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EXPLAINED: What is a Phase 1 clinical trial and why are clinical trials important

Clinical Trials BioPharma Services

The term ‘Clinical Trial’ has become synonymous with medication and drugs, especially during the COVID-19 or coronavirus pandemic that has taken millions of lives around the world. It took nearly a year for vaccines to be considered for approval for use among the general public. A lot of us must be wondering what phase 1 clinical trials are and why it takes so long to develop and test how effective a drug or vaccine is.

What are Clinical Trials?

The World Health Organization (WHO) defines clinical trials as “a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.” Simply put, clinical trials are used to test the safety and effectiveness of drugs and medical devices. The process typically spans across several months and years, depending on the stage and nature of the research study.

The various stages of clinical trials are as follows:

Phase 1 Clinical Trial

Phase I: Also known as Phase 1 clinical trial and the first phase of early stage clinical trials. In this phase, researchers aim to find the safe dosage range of a new drug with the fewest side effects. A panel of 20-100 healthy volunteers or people with the disease/condition participate in this phase of the study. Phase 1 clinical trials may continue for several months.

Phase 2 Clinical Trial

Phase II: The next stage of human clinical trials, known as Phase II trials, are carried out to test drug efficacy and monitor any side effects. Panels at this stage comprise several hundreds of people with the disease or condition the drug has been developed for. These trials continue for several months or even years.

Phase 3 Clinical Trial

Phase III: The primary purpose of phase III trials is to confirm the findings of the previous trials and drug efficacy, while closely monitoring adverse reactions, if any. These studies are conducted on hundreds and thousands of volunteers over a span of 1-4 years. Phase III clinical trials are often required before the FDA approves the new drug for general public.

Phase 4 Clinical Trial

Phase IV: Phase IV trials test the drugs approved by FDA and Health Canada. These trials assess the best way to use a drug and the long-term benefits and risks.

Although these steps seem pretty straight-forward, once we do the math, its clear that the different phases involved in the process take years for any drug or vaccine to be made available for the general public.

But there could be outliers. For instance, the COVID-19 vaccines were approved for emergency use in less than a year. Both the Pfizer-BioNTech and Moderna Covid-19 vaccines, unlike the vaccines we already use for other diseases, have been developed using ribonucleic acid (RNA) technology. RNA vaccines hold the promise of being faster, cheaper, more adaptable and easier to mass-produce than other vaccines, you can read more about this interesting topic here.

Participant Rights – Informed Consent

Before conducting a human clinical trial, every volunteer is explained the purpose and objective of the study alongside the process, timelines, and the safety measures the facility will be utilizing for protecting volunteers. The process essentially educates volunteers on what their role would be in the study and how the trial will work. Participation in first in human clinical trials is always voluntary.

Before enrolling in a clinical trial, the FDA mandates that the following information must be given to each potential volunteer:

  • An explanation of the purposes of the research.
  • The expected length of time for participation.
  • Description of all procedures that will be completed during enrollment.
  • Information about all experimental procedures that will be completed during the trial.
  • A description of any predictable risks.
  • Where more information may be found.
  • Questions about the research.
  • Research subjects’ rights.

Clinical Trial Safety During COVID-19

Organizations conducting clinical trials have faced several broad-ranging challenges through the COVID-19 pandemic and many have adapted to the new normal swiftly. The FDA has asked for new processes to be put in place or to modify existing processes to ensure the safety of trial participants. COVID-19 screening procedures have been mandated for all clinical trial research sites.

At BioPharma Services, we continue to implement stringent policies and procedures to guarantee a safe environment to all our volunteers. Our safety measures often go above and beyond government guidelines. BioPharma relocated its USA operations to a larger and technologically advanced facility in St. Louis, Missouri. Our Canadian facility continues to operate under strict safety measures with medical staff closely monitoring all visitors including volunteers for social distancing and for any symptoms during the entire time in the clinic.

Should you have any concerns regarding COVID-19 and clinical trial participation, please contact our Canadian Recruitment Team on (416) 747-5246 and USA Recruitment Team on (314) 528-2220.

About BioPharma Services Inc.

BioPharma Services Inc. is a Contract Research Organization and phase 1 clinical trial services that conducts early phase clinical research studies across all medical disciplines. Our offices and study sites are located in Toronto, Ontario and St. Louis, Missouri. For our current research studies, visit our Volunteer Hub today.

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    Details of the duration of a study can be found on the Volunteer Hub.

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    Wondering what to pack before your site visit? Visit our Packing List page to learn more.

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