Phases in Clinical Trials
Clinical trials are necessary when developing new medicines, treatments, and medical devices e.g. These trials ensure that new therapies are safe, effective, and ready to help people who need them. But before any treatment is approved, it must go through several stages of testing called phases. Each phase has a specific purpose and helps researchers answer important questions.
Preclinical Trials
Before a clinical trial starts, researchers spend years studying a new treatment in the lab. This is called preclinical research, where they test the treatment on cells and animals to evaluate its safety and how it works. Only when these studies show promise can the treatment move into clinical trials with human volunteers.
Phases of a Trial
Clinical trials are divided into four phases. Each phase has its unique purpose to help researchers answer various questions and make the procedure as safe as possible for the participant. Find out more about the phases here.
Phase I
The primary goal of phase 1 trials is to assess a drug's safety in humans. The study drug is tested for the first time in small groups with only healthy participants (20-100 participants) to evaluate safety, determine a safe dose of therapy and identify possible side effects.
Phase II
The study drug is given to a larger group of participants with a specific disease (100-300 participants) to see if the study drug has an effect and to evaluate the investigational medication’s safety. Phase 2 studies often use randomized controlled trial (RCT) designs, where participants are assigned to receive either the experimental drug, a placebo, or a standard treatment for comparison.
Phase III
The study drug is given to a large group of people (1000-3000) to confirm the investigational medication’s effect, to monitor side effects, to compare the study drug with older, existing medications, and to collect information so the study drug is used safely. One of the main objectives of Phase 3 trials is to compare the study drug with existing treatments to determine if it offers advantages in terms of effectiveness, safety, or other factors. Researchers collect detailed data on how the drug interacts with different groups of people, including various age groups, ethnicities, and individuals with comorbid conditions. This helps to ensure that the drug is safe and effective for the population that will ultimately use it.
Phase IV
This stage is also called post-marketing studies that examined how safe medications are after the products have entered the market. These examinations will take place after the study drug has been approved. Phase 4 studies aim to monitor the drug’s real-world performance. This includes evaluating rare side effects, long-term effects, and any other unexpected issues that might not have been apparent during earlier phases.
In Phase 4, researchers gather additional data on the drug’s benefits and risks, often through observational studies or continued clinical trials. This stage is crucial for detecting any rare adverse reactions that could emerge once the drug is used by a large and diverse population. It also helps to refine dosing guidelines, expand indications, and assess the drug's overall impact on public health.
Why are Clinical Trials Important?
Clinical trials are important because they serve as the foundation for evidence-based medicine, helping researchers, doctors, and policymakers make informed decisions about treatment options. Without clinical trials, it would be impossible to determine whether new treatments are safe or effective for the general population. These trials test new interventions in controlled environments to understand how they perform in different groups of patients, including various age groups, genders, and those with underlying health conditions.
One of the primary reasons clinical trials are vital is their role in ensuring patient safety. Before a new treatment is approved for widespread use, it must undergo rigorous testing to detect potential risks or adverse side effects. This process helps identify any harmful effects that could arise during treatment, which could be missed in non-clinical research or preliminary tests. By discovering and addressing safety concerns early, clinical trials help protect patients from unnecessary harm.
Clinical trials are also key to improving the effectiveness of medical treatments. By comparing new interventions with existing therapies, researchers can determine which options provide the best outcomes for patients. This comparison not only supports the development of more effective treatments but also ensures that patients are given the most appropriate care based on scientific evidence. Furthermore, clinical trials contribute to the advancement of medical knowledge by generating data that can inform future research, leading to the development of new drugs, vaccines, and treatment strategies
Patiro’s Role in Clinical Trials
Patiro works with a wide range of clinical trials by assisting in patient recruitment across global studies. Focusing on enhancing the efficiency and effectiveness of recruitment using digital tools and leveraging with local medical teams all around the world. Patiro has collaborated with several major pharmaceutical companies, such as AstraZeneca, FGK Clinical Research GmbH e.g.
Patiro plays an important role in clinical trial phases, particularly focusing on patient recruitment and retention, while operating across more than 40 countries and partnering with over 2,000 clinical sites worldwide to ensure a diverse, inclusive recruitment process. This extensive reach enables Patiro to effectively support global and hyper-local trials. Moreover, Patiro have been involved with various clients in the pharmaceutical and clinical research sectors, making significant contributions to reducing patient dropout rates and improving trial completion using innovate digital strategies.
Patiro has a unique pay-per-enrolled-patient model minimizes financial risks for trial sponsors, and they are recognized for accelerating recruitment timelines by up to 40% while significantly reducing dropout rates. Patiro’s adherence to strict ethical and regulatory standards (including ISO 27001, HIPAA, and GDPR compliance) underscores their commitment to quality and transparency throughout the clinical trial process.
How Can You Get Involved?
If you're interested in participating in a clinical trial, there are various opportunities to contribute to medical advancements and help improve future treatments. Clinical trials play a crucial role in the development of new therapies, and your involvement can make a meaningful difference in healthcare progress. To find clinical trials that are suitable for you, it's essential to consult with your healthcare provider, who can guide you based on your health condition and ensure your safety. Additionally, you can explore clinical trial registries and trusted resources, such as ClinicalTrials.gov, to discover relevant trials in your area.
