ONCOLOGY TRIAL

CANCER TRIAL
A cancer clinical trial is a medical research study in which people participate as volunteers to test new methods of prevention, screening, diagnosis, or treatment of a disease. A cancer clinical trial can also be referred to as a cancer clinical study. Some cancer patients may fear that enrolling in a cancer trial means they chance receiving no cancer treatment at all, but the reality is that patients in clinical trials receive either the best cancer treatment currently known for their cancer, or a new, and possibly more effective, therapy.

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 is about 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.

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 as well as new ways to use existing drugs To translate results of basic scientific research into better ways to prevent, diagnose, or treat cancer

WHY DO WE NEED THEM?

We need to know that any treatments we recommend are both safe and effective in humans Cell culture and animal work can only take us so far! Especially in Oncology, people are always looking for the miracle cure-and it is easy to get dragged into the idea Scientific, medical, evidence-based paradigm

DO MANY PEOPLE PARTICIPATE IN CANCER CLINICAL TRIALS?

Less than 5% of Adults with cancer participate in clinical trials

ONCOLOGY PHARMACEUTICS MARKET IN INDIA

Market in India: Oncology pharmaceuticals market in India is valued at Oncology pharmaceuticals market in India, a leading segment of the overall pharmaceuticals market is the fourth largest in volume and eighth largest in value in the global market. Since cancer is the second largest cause of death in the country, the Indian market is characterized by a huge demand for cancer drugs. It is a highly fragmented market with a large number of foreign and domestic 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 health insurance coverage and increasing amount of foreign direct investment (FDI) is helping the market to grow.

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

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 publicprivate 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

TYPES OF CANCER TRIAL

    

Cancer clinical trials differ according to their primary purpose. They include the following types: Treatment Prevention Screening Diagnostic Quality of life

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 therapy techniques, 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.

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 have a 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

There are cancer clinical trials for those at higher risk of the disease due to their family history. These are called cancer prevention trials. Prevention trials study ways to reduce the risk, or chance, of developing cancer. Most prevention trials are conducted with healthy people who have not had cancer. Some trials are conducted with people who have had cancer and want to prevent the return of cancer or reduce the chance of developing a new type of cancer.

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 have any 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).

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.

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 the amount of a specific protein and how trial participants responded to the treatment they received.

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.

PHASES OF CANCER CLINICAL TRIAL

Phase 1 Studies Phase 1 studies are the first introduction of an investigational 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 effectiveness of a drug for a particular indication or indications in patients with the type of cancer under study. The goal of Phase 2 studies is to determine the common short-term side effects and risks (if any) associated with a new drug.

Phase 3 Studies Phase 3 studies are performed after there is preliminary evidence suggesting that a new drug is effective for cancer treatment. In a Phase 3 study, researchers gather the additional information about the effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. In addition, information from a Phase 3 study is used to provide guidelines 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's risks, benefits, and optimal use