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EDITORIAL COMMENTARY
Year : 2022  |  Volume : 68  |  Issue : 4  |  Page : 197-198

Surgical trials in India, where do we stand?


Consultant WHO Collaborating Centre India, Seth GSMC and KEM Hospital, Mumbai, Maharashtra, India

Date of Submission29-Apr-2022
Date of Decision26-May-2022
Date of Acceptance30-May-2022
Date of Web Publication06-Oct-2022

Correspondence Address:
M Khajanchi
Consultant WHO Collaborating Centre India, Seth GSMC and KEM Hospital, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jpgm.jpgm_367_22

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How to cite this article:
Khajanchi M. Surgical trials in India, where do we stand?. J Postgrad Med 2022;68:197-8

How to cite this URL:
Khajanchi M. Surgical trials in India, where do we stand?. J Postgrad Med [serial online] 2022 [cited 2022 Dec 1];68:197-8. Available from: https://www.jpgmonline.com/text.asp?2022/68/4/197/358386




A double-blinded randomized controlled trial (RCT), systematic review and meta-analysis are considered the basis on which most current high-quality treatment recommendations are made. A well-designed RCT in surgery, is challenging due to methodological issues in conducting it.[1] Blinding, randomization, differences in surgical skills, experience, difference in peri-operative care in different settings make surgical trials challenging and at times impractical to conduct.[2],[3] Various strategies can be applied to minimize these challenges of conducting an RCT in surgery. Detailed prospective audit data collection, continuous evaluation of performance to determine if RCT is warranted, epidemiological and research training, defining interventions using photography or videography, only outcome assessor blinding are few of the ways to overcome challenges of the surgical research.[4]

Though India and other lower middle-income countries (LMICs) have two thirds of the global burden of surgical disease and should be the pioneers in deciding the surgical treatment with suitably conducted RCT's or long-term prospective studies this is not the scenario.[5] India like other LMICs lack the resources, funding, and training to conduct a well-designed RCT in surgery. Also, the intent and incentive to conduct a surgical trial in India is very low.[6]

Research studies published out of LMICs are always looked upon by suspicion for their quality and authenticity. Mohsina et al.[7] have published a systematic review in this issue of the journal which has given the number and quality of surgical trials published from India over an eight year period (2011-2018). They have done a critical analysis and discussed the factors affecting the quality of published RCT in surgery. These kind of studies are rare and give us an insight into the quality of surgical trials in India. Translation of RCT's into practice may take a longer time, but as the new generation doctors and the literate population is growing, we will be soon talking and practicing only what is robustly studied. Although there is paucity of surgical trials conducted in India, this article has shown that most published clinical trials from India have good quality.[7] One of the key findings of this article is the association of good quality RCT with those studies who have been scrutinized by Institutional Review Boards, but no association was found with studies which received large funds. These good quality RCTs will help to develop the standard treatment guidelines which can be used as a benchmark or standards for treatment in our own country. In addition, such reports from India will attract more national and international collaborations. While the quality of RCTs by scoring method is determined by assessing the blinding, randomization, power, significance, and dropout rate, other aspects which are essential while designing and conducting an RCT are biological plausibility, reproducibility, and generalizability, which are often ignored.[8]

Hundreds of new products enter the surgical market in India each year based on evidence generated elsewhere. We need to develop more robust clinical evidence from within our country and in addition to the better outcomes we need to factor in the cost-effective analysis in our studies. As clinicians and academicians, it is our responsibility to build the evidence in medicine and surgery and conduct meaningful, trustworthy, and quality research to help bring the goal of affordable and accessible healthcare to all.



 
 :: References Top

1.
The Lancet Psychiatry. Trials and tribulations. Lancet Psychiatry 2018;5:379.  Back to cited text no. 1
    
2.
Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials 2009;10:9.  Back to cited text no. 2
    
3.
Ferreira LM. Surgical randomized controlled trials: Reflection of the difficulties. Acta Cir Bras 2004;19(Suppl 1):2-3.  Back to cited text no. 3
    
4.
Farrokhyar F, Karanicolas PJ, Thoma A, Simunovic M, Bhandari M, Devereaux PJ, et al. Randomized controlled trials of surgical interventions. Ann Surg 2010;251:409-16.  Back to cited text no. 4
    
5.
Bickler SW, Weiser TG, Kassebaum N, Higashi H, Chang DC, Barendregt JJ, et al. Global burden of surgical conditions. In: Disease Control Priorities, Third Edition (Volume 1): Essential Surgery. 2015. p. 19-40.  Back to cited text no. 5
    
6.
Yadav SK, Agarwal P, Sharma D. Surgical clinical trials in India: Underutilized opportunities. Indian J Surg 2022;84(Suppl 1):162-6.  Back to cited text no. 6
    
7.
Mohsina S, Gurushankari B, Niranjan R, Sureshkumar S, Sreenath GS, Kate V. Assessment of the quality of randomized controlled trials in surgery using Jadad score: Where do we stand? J Postgrad Med 2022;68:207-12.  Back to cited text no. 7
[PUBMED]  [Full text]  
8.
Bellomo R, Bagshaw SM. Evidence-based medicine: Classifying the evidence from clinical trials--the need to consider other dimensions. Crit Care 2006;10:232.  Back to cited text no. 8
    




 

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Online since 12th February '04
2004 - Journal of Postgraduate Medicine
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