MicroBio 160 1st Edition Lecture 31 Outline of Current Lecture I Cancer Treatments II How do we Find and Test New Treatments III Clinical Trials IV How long does it take to Get FDA Approval V Participants of clinical trials VI Protections for Participating in Clinical trials VII Benefits for Participants VIII Risk of Participation Current Lecture Cancer Treatments Ultimate goal is complete removal or destruction of the tumor with minimal damage to host Surgery remove primary tumor Radiation and or chemotherapy destroy any remaining cancer cells Limits to radiation and chemo o Toxic side effects o Both treatments can cause damage to normal cells o This damage could be so severe that treatment results in sickness or death o Often these effects result in decreased or halted treatment o Drug resistance o Tumors learn how to evade chemotherapies o Can develop export pumps mutate inhibited enzymes o Resistant cells can survive therapy and recur as a resistant cancer Ultimate goal is to cure HIV Current therapies o Delay HIV progression to AIDS These notes represent a detailed interpretation of the professor s lecture GradeBuddy is best used as a supplement to your own notes not as a substitute o Treat symptoms o Do NOT cure HIV No vaccine available still No other preventative medication available yet How do we Find and Test New Treatments Clinical trials A research study in human volunteers to answer specific health questions Fastest and safest way to find treatments that work in people and ways to improve health Types of Clinical Trials o Prevention prevent disease in naive people or prevent disease recurrence o Screening test methods of detection o Diagnostic find better diagnosis methods o Treatment test new treatments o Quality of life improve comfort quality of life o Compassionate use provide partially tested unapproved therapeutics to a small number of patients who have no other realistic options FDA regulated Used in unresponsive patients Clinical Trial Design o Randomized Subjects are randomly assigned to receive either the study treatment or a placebo o Blind Subjects do not know which treatment they receive o Double blind Researchers also do not know o Placebo controlled The use of a placebo fake treatment allows the researchers to isolate the effect of the study treatment from the placebo effect perceived or actual improvement in a medical condition despite not receiving treatment Clinical Trial Phases o Phase I Goal initial safety and tolerability determine safe dosage range identify side effects Subjects 20 80 o Phase II Goal effectiveness Exploratory dose response further evaluation of safety Subjects 100 300 o Phase III Effectiveness confirmatory monitor side effects compare commonly used treatments collect info that will allow the drug or treatment to be used safely Subjects 1 000 5 000 o Phase IV Goal effectiveness in the general population optimizing drug use Subjects patient population sample You How long does it take to Get FDA Approval Preclinical testing 5 20 years or more o Investigational new drug application filed with FDA Clinical trials 5 10 years o New drug application filed with FDA FDA review 1 5 years o FDA approval Approved Treatment ongoing Do Many people participate in cancer clinical trials Only 3 of US adults with cancer participate in clinical trials 0 14 years old 50 15 19 year old 20 20 and older 2 5 70 and older 1 Protections for Participating in Clinical trials The government has strict guidelines to protect clinical trial participants Must be approved and monitored by an Institutional Review Board IRB An IRB is an independent committee of medical specialists nurses social workers medical ethicists and patient advocates who review clinical trial protocols at institutions that conduct medical research Informed consent must be obtained before participation is approved Possible Benefits for Participation Patients will receive at a minimum the best standard treatment If the new treatment or intervention is proven to work patients may be among the first to benefit Patients have a chance to help others and improve cancer care Risk of Participation New treatments or interventions under study are not always better than or even as good as standard care Even if a new treatment has benefits it may not work for every patient Health insurance and managed care providers do not always cover clinical trials Why do so few cancer patients participate in clinical trials Doctors might Lack awareness of appropriate clinical trials Be unwilling to lose control of a person s care Believe that standard therapy is best Be concerned that clinical trials add administrative burdens Sometimes patients Don t know about clinical trials Don t have access to trials May be afraid or suspicious of research Can t afford to participate May not want to go against physician s wishes
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