “I must be missing something” but the more I hear stories like yours the more I realize that it’s just universally terrible. Writing this felt like writing dystopian fiction instead of documenting the reality for so many sick patients.
Earlier this week, I finished re-reading The Trial by Franz Kafka. I’m struck that the clinical trial process that you have described is more kafkaesque than Kafka 😳
This is definitely something solely on the bureaucratic side of the equation from the hospital. Many sites use shadow research charts and this is not clinical care.
Jenna- can you expand on that a bit? I'm not familiar with shadow research charts.
OMG I typed out an entire reply and lost it!! 🤦🏻♀️ I will reply later but yes, happy to.
oh no! I hate when that happens. Thank you
Okay, take 2...
You're familiar with a regular clinical chart (usually electronic, e.g., EPIC). However, as you've seen in more complicated cases, especially in oncology, these charts can be massive, and filled with a lot of information that is not necessarily needed for a clinical trial (unless it's something basic such as establishing prior lines of treatment, or start and stop dates of treatment). It sounds like your husband is relatively early in lines, but I've seen some Phase I trials have upwards of 6-8 prior lines of treatment, so imagine those charts!
A shadow chart is going to have all of the information that's in the clinical chart but pertains only to the research procedures and requirements itself. It's not used for official clinical care but is for the research procedures, investigators, study team, and the monitors as well. Getting a monitor access to an EMR is arduous and it can be easier to have that background chart to use.
Additionally, in some cases, you just go to a research center or institute rather than dealing with the barriers of the big institutions.
I'm a molecular biologist in a field directly related to cancer research. My both my best friend and my cousin died of CIC::DUX4, non-Ewing's sarcoma this year (in what is a freakish coincidence, like winning the worst lottery I can imagine).
I cried reading part 1 and 2, remembering the chaotic way I followed the same path as you, thinking naively that it must be a straightforward process and being absolutely beaten down by the reality that the system is impossible to understand, even with expertise like ours.
Ultimately, neither my cousin nor my best friend ended up joining any trials, partially because they did not have resources to travel. I'm holding out lots of hope for you and Jake that a trial will make all the difference and win you valuable life time together. I think with your expertise and Jake's willingness to fight, you have a great shot.
Love to you and waiting for part 3!
Link to part three: https://open.substack.com/pub/bessstillman/p/please-be-dying-but-not-too-quickly-837?r=16l8ek&utm_medium=ios&utm_campaign=post
I’m so so sorry to hear about your friend and cousin. Sometimes, during this process, I thought “I must be missing something” but the more I hear stories like yours the more I realize that it’s just universally terrible. Writing this felt like writing dystopian fiction instead of documenting the reality for so many sick patients.
Sigh.
Indeed.
Earlier this week, I finished re-reading The Trial by Franz Kafka. I’m struck that the clinical trial process that you have described is more kafkaesque than Kafka 😳