Ethics in R&D

Non-interventional studies

”For Bayer non-interventional studies are an indispensable tool in the field of drug research as they deliver information about medicines under real-life conditions.“
  • Paul Jaekel, Head of Non-Interventional Studies, Bayer

Non-interventional studies (NIS) in pharmaceutical research

Non-interventional studies are usually conducted on the initiative of a pharmaceutical company. They may, however, also be required by a regulatory agency as a condition for product authorization or be obligatory, as in Korea or Japan. In contrast to interventional clinical studies, in which patients are exclusively treated for study purposes, NIS are studies carried out without any form of intervention; rather, patient data is gathered during routine treatments and evaluated using epidemiological methods. In this, treatment, diagnosis and monitoring do not follow a previously-developed protocol, but fall within current therapeutic practice.

Non-interventional studies (NIS) have proven to be useful tools for examining the safety, effectiveness and tolerability of a marketed medical product as it is used in day-to-day practice. These studies deliver important therapeutic findings and help physicians to take informed decisions on the treatment of patients.

Non-interventional studies: spotlight on patient safety

Non-interventional studies on drugs in current therapeutic practice are based on a large number of patients and provide indispensable scientific insights into the acceptance and practicability of a medicine, on possible interactions with other drugs, previously unknown, very rarely occurring side effects and possible new findings on efficacy. Typical questions addressed by NIS include the quality of patients’ life and the cost structure of the therapy under real life conditions.

Quality and transparency of non-interventional studies

The non-interventional studies of Bayer are registered and publicly accessible on www.clinicaltrials.gov.
To ensure high standards for quality assurance and transparency in planning, conducting and reporting a NIS, the German Association of Research-Based Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller, VFA) developed “Recommendations for Improving the Quality and Transparency of Non-Interventional Studies” for its members, like Bayer.
The respective codes of the European Federation of Pharmaceutical Industries and Associations (EFPIA) provide guidelines for planning, conducting and evaluating a NIS. For example, these guidelines recommend soliciting the guidance of an Ethics Commission before conducting a NIS or stipulate that the type and amount of compensation paid to physicians or clinics for their NIS participation should be calculated in such a way that there is no incentive for prescribing or recommending a certain medicine.
These guidelines govern that non-interventional studies are conducted based on strict scientific, medical and ethical principles.

Non-interventional studies at Bayer

Bayer conducts NIS for many indications and drugs – always with the goal of ensuring that its drugs are as safe as possible for patients. Bayer is committed to strictly observing all legal and regulatory requirements when conducting NIS as well as complying with all codes of the pharmaceutical industry. All NIS carried out by Bayer are coordinated, monitored and accounted for by its internal Medical Affairs department; furthermore, all Bayer employees involved are supervised and monitored by this department in order to comprehensively ensure compliance with these extensive requirements.
Information on non-interventional studies performed by Bayer is available at www.clinicaltrials.gov.