MicroBio 160 1st Edition Lecture 31Outline of Current Lecture I. Cancer TreatmentsII. How do we Find and Test New TreatmentsIII. Clinical TrialsIV. How long does it take to Get FDA Approval?V. Participants of clinical trialsVI. Protections for Participating in Clinical trials?VII. Benefits for ParticipantsVIII. Risk of Participation Current LectureCancer 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 chemoo Toxic side effectso Both treatments can cause damage to normal cellso This damage could be so severe that treatment results in sickness or deatho Often these effects result in decreased or halted treatmento Drug resistanceo Tumors “learn” how to evade chemotherapieso Can develop export pumps, mutate inhibited enzymeso Resistant cells can survive therapy and recur as a resistant cancer- Ultimate goal is to cure HIV- Current therapieso Delay HIV progression to AIDSThese 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 symptomso Do NOT cure HIV- No vaccine available still - No other preventative medication available, yetHow 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 recurrenceo Screening - test methods of detectiono Diagnostic - find better diagnosis methodso Treatment - test new treatmentso Quality of life - improve comfort/quality of lifeo 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 treatmentor a placeboo Blind: Subjects do not know which treatment they receive. o Double-blind: Researchers also do not knowo 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: 20-80o Phase II: Goal: effectiveness (Exploratory), dose response, further evaluation of safety; Subjects: 100-300o 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: 1,000-5,000o 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 approvedPossible 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 careRisk 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 trialsWhy 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
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