Developing a new medicine usually takes years and requires close cooperation between many pharmaceutical sector professionals. In addition to the participation of top researchers, healthcare personnel and public authorities, volunteers are also needed in clinical trials. Without these volunteers, it would be practically impossible to develop new medicines or improve those already on the market.
Pharmaceutical R&D is a long-term and expensive process, so if our research can also help other parties develop better treatments for diseases it is a very good thing. Therefore, cooperation and sharing of information by different research groups is very important.
We do everything in our power to make sure that the volunteers taking part in our studies feel it is safe to participate, not only in terms of their health but also in terms of data protection.
Find out the answers to frequently asked questions below.
Why do clinical trials need volunteers?
Volunteers are needed to test a medicine after laboratory tests have confirmed the efficacy and safety of a molecule that forms a suitable basis for a potential active pharmaceutical ingredient.
With the exception of oncology drugs, the first clinical trials are conducted on healthy volunteers. Tests are conducted to ensure that the medicine has the desired effects and is safe. The study population is then enlarged in the final phase to include patients of different ages and ethnic backgrounds and with various clinical pictures.
Is it safe to participate in clinical trials?
Our internal guidelines also include international codes of ethics. These focus on safeguarding the health of the participants and the scientific quality of the research. In many studies, patient safety is monitored by an independent external monitoring group appointed for the study.
The study protocols of all of our clinical studies first go through Orion’s internal approval process and then through an external approval process. The external approval process is carried out by independent experts in the field in question, ethics committees and authorities.
Participation in a clinical trial is always completely voluntary. People usually hear about the chance to participate in a study from their doctor. Advertisements placed in newspapers and magazines are often used to seek healthy volunteers. Participants are provided with detailed information on what it means to take part in the study and the potential benefits and adverse effects.
Volunteers can stop participating in a clinical trial at any time without giving any reason. The treatment received by an individual will not be affected if they refuse to participate in or pull out of a trial.
What information will be collected about me if I take part in a clinical trial?
Basic information, such as date of birth and sex, height, weight, disease progression and ethnic background, will be collected. We are not interested in names, identities or social security numbers. An ID number is used to link a person’s details together. Personal data is processed in accordance with strict data protection regulations and industry codes of ethics.
Why might it be necessary to share the research data of clinical trial participants?
Orion is committed to transparency and the sharing of clinical study data, and wants to contribute to the advancement of science and medicine. When research data has been collected on a sufficiently large study population, it is possible to find answers for why some medicines work better for some people than others, or what type of groups of people are more susceptible to certain diseases.
New medicines are often developed in cooperation, which is why we may also share research data with our partners' researchers. By participating in a clinical study conducted by Orion, you may also be contributing valuable information to global medical research.
We register all clinical trials of an approved product in trusted public registers.
- Clinical trials conducted in the EU are published in the EU Clinical Trials Register or the Clinical Trials Information System (CTIS), as required by the European Medicines Agency.
- Clinical trials conducted in the US are registered in the Clinicaltrials.gov database.
Who will have access to my data? And what data can be shared with researchers?
Independent researchers can ask Orion directly for data from our studies, including patient data. The decision on whether to share the data is based on the high scientific quality of the request. If we agree to disclose clinical study data for research purposes, the researcher will be given access to the agreed anonymised datasets and edited research documents for a limited period of time.
Anonymisation means, among other things, removal of the ID. And if a person with a disease of a sensitive nature, for example, is included in the study population, their data will be deleted before the information is shared.
We do not share information with independent researchers in the following situations:
- if there is a reasonable likelihood that an individual could be identified or the disclosure of information could otherwise violate privacy
- the medicine under development does not yet have a marketing authorisation
- if the clinical data has been collected under such laws, treaties or consent provisions that prohibit or restrict transfer to third parties
- if the participant’s consent to the clinical trial does not explicitly allow us to share the data with third parties.
How do we ensure that the personal data of trial participants do not fall into the wrong hands?
Orion’s data protection and research agreements contain very specific provisions on the protection of personal data.
- Orion does not have the names or social security numbers of the people participating in the trials, so it would be technically impossible to gain access to the personal data.
- We deal with participants using ID numbers. When patient data is shared with other independent researchers, the ID numbers are also removed. This anonymised data is not disclosed for any purposes other than research.
- Data about the study participants may be combined or coded to make them less accurate. This information could be, for example, sensitive information such as drug use.
- If datasets are transferred from one country to another within the EU, we comply with the EU’s data protection rules and the data transfer protocol. If the data is transferred outside the EU, the rules are even stricter.