A clinical drug trial is a scientific study that helps to determine how a new medicine or treatment works in humans. Through clinical trials, clinicians find new, and potentially better ways to prevent, detect, diagnose, control and treat illnesses.
Many years are spent researching and testing medications to determine the safety and usefulness before they are ever tried in humans. The Food and Drug Administration (FDA) requires that clinical drug trials in humans be conducted before a medication is approved for use in the general public.
Clinical drug trials are carried out in research centers like Omega Medical Research, in doctors’ offices, or at medical centers. At each site, a Principal Investigator who is a physician is selected to carry out the study’s protocol. The protocol is a carefully designed and FDA-approved study plan created by the sponsor of the study.
All study information is submitted to an institutional review board (IRB). An IRB is typically composed of health care professionals and community members not associated with the research site. This group makes sure all FDA and protocol requirements are followed. This board reviews all activities involved in the study and determines if the study is safe, ethical and offers no extreme risks to the volunteer. The research site, where the volunteer goes to participate, collects all the data involved in the study and reports any safety information to the sponsor and the IRB that is collected while the volunteer is in the study. The sponsors of research studies are pharmaceutical companies, research institutions or other health organizations that design the protocol and fund the research.
All data collected in the study is submitted to the sponsor in a most confidential manner. Those who analyze the data do so without ever knowing the volunteers name, address or other personal information that would identify the participant.
Although it is ideal for volunteers who enter the study to stay in the study until it is complete, a volunteer is just that, a volunteer who can withdraw for the study at any time and for any reason. (See Patient's Rights)
If you decide to volunteer to participate in a clinical trial, you have certain rights. At Omega Medical Research, we believe strongly that personal concern for every study volunteer is of the utmost importance.
As a participant in a clinical drug trial, you have the right:
1. To have adequate time to decide whether or not to participate and to make that decision without any pressure from the staff who are doing the research study.
2. To address any questions you have at any time with the research team or the Principal Investigator of the study.
3. To refuse to participate in the study, and to stop participating at any time after the study has begun without this affecting your right to usual care that is not related to the research.
4. To be told why the study is being conducted, what will happen while you are in the study and what your responsibilities are while you are in the study.
5. To be informed of any reasonable foreseeable risks, discomforts or side effects that may occur during the study.
6. To be told if there are any costs associated with being in the study and if you will receive any compensation for participating in the study.
7. To be informed who has access to your records and any information collected about you and how your confidentiality will be protected.
8. To be told whom to contact directly with questions about the research, about research-related injury, and about your rights as a research participant.
9. To receive a copy of your signed informed consent form.
10. To be told about the other non-research treatment choices you have.
11. To be told where treatment is available should you have a research-related injury, and who will pay for research-related treatment.
Common Research Language
Principal Investigator: The person qualified, by training and experience, as an appropriate expert to study the drug/device in human biological systems.
Clinical research coordinator/CRC: A person who handles most of the administrative responsibilities of clinical trials; acts as a liaison between investigative site and sponsor; reviews all data and records before monitor's visit.
IRB/Institutional Review Board: "Ethics Committee"- An independent body, constituted by medical professionals and non-medical members, whose responsibility is to verify that the safety, integrity and human rights of the subjects participating in a particular trial are protected, thereby providing public reassurance.
Wash-Out period: A period during a clinical trial when the trial subjects receive no active medication. The wash-out period is typically used to generate patient baseline data. Study sponsor: Pharmaceutical company responsible for creating the specific study designed protocol and elements.
Informed Consent: The informed consent is the process of learning key facts about a clinical research trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information to participants. The attending principal investigator and study coordinator are involved in the consent process to assist in explain or making clear any elements involved in the specific study design. If the participant's native language is not English, translation assistance can be provided. All study related risks and potential benefits are outlined in the informed consent. All participants are reimbursed for time and travel, and reimbursement stipends are discussed within the informed consent. It is important for each participant to understand that the informed consent is not a contract and therefore the study participant may withdraw from the study at any given time.
Patient Stipend: Each patient is reimbursed a specific amount for every completed office visit. The stipend is predetermined by the study sponsor and research site prior to enrollment of patients. Patient stipend amounts vary with each study.
Placebo: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebo's to assess the treatment's effectiveness.
Double blind procedure/study: An investigational study design feature which shields study participants 9subjects, patients, medical personnel administering treatment and/or medical personnel evaluating patients) from knowledge about which patients are being treated with experimental drug, standard drug or placebo. A trial that has been blinded stands the best chance of producing data that are relatively free of investigational assessment bias (this is what the FDA likes to see- objective data as opposed to subjective data). Therefore, double blind studies are when the patients, the investigators, nor the study coordinator know which patients are receiving the investigational drug.
GCP/ Good clinical practice: A standard by which clinical trials are designed, implemented and reported so that there is public assurance that the data are credible, and that the rights, integrity and confidentiality of subjects are protected.