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Conducting industry-partnered trials in orthopaedic surgery
Mohit Bhandari1, Anders Jönsson, Volker Bühren
1Division of Orthopaedic Surgery, McMaster University, Canada. bhandam@mcmaster.ca
Injury
|February 14, 2006
Summary
Large collaborative surgical trials offer better generalizability and recruitment. Industry co-sponsorship is viable due to funding limits, but requires strict protocols to prevent bias in surgical research.
Area of Science:
- Surgical research methodology
- Clinical trial design
- Medical economics
Background:
- The emergence of large-scale collaborative multi-center trials in surgery.
- Advantages include enhanced generalizability and efficient patient recruitment (≥1000 patients).
- High costs of drug development (~$500 million) and funding limitations in peer-reviewed agencies necessitate industry co-sponsorship.
Purpose of the Study:
- To explore the rationale for industry co-sponsorship in surgical trials.
- To propose strategies for mitigating biases in industry-funded surgical research.
- To ensure transparency and accuracy in reporting and execution of collaborative surgical studies.
Main Methods:
- Review of current trends in multi-center surgical trials.
- Analysis of the economic factors influencing research funding.
- Development of recommendations for managing industry-sponsored research.
Main Results:
- Large collaborative trials offer significant advantages in surgical research.
- Industry co-sponsorship presents a viable solution to funding limitations.
- Specific protocols are crucial for maintaining research integrity.
Conclusions:
- Industry co-sponsorship can be beneficial for large surgical trials.
- Implementing robust protocols is essential to address potential biases.
- Transparency in funding, design, and reporting is paramount for reliable surgical research.