On the other hand, the medical therapy that is included in the trial design is the best established therapy currently available for severe emphysema, and all patients in the trial will receive it. History is full of promising treatments, medical and surgical, that when evaluated under controlled conditions failed to live up to expectations of benefit and, in some cases, caused harm. And in the area of surgery, consider the recent example of extracranial-intracranial bypass. We consider the LVRS trial to be not only appropriate, but necessary to give both patients and their physicians the information they need to make informed, intelligent decisions about treatment of end stage emphysema. Although determining efficacy and setting guidelines for which patients are likely to benefit from LVRS will not guarantee a good outcome for all patients, it will increase the chances of success for most patients and, at the very least, allow patients to make decisions based on widely accepted scientific data, which do not now exist.
Patients have the right to know objectively whether the chances of success outweigh the risks.
As part of its review of the protocol before the trial begins, the DSMB will examine all available data on LVRS to ensure that the protocol is valid in terms of what is known. If the board concludes that an identifiable subset of patients clearly benefits from LVRS, the DSMB can recommend that the criteria for entry into the trial be modified accordingly. The DSMB can also recommend changes in the protocol, even after it is under way, if data show that a certain group of patients is highly likely to benefit from the surgery. We require this periodic review by an independent, scientific peer group in all of our clinical trials to ensure their safety, fairness, and scientific validity. Because of the unusual demand to have this procedure evaluated quickly, I have charged the investigators to have a protocol ready by June 1997, just one year after the release of the request for proposals.