MishenMed: Statistical Consulting for Clinical Trials

  What is immune-modulating therapy ? Immune - modulating therapies  are medications that alter the way that the  immune  system works. Because sarcoidosis is associated with an overreaction of the  immune  system, suppressing part or all of the  immune  response can help manage symptoms and prevent permanent damage. What does an immune modulator do? A substance that stimulates or suppresses the   immune   system and may help the body fight cancer, infection, or other diseases. Specific   immune   system   modulators , such as monoclonal antibodies, cytokines, and vaccines, affect specific parts of the   immune   system. What drugs are checkpoint inhibitors? PD-L1  inhibitors :   Examples   of drugs that target PD-L1 include: Atezolizumab (Tecentriq) Avelumab (Bavencio) Durvalumab (Imfinzi). ipilimumab ( Yervoy ®) blocks a checkpoint protein called   CTLA-4 .  pembrolizumab   ( Keytr...

  Background: Melanoma Also called: malignant melanoma The most serious type of skin cancer. Melanoma occurs when the pigment-producing cells that give color to the skin become cancerous. Symptoms might include a new, unusual growth or a change in an existing mole. Melanomas can occur anywhere on the body. Treatment may involve surgery, radiation, medications, or in some cases chemotherapy. Merkel cell carcinoma  (MCC) it is a very rare ,  highly aggressive, neuroendocrine carcinoma of the skin ;  it has a worse survival probability compared with more common cutaneous malignancies, including metastatic melanoma, and has been termed the “most lethal” skin cancer  as   p atients with metastatic MCC have a historical 5-year overall survival (OS) rate of 18% What Is Tumor Mutational Burden? TMB is defined as the frequency of certain mutations within a tumor’s genes.  To be counted towards TMB, mutations have to alter the protein that is made from a gene. ...

  PDF function : This function is the probability density function. It returns the probability density at a given point for a variety of distributions. (For discrete distribution, the PDF function evaluates the probability mass function.) CDF function : This function is the cumulative distribution function. The CDF returns the probability that an observation from the specified distribution is less than or equal to a particular value. For continuous distributions, this is the area under the PDF up to a certain point. QUANTILE function : This function is closely related to the CDF function, but solves an inverse problem. Given a probability, P, it returns the smallest value,  q , for which CDF( q ) is greater than or equal to P. RAND function : This function generates a random sample from a distribution. In SAS/IML software, use the  RANDGEN subroutine , which fills up an entire matrix at once.