A clinical research study or trial is medical research that involves people like you. People volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose, and understand human disease. It is a scientific study of how a new medicine or treatment works in people. Clinical research includes trials that test new treatments and therapies as well as long–term natural history studies, which provide valuable information about how disease and health progress. This testing in humans is permitted only if everyone who volunteers for participation understands the risks and benefits of taking part in a study. The Food and Drug Administration (FDA) requires clinical trials on all medication before they will approve a medication for public use.
Informed consent is the most important process for the volunteer to understand. It is the process of providing potential volunteers with the key facts about a clinical trial before they decide whether to participate. The process of informed consent (continuously providing study information) carries on throughout the study. To help someone decide whether or not to participate, members of the research team explain the details of the study.
The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and who to contact for further information. The informed consent document also explains risks and potential benefits. The participant then decides whether to sign the document. Informed consent is not a contract. Volunteers are free to withdraw from the study completely or to refuse particular treatments or tests at any time. Sometimes, however, this will make them ineligible to continue the study.
The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following:
• Who is eligible to participate in the trial
• Details about tests, procedures, medications, and dosages
• The length of the study and what information will be gathered
A Principal Investigator is a medical researcher in charge of carrying out a clinical research study’s protocol. This person is usually a doctor or pharmacist, but can be a nurse or other health care professional. He or she follows a protocol, a carefully designed, detailed study plan created by the study sponsor. The PI is the person who takes direct responsibility for completion of a funded project, directing the research and reporting directly to the funding agency
The clinical research coordinator is a health care professional who, under the supervision of the Principal Investigator, coordinates all the tests and procedures for the study, oversees patient safety, collaborates with the Principal Investigator at all times and schedules and implements the study visit requirements.
The study sponsor is the pharmaceutical company, research institution, or other health organization that funds a clinical research study and designs its protocol. Clinical trials are sponsored or funded by various organizations or individuals, including physicians, foundations, medical institutions, voluntary groups, and pharmaceutical companies, as well as federal agencies such as the National Institutes of Health and the Department of Veterans Affairs.
The following pre-appointment instructions will apply for most studies at Great Lakes Medical Research, but the study coordinator will always give you specific instructions for your visits.
1. Bring all medication bottles and/or cards to every appointment.
2. Do not take your study medication the morning of the visit.
3. Fast (don’t eat anything). WATER is OK; please drink water during the evening and morning. Your study coordinator will let you know how long to fast.
4. Bring any study diaries (paper or electronic), logs or forms which you have kept notes in with you to the appointment.
5. The visit will last approximately 60 minutes; depending on the required procedures your visit could be shorter or longer. Your study coordinator will help you determine the length of your visits
6. Please bring any new medications that you may have started since your last visit.
If you are unable to keep your appointment, kindly give us 24 hours’ notice by calling 716-326-4890. We will gladly reschedule your appointment to a more convenient time.
Recognizing that today’s research is vital to the growth and development of tomorrow’s healthcare practices, we at Great Lakes Medical Research are dedicated to conducting clinical research with compassion, expertise, and respect for each participant as a valued individual.