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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


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
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








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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

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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.