Strict rules for publication of post-marketing surveillance studies

 

In the future, the pharmaceutical companies organized in the German Association of Research-based Pharmaceutical Companies (VFA) will conduct and publish post-marketing surveillance studies according to stricter standards. As the VFA announced today, the companies have made this voluntary commitment on their own accord.

"Post-marketing surveillance studies are an important research instrument that may not fall into disrepute. As a result, the post-marketing surveillance studies of our member companies will be marked by a high, assured quality standard and better transparency. We would like for this instrument to regain the respect it deserves," Cornelia Yzer, Director General of the VFA, said in Berlin today. The underlying VFA recommendations apply to all so-called non-interventional studies, the most common form of which is the post-marketing surveillance study.

Non-interventional studies (NIS) describe all forms of pharmaceutical studies in which physicians are not provided with treatment requirements: They can include any patients for whom they prescribe the pharmaceutical in question. Apart from that, it is completely in their discretion how they treat the patients. The administration of the pharmaceutical is the full responsibility of the patient. This is different for clinical studies as required for the marketing authorization of pharmaceuticals: There are strict selection criteria for patients eligible for participation; for example, in most cases, patients who suffer from concomitant diseases will not be able to participate. The study plan clearly declares which concomitant treatments are permissible and which are not. Furthermore, the pharmaceutical administration is monitored by physicians and nursing staff.

During the post-marketing surveillance study as the most frequent NIS, many "treatment cases" with a certain drug are documented by physicians, and these records are evaluated by the manufacturer. This way, pharmaceutical companies can obtain information e.g. on very rare side effects and the drugs' reliability even if therapy compliance is not optimal.

"Post-marketing surveillance studies are an indispensable instrument in pharmaceutical research," Yzer said. In this respect, the VFA also agrees with the German Federal Institute for Drugs and Medical Devices (BfArM). Nevertheless, post-marketing surveillance studies have become the target of criticism. To counter this situation, the VFA has developed the following core recommendations:

• Within the company, non-interventional studies are within the scope of responsibility of the head of the medical department, both from an organizational and a budgetary standpoint. Employees from other departments may participate but will be reporting to the head of the medical department.
  
• For each NIS, a consultation with one of the German ethics commissions must be obtained.
  
• After being educated, all patients included in an NIS must consent to participating in the study in writing.
  
• At the start of the study, information is entered into a publicly accessible online register.
  
• A summary of the study results must be published no later than 12 months after completion of the NIS.

Other aspects are already clearly governed by the "Recommendations for the Planning, Execution and Evaluation of Post-Marketing Surveillance Studies" by BfArM and the Code of Conduct of the Voluntary Self-Regulation of the Pharmaceutical Industry (FSA). Both BfArM and the Code suggest orienting the compensation on the fee scale for physicians. All post-marketing surveillance studies including a list of the participating physicians must also be reported to the National Association of SHI-accredited Physicians, the head associations of the health insurance funds and to BfArM or alternatively to the Paul Ehrlich Institute.

Prof. Torsten Strohmeyer, Head of Research and Medicine at the VFA member company GlaxoSmithKline GmbH & Co. KG, also welcomed the new standards for post-marketing surveillance studies: "The result is an entire bundle of measures that makes these study forms even more transparent in the future and ensures that their medical quality meets rigid standards. As a physician, I'm telling you: We need high-quality post-marketing surveillance studies, because their findings have a direct impact on the evolution of our pharmaceuticals and therefore enhance the patients' safety."

The companies are free to choose the online register for study information. Starting on May 1, 2007, the VFA offers its own online register for the registration of non-interventional studies at www.vfa.de/nis, but companies can also use the large, international register for clinical studies at www.clinicaltrials.gov.

"However, our initiative should not remain restricted to the VFA," Yzer said. "We expressly invite pharmaceutical companies outside our association to commit to compliance with the strict NIS standards."

Stand: 23.04.2007