What is Clinical Research Site?
What is Clinical Research?
Clinical Research Study or Trials, begins at a scientific lab for therapeutic drugs, and for medical device on a lab bench. It is a scientific study to identify a new treatment that has proven promising in a laboratory studies. It is also a scientific study of how a new drug or treatment that is yet to be approved by FDA and marketed, works in people. Clinical study is a process that ultimately help doctors find new and effective ways to stop, detect, diagnose, control, and treat illnesses. A clinical research study is conducted through subjects who are volunteers willing to partake in advancing drug.
Clinical Trials must follow Good Manufacturing Practice guidelines (GCP) created by International Conference of Harmonization (ICH). All Clinical trials must also follow Food and Drug Administration (FDA) guidelines as well as Institutional Review Board (IRB) ethics guidelines, to ensure the rights, safety and welfare of the subjects involved in the clinical Research Study. Careful oversight and patient care steer the trial toward meaningful outcomes.
The Food and Drug Administration (FDA) requires clinical trials to be conducted on all new or improved drugs and new medical devices that usually falls under Class III device, before it can be approved to be available for the public use. Before a new drug reaches a clinical research trial, researchers spent many years testing, to determine the medication’s safety, risks, and efficacy.
Before a medical device reaches a clinical research trial, it must be classified by FDA to determine whether it will require a clinical study or not.
A research sponsor is either pharmaceutical company, Research Institution, Biotechnology Institution, or other Health Organization that funds a clinical research study and are responsible for designing the study protocol. Every trial is sponsored by one of these organizations. However, a medical doctor can also obtain funding through grants to conduct clinical study as a sponsor-investigator.
A clinical investigator is a medical researcher who oversees a study usually at a clinical research site such as TMEP Divinity Research Site. This person is usually a doctor or pharmacist. They can be a nurse or other health care professional although sponsors usually prefer a medical doctor. Clinical Investigator is also called a Principal Investigator who follows a carefully designed and detailed study plan created by the study sponsor.
The Clinical Research Coordinator, Principal Investigator, Sub-Investigator, Clinical Trial Manager, and others are healthcare professionals who are usually individuals involved in research at the site level.
At TMEP Divinity Research Site, we have qualified study team who are very passionate about maintaining the rights, safety and the welfare of the human subjects involved in the study we conduct at our site.
Why Participate in a Clinical Trial?
What are the benefits?
Offering to partake in a clinical drug or medical device trial, is one of the best ways to getting the understanding of diseases and the benefits of the development of a new drug or medical device. When you volunteer in a study, you become the most critical link to research and testing for the development of new drugs or medical device that could cure a broad range of health problems.
Benefits of volunteering include:
You get continuous medical care from physician during the study.
You receive medications before they become available to the open market.
You in most cases receive compensation for time and travel.
You become a part of the research process, that could lead to new advance therapies.
There is usually no cost to participating in a clinical trial. In many cases, you do not need medical insurance to qualify to receive the medication under clinical trial. Medical assessment, study drugs, and laboratory care mostly offered at no charge to you.
If you are interested in one of our studies, or want to learn more about our upcoming studies, please complete our form below and we will reach out to you.
What to Expect
Before you can partake in a clinical trial, you must be eligible for that specific trial. The initial step toward finding out if you are eligible for our clinical trials, is to speak with our Research Coordinator by calling or completing our forms. She will go over the inclusion and exclusion criteria to determine your eligibility. “Inclusion criteria” are criteria you must meet to be eligible and included in the trial and “exclusion criteria” are things that makes you ineligible, to be part of that specific trial.
If you qualify, you will be invited to visit our research site, for further information. You will be screen at the site to further determine your eligibility to participate in the trial. You will be provided a consent form, if when all other requirements are met. You will be given enough time, to review the informed consent document, or take it home to decide if you should participate in the study with your family. You will meet with both the Research Coordinator, and Physician (Principal Investigator), to answer any of your questions before signing the Informed Consent Document. The time frame and requirements of the trial will be explained to you, and all your questions will be answered.
During a trial, expect to be given the investigational product or drug, a placebo, or a current available treatment. You will be assessed by both the Principal Investigator (PI) and Research Coordinator at each visit. There are risks to participating in a clinical trial that are specific to the study. The risk of participating in a trial will be discussed, so you can decide whether to participate or not.
At the end of each trial, you will be guided to returning any unused study drug, and you will be asked to complete a short questionnaire about your experience. If results of the trials are made public, we will post them on our website.
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Why all people including people of color should partake in clinical research?
Participation Promotes Medical Impartiality
Clinical trials participants are the key to creating medical advancement, so is diversity among those participants.
To progress and promote equality in health care, it is essential that all people, including people of color, partake in clinical research studies. This is because
race, disability and socioeconomic standing, and other demographic reasons can affect folk’s risk of developing certain medical conditions.
It can also affect how they respond to medical interventions and their overall health results.
As more diverse group participants partake in clinical research trials, there is the likeliness that trial results and any decisions to begin or end clinical treatments will be applied to a diverse group of patients.
It is also essential that research students represent the people who are most affected by the illness or condition under investigation. For instance, certain cancers and sickle cell illness are frequent among people of color. Hence, it's crucial that people of color participate in clinical studies of these serious illnesses.
A recent evaluation of government-funded cancer research studies concluded that all racial and ethnic minorities were extremely underrepresented. Additionally, fewer than 2 percent of these clinical trials centers more on the needs of minorities.
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