Clinical Trials in CancerWhat are clinical trials?Clinical trials, which are also known as medical research studies are used to determine whether new drugs are safe and effective. They are done to determine the side-effects of the drugs, how effective are they and if they can be introduced in the market without violating any laws of the government. Phases in a clinical trial: Clinical trials are generally conducted in phases. There are four phases: 1. Trial of the drug on a small group of people (20-100) to evaluate its safety and side effects. 2. Drug given to a larger group of people (100-400) to evaluate its effectiveness and safety. 3. Drug given to even larger groups of people (in thousands) to monitor side effects, evaluate safety and effectiveness, and collect more information about the drug. 4. Studies done after the drug is marketed. Participants: Clinical trials are often conducted on patients suffering from an incurable disease who might benefit from the drug if it is effective. The first two phases require healthy volunteers while the last two require people suffering from the condition. All volunteers give an informed consent before the trials can be conducted. This means that the patient is willing to take the risks involved and providing all the information required for the trial. Clinical Trials are a long and lengthy process but they are scientifically correct and are necessary for a company to know about the potential and the effects of the drug. Cancer: Cancer is a group of diseases which involve unregulated cell growth. It is one of the most dangerous diseases and can develop in almost any organ or tissue. The causes of cancer remain unknown but it is generally related to the type of diet. Breast cancer is one of the most causes for the death of women in the United States. Cancer can be prevented by physical activity and maintaining a proper diet. Obesity is also considered as a factor for cancer. Clinical trials in cancer: Cancer clinical trials are research studies that find out the new drugs, new approaches to surgeries, and new methods of therapy. They include four phases: Phase I: It involved finding out the way of a new treatment, safe dose and the safety of the medication. It is done on people suffering from cancer and on whom other methods have not worked. Phase II: This involves finding out whether the treatment has an anticancer effect or any other side effects which may affect the treatment and the disease. Phase III: Comparison between two groups is done to find out which group has better survival rates and which one has fewer side effects. The selection of people to the groups is random. This phase includes thousands of people. Phase IV: This is done after the treatment is approved. It is done to provide additional details and if an improvement can be done in the treatment. During the process, the people undergo treatment and they are monitored by researchers and it is done by an informed consent. A protocol is followed during the cancer clinical trials. These protocols state how many people are participating for what duration and the objective of the research. Cancer clinical trials offer high quality care against cancer and help improve cancer treatment. Clinical trials in India: India is one of the major centres for clinical trials. There are a number of reasons why this has been made possible. The first and the foremost is the population of India. India has the second highest population in the world and it is on path to become the largest in the next 30-40 years. With a majority of the population living under extreme poverty, these people will be more than willing to participate in the clinical trials for meagre sums compared to the Western standards. Generally, cancer incidences are much lower in India than in the West. Nevertheless, the number of people suffering from major diseases like diabetes and cancer has risen in the last couple of years which has led India to be the outsourcing hub of clinical trials in cancer. Big pharmaceutical companies are estimated to invest $1-1.5 billion for drug trials in India. Another factor is the number of medical students and doctors available in India. These are not only high in number, but charge lesser than in the West and are highly talented. On top of that, infrastructure has improved drastically from the last couple of years and it is only a matter of time before Indian is the leading hub for clinical trials in the world. India also offers a set of complex and diverse cases which offer a unique opportunity. There have been cases of misconduct where the drugs have been tested without proper approval. The government has taken a strict and prompt action against this and have put a set of laws in place for such unethical and immoral behaviour. With the new regulations which support the investment of clinical trials in the country, balanced with the set of laws which protect the people, India is treading on the right path to become a major clinical trial hub, especially for diseases like cancer.
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