Frequently Asked Questions

The mission of Essence MD Research LLC is to improve health through innovative clinical research and development solutions. We are committed to introducing new medical treatments and interventions through professional, ethical and collaborative clinical research. Our dedicated and experienced team of clinical investigators work tirelessly to advance healthcare, maintain regulatory compliance, and conduct research in the best way possible.

Essence MD Research LLC conducts clinical trials in a variety of medical fields including pulmonology, infectious disease, internal medicine and sleep disturbance studies. 

Participating in clinical trials can offer several benefits:

1. Access to new treatments: Participants may gain access to innovative treatments that are not yet available to the public.

2. Contributing to medical research: By participating, individuals contribute to the advancement of medical knowledge and the development of potentially life-saving therapies.

3. Close monitoring and care: Participants receive close monitoring and medical care from experienced healthcare professionals throughout the trial.

4. Potential for improved health outcomes: Some participants may experience improved health outcomes as a result of receiving cutting-edge treatments or interventions.

5. Financial assistance: In some cases, participants may receive financial compensation or have their medical expenses covered as part of the trial.

6. Personal satisfaction: Many participants find satisfaction in knowing that they are contributing to the advancement of science and the improvement of healthcare for future generations.

Clinical trials are important in developing new treatments for diseases and to learn whether a new drug, treatment, device, or combination of drugs work and are safe for human use. A new treatment goes through several phases of clinical trials. Each phase has a different purpose:

Phase I: Clinical trials designed to determine the pharmacokinetics/pharmacological actions of the drug and the side effects associated with increasing doses. Drug interaction studies are usually considered as Phase I trials regardless of when they are conducted during drug development. Phase I trials are generally conducted in healthy volunteers, but may be conducted in patients when administration of the drug to healthy volunteers is not ethical.

Phase II: Clinical trials to evaluate the efficacy of the drug in patients with medical conditions to be treated, diagnosed or prevented, and to determine the side effects and risks associated with the drug.  If a new indication for a marketed drug is to be investigated, then those clinical trials may generally be considered Phase II trials.

Phase III: Controlled or uncontrolled trials conducted after preliminary evidence suggesting efficacy of the drug has been demonstrated. These are intended to gather the additional information about the clinical efficacy and safety under the proposed conditions of use.

Phase IV: Studies performed after the drug has been approved by the regulator for the market. These studies are often important for optimizing the drug's use. They may be of any type but must have valid scientific objectives. Commonly conducted studies include safety studies and studies designed to support use under the approved indication (e.g., mortality and morbidity studies, or epidemiological studies).

Before a clinical trial can start, it must be approved by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any possible benefits. An IRB is a committee of doctors, data experts, community advocates, and others who help ensure that a trial is done in an ethical way and the rights of participants are protected.

Each trial follows a carefully controlled plan (protocol) that explains what researchers will do during the trial. During the trial, researchers report the results to the trial’s IRB, to medical journals, and to government agencies. If problems such as severe side effects happen during a trial, it may be stopped or paused to protect participants.