Disclosure of clinical research information

Disclosure of Clinical Research Information

Any new medication that is developed has to prove in clinical trials that it is safe and effective. Clinical studies in
humans have to comply with ethical principles that protect the safety and well-being of the study subjects, as
laid down in the Declaration of Helsinki1 (DoH).
Providing access to information about clinical research studies and their results serves study participants, pa-
tients and their healthcare providers as well as the public at large. Such information can help people to make
informed decisions about their potential participation in a clinical study.
Publication of results in biomedical journals allows researchers to receive credit for their scientific work and
enables the scientific community to assess, correct and further develop these results.

Novartis Position

 Novartis is committed to timely disclosure of designs and results of all interventional clinical studies2
for innovative treatments in patients3. Results are made publicly available, whatever their outcome.  We commit to registering these studies on a publicly accessible database4 within days of the trial com- mencing5. Novartis will disclose all information requested by regulators as well as the minimum data set defined by the World Health Organization (WHO)6.  Results of all registered studies are made available on a publicly accessible database4 within one year  Novartis makes all efforts to comply with evolving national and international statutory requirements regarding disclosure of clinical studies and to do so in a timely manner. Where commitments (scope or timing) go beyond legal requirements disclosure of information of a competitive nature may be delayed.  We continuously strive to ensure that clinical study results are valid and credible. We design and con- duct all our clinical studies in accordance with ethical principles embodied in the DoH1, Good Clinical Practice (GCP) guidelines as well as national and international regulatory requirements.  We respect and defend researchers’ independence and freedom to participate in and to approve all aspects of a clinical study, including the results. Clinical investigators may have access to their own data once results have been processed and consolidated according to the agreed protocol, and they receive a summary on completion of the study and the clinical report.  Novartis supports transparent communication, independent opinions and the disclosure of any possible conflicts of interest by investigators and authors of clinical study publications. We ensure that authors of a publication on a trial receive a full clinical study report. We believe authorship should accurately re-flect contributions to the design and conduct of a clinical study and subsequent drafting of a publica-tion manuscript. The Declaration of Helsinki (DoH) forms the foundation of all significant international documents on ethical conduct in biomedical research. It establishes guiding principles and recommendations for physicians regarding ethics, human rights and medical norms in clinical research, and has been incorporated in the regulations, guidelines and laws of many countries as well as into international guidelines. Clinical Study/Clinical Trial and Intervention (WHO explanation): A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This includes adult patients as well as all EU paediatric Phase I-IV trials or trials mentioned in a Paediatric Investigation Plan (PIP). Novartis uses the following publicly accessible databases: www.clinicaltrials.gov and/or www.clinicaltrialsregister.eu for registering clinical studies, and www.clinicaltrials.gov and/or the Novartis Clinical Trials Result Database at www.novctrd.com for posting results. All databases can also be accessed through the IPFMA Clinical Trial Portal at http://clinicaltrials.ifpma.org. In case of any changes, e.g. legal requirements to post information on more than one registry, addresses will be updated accordingly. Trial start is defined here as First Patient First Visit (FPFV). Trial end is defined here as Last Patient Last Visit (LPLV). For vaccines trials end of trial can be as defined in the protocol, based on scientific necessities and acceptance of protocol by the regulators. “Minimum data set” as defined by the report of the WHO Technical Consultation on Clinical Trial Registration Standards: (currently available in the clinicaltrials.gov register) 20. Responsible contact person (Public contact) (estimated enrolment of the first participant) 21. Research contact person (Principal investigator) 23. Official scientific title of the study 10. (Is this information available yes/no. If yes, link to information) 24. (intervention for condition on outcome) 12. (Include time of measurement or time to completion)

Source: http://www.voltaren.com.hk/downloads/innovation/responsibly-tackling-the-challenging-issues/Disclosure-of-clinical-research-information-external.pdf