Ethical conduct of clinical studies

Ethical principles described in the Declaration of Helsinki and the International Council for Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) are always followed in our clinical studies, alongside a number of other international ethical and scientific guidances, e.g. those issued by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). These guidelines are also integrated into our internal Standard Operating Procedures, SOPs. 

We take very seriously our responsibilities towards the individuals involved in our clinical studies either as study participants or site personnel. We always ensure their rights, safety, integrity, confidentiality and well-being, wherever the study takes place in the world. 

The first clinical study in humans with a new drug candidate is conducted only after nonclinical research has confirmed that the drug is sufficiently safe for testing in humans. All our clinical study plans (study protocols and amendments) are first reviewed and approved by Orion’s own Research & Development (R&D) experts, and then reviewed and approved by applicable external experts, e.g physicians qualified in a relevant medical speciality related to the study therapeutic area, ethics committees and relevant regulatory authorities, depending on the location of the study conduct. 

Throughout the clinical development program, the safety and pharmacological aspects of the new drug candidate are evaluated with rigorous monitoring. All potential safety signals are assessed quickly and carefully. External specialists are consulted widely, and often an independent Data and Safety Monitoring Board is nominated to oversee the conduct of the study. 

Clinical investigators are medical doctors who are responsible for carrying out the clinical part of the study under a service agreement with Orion or Orion’s possible partner. Our clinical investigators are always specialists in their therapy area and in GCP. The investigators and their study teams are very familiar with and trained in the study protocol, and they have detailed understanding on the investigational medicine and the related risk-benefit aspects. They are therefore fully capable of ensuring each study participant’s safety and giving them the best possible care.  

An informed consent is obtained from every clinical study participant (healthy volunteer or patient) in writing before the study begins. In the participant information and informed consent document the study is explained profoundly so that they understand the potential benefits and possible risks of their participation in the study. The responsibilities, commitments, roles and rights of the participant, the investigator, other site staff members and the study sponsor are described carefully. Sufficient time is used for the discussion between the participant and the site staff member, and the study participants are encouraged to ask questions whenever additional information is needed. 

Participation in our studies is always voluntary. In certain cases, the authorised caregiver can make the decision of participation on behalf of the study participant. During the study the participant is free to withdraw from the study at any time without giving a reason. Refusal to participate in the study or withdrawal from the study do not affect the individual’s future medical care in any way. In clinical studies sponsored by Orion, we pay particular attention to the participant’s privacy, as well as the confidentiality of the data collected during the study. Individual participant’s data is protected by using secure data management systems and by following the principles outlined in relevant regulations and in the information notice given to the study participant. Sometimes this information is integrated to the participant information and consent document when deemed necessary or required by local/regulatory legislation. 

Patients participating in clinical studies are treated and followed up for free during the study. Each participant contributes to the development of new, better medicines for future patients. 

Orion registers all clinical trials in credible and publicly available registries as per requirements. The trials conducted in the US are always registered in Clinicaltrials.gov and also the trial results are posted there after the trial has been completed. In accordance with the EMA requirements, clinical trial information and  result summaries of clinical trials conducted in the EU are published in the EU Clinical Trials Register or Clinical Trials Information System (CTIS) database. Trial data can also be registered in other databases when there are specific local requirements or when deemed necessary. 

As a research-based company, Orion is committed to sharing study-level and participant-level clinical study data on its medicines and indications with relevant parties. Read more about sharing clinical data. 

In addition to medicines for humans, Orion also develops medicines for animals, mainly for companion pets like dogs and cats, and for livestock. Clinical studies in target animals are quite similar to human clinical studies and these studies also follow our internal Standard Operating Procedures. Veterinary clinical studies are conducted according to the principles of VICH (The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) and VICH Good Clinical Practice guideline. The necessary permissions from local authorities are obtained before starting the study. 

Participation in a veterinary clinical study sponsored by Orion is voluntary and requires an informed consent from the owner before an animal patient can be enrolled into the study. Investigators in our veterinary clinical studies are veterinary specialists or general practitioners, and they are responsible for the treatment and welfare of the animals participating in the study. Animal patients have been diagnosed with the disease under research and require proper treatment. When participating in a clinical study, they are treated and followed up for free and, together with their owners, they contribute to the development of new, better medicines for animals.