Himanshu Aggarwal: 1 mg/kg/d Thalidomide Non-Inferior to Standard Dose in Transfusion-Dependent Thalassemia
Himanshu Aggarwal, Biostatistician at Christian Medical College and Hospital, shared a post on LinkedIn:
“Exciting Publication Alert!
I am absolutely thrilled to share our latest research, just published in Blood Advances: ‘Efficacy and safety of thalidomide (1 vs 2 mg/kg/d) in transfusion-dependent thalassemia: A Non-Inferiority Trial.’
As the biostatistician on this study, working on a non-inferiority trial design was an incredibly rewarding challenge.
Statistically proving that a lower dose (1 mg/kg/d) is non-inferior to the standard dose (2 mg/kg/d) required careful sample size planning, strict non-inferiority margins, and rigorous data analysis.
But beyond the numbers and confidence intervals is a real-world impact for patients with Transfusion-Dependent Thalassemia (TDT).
By establishing that a lower dose is just as effective, we provide a data-driven path to reduce the burden of drug toxicity and side effects without compromising on the clinical benefits!
A massive thank you to Shruti Kakkar for her phenomenal clinical leadership, vision, and for trusting me to drive the statistical strategy.
It is always a privilege to collaborate with a principal investigator who truly values the synergy between clinical medicine and biostatistics.
Huge congratulations to the rest of our amazing co-authors and the entire clinical team for bringing this crucial trial to life!
When clinical expertise and rigorous statistics come together, patient care improves.”
Title: Efficacy and safety of thalidomide (1 vs 2 mg/kg/d) in transfusion-dependent thalassemia: A Non-Inferiority Trial
Authors: Shruti Kakkar, Amita Mahajan, Ratna Ajay Sharma, Nita Radhakrishnan, Mamta Manglani, Priyanka Dewan, Seema Dua, Manish Kumar Goel, Nupur Parakh, Himanshu Aggarwal, Varinder Singh, J S Arora, Sr., Jagdish Chandra
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