Clinical research encompasses every research that can carry out on healthy or ill people. The main focus of clinical research is on getting better disease knowledge, developing diagnostic procedures and new treatments or devices to ensure improved patient care.
Clinical research is conducted through different phases of clinical trials. These trials are an essential part of every drug development process. Researchers work closely with participants involved in the trials to understand the effects produced by newly developed medications.
As the documented data is collected, these researchers assess the overall effectiveness of the new treatment or medication. Finally, the data produced in the successful clinical studies yield new medications approved to market and saved for public use. These clinical trials are considered the testing grounds for new treatments.
Phases Of Clinical Trials
There are four phases of clinical trials to test any treatment, determine the right dosage, and assess the side effects. When a drug successfully passes the first three phases of a clinical trial, researchers declare the drug to be safe and effective.
The FDA then approves the drug for clinical use and keeps monitoring its effects. The processes involved in clinical research require proper management of time and budget. Therefore, it’s the duty of a clinical project manager to handle crucial clinical trials, selecting vendors, managing budgets, and reporting outcomes. The FDA approval to clinically use a drug is based on the success of the following phases involved in clinical trials.
Phase I trial: A phase one trial involves a small group of healthy individuals (20 to 80). In this phase of clinical trial testing, an experimental treatment is conducted on these healthy individuals to determine its safety and side effects. Moreover, this phase also helps in identifying the correct dosage form of the drug.
Phase II trial: A Phase II trial uses more participants (100 to 300) than a phase one trial. While phase one works on drug safety, the focus of the phase II trial is, particularly on effectiveness. This phase intends to obtain primary data on whether the experimental drug works in participants with a certain health condition or disease. Further, these trials also keep follow-ups to study the safety and short-term side effects of the drug.
Phase III trial: In this phase of the clinical trial, more information is gathered about safety and effectiveness, drug use in conjunction with other drugs, and analyzing various populations and dosage forms. The number of subjects involved in the phase III trial usually ranges from hundreds to around 3,000 participants. If the trial outcomes are positive, the FDA will approve the drug or medical device in question to be used by the public.
Phase IV trial: Phase IV trial comes into play after the FDA approved the experimental drug or device to be used by the general public. The drug’s effectiveness and safety are observed in diverse populations. The side effects can sometimes become clear after more people use it over an extended period.
Five Ways Clinical Research Help Develop New Treatments
Clinical research contributes to developing new treatments and medical devices to bring innovations in providing better patient care. In the following four ways, clinical research can support the development of new treatments!
1. Clinical Trials Discovering New Treatments
In discovering new drug treatments for various diseases and finding new methods to detect, diagnose, and decrease the likelihood of developing a disease, clinical research trials are required. These trials enable researchers to identify what is and isn’t useful in humans that cannot be experimented with in the laboratory or animals. Medical professionals decide whether the potential benefits of a drug outweigh its side effects. The outcomes of clinical trials should be positive to get FDA approval to market the new treatment for public use. While conducting the trials on a group of healthy or sick people, researchers remain uncertain about the results. However, people who participate in clinical trials are fully informed about the risks, potential benefits, and time required to complete the trials. Clinical trials bring innovations in developing new, more effective drug treatments for diseases.
2. Clinical Trials Improve Knowledge on Disease Progression
Clinical research needs inclusive and sophisticated testing in association with community members who are affected by a disease. With this information, researchers are better positioned to cure or treat certain illnesses.
According to NIH, clinical research is the only way to gain complete insights and understand the safety and effectiveness of treatments and therapies. Groundbreaking advances in the past scientific research were possible only due to the participation of healthy individuals and those with certain health conditions. The present and future of new drug development for diseases require this same approach. Otherwise, without clinical research, innovations in treatments for certain illnesses and diseases are not possible.
3. Clinical Researchers Exploring Ways to Improve Quality of Health
Clinical researchers are focused on improving patients’ disease management and overall quality of life. They provide increased knowledge on the effectiveness and safety of the medications to use by the general population. Outcomes obtained from clinical trials are a significant source of getting new information on experimental drugs or devices. These trials educate researchers and doctors on whether different types of treatments are effective when people use them. In addition, clinical research provides various medical options for treating patients with certain conditions.
4. Enrolling in a Clinical Trial
Clinical trials can be a long process as new drug development is a necessary process that requires accurate information from individuals participating in the trials. The phases of clinical trials can range from days to months and sometimes years. The safety of research participants is of utmost importance, and researchers must provide them with the necessary medical care associated with each trial. Additionally, every participant should be compensated for their time and travel. Most People voluntarily participate in a clinical trial to help improve treatments for future generations.
Clinical research is the foundation of bringing new scientific innovations into the healthcare industry. The effectiveness of a new drug can only be estimated through clinical trials that require proper time and budget. Therefore, it’s essential to conduct these trials under the strict supervision of clinical researchers and, more specifically, clinical project managers. Clinical research generates medical alternatives to treat individuals with certain diseases that existing treatments cannot cure. It is a great way to help improve healthcare for coming generations.