I have often marveled at the level of sacrifice that becomes evident when we investigators consider participation in clinical trials. In fact, it is such an integral part of our research by in vivo experimentation that I think we come to take such courage for granted.
For all the talk of the War on Cancer – a Nixonian coinage that shows no signs of attrition 5 decades later – and the valorization of patients-as-combatants, there is surprisingly little recognition of the bravery required to volunteer for a study. After all, there are no conscripts to studies; our medical ethics forbid such coercion, and rightly so. Thus, without abandoning their autonomy, the trial participant must willingly submit their body to an unproven intervention, forgoing not independence but the precedent that undergirds most therapeutic decision-making. There can be no past-as-prologue without these intrepid first authors. Change only comes through their contributions.
It is the most precarious of social contracts, vulnerable to atrocious perversions like the Tuskegee Syphilis Study. In ways far less egregious, I wonder if we have been upholding our half of the bargain, obeying the letter of the law but not the spirit of the exchange. As members of the scientific community, we have a moral responsibility to share the findings of our research activities, including both positive and negative results.
While hope springs eternal, my patients who enroll on therapeutic studies acknowledge that they may not derive direct benefit (our institutional review board carefully vets the language of informed consent to ensure that there is no over-promising of individual gain). Many of my patients share the same request: to be notified of the trials' outcomes. It is an understandable petition that assumes the transactional nature of data-sharing, especially with the original sources of said data.
The flow of data will stagnate as unidirectional if we do not make a greater effort to disseminate results back to our essential volunteers. Dead-ends to dialogue abound. A phase II trial may only be discussed at a professional meeting. A negative phase III trial may never find purchase in a journal. And even a published manuscript may be effectively sequestered away from patients behind cost-prohibitive paywalls. When data are commodified to such an extreme, the information economy can dispossess the very stakeholders with the most legitimate claims to ownership.
The importance of closing this loop was poignantly reinforced to me through recent contact with a widow. The trial in which her husband had participated came to fruition 3 years after his death and, in its maturation, provided a new therapeutic avenue for a relatively refractory disease. Although he clearly had not been sustained by this novel remedy, she said that “he would have wanted to know that even one person had been helped.”
Obviously, the posthumous delivery of results is far from the ideal circumstance in which to circle back with news of scientific progress. And so, we must embrace the opportunity to communicate with the fierce urgency of now. It is crucial to respect the agency with which patients literally give of themselves to further our understanding and it is the very least we can do to reciprocate by expanding theirs.
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Sources of Support: None. Conflicts of Interest: None