For Trial Subjects
Why Volunteer in a Trial?
Clinical research are medical studies involving people and clinical trials are important as they help shape the future of medicine by shedding light on the diagnosis and treatment of diseases. Clinical research depends on people who volunteer to participate in research to bring about the advances in medicine and patient care that we have today.
Study participants may be driven by a personal desire to possibly benefit from early access to new treatment options before they become generally available, or by an altruistic desire to benefit your loved one or the general public by participating in an experimental research trial and help advance medicine worldwide.
Whatever your reason for wanting to participate in a clinical trial, you must remember that there is never an obligation to join a research program and best practices is that you ask your doctor about possible risks and benefits before participating in a clinical trial.
What is a placebo?
Some clinical trials use an active drug and a placebo, others two or more active drugs.
In a clinical trial, a placebo is an inactive substance given to a group of participants to act as a control, allowing researchers to determine if any observed benefits in the group receiving the actual treatment are truly due to the drug being tested, rather than simply the patient’s belief in the treatment.
What are my obligations in a clinical trial?
For safety reasons, participants of a clinical research study are required to disclose all past and present medical conditions, illnesses, surgeries, and medications to the clinical study physician, adhere to the prescribed treatment plan with the investigational medicinal product and attend scheduled study visits as outlined by the Study personnel.
Where do clinical trials take place?
Clinical trials occur in diverse locations globally, from doctors’ offices to hospitals and research centers, meaning potential volunteers should carefully consider the facility’s proximity when deciding to participate, as most trials necessitate regular visits to the study physician.
Participate in a Trial
By joining a research study, you can actively contribute to the development of new treatments and make a significant impact on the advancement of medical knowledge.
1. Initial Phone screening
Participating in the clinical trial begins with a brief phone conversation with our team. We will inquire about your background and if there is a study that matches your profile, we will proceed to the next stage.
2. Take a Health Evaluation
Following your phone screening, you will visit your doctor’s office or our research center for a free physical examination and health assessment and to ask any questions you may have about the trial or investigational new drug.
3. Join the trial
Your participation in the clinical research study will start once you are accepted as a candidate and you are satisfied with the study criteria.
Understanding Clinical Trials //paraphrase content due to 100% plagiarized from: https://www.diabetesassociatesmedical.com/endocrinology-and-diabetes-care-research
For more details, below is a series of frequently asked questions about the clinical trial process, relevant terminology, and the participant’s role.
Introduction
https://clinicaltrials.gov/study-basics/learn-about-studies#q0
What is clinical research and why is it done?
https://clinicaltrials.gov/study-basics/learn-about-studies#q1
What are the types of clinical research?
https://clinicaltrials.gov/study-basics/learn-about-studies#q2
Who can join clinical research?
https://clinicaltrials.gov/study-basics/learn-about-studies#q3
Why do people join clinical research?
https://clinicaltrials.gov/study-basics/learn-about-studies#q4
What about safety and chance of harm (risk) during clinical research?
https://clinicaltrials.gov/study-basics/learn-about-studies#q5
What happens during clinical research?
https://clinicaltrials.gov/study-basics/learn-about-studies#q6
After clinical research, how do researchers share what they learned?
https://clinicaltrials.gov/study-basics/learn-about-studies#q7
Who carries out clinical research?
https://clinicaltrials.gov/study-basics/learn-about-studies#q8
Who pays for clinical research?
https://clinicaltrials.gov/study-basics/learn-about-studies#q9
Do participants have to pay any costs or do they get paid for taking part in clinical research?
https://clinicaltrials.gov/study-basics/learn-about-studies#q10
What is expanded access?
https://clinicaltrials.gov/study-basics/learn-about-studies#q11
Understanding Clinical Trials Posting
ClinicalTrials.gov is a US government database where researchers are required to register most clinical trials.nk
The Sponsor is the organization, institution, company, university, medical center, other research organization, or Investigator who initiates the study and is usually responsible for the management and financing of the study. The study plan or protocol describes what the researchers will do and the principal or head investigator is tasked with ensuring the protocol is followed. Typically, the study protocol will include a Brief Title of the Study, the Study Type, Outcome Measures, Participation or Eligibility Criteria, Arms and Interventions, , Contacts, and Study Site Locations.
The ClinicalTrials.gov Identifier (NCT number) is the number given after the study record passes the Protocol Registration and Results System (“PRS”) Review. The Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant.
In general, within 2 business days of registration, the study will be posted on the ClinicalTrials.gov website, and the study record becomes a permanent record on ClinicalTrials.gov and cannot be deleted.
The study record is typically verified and/or updated at least once a year by the Study Sponsor.
Additional resources
Additional resources can be found at:
Clinical Research Trials and You
National Institutes of Health
www.nih.gov/health-information/nih-clinical-research-trials-you
ClinicalTrials.gov
U.S. Food and Drug Administration
888-463-6332
druginfo@fda.hhs.gov
www.fda.gov
Biopharmaceutical/Sponsors/CRO
Our expertise is in Cardiovascular and Metabolic, Endocrinology, and Nephrology clinical research.
Curasite Integrated Research Organization (IRO) runs fully integrated operations to support rapid and simplified site selection, unified contact/budget/regulatory and start up, trial procedures to study close-out. Our unwavering commitment is time and resource efficiency in single point responses and communication, rapid turnaround for contract/budget, and study startup.
Curasite Integrated Research Organization (IRO) will improve your research by direct patient access at the point of care, where patients gain access to clinical trials via their trusted physicians, who offer tailored support throughout the process, leading to increased enrollment and retention rates. Curasite Integrated Research Organization (IRO) will facilitate digitalized EMR records database searches for inclusion and exclusion criteria.