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Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
Published on: February 6, 2015
Evidence-Based Medicine in Oncology: Commercial Versus Patient Benefit
Volker Schirrmacher1, Tobias Sprenger1, Wilfried Stuecker1
1Immune-Oncological Center Cologne (IOZK), D-50674 Cologne, Germany.
Abstract:
At times of personalized and individualized medicine the concept of randomized- controlled clinical trials (RCTs) is being questioned. This review article explains principles of evidence-based medicine in oncology and shows an example of how evidence can be generated independently from RCTs. Personalized medicine involves molecular analysis of tumor properties and targeted therapy with small molecule inhibitors. Individualized medicine involves the whole patient (tumor and host) in the context of immunotherapy. The example is called Individualized Multimodal Immunotherapy (IMI). It is based on the individuality of immunological tumor-host interactions and on the concept of immunogenic tumor cell death (ICD) induced by an oncolytic virus. The evidence is generated by systematic data collection and analysis. The outcome is then shared with the scientific and medical community. The priority of big pharma studies is commercial benefit. Methods used to achieve this are described and have damaged the image of RCT studies in general. A critical discussion is recommended between all partners of the medical health system with regard to the conduct of RCTs by big pharma companies. Several clinics and institutions in Europe try to become more independent from pharma industry and to develop their own modern cancer therapeutics. Medical associations should include references to such studies from personalized and individualized medicine in their guidelines.
Insights
This review discusses evidence-based medicine in oncology, highlighting Individualized Multimodal Immunotherapy (IMI) as an alternative to traditional randomized controlled trials (RCTs). IMI generates evidence independently, focusing on personalized and individualized cancer treatment approaches.
Area of Science:
- Oncology
- Evidence-Based Medicine
- Immunotherapy
Background:
- The rise of personalized and individualized medicine challenges traditional randomized controlled trials (RCTs) in oncology.
- Big pharma's commercial interests have impacted the reputation of RCTs.
- There is a growing need for alternative evidence generation methods in cancer research.
Purpose of the Study:
- To explain principles of evidence-based medicine in oncology.
- To present a model for generating evidence independently from RCTs.
- To discuss the role of personalized and individualized medicine in cancer therapeutics.
Main Methods:
- Review of evidence-based medicine principles.
- Explanation of personalized medicine (molecular analysis, targeted therapy) and individualized medicine (whole patient, immunotherapy).
- Introduction of Individualized Multimodal Immunotherapy (IMI) based on tumor-host interactions and immunogenic cell death (ICD) induced by oncolytic viruses.
- Systematic data collection and analysis for evidence generation.
- Critical discussion of RCTs conducted by pharmaceutical companies.
Main Results:
- Individualized Multimodal Immunotherapy (IMI) offers a method for generating evidence outside of traditional RCTs.
- Evidence generation is based on the unique immunological tumor-host interactions and the induction of immunogenic cell death (ICD) via oncolytic viruses.
- The study highlights the potential for independent clinics and institutions to develop novel cancer therapeutics.
Conclusions:
- Evidence can be generated independently from RCTs, particularly in personalized and individualized medicine.
- A critical dialogue regarding RCTs by big pharma is recommended.
- Medical associations should incorporate findings from personalized and individualized medicine studies into clinical guidelines.
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