The burden of cancer is continually increasing in India. The number of people diagnosed with cancer is projected to rise to around 16 lakh in 2025, from approximately 14 lakh in 2020. Globally, clinical trials have been key to figuring out what works and what doesn’t when treating different forms of cancer.
Before starting a clinical trial, doctors need to prove to the volunteer that there is a scope for the new treatment to work better than the present one. They research until they can confirm this. For example, they might test the treatment on laboratory animals. They do this to make sure it is safe to try in people.
In the recent past, there has been an impressive growth in the number of clinical trials launched worldwide, including India. Participation in well-designed oncology clinical trials is advantageous to the Indian healthcare system and cancer patients. However, the number of clinical trials being run in India is not commensurate with the cancer burden prevailing in the country.
What is a clinical trial?
- A way to be involved in the frontlines of research to advance cancer care.
- It drives progress in cancer treatment.
- It is the only mode to invent if a new drug or treatment is better than the prevailing one.
- It is the safest way for people facing cancer to get high-quality treatment and care.
- It is an opportunity to get help from a new treatment or method.
- An opportunity to assist future cancer patients and contribute to research.
- Clinical trials also help find new ways to prevent and detect cancer.
- And they help us improve the quality of life for people during and after treatment.
Why participate in a clinical trial?
There are many reasons to join a clinical trial for a cancer patient. Some patients join the clinical trial because their previous treatment did not work. Other people participate because no treatment is available for them at present. As a part of a clinical trial, the participants may learn about new treatments before they are widely available. Some studies are designed for healthy people who want to help in the research to prevent deadly diseases and benefit society. Clinical trials are the key to making progress against cancer.
Researchers propose cancer clinical trials to test new methods to-
- Treat cancer
- Diagnose cancer
- Prevent cancer
- Manage symptoms of cancer
Phases of clinical trial
Clinical trials are conducted to evaluate the safety and efficacy of new drugs and medical devices on human subjects. All clinical trials go through four phases.
Phase I – Phase I trials test a drug’s safety on healthy volunteers. A drug approved for human studies is tested in a small trial to determine the optimal safe dose. Phase I studies often involve patients with different kinds of cancer or, more recently, a single genetic change.
Phase II- Phase II trials test the drug’s efficacy on patients. In this phase, a drug’s safety on healthy volunteers is tested. When a drug can be given safely to people in the phase I trial, it is tested in a Phase II study. These are more extensive studies, usually for one or more specific types and stages of cancer. The goal of Phase II studies is to both determine the optimal dosing and provide an early assessment of whether the drug works.
Phase III- A phase III clinical trial tests a treatment that worked well for volunteers in phase II clinical trial. Doctors use the input of Phase III to compare the latest treatment with the standard treatment. They also want to know if the new treatment is better, has fewer side effects, or both. So, they put volunteers in different groups. The volunteers in each group get further treatment.
Phase IV- In this phase, trials are conducted once the drug is marketed to monitor its safety in a larger population. Doctors can prescribe this drug to their patients after getting approval from an authorized department. In this phase, doctors also check if the treatment benefits people as much as it did earlier in these clinical trials. They also look for more possible side effects. These clinical trials are called phase IV clinical trials.
Clinical trial in India
India has become the most preferred destination for global clinical trials because of its cost and resource advantages. There are many reasons India is considered a favourable condition for clinical trials. Some of them are mentioned below:
- Clinical trials in India are conducted at a lower price than in other countries.
- India has a higher number of English-speaking doctors.
- The time taken for obtaining the regulatory clearance of clinical trials is relatively less than in other countries.
- India has a trained workforce in Clinical research and experienced scientists, and all these initiatives boost the clinical research industry.
- India has a harmonized regulatory process as with US and international standards.
- Mandatory CTRI registration of clinical trials which allows more transparency of the process.
Clinical research abroad
Clinical research industry has grown around the world at an unparalleled rate in the past few years. Developed markets in the US, UK, China, Germany, and Japan are very much popular for clinical trials. Researchers constantly create new clinical trials and various organizations list the open clinical trials. This helps people find ones that may be appropriate for them.
There are many ways you can get help to find a clinical trial. You can talk to your doctor or other health care provider. Or, you can search ClinicalTrials.gov. You can sign up for a registry or matching service to connect you with trials in your area. Support groups and websites that focus on a particular condition sometimes have lists of clinical studies. Also, you may see ads for trials in your area in the newspaper or on TV.
Many cancer advocacy groups offer help finding clinical trials that might be a good fit for you. Because many of these groups focus on a specific type of cancer, they can help you find trials for your type of cancer. A list of some of these services can be found on the cancer.net website. If you don’t see your type of cancer on this list, you can search the internet for advocacy groups.
Some websites also give all the information about clinical trials. You can register there and be informed about it once there is a requirement as per your problem. You can sign up for a registry or matching service to connect you with trials in your area. Support groups and websites that focus on a particular condition website sometimes have lists of clinical studies. Also, the local newspaper and television ads carry information related to clinical trials.
Clinical Trial in the US and UK
The clinical research industry has grown worldwide at a phenomenal rate in the past few years. Researchers constantly create new clinical trials. And various organizations list the open clinical trials. This helps people find the clinical trials appropriate for them. Today, people live longer lives from successful cancer treatments that are the results of past clinical trials.
In developed countries like the US and UK, People are very much aware of clinical trials. It is common in those countries for their healthcare providers to inform them about different clinical trials as per their disease.
Doctors use clinical trials to learn whether a new drug, treatment, or combination works and is safe to use for people. Clinical trials are important in developing new treatments for severe diseases like cancer. All new treatments must go through clinical trials before being approved by the Food and Drug Administration (FDA). Cancer clinical trials can take years to complete. It can take months, if not years, to see if a cancer treatment does what it is meant to do.
In the United States, when phase III clinical trials (or sometimes phase II trials) show a new drug is more effective or safer than the current treatment, a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval. The FDA reviews the results from the clinical trials and other relevant information.
Based on the review, the FDA decides whether to approve the treatment for use in patients with the illness the drug was tested on. If approved, the new treatment often becomes a standard of care, and more unused medications may be tested against it before they can be approved.
If the FDA feels that more evidence is needed to show that the new treatment’s benefits outweigh its risks, it may ask for more information or even require that more studies be done.
Importance of clinical trials
Today, people are living longer lives from successful cancer treatments that are the results of past clinical trials. Through clinical trials, doctors determine whether new treatments are safe and effective and work better than current treatments. Clinical trials also help us find new ways to prevent and detect cancer. And they help us improve the quality of life for people during and after treatment. When you take part in a clinical trial, you add to doctors’ knowledge about cancer and help improve cancer care for future patients. Clinical trials are the key to making progress against cancer.