In the first part of this blog, we looked at how various Patients’ Bills of Rights – whether created by a state or by a health institution – have handled the idea of patients and clinical research. In this part, we pick up with questions related to the idea of ensuring patients are told about clinical trials for which they may be eligible.
What if a Patients’ Bill of Rights stated that patients have the right 1.) To be informed about all clinical research studies for which they might be eligible and that are being conducted by the facility in which they are receiving care, and 2.) To be provided with the essential information they need to know in order to decide whether or not they might be interested in participating?
What would be the rationale for including this tenet in a Patients’ Bill of Rights? Right off the bat, it would help to significantly increase patient approach rates, which, if only by sheer numbers, would increase consent rates at hospital-based sites, simply because not just site staff, but all providers involved in the care of a specific condition (not just conducting the study) would be obliged to inform patients of applicable studies underway. Is this a realistic expectation? Maybe. A similar task was achieved with the advent of HIPAA, in which all patients were required to be informed that their health information is private, and that they have say over who can and cannot review it. Of course, one could argue that, theoretically, sites are already always brining up their studies to potentially eligible patients. But making it an institutional mandate would help reinforce the need for the task to be ubiquitously applied – to rule out all patients, rather than to simply try to identify those who may be eligible.
I think the greater benefit of including the right to information about clinical trials would be that it would help raise not just awareness of, but also better comprehension of, what clinical trials offer in general. And this would help to change the public’s perception of studies – from being only for those with an altruistic leaning or people seeking compensation, to being a means of accessing emerging treatments and care, when appropriate.
Is this a realistic idea? Well, in Massachusetts we came close to articulating this in our Patients’ Bill of Rights. The law includes the following clause:
(h) In the case of a patient suffering from any form of breast cancer, [the patient has the right] to complete information on all alternative treatments which are medically viable.
This clause was included because the Massachusetts Bill became law at a time when there were serious health concerns emerging about breast implants. But the basic sentiment of providing information on all treatment options, including clinical trials, I believe is inherent. And, it hardly seems like a leap to see it being required for all conditions.
Additionally, as mentioned in Part one of this blog, institutions such as hospitals can and often do expand on a Patients’ Bill of Rights – whether borrowing from the AHA’s or furthering any rights mandated by law in their state. For example, Massachusetts General Hospital communicates the Massachusetts Patients’ Bill of Rights with regard to clinical trials in this manner:
You have the right to take part in a research study if you are asked. You also have the right to say no if you do not want to take part.
MGH also includes this statement:
You have a right to know all the facts we have about your illness, treatments and possible outcomes.
While MGH is not quite linking these two ideas together in the manner I’m suggesting, these elaborations on our state’s Bill demonstrate the ever-growing belief that patients have a right to all information related to their healthcare and treatment options (sparked in large part by the original idea of a Patient’s Bill of Rights, in fact). And my experience in patient recruitment repeatedly has shown that, once accurately informed of what study participation may offer, patients would very much wish to be informed about clinical trials for which they may be eligible, so that they can determine for themselves whether or not a given study is right for them.
Given the right scenario or series of events, I don’t think it’s unimaginable that an institution – such as a teaching hospital that conducts a great deal of research – would, on its own, come to recognize the value of ensuring that patients learned about all the institution’s clinical trials that offered them options. In fact, it would seem to go hand-in-hand with a practice many major institutions already have in place – asking the patient, when first admitted, whether or not they’d like to be told about clinical trials for which they may be eligible.
I wonder what might happen if our industry were to suggest this idea to these institutions – and to the greater community of healthcare providers – so many of which conduct our industry’s studies.