The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO)

The current and future role of the medical oncologist in the professional care for cancer patients: a position paper by the European Society for Medical Oncology (ESMO)

“…By actively engaging in health and research policy at national and European levels, medical oncologists and their specialist organisations such as ESMO can contribute to making sure that all cancer patients in Europe will have equal access to novel and standard diagnostic procedures, appropriate cancer medicines and high-quality palliative care services. This lobbying should also include the provision of adequate national approval and reimbursement systems and drug supplies, including the participation of oncology experts in risk-benefit assessment of new drugs and the definition of indispensable drugs, and drive improvements and harmonisation of national policies governing the off-label use of drugs, which is common practice in oncology [12].…”

Conflict of Interest Disclosure in Off-Label Oncology Clinical Trials

“…Larger studies, those published in journals with higher impact factors, and those with more complex regimens were more likely to have statements, as were studies performed in the United States, perhaps as a result of the influence of FDA policies regarding off-label therapies and the fact that US studies were conducted by more mature organizations and/or investigators. 13 COI and funding disclosures do not prevent conflicts, but they help to mitigate their impact and allow users of the information, such as clinicians and publishers of compendia, to make independent judgments about the source and potential impact of sponsorship and financial bias. Recent studies showed that research funded by pharmaceutical companies was more likely to be published, more likely to be associated with restrictions on data sharing and publication, and more likely to have outcomes favoring the sponsor than studies funded by another source.…”

Policymaking for Orphan Drugs and Its Challenges

“…Some researchers also raise the question of whether, even when given incentives to focus on rare diseases, the pharmaceutical industry concentrates only on commercially lucrative areas. At least 95 of the aforementioned 400-plus orphan drugs were for cancer treatment; orphan drugs used to treat rare cancer are the most profitable [13,[18][19][20]. Haffner and colleagues ask, does the "development [of orphan drugs] actually take place for the truly rare diseases, or only for the more common ones" within the rare group, like the rare cancers [21]?…”