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Clinical Cancer Research Theresa Higgins Cancer Center Beth Israel Deaconess Medical Center Boston, MA Drugs through Pipeline (From Birth to Market) How long does it take a drug to get to market? At Least 5 Years Phase I 1.5 Years Phase II 2 Years Phase III 3.5 Years 7 Years Review by FDA Postmarketing Surveillance Approval Clinical Studies File “New Drug Application” with FDA Preclinical Research File “Investigational New Drug” Application with FDA Timeline for Drug Development 1.5 Years Ongoing Preclinical Research At Least 5 Years Discovery and early screening of compound Large-scale synthesis Animal Testing File Investigational New Drug (IND) Application with FDA Investigational New Drug A new drug, antibiotic drug, or biological drug that is used in a clinical investigation A biological product used in vitro (test tube or artificial environment) for diagnostic purposes Phase I: Screening for Safety 10-100 people, typically healthy Seeking to learn maximum safe dose of drug Length: 1.5 yrs Cost: $10 Million Phase II: Establishing Protocol 50-500 patients with the disease being studied Define experimental conditions that will allow Phase III to give a definitive result Find the efficacy of treatment in the disease being studied. Length: 2 yrs Cost: $20 Million + Phase III: The Final Test 300-30,000 or more patients with the disease being studied Determine efficacy and tolerability relative to standard therapy. Length: 3.5 years Cost: $45 Million File “New Drug Application” with FDA Application submitted by the manufacturer of a drug to the FDA for a license to market the drug for a specified indication Review By FDA Length: 1.5 Years Labeling Phase IV Trials APPROVAL! Able to advertise and sell your product on the market Postmarketing Surveillance (Phase IV Trials) Watch for adverse reactions and product defects Time: Ongoing FDA usually provides strong suggestions of Phase IV trials at time of approval Ex. Prozac What are the different types of clinical trials? Treatment Trials Prevention Trials Screening Trials Quality of Life Trials Who can participate in a clinical trial? Inclusion/Exclusion criteria Age, gender, type and stage of disease, previous treatment, medical conditions Healthy vs. patient with illness What are the benefits of participating in a clinical trial? Patient plays an active role in their own health care Gain access to new research treatment before they are widely available Obtain expert medical care at leading health care facilities during the trial Help others by contributing to medical research What are the risks of participating in a clinical trial? There may be previously unknown side effects to experimental treatment that can be unpleasant, serious or even life-threatening The treatment may not be effective for the participant The protocol may require more time commitment and submission to procedures that would not be considered standard of care. What are side effects and adverse reactions? Any undesired actions or effects of drug or treatment Headache, nausea, hair loss, skin irritation, or other physical problems Immediate and long term side effects Ex. Viagra How is the safety of the participant protected? Ethical and legal codes (Federal and State Regulations) Institutional Review Board (IRB) Informed Consent Patient can leave the trial at any time Melanoma Trials Currently working on Melanoma Clinical Trials for Phase II and III Research Eligible Patients for Trials have Stage IIIV Disease Melanoma The most serious form of skin cancer Rapidly increasing incidence (over 50,000 cases each year in the US) Originates in melanocytes Risk Factors Fair or light skin One or more blistering sunburns as a child Family history of melanoma Abnormal Moles ABCD’s of Melanoma Asymmetry Most early melanomas are asymmetrical: a line through the middle would not create matching halves. Common moles are round and symmetrical. Border The borders of early melanomas are often uneven and may have scalloped or notched edges. Common moles have smoother, more even borders. Color Common moles usually are a single shade of brown. Varied shades of brown, tan, or black are often the first sign of melanoma. As melanomas progress, the colors red, white and blue may appear. Diameter Early melanomas tend to grow larger than common moles generally to at least the size of a pencil eraser (about 6mm, or 1/4 inch, in diameter). Staging of Melanoma Stage I Tumors that are 0-2.0mm without ulceration or 0-1.0mm with ulceration. Treatment: Surgical excision with 1-2cm margins and possible Sentinel Lymph Node Biopsy Staging of Melanoma Stage II Tumors that are 1.01mm or greater and are ulcerated or 2.01mm or more and are non-ulcerated Treatment: Surgical excision, Wide Local Excision, Sentinel Lymph Node Biopsy Staging of Melanoma Stage III Regional Disease: The primary tumor has satellite or in-transit metastasis or has spread to regional lymph nodes. Treatment: Surgery to remove all of the tumor, including lymph node resection and in most cases biologic therapy and/or chemotherapy. Staging of Melanoma Stage IV Distant Metastasis: Tumor has spread beyond the lymph nodes, usually to lung (70-80%), liver (54-77%), or brain (36-54%) Treatment: Surgery, if possible. Biologic therapy and/or chemotherapy or participation in a clinical trial. Current Research Therapies that have shown efficacy in more advanced cancers are being tested to see if they help prevent the progression of a cancer at an earlier stage. Job Opportunities with a Biology Degree Pharmaceutical Sales Marketing at a Biotech Firm Clinical Research International Sales FDA Medical Technology Safety for a Toxicology Lab in Biotech Technical Writing CDC (Center for Disease Control) Questions??? Resources www.clinicaltrials.gov www.skincancer.org www.cancer.org www.mpip.org www.bfmelanoma.com www.chiron.com Zivin, Justin A. “Understanding Clinical Trials” Scientific American. April 2000.