sustainability
Camurus’ position on ethics in clinical trials
Our approach
Camurus is committed to improving the lives of patients with severe and chronic diseases by empowering patients, supporting caregivers, and creating value for society by developing and giving access to innovative, long-acting medicines. To fulfill our commitment, we are determined to conduct our clinical trials in an ethical manner. This includes protecting the safety, well-being and legal rights of all participants, and adhering to the highest ethical standards for clinical research.
Ethics
For a clinical trial to be considered ethical, sufficient scientific and medical evidence base must exist to justify the exposure of individuals to the risks of the trial. There must be a clear medical need, and the potential benefits to be gained by the research must be weighed against the possible risks to the participating person.
Camurus follows high ethical standards for clinical trials such as the Declaration of Helsinki, International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines, and all applicable laws and regulations. Camurus’ employees and vendors’ employees involved in clinical trials are trained on all applicable ethical standards for clinical research.
Every clinical trial must be approved by the regulatory authorities and an independent ethics committee or Institutional Review Boards (US). The ethics committee monitors the trial and has the authority to modify or stop the trial at any time based on emerging data.
Camurus upholds the dignity and rights of all clinical trial participants. Our clinical trials should ensure the safety and well-being of participants.
All Camurus’ clinical trials are conducted with the participants’ informed consent and each participant has the right to withdraw their consent at any time during the trial.
The participants’ privacy is protected with strict measures in place to ensure the confidentiality of personal health information. Data collected during a trial is handled with the utmost care, in compliance with data protection laws and guidelines.
Camurus has oversight of all ongoing clinical trials, including trials conducted on behalf of Camurus by a contract research organization.
After completing a clinical program, Camurus strives to continue providing medicine to trial participants who, in the investigator’s opinion, have clinical benefit.
Diversity
Camurus aims to promote diversity, equity, and inclusion in all aspects of our clinical trials. A diverse participant population is important for understanding how different groups respond to medical interventions. We strive to include diversity amongst our trial participants to reflect the patient demographics affected by the studied condition.
Transparency
Camurus is committed to transparency and sharing clinical trial information in an unbiased and timely manner. Our transparency management is designed to ensure that all stakeholders, including patients, healthcare professionals, regulators, and the general public, have access to accurate and comprehensive information about our clinical trials.
Camurus’ ongoing clinical trials are registered, and results disclosed at clinicaltrials.gov or other public websites in countries where the trial is performed. Both positive and negative results are published to contribute to the overall scientific understanding. We engage with patient advocacy groups and healthcare professionals to ensure our research is aligned with their needs.
About clinical trials
What are clinical trials?
Clinical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health. Clinical trials are conducted according to a so called study protocol, which describes the types of patients who may enter the study, the schedules of tests and procedures, the drugs involved, the dosages or amount of the drug, the length of the trial, and what the researchers hope to learn from the trial.
Why are clinical trials carried out?
Clinical trials are conducted for many reasons. It could be to determine whether a new drug or device is safe and effective for people to use. Furthermore, it could be to study different ways to use standard treatments or current approved treatments to improve treatment efficacy, route of administration, decrease possible side effects or to expand the indication to new populations, e.g. children.
The clinical phases
Clinical trials are conducted in several phases to evaluate the safety, efficacy and optimal use of new treatments. Each phase plays a crucial role in ensuring that a treatment is both safe and beneficial for patients before it becomes widely available.
Phase 1
Phase 1 studies are the first studies of a product candidate in humans and generally includes a limited number of healthy subjects. The main purpose is to demonstrate the safety profile of the product in a dose range.
Phase 2
In Phase 2, the treatment efficacy and safety are studied in an increased number of patients. The focus is to determine treatment dose and administration for positive treatment outcome and safety profile.
Phase 3
In Phase 3, the substance is tested on a larger number of patients with the goal of demonstrating statistically proven and clinically relevant treatment efficacy and safety. The main objective is to show that the product candidate offers treatment benefits and a positive risk/benefit ratio for the indicated patient population upon market authorization approval.
Additionally, the drug candidate can be studied in a Phase 4 trial, which is performed after the product has been approved and marketed, to provide additional information.