Clinical Research is an exciting field that assesses the safety and effectiveness of new treatments, interventions, and technologies in humans. Across the United States and across the globe we are driving medical knowledge forward by bringing new therapies to market in the clinical research industry. The development of innovative and improved treatments depends on this type of research to advance medical science. This branch of healthcare is integral to discovering novel ways to prevent, diagnose and treat diseases, and improve the quality of life for us all.
Phases of Clinical Research Trials
There are four main phases in Clinical Research: phase 1, phase 2, phase 3, and phase 4. New medications, devices, and therapies are tested in human participants in each of these phases.
Before these new interventions are tested in humans, preclinical , new drugs or devices are tested on laboratory animals. This is called preclinical research. This preclinical activity helps us determine the safety and efficacy of newly developed treatments in animals and decide if we are ready to move forward with human testing. In addition, it can be used to identify potential side effects.
In phase 1 clinical trials, treatments are tested in humans for the first time. Tests are typically conducted first on a small group of healthy volunteers to determine whether the new treatment is safe and tolerable. In this phase we are looking at dosage, toxicity and safety.
If an intervention is found to be safe enough based on the data collected in phase 1, the intervention will enter Phase 2, the next stage of testing. This phase is conducted on a larger group of people (100 or 200 for example) and aims to determine the efficacy and safety of the new treatment in patients with a specific condition.
Let’s pause and think about this information for a moment! In phase 1, we cannot typically assess for efficacy, meaning we cannot measure if the intervention is working, because it is tested in healthy subjects! There are some exemptions here like in the case of medications that are too cytotoxic to test in a healthy person, such as chemotherapy. Once the intervention moves on to phase 2, we can assess efficacy because we are enrolling participants with the disease we are trying to treat.
Testing reaches its final stage when phase 3 begins. This phase involves a larger number of patients (sometimes thousands) and is used to confirm the efficacy and safety of the treatment. In addition to comparing it to existing treatments, this phase is also used to measure effectiveness. The data from phase 3 is analyzed and brought before the FDA (or other regulatory body in other countries) for final approval to market to consumers.
Types of Clinical Research
Several types of Clinical Research exist, each with a different goal and objective. Among them are:
- Observational Research: This type of research involves observing patients in their natural environment without intervention from the researcher. Studying medical records or spending time with patients is an example of observational research.
- Interventional Research: This type of research involves the researcher intervening and using new treatments or technologies. The use of drugs, devices, or other medical interventions can be part of interventional research.
- Randomized controlled trials (RCTs): This is the most rigorous type of Clinical Research and involves randomly assigning patients to different treatment groups. Comparing the effectiveness of various treatments and determining cause-and-effect relationships can be achieved through RCTs. Many trials are “blinded” or “double blinded” to the participant and the researcher to remove bias.
The Importance of Clinical Research
The Clinical Research industry is imperative for the advancement of medical science, and trials are conducted to develop improved medical treatments. A controlled and systematic study enables new treatments, interventions, and technologies to be tested and provides valuable information about their safety and effectiveness. Using evidence based scientific methodologies, researchers can decide how to use these treatments in clinical settings and develop new treatments to improve quality of life.
Clinical Research is a complex and time-consuming process, and it can take many years in each phase of clinical trials before a new treatment is finally approved for use on patients. Additionally, Clinical Research often involves significant uncertainty and risk because the safety of treatments cannot be guaranteed.
The Challenges of Clinical Research
There are many obstacles to overcome when conducting clinical research trials. And these challenges create wonderful employment opportunities for passionate individuals. Among these obstacles are difficulties with patient recruitment, and regulatory complexity. The technical considerations, such as the protection of patient rights and the potential risks and benefits of the study are given the utmost scrutiny before entering into a trial and while conducting the study.
The field of Clinical Research plays a crucial role in the development of new and improved medical treatments. The success of Clinical Research depends on the participation of volunteer patients (or participants), who ultimately reap the benefits of this research. Those interested in participating in Clinical Research trials either volunteer or be recruited by their healthcare provider.
Despite its challenges, it cannot be overstated how significant Clinical Research is. This field will continue to be an integral part of discovering new ways to prevent, diagnose and treat diseases, and improve the quality of life for patients. Clinical research is saving lives and improving our lives.
Who We Are at Clinical Research Fastrack?
The Clinical Research industry is an area of healthcare with a wide variety of different roles and the opportunity to advance your career quickly. Aspiring professionals from diverse professional, educational, and cultural backgrounds are breaking into the industry at a rapid rate with Clinical Research Fastrack’s training.
This course empowers research professionals empowered with the training (research skills), support and connections they need to not only break into the industry, but to advance into exciting leadership roles. Unlike traditional university programs, our training can be completed quickly and offers practical, hands-on experience and knowledge to every student. Our unique program trains motivated and passionate individuals to land their dream job and succeed in the field.