A Quick Guide To Clinical Trials And Studies

Clinical trials and studies are vital to understanding whether a medical technology, a new treatment, a device, or medication is effective and safe. Therapeutic medical discoveries involve several tests on multiple types of people—whether healthy or otherwise—and from varying demographics before commercial approval.  

According to research, the median cost for recently approved drugs is USD$ 48 million, owing to the high number of participants and clinical visits. The length of study varies, although it’s not uncommon for research teams and pharmaceutical companies to wait 15 years until their product gets sold.      

Whether you’re curious about clinical trials or plan to participate, learning what medical trials are and the stages of clinical trial pharmaceutical development is important. This article will discuss these and more. 

Understanding Clinical Trials and Studies  

Clinical studies involve two types of activities aimed at improving understanding of new treatments and the effects of health-related factors on specific populations. The former is called a clinical trial, while the latter refers to observational studies. While often used interchangeably, there is a difference between how these activities are performed. 

  • Clinical Trials 

Clinical trials represent the public’s most common understanding as they seek to determine whether a newly discovered drug, device, or method can treat certain illnesses or conditions and whether they’re safe for humans. If not safe, the trial will determine the whys and hows, including the doses where these treatments become unsafe, among other things. As such, clinical trials focus on different interventions based on the protocol designed by the research team. 

Types Of Clinical Trials 

Before launching a large-scale research activity, research teams will conduct pilot and feasibility studies to determine whether it’s viable to conduct the main research. These preparatory activities will determine if there are enough participants. It will also help determine the best methods of gathering and analyzing information.    

Investigators can determine which of these types works best according to research objectives: 

  • Explanatory Trials: These trials will help researchers understand how and why a certain intervention is effective. This is typically done in the earliest stages of drug development.   
    • Prevention Trials: This will determine if a proposed product, treatment, device, or approach can prevent a certain illness or condition.
    • Screening Trials: These are usually done on healthy people or those at risk of developing certain conditions. It can be launched to determine whether the proposed or current screening procedures are reliable. 
    • Treatment Trials: This seeks to determine the efficacy and safety of new treatment approaches or products.   
  • Multi-Arm Multi-Stage (MAMS) Trials: These trials enable researchers to be flexible in studying new treatments without necessarily starting from scratch as discoveries crop up.             

Depending on their research objectives, a clinical study may suggest changing certain procedures, drug administration methods, or a participant’s diet and behavior. 

To find out how a proposed medical product compares with the current approach, the trial will involve dividing the number of participants into at least three to: 

  • Administer the product in question in one group 
  • Provide the commercially available medication or device to another team
  • Give another group a placebo or withhold any intervention    

The research team will measure the impact of each intervention to determine efficacy and safety. Because new approaches and products are being studied yearly, researchers continuously look for additional participants for ongoing clinical studies and trials.  

  • Observational Studies 

Like clinical trials, observational studies aim to enhance understanding of the human body and its reaction in certain situations. The only difference is that participants in these activities aren’t subject to specific interventions. In other words, it doesn’t attempt to change the factors being studied.   


Types Of Observational Studies  

There are different methods of observational studies that research teams can use exclusively or in conjunction with each other depending on their goals:   

  • Case-Control Studies: These studies are used when researchers compare two or more participant groups or the impacts of different events.     
  • Cohort Studies: These are observational studies of people who share the same characteristics and determine which influences may cause differences in behavior or response.      
  • Cross-Sectional Studies: This occurs when researchers observe their participants in one particular period.     
  • Longitudinal Studies: These are when researchers observe participants over a prolonged period, intending to detect changes within the time.       
  • Naturalistic Observation: This is carried out when scientists observe animals or humans in their natural environment. These studies are done in the field instead of the laboratory premises.   
  • Participant Observation: This is somewhat like naturalistic observation, except that the researcher must immerse themselves in the group for a certain period.       
  • Structured Observation: This is when participants are observed in a controlled environment like a laboratory or research facility

By their very nature, clinical trials always involve human participants because of their core objectives. Observational studies, meanwhile, sometimes include animals, depending on the research design and goals.    

Wrapping Up 

Clinical trials and observational studies are conducted to improve medical and scientific knowledge about human bodies, behavior, and response. The team must establish the research design and protocols that align best with their pre-defined objectives.    

Between the two, clinical trials are primarily used in the different stages of drug development because it’s more effective in validating the efficacy of new treatments. Observational studies, meanwhile, can be used to determine the potential side effects and safety of a new medical product. Research results help government agencies and the private sector decide how to move forward.