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Clinical Trials

  • What are Clinical Trials?
  • Phases of Clinical Trials
  • Types of Clinical Trials
  • Risks of Clinical Trials
  • Benefits of Clinical Trials
  • Myths about clinical trials in India

What are Clinical Trials?

Clinical trials are research studies that help to explore and determine whether new treatments, drugs or devices are safe and effective for humans. They also may determine approaches that work best for specific diseases, conditions & groups of people.

Clinical trials are important for the following reasons:

  • They help in advancing medical knowledge and technology
  • They help find out ways to improve clinical outcomes
  • They help doctors to know whether a new approach or treatment works well in humans and is absolutely safe to use
  • They help to determine which treatment or strategy works best in a particular illness or in a particular group of people
  • They enable doctors to make evidence-based decisions

Phases of Clinical Trials

Clinical trials are divided into different phases or stages, with each phase having a different goal.

Phase I

This is an initial trial phase that recruits less people. If phase 0 trial or a laboratory tests show a promising drug or treatment for cancer cure; then phase I trial is done to find out:

  • Safe dosage of the drug
  • Potential side effects
  • Reaction and coping mechanism of the body to the drug
  • Resultant shrinkage of cancer on exposure to the drug

Phase II

Phase II trials are done after phase I. However, not all successful treatments from phase I reach phase II. The aim of phase II trials is to assess:

  • If the treatment / drug works in a particular cancer and is good enough to try in a larger number of people in phase III of the clinical trial
  • If any particular type of cancer responds positively to the new treatment
  • Any potential side effects of the treatment / drug and ways to manage them
  • The most effective dosage

Phase III

This phase of the clinical trial is often large scale and recruits many hundreds of patients from across the globe. Each patient enrolled in the study is sorted into one of the two groups namely: study and control where the study group gets standard treatment and the control group gets the new proposed treatment.

Once this phase has been completed, it is reviewed by the FDA who evaluates the results of the two groups and determines which of the treatments is better and can be approved for all patients suffering from a particular type of cancer.

Phase IV

This phase, if done, will always be performed after the FDA has approved a particular treatment or drug. The aim of phase IV trials is to assess:

  • Long-term risks and side effects of the drug
  • How well the drug works when used widely

Types of Clinical Trials

There are several types of clinical trials; and each trail is designed to answer a different research question. The various types of clinical trials include:

  • Treatment trials: most trials for cancer are treatment trails as they involve people who have cancer. The main aim of these trails is to test new treatments, drugs, vaccines etc.

  • Prevention trials: these trials involve healthy people. Here the participating individuals either do not have cancer but carry a high risk of developing cancer or have had cancer in the past and now are at a risk of developing a new cancer. The aim of these trials is to study the risks of cancer and ways to reduce those risks.
  • Screening trials: the aim of these trails to identify new to detect the disease early, hence have effective screening tests.

  • Supportive or Palliative care trials: these trials are aimed to study the quality of life of cancer patients. They also aim to understand the impact on quality of life from the side effects of cancer treatment. These trails look for new ways to help cancer patients cope with pain, nutrition, depression, etc.

Risks of Clinical Trials

  • It is important to understand that new treatments may not always be better than standard existing treatments

  • New treatment may not be as effective for everyone

  • There is always a risk of side effects that are different from what doctors expect

  • Clinical trials are not always covered by health insurance and its best to enquire before joining a trial

Benefits of Clinical Trials

  • Access to newest treatment that may increase chances of recovery and survival
  • Some people may not benefit from it but, provide scientific information to researchers
  • Treatment outcome within the study group of a trial receiving standard care may be better than the newly discovered treatment

Myths about clinical trials in India

  • The most common myth that people have about clinical trials is that they believe patients are treated as guinea pigs
  • My insurance won’t cover the costs
  • If I’m in the placebo group, I will end up popping sugar pills
  • I’m too old for a clinical trial
  • Clinical trial is my last resort
  • Once you consent to take part in a clinical trial, you cannot leave and come out of it.

The above statements are all myths associated with clinical trials in India and are the major reasons for reduced number of trials that help treat diseases like cancer.

