The key to the introduction of life-enhancing products for every medical condition that currently exists are clinical trials such as those that BloomTrials conducts for its pharmaceutical company sponsors.
But the key to the successful implementation and completion of these studies begins and ends with one thing. The volunteers who generously offer their time to participate in them. At BloomTrials, the traditional values of patient care remain the cornerstone of everything we do. We are committed to treating our patients with the care and concern they deserve as human beings, as we strive to genuinely improve their lives before, during and even after the clinical trial.
In addition, BloomTrials strives to inform the minority population of the importance of their participation in clinical trials that can be of benefit to their communities. We feel it is extremely important that every culture be represented in order to have a true picture of the population.
Finally, because the informed consent of participants is the core ethical standard for any clinical trial, we take the minimum standards for the industry and proudly exceed them with a very strong informed consent process. We make sure that patients and their families clearly understand the information by explaining it to them in language that steers clear of confusing medical terminology.
If you are considering the possibility of becoming a participant in one of our clinical trials, you will undoubtedly have questions or concerns about the process and your part in it. So on this page, we’ve provided a number of links that will help answer our participants’ most commonly asked questions. In addition, if you fill out the inquiry form to the right, one of our staff members will reach out to you immediately.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study in which volunteers receive investigational medical products developed by pharmaceutical and biotechnology companies. Qualified physicians called Investigators, as well as other research professionals, are selected by the sponsoring companies to conduct these trials in order to determine the benefits of their investigational drugs.
Clinical trials are usually conducted in three phases—phase I, phase II and phase III. A small number of people participate in phase I trials while the later phases encompass a larger number of volunteers.
Who can participate in a clinical trial?
There are guidelines that determine who can participate. First, a volunteer must qualify for the study. Criteria permitting volunteers to participate in a clinical trial are called “inclusion criteria.” Factors that disallow volunteers from participating are called “exclusion criteria.” Age, gender, the type and stage of a disease, previous treatment history, and other medical conditions are examples of such criteria.
Second, some clinical trials seek participants with specific illnesses or conditions to be studied. Others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participant safety, and ensure that researchers learn the information they need.
How does a clinical trial work?
In a clinical trial, a volunteer is usually assigned to a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.
A placebo is an inactive product used to assess the experimental treatment’s effectiveness. The participant, physician and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteer during the study. Regardless of which treatment is received, however, the level of medical attention and respect that each participant receives is the same.
What questions should I ask before choosing to participate?
Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. They should also understand the credentials and experience of the staff and facility involved in conducting the study. Questions to ask a physician or medical caregiver:
How long will the trial last?
Where is the trial being conducted?
What treatments will be used and how?
What is the main purpose of the trial?
How will patient safety be monitored?
Are there any risks involved?
What are the possible benefits?
What are the alternative treatments besides the one being tested?
Who is sponsoring the trial?
Do I have to pay for any part of the trial?
What happens if I am harmed by the trial?
Can I opt to remain on this treatment, even after the trial?
In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member. The participant’s health will continue to be monitored during and after the trial. A detailed description of what is expected of volunteers will be outlined in consent forms along with specific clinical trial information.
What is informed consent?
Prior to participating, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent, a process that can help you decide if participating in a trial is right for you.
When you give written consent to participate in a clinical trial, you acknowledge that you understand and accept all aspects of the research study, including any risks or benefits involved. However, informed consent is not strictly about signing a document. It is a process that involves ongoing conversations between you and the research staff before, during and even after you decide to become a study volunteer.
To begin, the research staff is obligated to discuss all the pertinent information about the trial with you, its purpose, the procedures involved, the potential risks and benefits. It is your responsibility to ask questions if there is something you don’t understand. You can ask the researcher to repeat the information or explain it in another way using everyday words.
If English is not your first language, research centers can and should be able to produce documents or explanations for you in your preferred language. If not, you shouldn’t participate in the study.
In some instances, a single visit may not be enough time for you to fully understand the information provided. Therefore, it is essential to take the time you need to make an informed decision.