Clinical Trial Transparency, Publication Practices, and Data Sharing
Radius is committed to conducting clinical trials in a transparent manner.
Clinical Trial Registration and Disclosure of Clinical Trials Results
- All Radius-sponsored phase 2 & 3 trials are registered on ClinicalTrials.gov or other relevant public registry no later than 21 days after enrollment of the first clinical trial subject.
- Updates to records follow standards set forth in the ClinicalTrials.gov Final Rule (42 CFR Part 11) Information.
- Clinical trial results are posted on ClinicalTrials.gov or other relevant public registry no later than 12 months after a study’s primary completion date.
- Radius is committed to publication of clinical trial results at congresses and in peer reviewed journals in a timely, balanced, and transparent manner.
- Publications are developed in accordance with Good Publications Practices (GPP)1 and follow authorship criteria set forth by the International Committee of Medical Journal Editors (ICMJE).2
- Radius provides all authors with complete access to relevant study data.
- All manuscripts reporting results from our clinical studies are published in an open access format, allowing for increased transparency and access to our research by clinicians and patients
Access to Clinical Trial Data
- Radius is willing to share clinical trial data with qualified external scientific and medical researchers to advance public health as described below:
- Data that underlie the results reported in a published article may be requested for further research 6 months after completion of FDA or EMA regulatory review of a marketing application (if applicable) or 18 months after trial completion (whichever is latest). Radius will review requests individually to determine whether (i) the requests are legitimate and relevant and meet sound scientific research principles, and (ii) are within the scope of the participants’ informed consent. Prior to making data available, requestors will be required to agree in writing to certain obligations, including without limitation, compliance with applicable privacy and other laws and regulations. Proposals should be directed to email@example.com.
- Research proposals will be reviewed by a committee of internal advisors and co-development partners (if applicable). Proposals with the purpose of re-evaluating safety and efficacy issues already addressed in the product labeling will not be considered. Requests that pose a potential conflict of interest or competitive risk may be declined.
1. Battisti WP, Wager E, Baltzer L, et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015;163:461–464. doi: https://doi.org/10.7326/M15-0288
2. International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Updated December 2019. Accessed at http://www.icmje.org/recommendations 10 March 2020.