Adam Feuerstein and Slingshot Insights recently interviewed Dr. Mark Ratain, an expert in the use of investigational agents to treat advanced tumors who has over 280 original publications. The interview focuses on how a clinician analyzes clinical trial results, and covers red flags, tools to spot issues, and when a redesign of a failed study might work. In 2011 they partnered to develop the well-known Feuerstein-Ratain Rule for predicting the failure of Phase III oncology trials for companies with a market cap under $300 million. The interview starts with an overlook of the history of oncology drug development, where Dr. Ratain states “oncology has always been different than other areas of drug development; it’s always been a concept of …show more content…
In regards to what to look at when investors have to quickly react to data releases, Dr. Ratain said the first thing to ask is if the study is randomized. He encouraged people to use clinicaltrials.gov to analyze “the quality of the sponsor from the design and design of trails from their portfolio.” Feuerstein asked Dr. Ratain about some of the problems with single arm Phase II studies, which he says are usually designed to combine an investigational drug with an already approved blockbuster drug. This frequently allows companies to say that their drug leads to better results than the blockbuster alone, when there may be “no signal” in the …show more content…
Dr. Ratain responded that the most important thing to look at is if the endpoint changes, or that the eligibility has changed to be either more narrow or broad than the previous trial. They go into further detail here using the example of Keryx’s perifosine, which both agreed was “a hypothesis testing study not a confirmatory study”. Dr. Ratain agreed that Feuerstein’s statement that “it’s really important to dig into that Phase II study even if it is randomized and say and look at the way it’s designed, look at the way it was changed, looked at the baseline characteristics of the patients, and see how that compares to the Phase III design and see if there are any
Memorial Sloan Kettering Cancer Center (MSKCC) has impacted the world nationally and internationally for their involvement and work with cancer, science, research, and medicine. A goal of Memorial Sloan Kettering Cancer Center (MSKCC) is through extensive research and training explore new ways to treat, cure, and control cancer on a national and worldwide level. Scientist and Researchers affiliated with MSKCC take their knowledge, investigation, and research to create clinical trials, studies and new treatments for cancer nationally and worldwide which create various economic opportunities throughout the nation and world.
Pharmaceuticals have examined and found to ”work by changing the biological functions of the target cells in the body through chemical agents“ (Doweiko, 2015, p. 16). ”Many people in the past have thought that drugs that
To continue the license, Merck had to convince the FDA that the effectiveness stayed at a similar rate over the years. Merck then designed an even more scientifically flawed methodology, this time incorporating the use of animal antibodies to artificially inflate the results, but it too failed to achieve Merck’s fabricated efficacy rate. Confronted with two failed methodologies, Merck then falsified the test data to guarantee the results it desired. Having achieved the desired efficacy threshold, Merck submitted these fraudulent results to the FDA and European Medicines Agency.
Blockbuster drugs are usually a significant therapeutic breakthrough compared to previously available therapies. However greater therapeutic value alone is not enough for cr...
...s little information about the possible benefits of the study or the side effects. The side effects proved to be significant (gastrointestinal complains, headache, and an elevation of alanine aminotransferase), while the benefits were minimal. This situation emphasizes the need for a balanced approach when it comes to drug clinical trials.
The pretest-posttest design, crossover design, placebo, quasi-experiments (lack randomization but involve intervention and is usually found to be more acceptable to a broader group of people who are not always willing to be randomized in clinical trials). The RCT study known as the “gold standard” (for interventional studies, controlled and randomized for comparing a controlled and interventional group variable) and The Cohort (prospective) design research (analysis or the observational design with cohort, it starts with a recognized cause and then goes forward to the recognized effect). The clarification of the outcomes of the statistical analysis in quantitative research, understanding the research practice and the identification of the basis of evidence-based practice contained by the sections of research and critiques of that research. By graining an understanding of these steps and knowing how to rethink research and revise my views of the research will aid in success of my practicing these tactics (Polit, & Beck,
... be in the patient’s best interest and getting the best results for the trial.
With new age purpose and research for the last 60 plus years, LLS has invested over $875 million dollars to advance cancer treatments. LLS invests time in blood cancer research with various programs. Two major programs are Specialized Center of Research (SCOR) and Transitional Acceleration Program (TAP). SCOR's research is surrounded around innovative blood research in the discovery to find the new drugs and treatments. While “through TAP, LLS forges partnerships with universities and biotechnology companies, bringing resources that can more rapidly transform promising research into critically needed therapies, including therapies that might otherwise go undeveloped.”
... in clinical trials. This decision will benefit pharmaceutical companies and CROs since it allows them to use placebo control even when a standard treatment is available [10 & 11].
For a drug to get to market it must go through several stages of research and development (Abbott and Vernon). Starting with discovery research, preclinical testing on animals, three phases of clinical trials on humans, and finally FDA (Food and Drug Administration) approval (Abbott and Vernon). Out of several thousands of drugs only a few will make it to the FDA approval stage (Abbott and Vernon). Testing is a highly regulated, time consuming, and expensive process. From beginning to end the process can take fifteen years and less than one of five compounds will make it to market where it is still not guaranteed to succeed (Abbott and
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
“Here bullet” is a poem by Brian Turner in which the persona is struggling to coup with the situation in which he finds himself. In this poem the persona is able to establish the low point in which they have reached with lines such as “If a body is what you want, / Then here is bone and gristle and flesh.” (LL 1-2). This line establishes right from the onset of the poem that the persona is at wits in. The poem could leave a first time reader of it wondering how the persona reached this point. This point in which the persona is fantasying about death with lines like “Here is where I complete the word you bring/ Hissing through the air, here is where I moan” (LL 10-11).
Turner, B. J., Newschaffer, C. J., Zhang, D., Fanning, T., & Hauck, W. W. (1999). Translating clinical trial results into practice. Annals of Internal Medicine, 130(12), 979-986.
In 2010 alone, three drugs reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) have failed to gain approval. EMDAC felt each drug (naltrexone/bupriopion, lorcaserin and phentermine/topiratate) had unacceptable safety issues (particularly cardiovascular risk profiles). The committee also concluded that lorcaserin did not provide enough convincing evidence of efficacy and safety to gain approval. EMDAC cite lack of diversity in the phase 3 trial population might result in efficacy of the drug being overstated while potential safety risks understated. Whi...
Appropriately, this motion picture correctly illustrates the amount of work, time, and money that actually goes into developing a medical innovation. In addition, this movie acts as a solid example of the grueling path one must take for permission in releasing a medical innovation to the public. Writing for the journal The Scientist, Jef Akst stated that the film acted as a good depiction of the “hard to swallow fiscal issues of drug development” (thescientist). However, this painfully hard process exists for good reasons; they must weed out the ideas that can not be safely practiced in modern society. Also, the regulations ensure that each innovation, whether drug, therapy, or procedure, will benefit the consumer more than the side effects could harm them. Moreover, the benefits of the innovations, as previously mentioned, must outweigh the costs for the patient and practicer for maximum