Dompé’s commitment
to clinical studies

Dompé’s top priority is the protection of patient’s health.
For a responsible clinical research that supports and benefits patients, the scientific community and the healthcare and regulatory authorities.

Dompé is an Italian biopharmaceutical company committed to identifying and developing innovative therapeutic solutions that may provide viable options to patients, particularly in the area of diseases that have not yet been adequately addressed. In accordance with the provisions set by the Regulatory Agencies, Dompé conducts international clinical trials in collaboration with physicians, universities and research centres. The clinical trials are planned in consultation with these stakeholders so as to ensure the highest level of safety for the participants, acting in full compliance with the ethical and scientific principles that govern clinical research and sharing the results of the studies with the scientific community, the regulatory authorities and the public institutions. In this respect, the Group operates in strict compliance with scientific, ethical and Good Clinical Practice (GCP) standards, ensuring the highest quality of the research activities conducted.

Safety for participants in clinical trials

Dompé is directly and indirectly committed to supporting clinical trials that aim to meet patients' unfulfilled needs. Of course, all clinical studies are subject to preliminary evaluation by an independent Ethics Committee, in addition to that of the Ethics Committees of the centres where the trial is conducted.

Dompé assures that the privacy, health and safety of the healthy volunteers and patients enrolled in clinical trials will be protected with the utmost care.

Other drugs may be administered during the study, if necessary for the well-being of participants. The enrolled subjects may discontinue their participation at any time, without losing any of the benefits acquired. In order to participate, patients are required to read the Patient Information Sheet and to sign an Informed Consent form after receiving exhaustive explanations from the doctor proposing enrolment. If the patient is a minor or an incapacitated person, and as such is unable to issue and sign the informed consent, the parents or guardian may sign it on behalf of the patient.

Access to the drug and to information after the clinical trial

Dompé is committed to making available innovative treatments for diseases for which no effective therapeutic options exist at this time.

This is why, in addition to conducting targeted clinical trials, the Group supports patients and healthcare and regulatory authorities with the objective to make the trial drug available for specific projects, when requested in certain geographic areas. Moreover, Dompé may set up programmes for the “compassionate” access to its drugs, in consultation with the regulatory authorities and in compliance with the regulations applicable in the individual countries, if these drugs are necessary to patients during the phases preceding registration by the authorities.

For the sake of maximum transparency, Dompé makes available the results of the clinical trials it supports, and, if necessary, also provides this information to the healthcare authorities while the study is still ongoing. Clinical trial data are available on public databases, for example www.clinicaltrials.gov.