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ONCOLOGY TRIAL
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CANCER TRIAL
A cancer clinical trial is a medical research study inwhich people participate as volunteers to test newmethods of prevention, screening, diagnosis, ortreatment of a disease. A cancer clinical trial can alsobe referred to as a cancer clinical study.
Some cancer patients may fear that enrolling in acancer trial means they chance receiving no cancertreatment at all, but the reality is that patients in
clinical trials receive either the best cancer treatmentcurrently known for their cancer, or a new, andpossibly more effective, therapy.
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WORLD: It is estimated that about 9 million new cancer cases are
diagnosed every year and over 4.5 million people die from cancer
each year in the world.
INDIA:The estimated number of new cancers in India per year isabout 7 lakhs and over 3.5 lakhs people die of cancer each year.
Out of these 7 lakhs new cancers about 2.3 lakhs (33%) cancers
are tobacco related.
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WHY ARE CLINICAL TRIALS
CONDUCTED IN CANCER?
To allow medical professionals and patients
to gain information about the benefits, side
effects and possible uses of new drugs aswell as new ways to use existing drugs
To translate results of basic scientific
research into better ways to prevent,
diagnose, or treat cancer
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WHY DOWE NEED THEM?
We need to know that any treatments werecommend are both safe and effective in humans
Cell culture and animal work can only take us sofar!
Especially in Oncology, people are always lookingfor the miracle cure-and it is easy to get dragged
into the idea Scientific, medical, evidence-basedparadigm
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DO MANY PEOPLE PARTICIPATE INCANCER CLINICAL TRIALS?
Less than 5% of Adults with cancerparticipate in clinical trials
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ONCOLOGY PHARMACEUTICS MARKET IN
INDIA
Market in India:
Oncology pharmaceuticals market in India is valued at Oncologypharmaceuticals market in India, a leading segment of the overallpharmaceuticals market is the fourth largest in volume and eighth largestin value in the global market.
Since cancer is the second largest cause of death in the country, theIndian market is characterized by a huge demand for cancer drugs.
It is a highly fragmented market with a large number of foreign anddomestic players.
The huge increase in the number of cancer cases, specially in lung
cancer and breast cancer cases; changes in the cancer treatment scenario,development of alternative cancer therapies, increased cancer healthinsurance coverage and increasing amount of foreign direct investment(FDI) is helping the market to grow.
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DRIVERS AND CHALLENGES
DRIVERS
Increasing number of cancer cases
Changes in the treatment scenario
Development of alternative cancer therapies
Increase in cancer insurances
CHALLENGES
Increased competition Drug patent problem
Drug portfolio management
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GOVERNMENT INITIATIVES
Reforms in tax structure
Reduction in drug prices
Public- private partnership (PPP) programmes: The Indian
Government, on its part is taking initiatives to work out public-private partnership projects (PPP) and reduce the essential drug
prices. The market is expected to exhibit steady growth over the
next few years.
Drug control programmes
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TYPES OF CANCER TRIAL
Cancer clinical trials differ according to their primary purpose.
They include the following types:
Treatment
PreventionScreening
Diagnostic
Quality of life
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TYPES OF CANCER TRIAL
Treatment. These trials test the effectiveness of new treatments or
new ways of using current treatments in people who have cancer.
The treatments tested may include new drugs or new combinations
of currently used drugs, new surgery or radiation therapytechniques, and vaccines or other treatments that stimulate a
persons immune system to fight cancer.
Combinations of different treatment types may also be tested in
these trials.
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Prevention. These trials test new interventions that may lower the
risk of developing certain types of cancer.
Most cancer prevention trials involve healthy people who have
not had cancer; however, they often only include people who havea higher than average risk of developing a specific type of cancer.
Some cancer prevention trials involve people who have had cancer
in the past; these trials test interventions that may help prevent the
return (recurrence) of the original cancer or reduce the chance of
developing a new type of cancer
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There are cancer clinical trials for those at higherrisk of the disease due to their family history. Theseare called cancer prevention trials.
Prevention trials study ways to reduce the risk, orchance, of developing cancer. Most prevention trialsare conducted with healthy people who have not hadcancer.
Some trials are conducted with people who have had
cancer and want to prevent the return of cancer orreduce the chance of developing a new type ofcancer.
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TYPES OF CANCER TRIAL
Screening. These trials test new ways of finding cancer early.
When cancer is found early, it may be easier to treat and there may
be a better chance of long-term survival.
Cancer screening trials usually involve people who do not haveany signs or symptoms of cancer.
However, participation in these trials is often limited to people
who have a higher than average risk of developing a certain type
of cancer because they have a family history of that type of cancer
or they have a history of exposure to cancer-causing substances
(e.g., cigarette smoke).
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Diagnostic. These trials study new tests or procedures that may
help identify, or diagnose, cancer more accurately.
Diagnostic trials usually involve people who have some signs or
symptoms of cancer. Quality of life or supportive care. These trials focus on the
comfort and quality of life of cancer patients and cancer survivors.
New ways to decrease the number or severity of side effects of
cancer or its treatment are often studied in these trials.
How a specific type of cancer or its treatment affects a persons
everyday life may also be studied.
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CORRELATIVE RESEARCH
In addition to answering questions about the effectiveness of new
interventions, clinical trials provide the opportunity for additional
research. These additional research studies, called correlative or
ancillary studies, may use blood, tumor, or other tissue specimens
(also known as biospecimens) obtained from trial participants
before, during, or after treatment.
For example, the molecular characteristics of tumor specimens
collected during a trial might be analyzed to see if there is a
relationship between the presence of a certain gene mutation or theamount of a specific protein and how trial participants responded
to the treatment they received.
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Information obtained from these types of studies could lead to
more accurate predictions about how individual patients will
respond to certain cancer treatments, improved ways of finding
cancer earlier, new methods of identifying people who have an
increased risk of cancer, and new approaches to try to prevent
cancer.
Clinical trial participants must give their permission before
biospecimens obtained from them can be used for research
purposes.
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PHASES OF CANCER CLINICAL TRIAL
Phase 1 Studies
Phase 1 studies are the first introduction of aninvestigational new drug into humans. These studies are
closely monitored and may be conducted in patients. Phase 2 Studies
Phase 2 studies are conducted to evaluate the effectivenessof a drug for a particular indication or indications inpatients with the type of cancer under study. The goal ofPhase 2 studies is to determine the common short-termside effects and risks (if any) associated with a new drug.
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Phase 3 Studies
Phase 3 studies are performed after there is preliminaryevidence suggesting that a new drug is effective for cancertreatment. In a Phase 3 study, researchers gather the additional
information about the effectiveness and safety that is needed toevaluate the overall benefit-risk relationship of the drug. Inaddition, information from a Phase 3 study is used to provideguidelines for physician labeling.
Phase 4 (or Postmarketing) Studies
After a drug has been approved for marketing by the FDA,Phase 4 studies gather additional information about the drug'srisks, benefits, and optimal use