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Clinical Trials in Surgical Specialties in India—an Analysis and Interpretation of Trials Registry Data

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Abstract

Surgical trials have always been difficult to conduct and have often been criticized both for the quality and the quantum compared with non-surgical specialties. There have been no studies to analyze the status of surgical research in India. We performed a study to evaluate the proportion and the quality of surgical research registered with the trial’s registry in the country. The Clinical Trials Registry of India (CTRI)—a public registry was accessed to understand the number of surgical trials registered since its inception in July 2007 to April 2018. We defined surgical trials as any trial done to assess and/or compare distinct surgical procedures or devices, surgical techniques, and addition of another treatment to surgery. Different characteristics of these studies including registration year, specialty, study design, sample size, and funding were analyzed. Among 13,301 trials registered in the study period, only 373 (2.8%) were surgical trials. Most of the surgical trials were RCTs (n = 224, 60%), followed by observational studies (n = 120, 32%). Oncology-related surgical trials constituted only 10% (n = 39/373), with the majority being RCTs (n = 25, 64%). Surgical trials were performed most often in surgical gastroenterology (n = 74, 19.8%) and ophthalmology (n = 72, 19.3%). Funding for surgical trials was mostly through institutional funds and only a few trials received extramural funding (n = 56, 15%). Surgical trials constituted less than 3% of all trials registered with CTRI. However, the majority of them were RCT’s and mostly funded by intramural funding. The reasons for these small numbers could be many.

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Acknowledgments

The authors are thankful to the CReDO - Research Protocol Development Workshop.

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Authors and Affiliations

  1. Department of Head & Neck Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, 400012, India

    Shivakumar Thiagarajan

  2. Department of Head & Neck Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, Maharashtra, 400088, India

    Shivakumar Thiagarajan

  3. Bombay Hospital, Mumbai, Maharashtra, India

    Khuzema Fatehi

  4. Tata Memorial Hospital, Professor of Surgical Oncology (Thoracic Surgery), Tata Memorial Centre, Homi Bhabha National Institute, Parel, Mumbai, Maharashtra, 400088, India

    C. S. Pramesh

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  1. Shivakumar Thiagarajan
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Contributions

Dr. Shivakumar Thiagarajan: concept, design, analysis and interpretation, manuscript writing, and editing. Dr. Khuzema fatehi: data collection, manuscript writing, and editing. Dr. CS Pramesh: concept, manuscript writing, and editing.

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Correspondence to Shivakumar Thiagarajan.

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Thiagarajan, S., Fatehi, K. & Pramesh, C.S. Clinical Trials in Surgical Specialties in India—an Analysis and Interpretation of Trials Registry Data. Indian J Surg 82, 1081–1087 (2020). https://doi.org/10.1007/s12262-020-02230-x

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  • DOI: https://doi.org/10.1007/s12262-020-02230-x

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