501c3 Mew Mexico Charitable Organization founded in 2002 NMCCA includes 121 physicians from private

1
501(c)(3) Mew Mexico Charitable Organization
founded in 2002NMCCA includes 121 physicians
from private practice and major healthcare
institutions in New MexicoNMCCA is dedicated to
providing New Mexican cancer patients with local
access to the latest clinical trials available
New Mexico Cancer Care Alliance (NMCCA)
2

• Cancer Clinical Trials

3
What are Cancer Clinical Trials?

• Research studies involving people
• Intended to answer scientific questions to find
  better ways to diagnose,
• prevent and treat cancer
• There are different types and phases of trials
• They follow strict scientific guidelines called
  a protocol

4
A clinical trial starts with an idea.
5

• Basic Science
• Scientists test their theory in the laboratory
• Preclinical Studies
• Scientists conduct clinical studies on animals
• Clinical Studies
• The drug is tested on humans

6
Types of cancer clinical trials

• Treatment Trials
• Prevention Trials
• Early-detection/screening Trials
• Diagnostic Trials
• Quality-of-life/supportive care Trials

7
Treatment trials determine what is the most
effective and new treatment that can help people
with cancer.Prevention trials find new
approaches that can prevent a specific cancer
from developing in people who do not have
cancer. Early-detection trials develop new ways
of finding cancer in people before they have
symptoms.
8
Diagnosis trials find new tests or procedures
that identify cancer more accurately and at an
earlier stage.Quality-of-life trials find new
approaches to improve the quality of life for
cancer patients.
9
Phases of Clinical Trials

• Phase 1
• Phase 2
• Phase 3
• Phase 4

10
(No Transcript)
11
How Long Does it Take?
Preclinical Testing ? Phase 1 ? Phase 2 ? Phase 3
? Post Clinical Trials

Inform FDA of Phase 3 results/FDA approval or
denial
Obtain FDA approval to test in humans
4.4 years 8.6 years
1.4 years
Average Number of Years for FDA approval for a
New Drug 14.4 years
The cost of developing a successful new drug has
been estimated at about 1 billion dollars.
12
Milestones in Cancer Treatment

• 1882 First Mastectomy for breast cancer
• 1895 X-rays were discovered
• 1900 PAP smear
• 1943 Linear Accelerator designed for radiation
  treatment
• 1946 Beginning of chemotherapy (mustard gas for
  non-Hodgkins lymphoma)
• 1950s DNA structure, interferon, 5-FU,
  methotrexate (first drug to cure solid tumors)
• 1960s Combination therapies successful,
  epidermal growth factor (EGF) and receptors for
  estrogen are identified
• 1970s CT, MRI, and PET are developed, molecular
  cloning, cisplatin for testicular cancer, DNA
  sequence, monoclonal antibodies, oncogenes
• 1980s Anti-nausea drugs, C-erB2 gene (HER2),
  nerve-sparing prostatectomy, intensity-modulated
  radiation therapy (3-D), vascular endothelial
  growth factor (VEGF)
• 1990s First gene therapy is attempted, BRCA1,
  Monoclonal antibody (Rituxan), Tamoxifen,
  Herceptin for metastatic disease,
• 2000s Gleevec, Avastin, Oncotype DX, Herceptin
  for early stage, Nexavar (liver cancer),
  molecular marker KRAS for metastatic colon cancer

13
Participant Protection and Rights in Clinical
Trials
The rights and safety of a participant in a
clinical trial are protected by Federal
Regulations.

• Informed Consent
• Two Review Committees
• Monitoring

14
Informed Consent

• Informed consent is an ongoing process before and
  during the clinical trial in which the
  participant learns important information about
  the trial.

• The informed consent contains the following
  information
• The Nature, Purpose, Duration, and Procedures
• The Risk and Discomforts
• The Benefits
• Alternate Procedures or Treatments
• Confidentiality of Records
• Procedures if the trial involves more than
  minimal risk
• Contact information
• Voluntary Participation-patient may stop
  participating at
• any time

15
Protocol Review Committees
The clinical trial protocol (the scientific
guidelines or directions) must be approved by two
review committees.

• A Scientific Review Committee
• The Institutional Review Board (IRB) that
  oversees clinical
• research at the local participating
  institution

16
Monitoring

• IRBs monitor patient safety during the trial
• Data and Safety Monitoring Boards (DSMBs) for
  Phase 3 trials monitor for conduct and safety of
  the trial
• Federal Agencies require reports

17
Clinical Trial Coverage

• Health insurance and managed care providers often
  do not cover the patient care costs associated
  with a clinical trial.
• New Mexico has a law (Senate Bill 42) that
  requires health insurances to cover standard of
  care costs associated with treatment on a
  clinical trial.
• Testing or treatment specific to the clinical
  trial is usually covered by the sponsor of the
  trial.

18
FACTS

In New Mexico an estimated 8,000 people will be
diagnosed with cancer in 2007 (1 of 240 people).
19
Barriers to Clinical Trial Participation
Only 3 of adults with cancer participate in
clinical trials.

• Barriers for the General Populations
• Lack of awareness of clinical trials
• Lack of access to trials
• Fear, distrust, or suspicions of research
• Practical or personal obstacles
• Insurance or cost problems
• Unwillingness to go against personal
  physicians wishes
• Cultural and ethnic backgrounds
• Language or literacy

20
Finding Clinical Trials

• Clinical Trials open in New Mexico
• New Mexico Cancer Care Alliance www.nmcca.org
• Clinical Trials Open Nationally
• NCI www.cancer.gov
• NIH www.clinicaltrials.gov
• Coalition of Cancer Cooperative Groups
• www.cancertrialshelp.org

21
References
Cancer Clinical Trials, The Basic Workbook,
National Institutes of Health, National Caner
Institute, 2002 Cancer Clinical Trials, The
In-Depth Program, National Institutes of Health,
National Caner Institute, 2002 Cancer Research
A Self-Study Guide to Clinical Trials, Coalition
of Cancer Cooperative Groups New Mexico Cancer
Plan 2007-2011 Cure Cancer Updates, Research,
and Education
22
New Mexico Cancer Care Alliance Website
www.nmcca.org
23
Clinical Trial Search