Clinical trials have been mentioned frequently in the media during the COVID-19 pandemic, as doctors and scientists seek treatments and vaccines to slow the spread and impact of the virus. So what are clinical trials, exactly? 

Clinical trials are structured experiments that study the safety and efficacy of new medical and surgical treatments and devices in humans. It’s common to talk about clinical trials in terms of new drugs and new devices, as these make up the majority of interventions studied in clinical trials. They are carried out in three to four phases so that the most critical safety information is collected first, and risk to participants is minimized. More specific aspects of the phases of clinical trials are discussed here.

How does a clinical trial get started?
The whole process of bringing a new treatment or device to the patients who need them is called “research and development” or “bench to bedside” and can take upwards of ten years. Experts, including pharmaceutical scientists and other medical researchers, are involved in the first stage, called discovery, where a drug or device is engineered and studied in a laboratory before being selected to be studied further in a specific disease or indication.  

At this stage, the drug or device is not yet ready for clinical trials. The next stage, called the preclinical stage, is where the device or drug is studied in a number of different species of animals to get preliminary information about its effects before it can be tested in humans. 

Finally, a new drug or device is ready for clinical trials. At this time, a protocol is written which outlines exactly how the clinical trial is to be conducted.

Who is involved?
Usually, a clinical trial has a sponsor who funds the costs of the trial, and will file applications for approval of the drug or device. Sponsors can be pharmaceutical companies, government agencies, research institutes, or healthcare organizations. Every clinical trial also has a principal investigator, often a physician, who is responsible for conducting the trial and ensuring the safety of the participants. Sometimes, a trial will also involve a company that facilitates data collection and various other aspects of the trial for the sponsor; these companies are called contract research organizations, or site management organizations.

Clinical trials are overseen by Institutional Review Boards, who ensure the trial is designed and conducted in a way that is ethical and protects the rights and safety of the participants. Sponsors will often also monitor the conduct of the trial through periodic audits that look to see that investigators have been following the protocol and collecting the required information consistently and accurately. 

The US Food and Drug Administration (FDA), who also provides oversight of all clinical trials in the US, can perform inspections of the sites where the trial is being conducted; typically sites are hospitals or healthcare centers. They will inspect the sites to make sure equipment and facilities, processes, policies and proper documentation are in place in accordance with federal regulations. The FDA also ultimately approves or rejects the new drug or device for a particular use after reviewing all the data collected in the clinical trials.

Last, but certainly not least, participants, or patients who enroll in the trial, are the most crucial and indispensable stakeholders in clinical trials. They provide all of the data, without which advances in medicine would not be possible. In the last several years, efforts have been made to make clinical trials more patient-centric — meaning that sponsors and investigators are trying to focus on what is important to the participants and align the requirements of the trial with those specified patient values.

This blog is intended to be informational in nature. The information and other content provided in this blog, or in any linked materials, are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment.

If you have any questions or concerns, please talk to your doctor. Never disregard professional medical advice or delay in seeking it because of something you have read on this blog or in any linked materials. If you think you may have a medical emergency, call your doctor or emergency services immediately.

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