What is a clinical trial?
A clinical trial is a type of clinical research that follows a predefined plan or protocol. By taking part in clinical trials, you not only play a more active role in your own health care, but you can also access experimental treatments and help others by contributing to medical research.
By becoming a participant, you will receive interventions that are being tested for the clinical trial. These interventions can either be medical products (ex. drugs, devices, procedures) or changes in the participants behavior (ex. diet). The whole purpose of a clinical trial is to compare a new approach to one that is already available. This is to see if the new approach being studied will be either be beneficial or not to the public, while taking into consideration the risks associated with the intervention. The results / outcomes in the participants who participate in a clinical trial will help determine whether the results of the intervention.
Who is in charge of conducting the clinical trials?
Any person with medical qualifications can conduct a clinical trial. ABS Health, LLC has a highly qualified research team consisting of scientists, study coordinators, medical assistants and other professionals supporting the Physician(s).
Who leads the clinical trials?
A principal investigator (PI) leads the clinical trial. A PI can be a research scientist, nurse practitioner or a medical doctor.
Who sponsors the clinical trials?
Sponsors are individuals or institutions that fund the trial. Individuals who donate money for research. Pharmaceutical companies, government agencies and other organizations can all sponsor a trial. The sponsors are responsible for initiating and managing the trial as well as providing enough funds for trial completion but in most typical scenarios sponsors are not the ones conducting the research trial.
Where are Clinical Trials conducted?
Clinical trials are generally conducted in a medical facilities such as hospitals, universities, a doctors’ office and community clinics.
Why should I participate in a clinical trial?
By participating in a clinical trial you contribute to medical research and you are serving your community. This will help benefit many patients in the future. For many diseases there is an optimal standard of care. By participating in a trial you get better health care for yourself, your family and your community. Both healthy and ill patients can participate in clinical trials.
What is a standard protocol for clinical trials?
A protocol is designed to balance the potential benefits and risks to participants. A protocol will also answer specific research question. A standard protocol will describe the following:
- The goal of the study
- Who is eligible to participate in this study
- Protection against risks for participants
- Details about the tests, procedures and treatments
- Duration of the trial
- The information that will be gained from this trial
How do I know if I am eligible to participate in a clinical trial?
All clinical trials do have standards to determine what kind of participants will be eligible. These standards are an eligibility criteria and will be listed in the protocol. The criteria can differ depending on the type of trial. Certain trials will look for healthy participants, or participants with a specific condition / illness, or even a specific group of people that the study is focusing on.
The eligibility criteria essentially determines who is eligible to participate in these trials. These criterias can include age, gender, type and stage of a disease, any previous treatment done and other medical conditions. All these factors will help the studies find an ideal participant for their trial.
How am I protected during this trial if I become a participant?
Informed consent is the process where you will be provided with all of the important information regarding the research study. All of the information that you receive will help you decide if you want to participate in the study or not. If you choose to participate, you will periodically continue to receive more information throughout the study. The research team is responsible for providing a document that explains the study in a detailed manner. Details includes, the purpose, how long it will last, tests / procedures that will be administered during the study, and the person to contact for further information. This will also provide all the risks and benefits associated with the study. Remember that if you choose to become a participant, you are allowed to leave the trial at any time.
Each clinical trial that is regulated by the FDA must be reviewed, monitored, and approved by an institutional review board (IRB). The IRB consists of doctors, researchers and other members of the community. The purpose of IRB is to ensure that the study being conducted is ethical and that you will be well protected throughout the study. This ensures that any risks that might be taken are done in relation to new benefits. They will also review the informed consent document.
Some clinical trials may be monitored by a data monitoring committee. The data monitoring committee are a group of scientists who are in charge in monitoring the safety and integrity of a clinical trial. They DMC can persuade the sponsors to stop the trial if they feel that the trial is harming the participants, not effective, or not serving the purpose that it is intended for. The members of this committee are chosen solely based on their scientific skills and knowledge that will be required to monitor a particular trial.
Other agencies, such as Office of Human Subjects Research Protection and FDA also have the power to determine if certain sponsors for these clinical trials are offering the proper protection towards their research participants.
What kind of questions should I ask regarding the clinical trial?
If you are interested in participating in a clinical trial, you should know as much as possible regarding the study before you decide if you want to participate in the trial or not. While the informed consent should provide an answer to the majority of these questions, you can also ask the following questions if they aren’t already answered in the informed consent.
- What is this trial studying?
- Why do researchers want to test this? What potential benefits will come out of it? Has this been previously tested before?
- What type of medication/treatment/procedure might I be receiving during this trial?
- Who will know what medication/treatment/procedure I receive during this trial? Will I know? Will the research team know? Will we both know?
- Am I required to do anything during the trial?
- How are the possible risks, side effects and benefits of this trial different to those of my current treatment?
- Will I have to be hospitalized? Will I have to visit the hospital / clinic, etc a certain amount of times in a week or month?
- How long is this study expected to last?
- Will I be reimbursed for my participation? If so, who will be responsible for reimbursing me?
- What expenses will be reimbursed exactly, if any?
- How often will I get reimbursed? (monthly, quarterly, etc)
- If this clinical trial proves to be successful for me, can I continue with the medication/treatment/procedure even after the trial is over?
- Will I be informed of the results for this study?
- What happens when I am injured during this study?
- Who will be responsible for my medical care while I am participating in this trial?
These are just some examples of questions that you would want to ask before deciding if you want to participate in this trial. Just be sure to get all of the information that you can before making a decision to participate in this trial.