EXPLAINED: What is a Phase 1 clinical trial and why are clinical trials important
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 phase 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 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.
What are early phase clinical trials?
Clinical Trials are divided into 4 phases. Phase 1 and 2 trials constitute early phase trials, Phase 3 and 4 research studies are late-phase trials.
The primary objective of Phase 1 studies is to determine the correct drug dosage by evaluating drug safety and determining if there are any side effects. Phase 1 trials are conducted in healthy volunteers.
Phase 2 studies also study the safety of a drug but focus on evaluating its effectiveness. These studies can be conducted in healthy volunteers or in individuals who have a certain disease or condition.
What is a clinical trial?
A Clinical trial is a process which is performed to determine whether an investigational drug, device or therapy is safe and effective. In early phase research (i.e. Phases 1 and 2), the safety and effectiveness of the drug will be evaluated in healthy volunteers.
What is an investigational drug?
An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:
- If the drug is safe and effective.
- How the drug might be used in that disease.
- How much of the drug is needed.
- Information about the potential benefits and risks of taking the drug.
Why do you need to take blood draws and how many blood draws will be required?
In order to evaluate the drug profile, we need to understand its pharmacokinetics. This is essentially how the body reacts to a drug after its administration through the mechanisms of absorption, distribution, as well as the metabolic changes. Therefore, blood draws are collected at various time points to better understand this mechanism. Each study requires a specific number of blood draws and total blood volume. These values will be provided to you and clearly stipulated in the informed consent form (ICF). The amount of blood that will be taken is outlined in the ICF.
Should I expect to experience any side-effects while doing studies?
As every study is testing an investigational product, there may be side effects. You will be provided with a list of side effects that have been reported in previous trials (if any), so you can make an informed decision whether or not to participate in the trial. During the trial you will be required to immediately inform clinic study staff of any adverse effects that you are experiencing. These side effects usually resolve upon discontinuation of the study drug.
Will I be compensated for doing a clinical study?
Volunteers are compensated and the amount varies depending on the length of the clinical trial, length of stay and number of follow-up visits. The compensation is not specifically related to the risks or type of drug involved in the trials or studies. Every study is different and therefore, the compensation will vary. Study volunteers may receive between $1000 to $4000 for a trial (based on the factors listed above).
Are food and accommodation provided over the course of the trial?
Food – Clinical trials are conducted in a controlled setting which means that all food is provided and trial volunteers receive standardised meals. Individual meal plans or meal preferences cannot be provided. If you have any food allergies or hypersensitivity to food product(s) that are clinically significant or life-threatening you may not be able to participate in a trial. Please contact us to discuss any food issues.
Accommodation – During your in-clinic stay you will share sleeping areas with other volunteers who are of the same gender. Similar to a hospital setting, supervision will be provided to ensure that your health and safety are being monitored.
What is the length of a study and do I have to complete all the visits?
What is informed consent and how is it carried out?
Before you decide whether or not to take part in a clinical research study, you will be required to read and understand the information provided in an Informed Consent Form (ICF). The ICF describes the clinical research study and the nature of the investigational product to be used, including:
- Your rights and responsibilities as a study participant.
- What you will be asked to do during study participation.
- The potential risks that you should be aware of.
During this process, you will have the opportunity to discuss and ask questions related to the conduct of the clinical research study with the study doctor/ study staff. You are under no obligation to participate and your decision to take part in a clinical trial is voluntary.
Can I bring my own device?
Yes, we encourage you to bring items that will help to pass the time while you are in the clinic. You can use the time to study or work or catch up on the movies you’ve been meaning to watch.
What do I need to pack?
When do I receive compensation for taking part in a study?
You will receive compensation as outlined during the Informed Consent process. Typically, you will receive compensation once all study visits have been completed. If, for any reason, you do not complete all study visits, your compensation will be on a pro-rated basis (i.e. for the time that you have participated in the trial)
Where will I sleep during the clinical study?
What COVID-19 precautions are you taking?
Can I bring my own food?
All aspects of clinical trials are closely monitored including the food and drink consumed by participants. While you are in the clinic, you will be provided with all meals as per the study guidelines. You will need to eat all the food provided to ensure the guidelines are met. Watch video