Ethics in the Clinical Research Phases

At Orion, we design and conduct all our clinical studies in accordance with high-level ethical principles as well as international and national regulatory requirements. 

Ethical guidelines such as the Declaration of Helsinki and the International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) are always followed in our clinical studies, in addition to a number of other international ethical and scientific guidancies, such as those issued by the EU European Medicinal Authority EMA and the US Food and Drug Administration FDA. These guidelines are integrated into our internal Standard Operating Procedures, SOPs.

We take very seriously our responsibilities towards the persons participating in our clinical studies as study subjects or site personnel, always ensuring their rights, safety, integrity, confidentiality and well-being, wherever the trials take place.

The first clinical study in humans can be conducted with a new molecule only after nonclinical research has confirmed that it is sufficiently safe for testing in humans. All our clinical study plans (study protocol and amendments) are first reviewed and approved by Orion’s own highly educated R&D specialists, after which they are reviewed and approved by applicable external experts, ethics committees and relevant healthcare regulatory bodies, depending on the location of the study conduct.

Throughout all the clinical study phases of the program, the safety and the behaviour of the new drug candidate in the human body is explored with rigorous monitoring. We assess all signals of potential safety concerns carefully. Independent external specialists are consulted widely and the project’s independent Data and Safety Monitoring Board oversees the study.

Investigators are medical doctors carrying out a determined part of the clinical study under a service contract with Orion or our possible partner. Investigators in our studies are always highly educated specialists in their therapy areas. They are responsible for all necessary activities at the site of the study. The investigators are well familiar with the purpose and protocol of the study, having a detailed understanding about the investigational medicine and its risk-benefit aspects. With their high level medical competence and deep knowledge about the study they can ensure the best possible safety and well-being of the study participants.  

A personal informed consent from every clinical study participant (healthy volunteer or patient) shall be obtained in writing before a trial begins. In the informed consent the study is introduced and explained to the participants profoundly so that they understand potential benefits and possible risks in the clinical study. The responsibilities, commitments, roles and rights of the participant, the investigator, the study nurse and the study sponsor are described carefully. We take enough time for the introduction, and we encourage the study participants to ask instant questions or whenever additional information is needed.

Participation in our studies is always voluntary. In certain cases, the authorised caregiver can make the participation decision on behalf of the participant. During the study the participant is free to withdraw from the study at any time without explanation. In the clinical studies sponsored by Orion, we pay particular attention to the patient’s privacy, as well as the confidentiality of the data collected during the study. Individual patient data is protected by using secure data management systems and by following the principles determined  in regulatory requirements and the informed consent.

Patients participating in clinical study programs are treated and followed up for free during the study phase. Each patient also contributes to developing better medicines.

Orion registers all clinical trials in credible and publicly available databases as per requirements ─ typically ClinicalTrials.gov. In accordance with the EMA guidance, clinical trial summary results shall be published in the European Clinical Trials Database (EudraCT). Trial data can be registered in other databases, if there are specific local requirements.

As a research-based company member of the European Federation of Pharmaceutical Industries and Associations, EFPIA, Orion is committed to sharing study-level and patient-level clinical study data on its medicines and indications according to the principles described in the EMA Policy on Publication of Clinical Data and in the EFPIA Commitment. Information about the scientific publications and abstracts presented by Orion in scientific conferences is shared on Orion’s corporate website. By providing access to study-level and patient-level data on our clinical studies we show transparency and willingness to contribute to improved knowledge of new medicines and indications. After a marketing authorisation has been granted to our new drug, we allow access to our patient-level data based on a scientific review of the request and the proposal from the external research group consisting of qualified scientific and medical researchers. Before sharing, any patient-level data will be anonymised to protect identifiable information.

In addition to drugs for humans, Orion also develops medicines for animals, mainly for pets like dogs and cats, and for livestock. The clinical studies in the target animals are very similar to human clinical trials and also here we follow the similar internal Standard Operating Procedures. Veterinary clinical studies are conducted according to the principles of VICH (Veterinary International Conference on Harmonization) and Good Clinical Practice guidelines, and permissions from local healthcare authorities are needed before starting a study.

Participation in a veterinary clinical trial sponsored by Orion is voluntary and requires an informed consent from the owner before an animal patient can be enrolled in a study. Investigators in our veterinary clinical trials are veterinary specialists or general practitioners, and they are responsible for the treatment and welfare of the animals participating in the study. Animal patients are suffering from the disease concerned, needing proper treatment. By participating in a clinical study program they are treated and followed up for free and, together with their owner they contribute to developing better medicines for animals.

 

The next page of the Policy:

Ethics in the Marketing Phase >>