What Are Clinical Trials?

 

Clinical trials are research studies to determine the safety and effectiveness of new medical treatments, drugs or medical devices. These trials can help test the efficacy of these interventions and determine their potential side effects on human participants.

Clinical trials involve steps or phases, beginning with small-scale tests of the treatment’s safety and effectiveness and progressing to larger, more rigorous tests. Pharmaceutical companies or research organizations typically conduct clinical trials collaborating with medical professionals and hospitals.

The participants are usually volunteers expected to meet certain eligibility criteria, such as having a specific medical condition or being in a certain age group.

Clinical trials’ main objective involves gathering scientific evidence to support the approval and use of new medical treatments, drugs or devices. Regulatory agencies use this evidence to evaluate these interventions’ safety and effectiveness before making them available to the general public.

Why are clinical trials important?

Clinical trials provide researchers with valuable data about the new treatments’ safety and effectiveness. This allows them to refine their approach and develop better therapies for patients. They also help identify potential side effects and risks associated with these treatments to ensure patients can make informed decisions about their health.

Patients can actively advance medical knowledge and improve healthcare outcomes by participating in clinical trials. Additionally, clinical trials help participants access new treatments that may not be available to the general public and provide them with life-saving therapies.

However, certain criteria determine who will participate in this testing procedure to avoid unnecessary health complications.
 

Who can take part in a clinical trial?

Anyone can potentially participate in a clinical trial, depending on the study’s specific requirements and eligibility criteria. However, each clinical trial has specific inclusion and exclusion criteria that participants must meet to ensure the study’s scientific validity and safety.

Some common inclusion criteria for clinical trials may include age, gender, specific health conditions and previous medical history. For instance, a clinical trial for a new drug designed to treat a particular type of cancer may require participants to be diagnosed with that cancer type.

Exclusion criteria may involve medical conditions, medications or lifestyle factors that could affect the study’s results or pose a risk to the participant’s safety. For instance, a clinical trial for a new drug may exclude pregnant participants or those who have a history of severe allergic reactions.

Participants will be screened to determine whether they meet the study’s eligibility criteria before enrolling in a clinical trial. It’s essential to carefully review the trial’s informed consent documents and discuss any questions or concerns with the study’s research team before participating.

 

The different phases of clinical trials

Clinical trials are usually carried out in four phases, each serving a specific purpose. These are described in detail below:

Phase 0

Phase 0 clinical trials (exploratory or early-stage preclinical trials) involve a small number of participants (typically less than 15) who receive a low dose of the treatment under investigation. The primary objective of this clinical trial phase is to determine whether or not the treatment works in the human body as intended. If it does, gather preliminary data on its safety, dosing and pharmacokinetics.

Phase I

Phase I clinical trials are the first stage of drug development, conducted to evaluate the safety and tolerability of a new drug. These trials involve a few dozen healthy volunteers or patients to determine the drug’s maximum tolerated dose (MTD). These trials also help understand the pharmacokinetics and pharmacodynamics of the drug.

Phase II

Phase II clinical trials evaluate the new drug’s efficacy and safety in a larger group of patients with the disease or condition that the drug is intended to treat. These clinical trial phases usually involve several hundred patients to determine the optimal dosage and assess the drug’s effectiveness in treating the disease.

Phase III

Phase III clinical trials are the largest and most expensive trials and are carried out to confirm the safety and efficacy of a new drug in a large population of patients. These clinical trial phases typically involve thousands of patients and can last several years. The primary goal of Phase III trials is to provide the data necessary for regulatory drug approval.

Phase IV

Phase IV clinical trials, or post-marketing surveillance trials, are carried out after regulatory agencies have approved a drug. These clinical trial phases are designed to monitor the long-term safety and efficacy of the drug in a larger and more diverse population. Phase IV trials can also help investigate new indications or dosages for the drug.

Participating in a clinical trial has many benefits. These can help patients and researchers determine the treatment required for the target disease or condition.

Advantages of taking part in a clinical trial

Participating in a clinical trial has risks and advantages that potential participants should consider before enrolling. There are several benefits of participating in a clinical trial:

• Access to Cutting-Edge Treatments: Clinical trials often test new treatments or therapies unavailable to the general public. By participating in a trial, you may have access to these treatments before they become widely available.

• Expert Medical Care: Clinical trials are conducted by medical professionals who are experts in their fields. You will receive close medical attention and monitoring by participating in a clinical trial.

• Helping Others: Clinical trials are an important aspect of medical research. You may contribute to developing new treatments by participating in a trial to help others in the future.

