A clinical trial is a medical research study involving the testing and evaluation of medical, surgical, or behavioral interventions for specific conditions. Its primary objective is to validate the effectiveness and safety of a new treatment or prevention.

The medical care you receive from your general practitioner will not be affected. You can continue to see your doctor for regular care, as long as the medical issues are unrelated to the trial. We will ensure to keep your GP informed about your participation in the trial.

To participate, please sign up for any of our studies on our website. Once you sign up, we will provide you with detailed information to help you make an informed decision. It is also important to discuss your decision to participate with your family members and close associates.

Participation in a clinical trial offers the opportunity to evaluate a new treatment, which may or may not surpass existing options. As a participant, you also contribute to the comprehension of treatment efficacy across diverse demographic groups, including those of varying races and genders, as responses to investigational products may differ. Regulatory bodies such as the FDA prioritize the inclusion of individuals from diverse age groups, races, ethnicities, and genders in clinical trials to ensure comprehensive assessment.

Reasons for engaging in a Clinical Trial:

• Access to novel treatments not yet available on the market
• Access to complimentary medication
• Remuneration for participation in certain trials
• Fulfillment derived from contributing to the progression of medical research
• Voluntary participation, allowing for withdrawal from the study at any juncture

Every clinical research study has specific eligibility criteria that individuals must meet to enroll in the study. Consequently, not all applicants will meet the criteria for acceptance into the study.

Types of clinical research studies include:

1. Prevention studies, aim to find better ways to prevent disease in individuals who have never had the disease or to prevent a disease from recurring. These may involve medications, vitamins, vaccines, minerals, or lifestyle changes.

2. Treatment studies, which test new treatments, drug combinations, or therapeutic approaches.

3. Diagnostic studies, which seek improved tests or procedures for diagnosing specific diseases or conditions.

4. Screening studies, which test the most effective methods for detecting certain diseases or health conditions.

5. Quality of Life studies (or Supportive Care studies), which explore and measure ways to enhance comfort and improve the quality of life for individuals with chronic illnesses.

Clinical trials commonly involve the comparison of a novel product or therapy with an existing treatment or a placebo to evaluate its efficacy in managing or preventing a specific disease or condition. In a blinded study, participants are randomly allocated to receive the investigational product, an approved therapy, or a placebo, without knowledge of which they are receiving. Comparing against a placebo is often the most expeditious and reliable method for demonstrating the therapeutic effectiveness of new products.

Informed consent is a critical component of the ethical conduct of research, mandated by the FDA to ensure that individuals contemplating participation in a study are provided with exhaustive information about the study before granting their consent. The informed consent documentation must be formulated in a manner that facilitates comprehension for the participant and should include:

• The purpose of the research
• The expected duration of the study
• Details about the experimental aspects of the study
• Potential risks or discomforts involved
• Potential benefits of participation
• Alternative procedures or treatments that participants may want to consider instead of the treatment being studied
• The FDA may review study records, but these records will be kept confidential
• Participants should be informed about the availability of medical treatments in case they get injured, where these treatments can be accessed, and who will cover the cost.
• There should be a contact person available to answer any questions about the study, participant rights, or what happens if a participant gets hurt.
• Participants have the right to quit the study at any time.

If the information contained in the informed consent form is not clear to you, you must seek clarification from the physician or another member of the research team. This discourse should take place in a confidential setting, and you must be afforded sufficient time to arrive at an informed decision. In most instances, you should be permitted to take the consent form home for further consultation with relatives, caregivers, and primary healthcare providers. It is paramount that you comprehend all aspects of the form before consenting to participate in the study.

Before enrollment in the study, it is mandatory to endorse the informed consent form, signifying that you have been apprised of this information and have full comprehension of its contents. Notably, the informed consent form does not constitute a binding agreement, and you retain the prerogative to withdraw from the study at any juncture, for any reason. You are entitled to seek elucidation at any stage during the study. Furthermore, you must be kept abreast of any new disclosures arising from the study that might impact your willingness to prolong your participation.

The typical process during the conduct of a clinical research study involves:

Pre-Screening Process

The clinical research team will conduct a thorough review of their existing patient databases and medical charts to identify potential candidates suitable for participating in the clinical research study. In addition, they will engage in targeted advertising through various channels such as the Internet, newspapers, radio, and television to attract prospective participants. Furthermore, the team may host seminars, provide complimentary health screenings, and facilitate forums to engage potential participants. Subsequently, individuals identified through these pre-screening initiatives will be contacted and subjected to brief interviews to ascertain their potential eligibility for participation in the clinical research study.

Informed Consent

Upon potential eligibility for participation in a clinical research study, an appointment will be arranged for your visit to the clinical research site to confer with a member of the research personnel. Before the commencement of any study-related procedures, you must furnish a signature on an informed consent form. This documentation comprehensively outlines the study's design, associated risks and benefits, your entitlements as a study participant, and pertinent emergency contact information. Throughout the informed consent process, you will be allowed to address any queries regarding the study and your involvement. A duplicate of the signed informed consent form will be furnished to you for your archival and future reference purposes.

Screening Visit

After giving your consent and signing the informed consent form, you will undergo screening procedures for the clinical research study. The purpose of the screening visit is to determine if you meet the specific inclusion and exclusion criteria for the study. During this visit, you will be asked about your medical history, medications, and other treatments, and may need to complete questionnaires. A member of the research team may also conduct a physical examination, EKG, and collect blood/urine samples to assess your general health. Please note that the investigational product will not be given during the screening visit.

