CLINICAL TRIALS: WHAT YOU NEED TO KNOW

Volunteer participation in clinical trials is strictly based on eligibility, safety, and potential benefits.

All studies have undergone ethical review and received approval from the State Expert Center for conduct at St. Luke’s Hospital | Acinus.

Our research team is highly qualified and experienced in clinical research.

Clinical trials involve human volunteers who help evaluate the safety and effectiveness of new medications.

These studies are conducted according to international Good Clinical Practice (GCP) guidelines.

When we purchase a medication from a pharmacy, we typically read the accompanying instructions. We pay attention to the indications for use, specific administration instructions, potential side effects, and contraindications.

We should be grateful to the individuals who participated in the trials of these medications and contributed to understanding their impact on the human body. No medication can be brought to market without undergoing clinical trials. Only after a drug has successfully completed clinical trials and demonstrated positive results can the pharmaceutical company submit an application for its registration.

The primary participants involved in the clinical trial process are the sponsor, investigator, volunteer, and regulatory authority. 

Each party plays a distinct role!

The sponsor can be a pharmaceutical company developing the drug.

The sponsor also provides insurance coverage for all volunteers participating in the study.

The sponsor develops the protocol, which is the cornerstone of a clinical trial.

It includes the study duration, inclusion and exclusion criteria for participants, medication schedules, and a list of assessments and analyses to be conducted.

During the trial, the protocol serves as the guiding document for the investigators.

Participation in research is a free choice of everyone.

Volunteers have the right to withdraw from the study at any time.

In some cases, immediate withdrawal may not be feasible (e.g., when abruptly discontinuing a medication could be harmful), and a gradual tapering off may be necessary.

Throughout the study, participants are under continuous medical supervision and receive necessary qualified medical care.

Volunteers have the right to receive complete and understandable information about the study drug and their health status.

Volunteers have the right to confidentiality of their personal data. All information about them is stored in a coded format and cannot be traced back to the individual.

Medical records can only be accessed by a limited number of individuals, including company monitors, auditors, and authorized government inspectors.

Prior to the study’s commencement, the organizing company must obtain approval from the Ministry of Health of Ukraine.

◾️ Informed consent: Participants must provide informed consent before enrolling in a clinical trial.

◾️ Safety: The safety of participants is the highest priority in all clinical research.

◾️ Efficacy assessment: Clinical trials are designed to evaluate the efficacy of new interventions.

◾️ Data integrity: Data collected in clinical trials must be accurate, complete, and reliable.

◾️ Inclusion criteria adherence: Participants must meet specific criteria to be included in a clinical trial.

◾️ Protocol compliance: All aspects of a clinical trial must adhere to the approved protocol.

◾️ Timely Conduct: Clinical trials must be conducted within the specified timeframe.

Informed consent is a document that explains a clinical trial in simple terms. It tells you about the purpose of the study, what will happen, and what the possible risks and benefits are.

When you sign the informed consent form, you’re saying that you understand what the study is about and you’ve chosen to be part of it.

Your safety is our top priority. We will closely monitor your health throughout the study.

Before we can test a new medicine on people, we have to do a lot of tests in a lab.

Only medicines that are safe and effective during research are approved for widespread use.

The ethics committee reviews whether the research protocol complies with ethical standards, whether the research participants are adequately protected, and assesses the qualifications of the physicians conducting the clinical trial.

The study timeline is always specified in the protocol.

Ethics committees monitor the study from its inception to completion.

The ethics committee has the authority to halt the study at any point if they believe it endangers the safety of the participants.