The Journey of a Clinical Trial: From Concept to Reality

The Journey of a Clinical Trial: From Concept to Reality

Adding a new drug to the market takes a lot of planning and processes. There are many steps in the drug development process. Clinical trials occur in the middle of the process. Clinical trials test the results of a novel drug using a certain number of human subject participants. 

Before a clinical research team can even consider building a clinical trial, they must first receive funding and begin research and development, followed by preclinical research, usually reserved for animal testing. The next step is clinical research, where the clinical trial process begins. 

Funding Clinical Trials 

Sponsors fund clinical trials. The role of sponsors in clinical trials is to support and manage the clinical trial and become responsible for any positive or negative effects found throughout the study. 

There are several different clinical trial funding sources, including government agencies like the Food and Drug Administration (FDA), pharmaceutical companies, academic research sites, independent research sites, private investors, and charities. 

The Clinical Trial Process 

Studies begin with the clinical trial development process. The first step is to design the clinical trial. Clinical trials are built to answer a fundamental research question about a particular drug. Determining the question(s) and objective(s) a clinical trial will have is the job of the clinical research team and the principal investigator (PI). 

The questions and objectives should cover: 

  1. The criteria for human participants 
  1. The number of participants allowed in the clinical trial 
  1. The length of the clinical trial 
  1. The use of control of placebo participants in the clinical trial 
  1. The dosage of the drug 
  1. The types of tests that will be used to study the drug 
  1. The periods for data collection 
  1. The specific data that is relevant to the drug being tested 
  1. The review process of the data collected 

Once clinical researchers have determined the goals and objectives of the clinical trial, the next step is submitting an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). 

The application contains data regarding the preclinical trial or animal study, known side effects from testing, manufacturing information, protocols for the clinical trial, any data from previous human subjects (relevant in later phase clinical trials), and detailed information on the PI. 

After the FDA approves the IND, clinical research teams can begin searching for participants for Phase 1 of the clinical trial. Phase 3 is the final step before clinical trial data is submitted to the FDA and a new drug is approved for the market. 

Participant Recruitment in Clinical Trials 

The key to successful clinical trials is an extensive number of participants with the targeted condition or disease and a healthy number of volunteers with no health conditions. 

Patient recruitment aims to satisfy the study of the new drug while maintaining the participants’ safety throughout the clinical trial process. 

Several supervisory bodies and protocols, such as informed consent, have been established to maintain clinical trial participant rights. Informed consent is the process of clinical researchers sharing all relevant information about a new drug with potential participants before they agree to volunteer in any phase of a clinical trial. 

Clinical trial safety monitoring specialized boards like the institutional review boards (IRBs) and independent ethics committees (IECs) ensure that participants are chosen unbiasedly, favorable benefit-risk ratios are acceptable, patient privacy is instituted throughout the trial, and data is shared appropriately with participants. 

Clinical researchers aim to include diverse demographics in patient recruitment. There have been great strides in the inclusion of women in studies. 

However, there is still a limited number of African American, Asian, Hispanic, and Indigenous participants in most trials. A more diverse population can help control the effects of new drugs on different ethnicities before the drugs go to market. 

Clinical Trial Phases Explained 

There are four total Investigational drug testing phases: Phase 1 through Phase 4. Understanding the clinical trial stages begins with learning the purpose of each phase in the process.s 

Phase 1 

 The first phase of clinical trials tests the new drug’s safety on participants and the correct dosage amounts. Although each clinical trial has its criteria, the standard requirements for a Phase 1 clinical trial are: 

  • A mix between 20-100 volunteers with no known health issues and patients currently diagnosed with the target condition 
  • A clinical trial period of several months 

Phase 2 

If a drug moves to Phase 2, the primary objectives for the clinical trial are efficacy or how well the drug performs to treat the condition and side effects. To conduct a Phase 2 clinical trial, the study must include: 

  • A few hundred participants diagnosed with the condition being treated 
  • A clinical trial period between several months and two years 

Phase 3 

 The last phase before potential FDA approval is Phase 3. In Phase 3, clinical trials test for efficacy again, as well as adverse reactions caused by other known or underlying health conditions. Phase 3 clinical trials need: 

  • Between 300 and 3,000 participants with the targeted condition 
  • A clinical trial period between one and four years 

Phase 4 

 If a new drug reaches FDA approval and is added to the market, clinical researchers may conduct further clinical testing, referred to as Phase 4 clinical trials. A Phase 4 clinical trial aims to test the drug’s safety and efficacy further. 

Phase 4 clinical trials utilize several thousand participants with the condition in the study. 

Only some new drugs that begin Phase 1 will continue throughout the clinical trials process. According to the FDA, about 70% of Phase 1 clinical trial drugs move to Phase 2. From there, about 33% of Phase 2 clinical trial drugs move to Phase 3. Between 25%-30% of Phase 3 clinical trial drugs move on to the FDA approval process. 

The Clinical Trial Data Analysis Process 

Once Phase 3 of a clinical trial is completed, the data will suggest whether the study can proceed to the drug approval process or resume testing in a Phase 1 or 2 clinical trial. 

The sponsor, with the help of the clinical research team, principal investigator (PI), research practitioner (RP), clinical research associate (CRA), and clinical research coordinator (CRC), collects and analyzes the data. 

To continue toward FDA approval, the clinical trial data should answer the questions and objectives the clinical trial set out to answer when the study was built. 

The data should also show that the drug is safe and effaceable, has minimized side effects, and has uncovered adverse risks from other health conditions. 

Find a Clinical Trial for You 

Sponsors and clinical researchers build clinical trials for almost all medical diseases and conditions. There is always a need for more participants and healthy volunteers throughout Phases 1, 2, 3, and 4. 

Wake Research is one such research site and provides clinical trials across the United States. Interested in joining a study or want to learn more? View a list of our currently enrolling studies