The data collected by pharmaceutical companies in the course of clinical trials and sent to the authorities for authorisation purposes are protected and covered by strict data protection regulations. This is the only way to ensure that patients’ privacy is adequately protected. The regulatory authorities use the submitted data to examine the benefit-risk profile of a new medicinal product and to grant authorisation if the result is positive.
In recent years, there has been growing discussion of the disclosure of clinical data relevant for authorisation so that not only the regulatory authorities but also other scientists can examine the benefit-risk profile of a medicine. However, this raises a number of problems. There is a danger that study participants could be re-identified, for example through social media. This would undermine the protection of individual privacy, leading to a reduction in people’s willingness to participate in clinical trials and a consequent negative impact on the introduction of new, effective therapies. Secondly, the integrity of the regulatory authorities would be undermined. These authorities assess the benefit-risk profile of new medicines. The consequences (for the authorities and the companies concerned) would be correspondingly severe if an authorisation decision had to be corrected subsequently. Thirdly, clinical data may also contain confidential commercial data that require protection in order to protect companies against “free riders” and ensure that they can continue to invest in the development of new medicines and indications.
Data transparency guidelines
Against this background, the pharmaceutical industry supports efforts to achieve greater transparency. For instance, the European pharmaceutical industry association EFPIA has agreed joint data transparency guidelines with the US association PhRMA that foresee the following measures:
- Clinical data and study protocols for medicinal products authorised in the EU and the USA will be made available to scientists working on justifiable research projects. Requests for this information will be examined by a Scientific Review Board to which external experts also belong. The requests and the identity of the requester will be made public. The scientists must undertake not to pass on the data to third parties and to submit their studies for peer review (assessment by other scientists).
- The summary of the clinical trial reports sent to the regulatory authorities will be published.
- The patients involved in the trial will be provided with a summary of the trial results.
- Irrespective of the outcome, all industry-funded trials will be published in a suitable form.
Obligation to register
Years ago, the research-based pharmaceutical companies all over the world undertook to register all their clinical trials in study registries. This voluntary obligation also applies in Europe. In Switzerland, there has additionally been a legal obligation to register trials since the Human Research Act came into force in 2014. According to this obligation, all clinical trials performed in Switzerland must be registered in a study register recognised by the World Health Organization (WHO) or the official register in the USA, clinicaltrials.gov, before they begin. In addition, the trial must be registered in the supplementary database operated by the Confederation.