Understanding Clinical Research and the Clinical Trials Process

August 7, 2024

Clinical research is a crucial aspect of advancing medical knowledge and improving patient care. It involves conducting studies to evaluate the safety, efficacy, and potential side effects of new treatments, drugs, medical devices, or diagnostic tools. One of the primary methods used in clinical research is through clinical trials.

This article will focus on breaking down the Clinical Trials Process for healthcare professionals and medical personnel. This may be particularly helpful for those who are considering a career transition into the life science industry (e.g. biotechnology, pharmaceuticals, clinical research). As you begin learning more about specific job functions and titles, you will notice that many job descriptions will require or strongly encourage candidates to have a basic understanding of clinical research.

Don’t worry, if you still don’t quite understand the difference between biotech and pharma, check out this article first to learn more.

Now, let's dive into what clinical research entails and walk through the clinical trials process, breaking it down into simple terms for anyone new to the field.

What is Clinical Research?

Clinical research refers to studies involving human participants that aim to answer specific health-related questions. These studies can range from investigating the effects of a new drug to understanding the impact of lifestyle changes on health outcomes. The goal is to gather data that can lead to new medical treatments, better patient care, or improved health policies.

The Clinical Trials Process

Clinical trials are a key component of clinical research. They follow a structured process to ensure that the findings are reliable and can be used to inform medical practice. Here's a step-by-step breakdown of the clinical trials process, including key job titles and their roles:

• Preclinical Research

Example Scenario: Before testing a new cancer drug in humans, researchers conduct laboratory tests and animal studies to evaluate its safety and potential effectiveness. This stage helps determine whether the treatment should be tested in humans.

Key Job Title: Research Scientist

Research scientists design and conduct preclinical studies, analyzing data and preparing the results for regulatory approval.

• Phase 1: Safety Trials

Example Scenario: The new cancer drug is now ready for its first human trials. In Phase 1, a small group of healthy volunteers (or sometimes patients) receives the drug to assess its safety, determine a safe dosage range, and identify any side effects.

Key Job Title(s): Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), Principal Investigator (PI)

CRCs manage the day-to-day operations of the trial, including participant recruitment, data collection, and ensuring compliance with protocols.

CRAs monitor the trial's progress, ensure compliance with regulatory requirements, and manage site activities. They also visit trial sites to review data and support site staff.

PI's oversee the clinical trial, ensuring it adheres to the protocol and applicable regulatory guidelines.

• Phase 2: Efficacy Trials

Example Scenario: If the drug is deemed safe in Phase 1, it moves to Phase 2. Here, a larger group of patients with the specific condition the drug aims to treat is recruited. The focus is on assessing the drug's efficacy (how well it works) and further evaluating its safety.

Key Job Title(s): Biostatistician

• Phase 3: Confirmatory Trials

Example Scenario: The cancer drug has shown promise in Phase 2, and now Phase 3 involves a larger and more diverse patient population. This phase aims to confirm the drug's effectiveness, monitor side effects, and compare it to standard treatments.

Key Job Title: Principal Investigator (PI)

The PI is usually a medical doctor who oversees the clinical trial at a specific site, ensuring that it adheres to the study protocol and protecting the safety of participants.

• Phase 4: Post-Marketing Surveillance

Example Scenario: After the drug receives regulatory approval, Phase 4 studies continue to monitor its long-term effects and gather additional information on its risks, benefits, and optimal use.

Key Job Title(s): Regulatory Affairs Associate

Regulatory Affairs professionals ensure that all aspects of the clinical trial and marketing meet government regulations. They prepare and submit documentation to regulatory bodies.

Real-Life Example: A New Vaccine Trial

Imagine a scenario where a pharmaceutical company develops a new vaccine for a respiratory illness. The clinical trials process might involve the following steps:

• Preclinical: Lab tests show the vaccine triggers a strong immune response in animals.
• Phase 1: A small group of healthy volunteers is given the vaccine to check for adverse reactions.
• Phase 2: Hundreds of people from different age groups and health conditions receive the vaccine to evaluate its effectiveness in preventing the illness.
• Phase 3: Thousands of participants are recruited to confirm the vaccine's efficacy and safety, comparing it to a placebo or existing vaccine.
• Phase 4: After approval, the vaccine is distributed to the public, and researchers continue to collect data on its long-term effects.

Throughout the process, various professionals, from CRAs to PIs and regulatory professionals, play critical roles in ensuring the study's success and the safety of participants. Each phase of clinical research requires a team of professionals working together to ensure that the study progresses smoothly and meets all regulatory and scientific standards.

The above examples provide a small glimpse into the complex landscape of clinical research and the job functions that exist to move drugs from concept to clinic. Here are a few additional titles to explore and understand as you develop a deeper understanding of how your role in the life science industry contributes to the development of medical products and the healthcare ecosystem.

1. Preclinical Phase

• Principal Investigator (PI): Oversees the entire study and ensures compliance with protocols and regulations.
• Research Scientist: Conducts laboratory experiments and preclinical studies to establish the basis for human trials.
• Regulatory Affairs Specialist: Ensures that all preclinical studies meet regulatory requirements and prepares necessary documentation for regulatory bodies.

2. Phase I: Safety and Dosage

• Clinical Research Coordinator (CRC): Manages the day-to-day operations of the clinical trial, including participant recruitment and data collection.
• Clinical Research Associate (CRA): Monitors the trial’s progress, ensures compliance with protocols, and verifies data accuracy.
• Clinical Trial Manager: Oversees the planning, implementation, and administration of the clinical trial.
• Pharmacokineticist: Studies how the drug is absorbed, distributed, metabolized, and excreted in the body.
• Safety Officer, Drug Safety Officer: Monitors adverse effects and ensures participant safety.

3. Phase II: Efficacy and Side Effects

• Principal Investigator (PI): Continues to oversee the study, focusing on efficacy and monitoring for side effects.
• Clinical Research Coordinator (CRC): Manages participant recruitment, data collection, and adherence to protocols.
• Clinical Research Associate (CRA): Ensures compliance with trial protocols and monitors site activities.
• Biostatistician: Analyzes data to determine the drug's efficacy and safety.
• Regulatory Affairs Specialist: Manages regulatory submissions and ensures ongoing compliance.

4. Phase III: Efficacy and Monitoring

• Principal Investigator (PI): Leads the study and ensures proper conduct and adherence to protocol.
• Clinical Research Coordinator (CRC): Coordinates site activities, manages participant interactions, and collects data.
• Clinical Research Associate (CRA): Conducts site visits to ensure protocol compliance and data integrity.
• Data Manager: Oversees data collection, management, and integrity.
• Medical Monitor: Provides medical oversight and ensures participant safety throughout the trial.

5. Phase IV: Post-Market Surveillance

• Pharmacovigilance Specialist: Monitors and evaluates the drug’s safety profile in the general population.
• Regulatory Affairs Specialist: Manages post-marketing regulatory requirements and submissions.
• Market Access Specialist: Works on strategies to facilitate the drug’s entry into the market.
• Medical Science Liaison (MSL): Communicates clinical and scientific information to healthcare professionals and stakeholders.

Conclusion

Clinical research and clinical trials are essential for advancing medical science and bringing new treatments to patients. Understanding the clinical trials process helps us appreciate the rigorous steps taken to ensure that new drugs and therapies are safe and effective. Whether you're considering a career in clinical research or simply curious about how new treatments come to market, this overview provides a glimpse into the world of clinical research and the critical roles involved.