Clinical trials in cancer

Clinical research is human subjects-based medical investigation. Clinical trials and observational research are the two categories. Observational studies look at people in everyday environments. Information is gathered, participants are grouped according to general characteristics, and changes over time are compared. For instance, to understand more about the impacts of various lifestyles on cognitive health, researchers may gather information over time about a group of older adults through medical exams, tests, or questionnaires. These investigations might suggest fresh avenues for clinical trials.

Clinical trials are research projects conducted on human subjects with the goal of assessing a therapeutic, surgical, or behavioural intervention. They are the main method used by researchers to determine whether a new treatment, such as a new medication, diet, or medical gadget (such as a pacemaker), is safe and effective in humans. A clinical trial is frequently performed to determine whether a new treatment is more efficient than the current treatment and/or has fewer negative side effects.

Some clinical studies examine methods for detecting diseases early on, often even before symptoms appear. Others research strategies to avoid a health issue. A clinical trial may also focus on ways to improve quality of life for those who have chronic health issues or life-threatening illnesses. Clinical trials occasionally investigate the function of carers or support networks.

Four phases of clinical trials

Four stages are included in clinical trials, which are used to evaluate a medicine, determine the right dosage, and check for side effects. The FDA approves a medicine for clinical use and continues to monitor its effects if studies conducted in the first three phases show it to be safe and effective.

Drug clinical trials are typically broken down by phase. Phase I, II, and III trials are frequently necessary for the FDA to decide whether to approve a medicine for usage.

  • Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
  • Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
  • Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
  • Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug’s effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.

Why should a patient participate in clinical trials?

People decide to participate in clinical trials for a variety of reasons. Some people enrol in a study because the treatments they’ve tried to treat their health issue have failed. Others take part since there is no cure for their medical condition. Participants in clinical trials could learn about novel medicines before they are generally made available. Some studies are made for, or include, individuals who are in good health but want to contribute to the search for cures for diseases that may run in their families.

Many claim that taking part in clinical trials allows them to become more involved in their own healthcare. Others claim they want to assist researchers in learning more about certain health issues. Regardless of your reasons, choosing to take part in a clinical trial makes you a part of scientific research. Also, your support may contribute to healthier lives for future generations. Without the generosity of clinical trial participants, whether young and old, significant medical advancements would not have been possible.

What happens in a trial ?

Here’s what happens in a trial:

  1. Study staff explain the trial in detail and gather more information about you.
  2. Once you have had all your questions answered and agree to participate, you sign an informed consent form.
  3. You are screened to make sure you qualify for the trial.
  4. If accepted into the trial, you schedule a first visit (called the “baseline” visit). The researchers conduct cognitive and/or physical tests during this visit.
  5. You are randomly assigned to a treatment or control group.
  6. You and your family members follow the trial procedures and report any issues or concerns to researchers.
  7. You may visit the research site at regularly scheduled times for new cognitive, physical, or other evaluations and discussions with staff. At these visits, the research team collects information about effects of the intervention and your safety and well-being.
  8. You continue to see your regular physician for usual health care throughout the study.

How can I participate in a clinical trial?

Patients can check our website regarding some of the important clinical trials happening around the globe and send your request to participate. We will coordinate with the hospital on eligibility etc.

You can send your medical reports by email or on WhatsApp to +91 96 1588 1588.

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