Over the last decades, the quality of evidence generated by clinical trials that lead to oncology drug approvals shows important shortcomings, and with a low bar set by regulatory agencies for drug approvals, many often expensive drugs become available with limited (if any) benefit.1 Gyawali et al. offer a timely and critical view of the unethical practice of running phase 3 clinical trials with substandard control arms in low-and-middle-income countries (LMICs),2 increasing the chance of a positive outcome in the experimental arm. Survival benefit in global trials that accrue LMIC patients can also be driven by, at least in part, the lack of local post-trial treatment options. Such studies subsequently lead to approvals in high-income countries (HIC) based on flawed evidence and offer no benefit to patients in either HIC or in LMIC. The authors’ firm statements should resonate and lead to regulatory action. We would like to support their statements by mentioning another harmful consequence of such practices; the disruption of trust in the physician-patient relationship.
Physicians aware of the low value of such oncological drugs, especially when working in countries with relatively limited recourses, cannot (and should not) offer them despite their inclusion in international guidelines. In small developing countries with limited medical staff, treating physicians are often involved in the development of local or national practice guidelines and, therefore, are involved in decision making as to whether certain drugs should be made available to the very patients they are treating. With aggressive direct to consumer marketing, patients will often present with unrealistic expectations of the newest ‘break through’ and ‘game changing’ drugs. Properly limiting treatment options to true high value choices can even risk malpractice claims while protecting patients from futile medical care and society from unsustainable health care costs.
We feel that these important issues and authors whom over many years have contributed greatly to increase knowledge and awareness on these topics via research,2,3 educational materials (like podcasts,4 books3 and tutorials5) deserve central stage in core medical journals, at major medical meetings and in medical curricula. Only by broadly increasing awareness and implementing dedicated education programs early in the curriculum of (future) physicians can the oncological landscape be sustainably transformed in such a way that cancer patients and society benefit of only truly high value medical care.
Contributors
All authors contributed to design and writing of the manuscript.
Declaration of interests
The authors declare no conflict of interest.
Funding
The authors received no specific funding for this work.
References
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