Study Visits (Treatment Visits)

Participants who meet specific inclusion and exclusion criteria, including satisfactory laboratory and medical results, for the study, will be requested to attend a series of study visits, also known as Treatment Visits, at the clinical facility. These visits entail the administration of the investigational product or the comparator product (which may be a placebo). The frequency and number of study visits vary depending on the particular study.

End of Study Visit

Upon completion of the treatment visit, an End of Study Visit will be scheduled. This visit will entail a repetition of the initial assessments conducted before the administration of the investigational product. Furthermore, the research team will provide an in-depth discussion regarding post-treatment options, which may encompass the potential receipt of standard care treatments for your medical condition. Should the study necessitate, your presence may be required for a follow-up safety visit at the research site.

Follow-up Safety Visit

The frequency and timing of follow-up safety visits vary depending on the specific study. The objective of this visit is to confirm that participants are not experiencing any residual adverse effects attributable to the investigational product or the overall involvement in the study.

The study protocol specifies the eligibility criteria for participation in a clinical research study, known as the Inclusion/Exclusion Criteria. Inclusion criteria pertain to the factors that warrant participation, whereas exclusion criteria disqualify potential research subjects. These criteria are predicated on variables such as age, gender, disease type and stage, treatment history, and other medical conditions. A research subject is an individual meeting the inclusion/exclusion criteria who consents to partake in the study and may encompass both healthy individuals and those affected by a specific disease or condition.

Clinical research studies are led by a Principal Investigator, who is often a licensed medical doctor, along with a clinical research team that may include doctors, nurses, social workers, and other healthcare professionals. In general, the roles and responsibilities of the clinical research team include:

• Principal Investigator (PI): The Principal Investigator holds the responsibility for ensuring the ethical conduct of the research study. This encompasses the protection of human subjects' rights, safety, and welfare, as well as compliance with protocol (study), institutional, state, and federal regulations and guidance. The PI is accountable for obtaining informed consent from each participant and maintaining accurate study records. Financial and administrative policy compliance, overall fiscal management of the project, and disclosure of conflicts of interest fall under the PI's purview. While the PI oversees all aspects of a clinical trial, the delegation of certain tasks to other research team members (Co-Investigators and Key Personnel) is recognized. The PI must ensure that all research team members possess the requisite education, training, and qualifications to undertake delegated study tasks. Additionally, all study team members share the responsibility to ensure compliant conduct of the study according to institutional, state, federal, and industry regulations and guidance.

• Sub-Investigator: The Sub-Investigator, in the context of a research study, is an individual who may undertake certain or all functions typically carried out by the Principal Investigator (PI). This includes tasks related to the management and oversight of the study. However, it's important to note that the sub-investigator does not assume primary responsibility for the study. Rather, they operate under the guidance and supervision of the PI. The sub-investigator is tasked with executing specific study-related procedures and may also be entrusted with making significant study-related decisions. These responsibilities must be fulfilled in strict accordance with the ethical standards and guidelines governing the conduct of the study.

• Research Coordinator: The Research Coordinator is responsible for overseeing and coordinating the daily activities of clinical research studies. They work closely with clinical teams and investigators to ensure that all protocol-required procedures and visits occur according to protocol-specified guidelines. Research Coordinators generally manage participant enrollment and ensure compliance with the protocol and other applicable regulations. This includes but is not limited to, participant recruitment, obtaining informed consent, educating participants on the details of the research study, assessing participant eligibility, facilitating participant care and follow-up per protocol, creating source documentation, assisting in the assessment of toxicities/adverse events, and reporting serious adverse events per IRB and sponsor requirements. They are usually the main point of contact for the research subject.

Privacy of Personal Health Information (PHI)

Ensuring the confidentiality of your Personal Health Information (PHI) is paramount to the clinical research team. Your PHI will be handled with the utmost confidentiality and will not be disclosed without your explicit consent, except when mandated by law. Should you opt to provide your information via this website, it will be securely stored in our clinical research database for both present and potential future research endeavors, only with your explicit approval. You retain the right to request the removal of your information at any point. Similarly, if you choose to engage with our research specialists via telephone, your information will be documented in our electronic database. This process is entirely voluntary, and you reserve the right to have your data deleted at your discretion.

In most clinical research studies, all visits, tests, and procedures related to the study are provided at no cost. This includes any medications, laboratory tests, and medical procedures that are part of the study protocol. Additionally, if you meet the criteria for participation in our research studies, you may be eligible to receive compensation for your time and travel. The specific amount of compensation, as well as any out-of-pocket expenses not covered by the study, will be thoroughly explained and discussed during the informed consent process. We want to ensure that you have a clear understanding of any potential costs and the compensation that may be available to you as a participant in our research studies.

The duration and frequency of appointments/visits are contingent upon the study design. Typically, the visit duration is a minimum of 30 minutes, with some lasting several hours. The initial visit, also known as the screening visit, is generally lengthier as it encompasses the informed consent process, a comprehensive medical history assessment, the collection of laboratory samples, and the completion of various study-related questionnaires. Throughout the informed consent process, participants are furnished with detailed information regarding the study visits and the overall duration of the study.