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• Correspondence on Influence of active versus placebo control on treatment responses in randomised controlled trials in rheumatoid arthritis" by Kerschbaumer et al
  Young Ho Lee
  Published on: 3 February 2023

• Published on: 3 February 2023

  Correspondence on Influence of active versus placebo control on treatment responses in randomised controlled trials in rheumatoid arthritis" by Kerschbaumer et al

  • Young Ho Lee, Professor Korea University

  I am writing a correspondence on the article "Influence of active versus placebo control on treatment responses in randomised controlled trials in rheumatoid arthritis" by Kerschbaumer et al 1. The authors' systematic approach to comparing the treatment effects of pharmaceutical compounds in rheumatoid arthritis clinical trials with placebo and active treatment controls is commendable. The results of the study, showing significantly higher responses in active comparator trials compared to placebo controlled trials, provide valuable insights into the influence of control groups in RCTs. However, I have a few critical points to raise regarding the study's methodology and conclusions. Firstly, the matching of active treatment arms to comparable regimens, populations, background therapy, and outcome reporting was based solely on the nature of the control group, which is not an ideal approach. This method of matching could have led to unequal comparison groups and biased results 2. In order to ensure that the comparison between active treatment and control groups is fair and accurate, a more comprehensive and systematic approach to matching should have been employed. Secondly, the conclusion that placebo controlled trials lead to smaller effect sizes of active compounds in RCTs compared with the same compound in head-to-head trials may be an overgeneralization. The authors did not consider other potential confounding factors that could explain the difference...

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  I am writing a correspondence on the article "Influence of active versus placebo control on treatment responses in randomised controlled trials in rheumatoid arthritis" by Kerschbaumer et al 1. The authors' systematic approach to comparing the treatment effects of pharmaceutical compounds in rheumatoid arthritis clinical trials with placebo and active treatment controls is commendable. The results of the study, showing significantly higher responses in active comparator trials compared to placebo controlled trials, provide valuable insights into the influence of control groups in RCTs. However, I have a few critical points to raise regarding the study's methodology and conclusions. Firstly, the matching of active treatment arms to comparable regimens, populations, background therapy, and outcome reporting was based solely on the nature of the control group, which is not an ideal approach. This method of matching could have led to unequal comparison groups and biased results 2. In order to ensure that the comparison between active treatment and control groups is fair and accurate, a more comprehensive and systematic approach to matching should have been employed. Secondly, the conclusion that placebo controlled trials lead to smaller effect sizes of active compounds in RCTs compared with the same compound in head-to-head trials may be an overgeneralization. The authors did not consider other potential confounding factors that could explain the difference in response rates. For example, factors such as the placebo effect, patient expectations, and the impact of patient-provider interaction could all contribute to the difference in response rates between the two types of trials. The authors also should have discussed the potential impact of study design, population, and background therapy that could have influenced the results. The study design may have limitations such as sample size, randomization, or blinding that can affect the results 2. Moreover, the study population, including patient characteristics and co-morbidities, can also impact the results and generalizability of the findings to other populations 3. In conclusion, while the study provides valuable insights into the influence of control groups in RCTs in rheumatoid arthritis, the limitations discussed above should be considered when interpreting the results and drawing conclusions.

  REFERNECES
  1 Kerschbaumer A, Stimakovits NM, Smolen JS, et al. Influence of active versus placebo control on treatment responses in randomised controlled trials in rheumatoid arthritis. Annals of the Rheumatic Diseases 2023
  2 Sella F, Raz G, Cohen Kadosh R. When randomisation is not good enough: Matching groups in intervention studies. Psychonomic Bulletin & Review 2021;28:2085-93.
  3 Chidambaram AG, Josephson M. Clinical research study designs: The essentials. Pediatric investigation 2019;3:245-52.

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  Conflict of Interest:
  None declared.

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