What are clinical trials, and why are they important?

What are clinical trials, and why are they important?

Humans have come a long way in the field of medicine. Be it controlling illnesses, creating antidotes and vaccines, or even finding cures. It is amazing, the progress we’ve made. And there’s one thing that is and has been a huge, essential part of all the discoveries - clinical trials. 

You may have come across the term clinical trials but have you ever wondered what it is or why it is so important? We have tried to answer it for you in the blog. Read on to get an idea about the importance of clinical trials in resolving problems and achieving medical advancements. 

Clinical Trials: The First Step

A clinical trial is a research process that involves human participants volunteering for medical or healthcare welfare. The data received from the findings of these trials help determine possible alternatives and most-likely solutions of the problem at hand. So, be it clinical studies on supplements or a life-saving drug, clinical trials serve as the first step in the problem-solving process. [1] [2]

Any clinical research can be branched and identified into two categories: observational studies and interventional studies or clinical trials. 

Observational Studies

Just as the name suggests, observational studies are carried out by observing people in their natural and normal environment. Based on the observations of groups, researchers create/collect data as per a research plan or protocol to either prove a hypothesis or to get to a conclusion.

An example of an observational study would be investigators carrying out research to study the effects of stress on participants working from home.

Interventional Studies/Clinical Trials

Under a clinical trial, the participants receive specific interventions based on the research plan or protocol chalked out by the investigator. These interventions can be medical devices or drugs, certain procedures, or they could be some changes in lifestyle such as diet or physical activity. (Nutraceuticals and health supplements do not require clinical trials, however, product formulations can be studied to understand their efficacy.)

Clinical trials largely focus on testing out whether the new or proposed treatment is safe and/or effective for humans or not.

The significance of clinical trials is that they allow investigators to study the effects of these treatments; whether they will enhance the solutions, eradicate the problems, or to understand the number of challenges/ possible side-effects the proposed solution might have, among other things. 

To thoroughly evaluate the effectiveness, side-effects and to decide on an appropriate dosage, clinical trials have to progress through four phases. To get any medical product approved for use, Phase I, Phase II, and Phase III trials have to be carried out with optimal results to back the efficacy.

Benefits of clinical trials

Every treatment you witness in the market, minor or significant, is a result of years of research and hard work put into resolving the problem. Most medical advancements today are the result of the constant research and development carried out through clinical trials. 

Although uncertainty is a part of the research, clinical trials are a necessary step toward discovering a solution. Here are some of the benefits of clinical trials that throw light on their importance in the field of science:

  • Clinical trials are the first step towards discovering a solution and finding ways in which new treatments can be developed. [3]
  • Whenever a new drug or product is about to be introduced, research-backed data generated through a clinical trial can help understand its efficacy and safety. 
  • While computer simulations or animal testing may be safer options, data received through trials on human participants is bound to yield more accurate results.
  • Introducing a new way to deal with a problem also encourages additional research in the field, eventually leading to a breakthrough.
  • New treatments can impact the lives of countless individuals by letting them live longer, with less pain or disability.
  • By conducting clinical trials, researchers can assert that the medication or the product does not have a limited appliance and the results have a widespread effect.
  • Most importantly, research-based products raise the standard of products or drugs, eventually discouraging and preventing the use of unlicensed or off-label medications that could prove dangerous and often, fatal [4].

As efficient and beneficial clinical trials may be, they do come with their fair share of challenges and concerns [5]. Here are some of the challenges that a researcher may face while carrying out clinical studies or trials:

Hurdles to overcome during clinical trials


It is no surprise that the ever-advancing technology is responsible for enhancing the results of the research. However, the benefits of technology come with challenges. Amidst the various technological upgrades, it might become difficult for the researcher to choose the right alternative to get optimised results. [6]

Moreover, advanced technology can also be a hurdle for the participants as well as the researchers. 

Obtaining approval from Institutional Review Boards

With the number of clinical trials and research increasing steadily, the approval from Institutional Review Boards is also expected to face much stringent scrutiny. While it is essential for the board to properly assess and only upon certainty approve the trials, the process often tends to become time-consuming and tedious. 

Recruiting patients

Another challenge faced by several researchers is finding suitable and healthy participants for the trials and then recruiting them. Oftentimes, owing to the complexity of the trials or the lack of incentives, eligible people tend to be uninterested in participating in the research.

The complexity of trials: meeting the challenge of focusing on the best design

As researchers dig deeper to find answers, the complexity of the path leading to answers is bound to increase. In the meantime, there is constant pressure to submit answers that are simpler and easier to understand. And this attempt to simplify and prepare an unobtrusive design for participants and reviewers can be a challenging task (among others). 

Facing complex guidelines and regulations

Unsurprisingly, with the increasing number of research studies, regulatory authorities need to put forward stringent regulations and guidelines. However, adhering to a series of complex guidelines set up by various institutions can make it difficult for the researchers to keep up with both the regulations and the research.


With all the challenges mentioned above, an increase in budget becomes inevitable. For instance, in clinical trials for medical devices, a certain heterogeneity is required in participants which can lead to an increase in the budget. And amid the lack of funding options, this can prove to be a hindrance to the ongoing studies. 

Having said that, we at Nutrova believe that the benefits of the clinical trials outweigh their challenges. And so, we hope your queries and doubts around clinical trials have been resolved and you, like us, believe in their efficacy to make things better for all of us. 

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