Ep3 - Clinical Trials 101 (Part I)

Posted on Tuesday, May 12, 2020
Dr. Sabah Kadri and Arshi Arora discuss the basics of clinical trials and give the listeners a fun 101 course on how trials are designed and some fundamental concepts of the process. You do not need to be an expert in Science to learn about Clinical Trials with us!.

Show Notes

Why Clinical Trials?

We need clinical trials to bring in new treatments or therapies to market, to measure their safety and efficacy without any bias. Infact the field of Clinical and Translational Research asks how can we move interventions from bench to bedside, from the lab to your home. And they achieve this by doing research and finally implementing an approved clinical trial.

What are Clincial Trials?

A Clinical Trial in its essence is an experiment comparing the effect and value of interventions against a control in human beings. An intervention can be medical, surgical or behavioral.

References

  1. Columbia University course P8140 Fall 2015
  2. Study Management https://hub.ucsf.edu/clinical-study-management
  3. Fundamentals of Clinical Trials Authors: Friedman, L.M., Furberg, C.D., DeMets, D., Reboussin, D.M., Granger, C.B.
  4. Kola I Landis L “Can the pharmaceutical industry reduce attrition rates? Nature Reviews Drug Discovery 3, 711-716 August 2004
  5. https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf
  6. Nardini, Cecilia. “The ethics of clinical trials.” Ecancermedicalscience 8 (2014).
  7. Mohr, J. P., et al. “A comparison of warfarin and aspirin for the prevention of recurrent ischemic stroke.” New England Journal of Medicine 345.20 (2001): 1444-1451.
  8. Moseley, J. Bruce, et al. “A controlled trial of arthroscopic surgery for osteoarthritis of the knee.” New England Journal of Medicine 347.2 (2002): 81-88.
  9. Williams, John R. “The Declaration of Helsinki and public health.” Bulletin of the World Health Organization 86 (2008): 650-652.
  10. Department of Health, Education. “The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.” The Journal of the American College of Dentists 81.3 (2014): 4.
  11. Brooks, Sharon L., Wallin E. McMinn, and Erika Benavides. “A clinical trial of the Nomad portable X-ray unit.” The Journal of the Michigan Dental Association 91.2 (2009): 54-58.

Hosts

Arshi Arora

Arshi Arora

Arshi Arora is a Research Biostatistician at Memorial Sloan Kettering Cancer Center. She holds a double Masters of Science degree in Computational Biology and Biostatistics from Carnegie Mellon and Columbia University respectively. Her interests lie in creating elegant solutions to biological and clinical questions via simple yet compelling statistical models. She is a minimalist and follows an intense recycling waste regimen.

Sabah Kadri, PhD

Sabah Kadri, PhD

Dr. Sabah Kadri has a background in Computer Engineering with a PhD in Computational Biology from Carnegie Mellon University. Dr. Kadri leads a team of bioinformaticians and scientists to design, develop and implement cloud-based computational infrastructure and containerized bioinformatics software in clinical diagnostic services for germline and somatic next generation sequencing (NGS) testing. She has experience building clinical diagnostics pipelines and systems for adult and pediatric diseases and continues to work on informatics solutions and research questions for translational ‘omics’ and biomedical research to promote personalized medicine.

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