All About Clinical Trials and Clinical Research – A Brief Guide!

The clinical research industry is growing at an estimated compound annual growth rate of around 14%. Clinical trial and research is now a significant business worldwide. With over 100 companies currently conducting clinical trials and more than 100 drugs are approved by the “Central Drugs Standard Control Organization” each year. 

But, what exactly is a clinical trial?

A term “Clinical” refers to the medical care of actual patients. And “Clinical trials” are a form of medical research that follows a defined protocol that has been developed to answer a specific patient care question.

In a clinical trial, participants receive specific interventions according to the investigators’ research plan or protocol. And these inventions could be anything; it may be medical products, such as drugs or devices; procedures; or changes to participants’ behaviour, such as diet.

Clinical trials are in use to test:

  • Cancer therapies
  • Treatments for cardiovascular disease
  •  The safety and efficacy of new drugs
  • Cells and other biological products
  • Dietary changes
  • Vaccines
  • Medical devices
  • Behavioural Therapies
  • Prevent health problems

Phases of Clinical Trials:

Phase 0: It refers to analyzing the small doses of a new drug in a few people. This trial test is used to collect the preliminary data. It includes whether the drug reaches the tumor, how it reacts with the body or how cancer cells react with the vaccine or drug. 

Phase 1: Conduct a vaccine test on a small group of people nearby 20 to 80 participants to analyze the safety. 

Phase 2: If drugs well react in phase 1, then it goes for testing in phase 2. This clinical trial assesses an intervention in a larger group of people to determine whether it works as efficacy and to further evaluate its safety.

Phase 3: This clinical trial assesses an intervention in a broad range of participant groups. It provides further information about the safety and effects of an intervention. Most health organizations conduct clinical trials and consider up to all three phases to approve a new drug or vaccine.

Types of Clinical Trials:

If we talk about the types of clinical trials, they are categorized according to their objectives. Or you can say that according to the way a trial is organized. Here are some types are considered below: 

  • Treatment Research Trials: These types of clinical trials generally involve an intervention. It includes medication, psychotherapy, or new approaches to surgery or radiation therapy.
  • Prevention Trials: This type comes into use to improve prevention or recurrence of the disease. 
  • Double-Blind Clinical Trial: Trial in which neither the subject nor the observer knows which treatment is being administered.
  • Screening:  Method of identifying certain diseases or health conditions.
  • Diagnostic: Trial to identify the technique and a procedure to diagnose any disease or health condition.  
  • Supportive care: Examining the preventive procedures to improve comfort and quality of life for patients with chronic conditions.
  • Health services research: Analyze the delivery, process, management, organization, or financing of healthcare.
  • Basic Science: The primary trial to analyze or examine how an invention works. 

Why Are Clinical Trials Done?

Well, they are done for several reasons. A few of them are considered below:

  • To analyze whether the drug is safe and effective for people to use.  
  • Evaluate one or more diagnosis interventions that might identify or diagnose a particular disease or condition.
  • Explore supportive care procedures to enhance the quality of life of people with significant health issues. 
  • To know which population you can safely use the treatment for which the treatment has not been tested before.
  • Study the use of standard treatment in various ways to be more effective and easier to use without any specific side effects. 

Fast Facts on Clinical Trials:

  • Clinical trials have three phases before getting the Food Drug Administration (FDA) approval.
  • Most trials are randomized, which means that the participants are randomly allocated to their treatment groups.
  • Participating in a clinical trial could provide benefits that could improve the quality of life. 
  • Clinical trials’ main goals are to find new drugs or therapies to improve or cure health conditions.
  • Research clinical trials must have safeguards to protect participants from possible harmful side effects of the tested treatments. 
  • In many research, you can bring a family member with you to a clinical trial for support.
  • One more interesting fact, you can ask any question to researchers at any time when participating in a clinical trial. 

Who Can Conduct The Clinical Trial?

Researchers conduct clinical trials in various settings. When conducting a clinical trial, every clinical study is led by a principal investigator, or you can say by a well-professional doctor. Clinical trials also have a research team, including doctors, nurses, social workers, and other health care professionals.

Where Are Clinical Trials Conducted?

Clinical trials conduct generally depends on the types of research study and the most important who is organizing it. As per the health care organization, everyday clinical trials on conduct in locations include:

  • Hospitals
  • Universities
  • Medical Centers
  • Doctors’ Offices
  • Community Clinics
  • Federally-Funded And Industry-Funded Research Sites

How Long Clinical Trials Do Last?

As you know, during clinical trials, new drugs pass through the various phases before the FDA approves them for public use. And this is why most clinical trials are complete in days, and others last for 2 to 3 years on average to complete

Who can participate in clinical trials? 

If you want to be a part of clinical trials, then trial eligibility requirements are determined by inclusion and exclusion criteria. Yes, generally, these two criteria listed in trial databases and briefly in the study. It may include:

  • Age and Gender.
  • Stage of disease.
  • Previous treatments a patient did take.
  • Medications a patient is currently taking.
  • Medical conditions are other than the one being studied.

Not everyone is chosen to participate. People who participate in running clinical trials do so freely and of their own will. They are volunteers because they have common health conditions. It includes kidney disease, high blood pressure, or diabetes.

In simple words, if you want to become a clinical trial participant, you must qualify for both the inclusion and exclusion criteria. These criteria are used to protect your safety during a clinical trial.

Is Participation In Clinical Trials Needs to Pay?

When participating in clinical research trials, most of you think you have to pay for it. But it is not true because some clinical trials offer monetary compensation for participants and others offer free health care. All you have to do is satisfy the participating clinical criteria.

Let’s considered some reasons why Clinical Trials are Important:

Can Help or Affect Many More Patents: 

If we consider a doctor, then its primary aim is taking care of his patient. And he can only see 20 patients in a day. But clinical trials allow professionals to impact thousands or even millions of lives potentially. They can help many patients at a single time.

Bring New Treatment in the Market: 

Another reason that clinical trials are essential is that they bring a new treatment to the market. In a clinical trial, every medicine, dung, vaccine or devices have been rigorously tested in many phases before they are ever used in a doctor’s office or surgical suite. And without these clinical research trials, it is not possible to discover and outcome in medical technologies.

Provide Complete and Accurate Information:

Suppose, to treat a particular condition; you have two medicines. And write a description for patients, if it works, then excellent otherwise switch to another one. But is it a good way? And it is also possible that it affects the patent incorrectly. But if you conduct a clinical trial with those medicines, you have complete data about which one is effective with the patient’s health or not and enhance the quality of life. 

Less Potential Risk:

Another reason the clinical trial is necessary because they test safety and efficacy. There are four different trials and many regulatory bodies overseeing the safety and efficacy before it gets approval. Moreover, it automatically reduces the chances of health risks.

Whether you participate in a clinical trial, or not is a personal decision. But if you want to be a part of clinical trials, then we at Vial Trials embed a coordinator to integrate research into your clinical operations smoothly. We bring you the best clinical trial opportunities. For more queries, consult us today! We feel happy to assist you.

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