Risks of taking part in a clinical trial

While there are potential benefits to participating in a clinical trial, there are certain risks that participants must know and realize. These risks include:

• Side Effects: The treatment being tested may cause side effects that are not yet known or fully understood. These can range from mild to severe and harm the patients’ quality of life.

• Uncertainty: As clinical trials involve testing new treatments, there may be uncertainty around their effectiveness. You may not receive the same benefits from the treatment as you would from standard care.

• Time Commitment: Clinical trials can be time-consuming and require frequent visits to the study site and adherence to a strict schedule. However, the adoption of DCTs and their methodologies is significantly reducing the commitment to participation. This simplifies the process to enter into a clinical trial.

• Ethics: There may be ethical concerns related to clinical trials, such as whether participants are fully informed about the potential risks and benefits.

• No Guarantee of Benefit: Participating in a clinical trial does not guarantee that you will receive the treatment being tested or that it will be effective.

It’s important to consider the risks and benefits of participating in a clinical trial before deciding. Additionally, it’s recommended to thoroughly understand the trial protocol and ask any questions before participating.

How to find a clinical trial

There are several ways to help you find a clinical trial that suits your needs. Below are some ways to find a clinical trial:

• ClinicalTrials.gov: This is a searchable database of clinical trials conducted worldwide. You can search for trials by condition, location or other criteria from this database.

• National Cancer Institute: The institute maintains a database of searchable cancer clinical trials by location, type of cancer and other factors.

• Patient Advocacy Groups: Many patient advocacy organizations maintain databases of clinical trials related to specific conditions. You can contact these organizations to find out about ongoing studies.

• Your Healthcare Provider: Your doctor or healthcare provider may refer you to appropriate clinical trials for your condition.

• Social Media: Some researchers use social media to recruit participants for clinical trials. You can follow relevant organizations and researchers on social media to stay up to date on opportunities to participate in trials.

Note: Although anyone can become a participant, not all clinical trials are appropriate for everyone. Before joining a trial, it is recommended to carefully review the informed consent documents, discuss any concerns with the study’s research team and consult your healthcare provider.

Where Are Clinical Trials Conducted?

Clinical trials are usually conducted in various settings, including hospitals, clinics, research centers and universities. The trial’s location will depend on the study’s nature and the appropriate resources.

For instance, many clinical trials occur in academic medical centers with the expertise and infrastructure to conduct complex studies. However, clinical trials are often conducted in community-based settings, including primary care clinics or community hospitals.

Clinical trials may also be conducted in other countries, particularly if the study focuses on a prevalent health condition in that region. It’s important to carefully review the informed consent documents and understand any potential risks associated with the study before participating in a clinical trial.

Clinical trials are conducted for a specific period depending on the purpose, location and condition to be cured. As a result, the duration of clinical trials may vary with different types of procedures.

How Long Are Clinical Trials?

The clinical trials’ length can vary widely depending on the study’s design and objectives. While some trials may last only a few months, others can continue for several years.

The length of a clinical trial is often determined by the outcomes being studied. For instance, a new cancer drug trial may require monitoring participants for several years to determine whether the drug effectively prevents cancer recurrence.

Before enrolling in a clinical trial, understand the expected duration of the study and any requirements for follow-up visits or procedures. This information should be included in the informed consent documents provided by the study’s research team.

What to consider before taking part in a clinical trial

Before participating in a clinical trial, it is important to consider several factors to ensure it is a suitable and safe option. Additionally, participants must find out as much information as possible about the study before joining. Here are some questions to consider before becoming a participant:

• What is the trial’s purpose, and how will it benefit me or others in the future?
• What are the risks and side effects of the treatment?
• What is the duration of the trial, and what is expected of me as a participant?
• Who is conducting the trial, and what is their reputation and experience?
• Will I have access to other treatments if needed during the trial?
• What are the financial costs and potential compensation for participating?
• Can I withdraw from the trial anytime, and what are the consequences?

It is also essential to gather as much information as possible about the trial, the treatment and the research team before joining. This includes carefully reading the informed consent document and discussing any questions or concerns with the study team or your healthcare provider.

Avantor’s clinical trial services

Avantor provides various scientific products, services and solutions to support research and development in various industries, including clinical trials. Avantor’s clinical trial services include equipment sourcing, equipment rental and asset management. Avantor’s clinical trial services help ensure that clinical trials are conducted efficiently, safely and in compliance with regulatory requirements.