Clinical Trials

General information

At MBAL and DCC VITA, clinical trials of medicines and medical devices are actively conducted as part of the hospital’s scientific and research activities, in full compliance with all modern quality standards in medical science. Clinical trials are important research studies aimed at discovering new treatments and improving existing therapies. If you wish to participate, your safety and rights are our top priority. Clinical trials follow strict ethical guidelines to protect your confidentiality and well-being.

Frequently Asked Questions

– What are clinical trials?
Clinical trials are research studies conducted to evaluate new medical interventions – drugs, medical devices, or treatment approaches.

– Is participation voluntary?
Yes, participation in clinical trials is entirely voluntary. To take part, you must provide explicit written consent after receiving detailed information about the study (so-called “informed consent”), with the opportunity to ask all questions of interest to you.

– How are patients protected during clinical trials?
All clinical trials are approved by national regulatory authorities and an ethics committee before they are permitted at the hospital and offered to participants. This ensures that the trials are safe, ethical, and pose no unjustified risk. The MBAL VITA medical team is trained according to all modern standards and is fully familiar with Good Clinical Practice (GCP). Patient participation is additionally insured.

– How is participant safety guaranteed?
Safety and well-being are our top priority. During and after the trial, patients are closely monitored by medical staff, and appropriate measures are taken when necessary. All trials are pre-approved by the Bulgarian Drug Agency and the Ethics Committee for Clinical Trials, which guarantee their ethical and scientific soundness.

– Can I withdraw from participation?
Yes, you may withdraw your consent at any time without giving a reason and without it affecting your subsequent treatment or routine medical care.

– What is the significance of my participation?
By participating, you contribute to the discovery of new treatments and to advancing medical science for future patients. Clinical trials also often provide access to innovative therapies that are not yet widely available. Throughout the study, your health is actively monitored with a complete set of tests and procedures.

– What are the rights and responsibilities of participants?

Rights:

Right to information: clear and complete details about the trial, including objectives, methods, risks, and benefits
Right to data protection and confidentiality
Right to withdraw at any time without negative impact on further treatment
Right to appropriate medical care during the study

Responsibilities:

Follow the instructions of the research team and report any adverse reactions or changes in your condition
Attend all scheduled medical examinations and consultations
Provide accurate and complete medical information; in some cases, avoid certain foods or drinks depending on the treatment specifics

MBAL and DCC VITA employ qualified medical specialists in approximately 30 therapeutic areas, as well as a clinical pharmacist, directly engaged in conducting and monitoring trials to ensure high-quality results and patient well-being.

For questions or more information about current clinical trials:
Tel: +359 2 45 22 741
E-mail: clinicaltrials@vita.bg, s.stoev@vita.bg

For CROs or companies conducting or monitoring clinical trials seeking collaboration with MBAL and DCC VITA:
Tel: +359 2 45 22 741
E-mail: s.stoev@vita.bg

Thank you for considering joining our clinical trials. We appreciate your trust in our highly qualified medical team!