Who Should Participate in Clinical Trials?

https://docs.google.com/file/d/0B-CzY4x3aATQYkppaXI5X0FBTlU/edit?usp=sharing

Pharma champions the image of the clinical trial participant as a sufferer of a medical condition unresponsive to current market drugs, for whom participation in phase II/III trials presents an opportunity for newer, better treatment. This, however, is not the case for most clinical trial participants, who are testing drug for common, non-life threating illnesses. For most participants, clinical trials are a way to earn income or to gain access to the otherwise unavailable medical establishment.

Fisher identifies this subject pool as signaling fundamental imbalances of power, and argues that pharma cultivates recruits for clinical trials through a process that “capitalize[s] on the political and economic conditions that disadvantage populations around the world.” Data on clinical study participants in the US supports her claim: domestic participants are typically low-income/uninsured and are enrolled in trials out of desperation for money/medicine.

To correct this imbalance, Fisher recommends that we fundamentally reevaluate “the structural conditions in the United States that make clinical trial participation necessary for these groups.” She aims for a scenario where clinical trial participation is never necessary, but always optional. Is she saying that we should change the way trials are marketed so that they are more appealing the more privileged, or that we should change healthcare conditions so that the poor and uninsured do not have to resort to clinical trials? Either way, given that populations with greater means and more options do not often choose to enroll in clinical trials, her scenario would create a drastic need for participants. Fisher aims for ideal but unrealistic change.

There are more reasonable alternatives. Fisher dismisses solutions proposing new research models that engage the trial participants in the research discourse, expanding their awareness of their role and thereby permitting more complete consent. This solution aims to beneficially adapt the current drug development process, yet a more radical solution – one that would dramatically reduce the need for clinical trial participants altogether – would be to abandon the randomized controlled trial process.     As long as randomized controlled trials remain the gold standard in drug development, we need people working this undesirable and sometimes risky job.

It seems unlikely that randomized controlled trials could be supplanted with an equally good evidence method, yet change in the drug development process is far more feasible than changes in economic and social imbalances of power.

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