Oncology Trial

8/3/2019 Oncology Trial

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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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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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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

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Oncology Trial