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Clinical research in surgery 'essential' to care advancements

23 May 2016
Clinical research in surgery 'essential' to care advancements

Surgery has an over-arching role every field of cancer, from prevention, diagnosis, treatment (curative, supportive and reconstructive) and palliation, with ~80% of all cancers needing some form of surgical treatment and an estimated global need for cancer surgery at reaching 45 million by 2030. 

Yet, surgical care and research is rarely included in global, or even national priorities, limiting the advancement of cancer treatment in this key arena.

Much of this may be owed to a comparison made ninety years ago, branding surgical research as a “comic opera” because of the inability of the surgical community to continuously deliver successful randomised clinical trials.

However, in Surgical Perspective, the challenges of surgical research are been identified and proposals to overcome them have been discussed.

In the article “From a Comic Opera to SURCARE: An open letter to whom clinical research in surgery is of importance”, strategies including alternative research methodologies, addressing surgical questions and use of innovative techniques are set out, alongside quality control measures in a surgical trial and the use of prospective observational studies to complement randomised clinical trials.

This call for consistent, cohesive care and ongoing education in surgery is matched in part by e-learning materials currently available through ecancer, with online courses in breast cancer surgery and pancreatic cancer surgery for postgraduate surgical trainees.

The authors of the letter now call for industry-wide considerations of developing a sustainable surgical research platform and quality assurance infrastructure, which they propose to lead the new wave of high quality surgical trials.

This publication also highlighted the important collaboration by 3 leaders in the field of surgical oncology and research: The European Organization for Research and Treatment of Cancer (EORTC), European Society of Surgical Oncology (ESSO) and Japan Clinical Oncology Group (JCOG).

Together, they are building SURCARE: “High Quality Standards for Prospective Surgical Clinical Research”.

Several components of this alliance will serve together to forward clinical research, supported by:

  • a framework to implement QA methodology for surgical trials
  • a platform to develop prospective and multidisciplinary studies
  • a global network of surgical researchers 
  • educational program for a new generation of surgeons oriented to the culture of research
  • a platform to facilitate greater patient involvement in research development and surgical outcome monitoring.

With the organisational support and a schema comprising of phase 0 design to phase III trials, the authors are already reporting on SURCARE strategies.

"The first project is CLIMB-EORTC where 1409 enrolling patients with initially inoperable liver-limited colorectal cancer metastases (CLM) with the first quality assessment after enrollment of the first hundred patients converted to resectability with curative intent. The second project is DREAM-EORTC where 1527 patients devoted to the management of CLM by diffusion-weighted MRI in the context of conversion chemotherapy and disappearing CLM." they say, with hospitals around the globe contributing to trials. "We intend to launch a new project every year, covering all aspects of surgical oncology."

"Much progress can be made by improving surgical techniques. We also know that postoperative complications decrease overall postoperative survival. With SURCARE, we aspire to enroll young surgeons in pragmatic, feasible, high-quality prospective research."

"The choice can no longer be between retrospective series and RCTs; alternative ways must be found when RCTs are not feasible. SURCARE is one way to unlock this problem for surgeons and produce high-level data with a rapid return on investment for funding organisations. Comparable initiatives do exist in the US and joining our forces together would be beneficial. Lastly, the scientific community has to endorse this new approach."

Source: Surgical Perspective