Designing a randomized clinical trial (RCT) of IO care’s safety and efficacy, and not just a single agent treatment, faces several methodological challenges. First, federally-funded trials of IO care would require FDA approval to conduct research (INDs) for each element of IO care that involves a therapeutic substance (T. versicolor mushroom extract, mistletoe, curcumin, green tea, resveratrol, artemisinin, silymarin and melatonin to mention just a few commonly used IO treatments). Second, an IO RCT would require the development of a single standardized treatment algorithm that could be used as a strict protocol. Most IO clinics do not have strict standards of care or protocol guidelines of the sort needed for a definitive RCT, instead allowing providers to customize care to each individual patient. Third, once such a protocol is developed an estimated effect size for the protocol as a whole will be needed. If IO treatments are synergistic and their combination is more than the sum of their individual effects, this effect size could not be computed based on the effects found in single treatment studies. Estimates for conventional medicine RCTs examining behavioral and nutritional interventions commonly come from epidemiological research studies often conducted using non-randomized study designs and matched comparison groups.
There is also a potentially significant problem for an IO care RCT in patient recruitment. Patients already seeking IO care would be unlikely to enroll in a study with possible randomization to a non-treatment group. Similarly, those not already seeking IO care may be reluctant to sign up for randomization to IO activities they might find burdensome and that are not demonstrated to improve health.
Building strong evidence for efficacy of IO care may likely require RCTs. However, until we know more about the likely effects of IO care, we cannot proceed with RCTs. Therefore, it is appropriate to use other designs to create evidence to support an RCT proposal. For now, prospective outcomes studies using matched comparison women to assess the effects of IO care holistically via a health services approach may be most appropriate. The ethics of using clinical data collected from patients receiving reimbursed healthcare to evaluate those health services has been evaluated favorably. 24 (link)
There is also a potentially significant problem for an IO care RCT in patient recruitment. Patients already seeking IO care would be unlikely to enroll in a study with possible randomization to a non-treatment group. Similarly, those not already seeking IO care may be reluctant to sign up for randomization to IO activities they might find burdensome and that are not demonstrated to improve health.
Building strong evidence for efficacy of IO care may likely require RCTs. However, until we know more about the likely effects of IO care, we cannot proceed with RCTs. Therefore, it is appropriate to use other designs to create evidence to support an RCT proposal. For now, prospective outcomes studies using matched comparison women to assess the effects of IO care holistically via a health services approach may be most appropriate. The ethics of using clinical data collected from patients receiving reimbursed healthcare to evaluate those health services has been evaluated favorably. 24 (link)