  • What are Clinical Trials?
  • Phases of Clinical Trials
  • Types of Clinical Trials
  • Risks of Clinical Trials
  • Benefits of Clinical Trials
  • Myths about clinical trials in India

What are Clinical Trials?

Clinical trials are research studies that help to explore and determine whether new treatments, drugs or devices are safe and effective for humans. They also may determine approaches that work best for specific diseases, conditions & groups of people.

Clinical trials are important for the following reasons:

  • They help in advancing medical knowledge and technology
  • They help find out ways to improve clinical outcomes
  • They help doctors to know whether a new approach or treatment works well in humans and is absolutely safe to use
  • They help to determine which treatment or strategy works best in a particular illness or in a particular group of people
  • They enable doctors to make evidence-based decisions

Phases of Clinical Trials

Clinical trials are divided into different phases or stages, with each phase having a different goal.

Phase I

This is an initial trial phase that recruits less people. If phase 0 trial or a laboratory tests show a promising drug or treatment for cancer cure; then phase I trial is done to find out:

  • Safe dosage of the drug
  • Potential side effects
  • Reaction and coping mechanism of the body to the drug
  • Resultant shrinkage of cancer on exposure to the drug

Phase II

Phase II trials are done after phase I. However, not all successful treatments from phase I reach phase II. The aim of phase II trials is to assess:

  • If the treatment / drug works in a particular cancer and is good enough to try in a larger number of people in phase III of the clinical trial
  • If any particular type of cancer responds positively to the new treatment
  • Any potential side effects of the treatment / drug and ways to manage them
  • The most effective dosage

Phase III

This phase of the clinical trial is often large scale and recruits many hundreds of patients from across the globe. Each patient enrolled in the study is sorted into one of the two groups namely: study and control where the study group gets standard treatment and the control group gets the new proposed treatment.

Once this phase has been completed, it is reviewed by the FDA who evaluates the results of the two groups and determines which of the treatments is better and can be approved for all patients suffering from a particular type of cancer.

Phase IV

This phase, if done, will always be performed after the FDA has approved a particular treatment or drug. The aim of phase IV trials is to assess:

  • Long-term risks and side effects of the drug
  • How well the drug works when used widely

Types of Clinical Trials

There are several types of clinical trials; and each trail is designed to answer a different research question. The various types of clinical trials include:

  • Treatment trials: most trials for cancer are treatment trails as they involve people who have cancer. The main aim of these trails is to test new treatments, drugs, vaccines etc.

  • Prevention trials: these trials involve healthy people. Here the participating individuals either do not have cancer but carry a high risk of developing cancer or have had cancer in the past and now are at a risk of developing a new cancer. The aim of these trials is to study the risks of cancer and ways to reduce those risks.
  • Screening trials: the aim of these trails to identify new to detect the disease early, hence have effective screening tests.

  • Supportive or Palliative care trials: these trials are aimed to study the quality of life of cancer patients. They also aim to understand the impact on quality of life from the side effects of cancer treatment. These trails look for new ways to help cancer patients cope with pain, nutrition, depression, etc.

Risks of Clinical Trials

  • It is important to understand that new treatments may not always be better than standard existing treatments

  • New treatment may not be as effective for everyone

  • There is always a risk of side effects that are different from what doctors expect

  • Clinical trials are not always covered by health insurance and its best to enquire before joining a trial

Benefits of Clinical Trials

  • Access to newest treatment that may increase chances of recovery and survival
  • Some people may not benefit from it but, provide scientific information to researchers
  • Treatment outcome within the study group of a trial receiving standard care may be better than the newly discovered treatment

Myths about clinical trials in India

  • The most common myth that people have about clinical trials is that they believe patients are treated as guinea pigs
  • My insurance won’t cover the costs
  • If I’m in the placebo group, I will end up popping sugar pills
  • I’m too old for a clinical trial
  • Clinical trial is my last resort
  • Once you consent to take part in a clinical trial, you cannot leave and come out of it.

The above statements are all myths associated with clinical trials in India and are the major reasons for reduced number of trials that help treat diseases like cancer.

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