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Author Archive: Jonathan Kimmelman

About Jonathan Kimmelman

10/04/2012

Missing Reports: Research Biopsy in Cancer Trials


A growing number of drug trials are collecting tissue to determine whether the drug hits its molecular target.  These studies are called “pharmacodynamics.”  And in cancer, many pharmacodynamics studies involve collection of tumor tissue through biopsies.  These procedures are painful, and are performed solely to answer scientific questions.  That is, they generally have no diagnostic or clinical value.  As such, some commentators worry about their ethics.


In a recent issue of Clinical Cancer Research, my Master’s student Gina Freeman and I report on publication practices for pharmacodynamics studies involving tumor biopsy.  The basic idea is this: the ethical justification for such invasive research procedures rests on a claim that they are scientifically valuable.  However, if they are never published, it is harder to argue that they have a sound scientific justification.  So we set out to determine how frequently results are published, and reasons why some results are never reported. Briefly, we found that a third of promised analyses are not published- which is more or less in line with the frequency of nonpublication for trials in general.  We also find that researchers who perform pharmacodynamics studies regard reporting quality as fair to poor, and many perceive the most common reason for nonpublication to be “strategic considerations” (as in: result does not fit the narrative of the overall trial).


Does our article support a definitive statement about the ethics of research biopsy in cancer trials?  No.  But it does point to a number of ways that the ethical justification can be strengthened- and questions clinical investigators and ethics boards should be asking when designing and/or reviewing protocols involving research biopsy. (graphic: cole007 2011)

Full Article

This entry was posted in Health Care and tagged , . Posted by Jonathan Kimmelman. Bookmark the permalink.

10/04/2012

Missing Reports: Research Biopsy in Cancer Trials


A growing number of drug trials are collecting tissue to determine whether the drug hits its molecular target.  These studies are called “pharmacodynamics.”  And in cancer, many pharmacodynamics studies involve collection of tumor tissue through biopsies.  These procedures are painful, and are performed solely to answer scientific questions.  That is, they generally have no diagnostic or clinical value.  As such, some commentators worry about their ethics.


In a recent issue of Clinical Cancer Research, my Master’s student Gina Freeman and I report on publication practices for pharmacodynamics studies involving tumor biopsy.  The basic idea is this: the ethical justification for such invasive research procedures rests on a claim that they are scientifically valuable.  However, if they are never published, it is harder to argue that they have a sound scientific justification.  So we set out to determine how frequently results are published, and reasons why some results are never reported. Briefly, we found that a third of promised analyses are not published- which is more or less in line with the frequency of nonpublication for trials in general.  We also find that researchers who perform pharmacodynamics studies regard reporting quality as fair to poor, and many perceive the most common reason for nonpublication to be “strategic considerations” (as in: result does not fit the narrative of the overall trial).


Does our article support a definitive statement about the ethics of research biopsy in cancer trials?  No.  But it does point to a number of ways that the ethical justification can be strengthened- and questions clinical investigators and ethics boards should be asking when designing and/or reviewing protocols involving research biopsy. (graphic: cole007 2011)

Full Article

This entry was posted in Health Care and tagged , . Posted by Jonathan Kimmelman. Bookmark the permalink.

08/20/2012

Targeted Cancer Drugs: The "Price of Progress"?

So here is the party line on the newest generation of cancer drugs.  Unlike older generation drugs, which are generalized poisons, newer cancer drugs hone in on very specific molecular targets.  Because of this specificity, they have fewer "o...

Full Article

This entry was posted in Health Care and tagged , . Posted by Jonathan Kimmelman. Bookmark the permalink.

08/20/2012

Targeted Cancer Drugs: The "Price of Progress"?

So here is the party line on the newest generation of cancer drugs.  Unlike older generation drugs, which are generalized poisons, newer cancer drugs hone in on very specific molecular targets.  Because of this specificity, they have fewer "o...

Full Article

This entry was posted in Health Care and tagged , . Posted by Jonathan Kimmelman. Bookmark the permalink.

05/02/2012

Registration of Trials: A Census

Apologies to the millions of avid followers of Lost in Translation for the long haitus.  In response to an international petition campaign, with several Nobelist signatories, I am cautiously restarting this blog with the aim of (monthly??) blogpos...

Full Article

This entry was posted in Health Care and tagged , . Posted by Jonathan Kimmelman. Bookmark the permalink.

05/02/2012

Registration of Trials: A Census

Apologies to the millions of avid followers of Lost in Translation for the long haitus.  In response to an international petition campaign, with several Nobelist signatories, I am cautiously restarting this blog with the aim of (monthly??) blogpos...

Full Article

This entry was posted in Health Care and tagged , . Posted by Jonathan Kimmelman. Bookmark the permalink.

03/21/2011

Tea Leaves: Predicting Risk and Benefit in Translation

Every early phase trial begins with a series of predictions: that a new drug will show clinical utility down to road, that risks to study volunteers will be manageable, and perhaps, that patients in trials will benefit. Make a bad prediction here, and...

Full Article

03/21/2011

Tea Leaves: Predicting Risk and Benefit in Translation

Every early phase trial begins with a series of predictions: that a new drug will show clinical utility down to road, that risks to study volunteers will be manageable, and perhaps, that patients in trials will benefit. Make a bad prediction here, and...

Full Article

02/08/2011

Dirty Windows of Drug Development

Think of clinical trial data as a window on the efficacy and safety of a drug. Think of data protection and trade secrecy as soot. The above picture? This is the public view on drug safety and efficacy.According to a recent report in Nature Biotechnolo...

Full Article

This entry was posted in Health Care and tagged , , , , , , , , . Posted by Jonathan Kimmelman. Bookmark the permalink.

02/08/2011

Dirty Windows of Drug Development

Think of clinical trial data as a window on the efficacy and safety of a drug. Think of data protection and trade secrecy as soot. The above picture? This is the public view on drug safety and efficacy.According to a recent report in Nature Biotechnolo...

Full Article

This entry was posted in Health Care and tagged , , , , , , , , . Posted by Jonathan Kimmelman. Bookmark the permalink.