Clinical Cancer Research

Theresa HigginsCancer 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?

Timeline for Drug Development

Preclinical Research

At Least 5 Years

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Clinical Studies

7 Years

Phase I

1.5 Years

Phase II

2 Years

Phase III

3.5 Years

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Review by FDA

PostmarketingSurveillance

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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 II-IV 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

                    

              

AsymmetryMost early melanomas are asymmetrical: a line through the middle would not create matching halves. Common moles are round and symmetrical.

 

                    

              

BorderThe borders of early melanomas are often uneven and may have scalloped or notched edges. Common moles have smoother, more even borders.

 

                    

              

ColorCommon 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.  

                    

              

DiameterEarly 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).

ABCD’s of Melanoma

Staging of MelanomaStage 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 MelanomaStage 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 MelanomaStage 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 MelanomaStage 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.