What are Clinical Trials?
- Clinical Trials are Research Studies involving volunteers to answer specific health questions.
- Carefully conducted Research Studies are the safest and fastest way to find treatment that work in people and new ways to improve health.
- Research Studies are conducted according to a plan called a protocol.
- A protocol describes what types of patients may enter the study: schedules of tests and procedures, drugs, dosages, and length of study, as well as outcomes that will be measured.
- Each person participating in the study must agree to follow the protocol
Why are Clinical Trials conducted?
- To learn and become better educated about the drug, treatments or device and the disease in question.
- To improve the quality of our lives and the lives of future generations.
What are the Benefits to Patients?
- Patients are paid for their participation and travel;
- Obtain the clinical trial medicine at no cost, through the duration of the study;
- Patients gain earlier access to treatments which are not available to the public;
- Receive specialty medical care including laboratory and diagnostic testing associated with the clinical trial at no cost to you;
- You are helping others by contributing to medical research and treatment advances.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical team includes doctors and clinical research professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trail, monitor the participant carefully during the trial, and stay in touch after the trial in completed.
Some Research Studies involve more tests and visits than other trials. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
What is a placebo?
A placebo is an inactive pill, liquid, or powder
What are the phases of clinical trials?
Clinical trials are conducted in phases. the trials at each phase have a different purpose and help scientists answer different questions:
In Phase II trials, the study drug or treatment is given to a large group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use
How are volunteers protected?
All patients are closely monitored and your privacy protected.
After the trial is over, how will I get put back on medicine?
Our medical doctors will guide you on the appropriate instructions for resuming medications. Should the need arise, they can write you a short term prescription to aid in the transition until you can visit your primary care physician for the future treatment.
If the medicine is not approved yet, and it works for me, how will I find out what it is?
Information regarding the study medication will be found in the study Informed Consent Form (ICF). All patients will receive a copy of the ICF after it is signed, so it is important that you keep that document in your records for future reference. Once the study ends, additional information can be found at https://clinicaltrials.gov/. This website contains a results database of publicly and privately supported clinical studies of human participants conducted around the world. Study staff are also available to answer any questions regarding the medication that you might have both during participation and after your participation ends.
Federal Regulations Compliance: All clinical trials are governed by specific regulations of the FDA and all clinical trials must be reviewed and approved through an independent Institutional Review Board (IRB) with the primary and most significant obligation to ensure the welfare of all patients’ safety in participation in a clinical trial. MediSphere has been audited by the FDA four times in the past 15 years and successfully passed each inspection
For more information you can visit: ClinicalTrials.gov