Who conducts clinical trials?
Many pharmaceutical companies, research institutions, or other health organizations may be the sponsor of a clinical trial. The sponsor is responsible for funding and for designing a protocol with a set of detailed guidelines that are required to be followed in order to conduct the same clinical trial at several different locations throughout the United States, and often times in several foreign countries as well.
Although sponsors fund a clinical trial, independent doctors, nurses, and medical researchers conduct the trial in accordance with the Food and Drug Administration (FDA) regulations and abiding by the International Conference on Harmonization Good Clinical Practice (ICH GCP) guidelines.
Who can participate in a Clinical Trial?
A volunteer must qualify for the clinical trial by meeting specific criteria stated in the protocol and must pass a screening process to ensure they are a suitable candidate for the clinical trial.
Some research trials seek volunteers with illnesses or conditions to be studied, while others need healthy volunteers.
It is best to ask your research doctor or research nurse about the criteria required to enter a clinical trial.
Will I be paid for taking part?
You will be compensated for your time and inconvenience to participate in a trial. The study drugs and care is also free to you.
The way these payments will be made will vary depending on your trial, but will be described in full in the Informed Consent Form that will be fully understood before you can start a clinical trial
What if I want to keep taking the study medication?
Because most of the potential drugs we are studying have not been approved for public use, continuing on the investigational drug after your trial ends might not be an option. However, this is decided on a trial-by-trial basis. Even if you can’t continue on your investigational drug, we can provide you with appropriate referrals for treatment at the end of the trial.
Can I continue to take my regular medications during the trial?
It depends on the clinical trial protocol. You will need to tell your study team about all medicines you are currently taking so they can inform you of all medications that will not be allowed. The study team will let you know if you can, or cannot, continue on your current medication prior to your decision to volunteer for the trial. You and your physician will discuss if the clinical trialwill be a good fit for you
What if I have a problem?
When you decide to volunteer for a clinical trial, you will be supported 24/7 throughout your time in the trial. During business hours, you will call the research clinic and a research nurse or physician will help you. After hours, you will reach an answering service which will alert the appropriate person to contact you.
How long do the trials last?
Each trial is different, so your involvement will vary based on the trial’s pre-determined plan, or protocol. You will need to visit theclinical trial clinicat different intervals depending on the protocol requirements. This will vary depending on the trial, but the research staff fully described and explained this to you prior to starting a clinical trial. This will also be clearly written in the Informed Consent Form you are given prior to deciding to volunteer.
Who will I interact with during the clinical trial?
You will have a team of medical professionals dedicated to your individual care throughout your time on the trial. This includes board-certified physicians with advanced practice professionals (also called investigators), as well as trained research nurses and research administrative staff. You are encouraged to maintain close contact with PRC staff with all questions and concerns during your participation in a clinical trial.
Your health and safety are always are top priority.
What is needed of me?
You need to work to fully understand your commitment to the completion of the protocol required visits and procedures prior to agreeing to participate.
You need to be open and honest with your research team throughout the trial. The research team needs to know all your concerns, problems, health changes, hospitalizations, new diagnosis, changes or additions of medication, travel plans, schedule conflicts, etc. so we can evaluate if there are any current or potential safety concerns.
You need to follow all instructions in regard to the study medication storage, preparation, handling, administration and diary completion.
You need to follow all instructions given to you by the research team.
Your full cooperation and participation is needed to collect reliable and valid information for accurate study results.
We are always available for a conversation
To learn more about potential eligibility, please submit the information below and we will contact you:
Learn more about common medical terms associated with a clinical trial so you will have a full and meaningful understanding of the process.
An unexpected event, either positive or negative, which occurs during a study.
CONTRACT RESEARCH ORGANIZATION (CRO):
A business that contracts with the pharmaceutical sponsor to conduct all or part of the activities involved in the clinical trial or product development process.
DOUBLE BLINDED STUDY:
A clinical trial in which neither the research volunteer nor the study staff know which of the study dosing arms the volunteer is assigned to.
FOOD AND DRUG ADMINISTRATION (FDA):
The FDA is a federal agency of the Department of Health and Human Services, is responsible for protecting and promoting public through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods and feed, and veterinary products. The FDA has the authority to authorize the approval of new drugs.
INFORMED CONSENT FORM (ICF):
A document that outlines the key facts about the trial including information on the potential risk associated with participating in the study and all available data on the drug being tested. Key information which must be included in an ICF include:
- Why the research is being carried out
- What will be done during the trial and for how long
- What risks are involved in the trial
- What the researchers want to achieve by carrying out the trial
- The fact that participants have the right to leave the trial at any time
INDEPENDENT REVIEW BOARD (IRB):
A key goal of IRBs is to protect human subjects from physical or psychological harm, by reviewing research protocols and related materials. The protocol review assesses the ethics of the research and its methods, promotes fully informed and voluntary participation by prospective subjects capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy), seeks to maximize the safety of subjects, seeks to protect volunteers’ rights, and analyze the risks and benefits of the clinical trial to determine if the research trial should be conducted.
*The IRB is also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board(REB).
INTERNATIONAL COUNCIL OF HARMONIZATION (ICH):
The mission of the ICH is to promote public health by achieving greater harmonization through the development of technical guidelines and requirements for pharmaceutical product registration. Harmonization leads to a more rational use of resources, an elimination of unnecessary delay in the global development, and provides a framework for quality, safety, efficacy, and regulatory standards to protect public health
The branch of pharmacology concerned with the effects of drugs and the mechanism of their action on the body.
The branch of pharmacology concerned with the movement of drugs within the body: absorption, distribution, metabolism and excretion.
An inactive substance that has no treatment value.