Right-To-Try will Kill Clinical Trials in High-Risk Patients
[Posted on: Thursday, June 28, 2018] The informed consent for any clinical trial requires the sponsor to inform the potential participants about available treatment options outside the trial. For life-threatening indications, it would mean telling the patients that they could get the same investigational drug via the Right-to-Try law without participating in the trial, thereby eliminating the very reason these patients were enrolling in the said trial. The biggest incentive for patients with practically all life-threatening indications for participating in clinical trials has been access to new treatments that otherwise would not be available. For example, most oncology trials for new treatments are conducted in patients who have failed at least one line of treatment. By removing the requirement to participate in clinical trials to get such drugs, the Right-To-Try Law will literally make it less likely for such patients to want to enroll in controlled clinical trials effectively killing recruitment to such trials. It would be illegal to not tell the patients that there are ways other than the clinical trial to get the investigational drug. Although access to experimental therapies was available earlier through the compassionate- or emergency-use INDs, the process still required getting FDA and IRB approvals, and for manufacturers to provide the investigational drug for free. The Right-To-Try law does not prohibit the manufactures from charging for the experimental drug; there have been some reports of companies using this new law for generating revenue. So, for patients willing to pay for the experimental therapy, the door just opened to legally buy such therapies. Moreover, the manufactures have no liability for the safety of the drug; any negative information from the use of products under the Right-To-Try law cannot be used against the company. The only condition for the manufacturer is to have an active IND for the investigational product, which is a pretty low bar for products intended to treat life-threatening conditions. Although the law requires a given patient to have exhausted all treatment options, this is also an easy condition to meet for most patients who would want to try such experimental drugs. The law literally creates a disincentive for the patients to participate in clinical trials if they have rare, life threatening conditions. Since patients with life-threatening conditions no longer require participation in clinical trials to get new unapproved drugs or biologics; they would be unlikely to do so. This should effectively kill recruitment to controlled clinical trials in patients with life-threatening conditions unresponsive to standard of care, the key target demography for such trials. It could be argued that it is unethical to conduct clinical trials in patients who have failed all therapies available to them and are desperate for any hope. But without controlled good quality data, such patients may never get approved therapies, and more patients may be at risk in future. Now that Right-To-Try is the law of the land, we will need to find better ways to test drugs intended for life-threatening conditions under the new realities of the times.
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