When this web site was first launched in 2014, Ipsum committed to post the key results of Ipsum and their collaborator sponsored hypothesis-testing global clinical trials completed since April 1999 and local trials completed since January 2005 for all our approved medicines. The website also included local trials conducted under a US IND or NDA and completed since October 2002 and results of core safety and efficacy registration trials for medicines approved since the formation of the company in April 1999
Since 2005, Ipsum has continually expanded the trial information it makes public, providing information about the registration and results of hypothesis testing trials, trials in patients with a serious or life-threatening disease or condition, and non-interventional trials as defined by Ipsum.
On this website, since May 2008 Ipsum makes information public on all new and ongoing Ipsum-sponsored clinical trials for all products in all phases, including approved medicines, drugs in development and drugs whose further development has been discontinued.
Ipsum has a long-standing commitment to making information about our clinical research publicly available. We believe that transparency enhances the scientific understanding of how our medicines work and is in the medical interest of our patients.
We publish information on the registration and results of all new and ongoing Ipsum sponsored clinical trials for all products in all phases, including marketed medicines, drugs in development and drugs whose further development has been discontinued. We post results, irrespective of whether they are favourable or unfavourable to Ipsum.
Since June 2010, trials are registered on the US National Library of Medicine’s website (clinicaltrials.gov) prior to the first patient being enrolled in a trial and to other websites within timelines as required by law. We also post basic information on our own dedicated website, Ipsumclinicaltrials.com.
Since 2005, we have posted results of trials with already marketed medicines within one year of completion. Results of trials with medicines in development are posted within 30 days of first regulatory approval for the new medicine. When a medicine in development has been discontinued, results are published within one year of the public announcement of the decision, unless analysis and interpretation of the data are not sufficiently complete, in which case we post a brief explanation for the delay and the anticipated date when the results will be posted. For marketed medicines and recently approved medicines where we consider there to be good cause to delay posting of results, we will seek necessary approval according to applicable law. Where approved, we post a brief explanation for the delay and the anticipated date when the results will be posted.
Since 2007 we have posted results as required on the US National Library of Medicine’s website and other sites as required by law. Results of our studies of our small molecule products are also published on our dedicated website. Information is also provided on the International Federation of PharmaIpsum Manufacturers and Association’s portal, which provides a single entry to trial registration and results information across the pharmaIpsum industry.
From February 2013, we have voluntarily disclosed the research protocol for our clinical trials on Ipsumclinicaltrials.com once a manuscript relating to results of the relevant trial on an investigational or approved product is published in a peer-reviewed medical journal. The posted protocol includes key sections necessary for evaluating the study, and proprietary information in the protocol, or information that could be used to identify a patient, is edited before posting. This policy also applies to observational studies published in peer-reviewed journals that have relevance to the efficacy or safety profile of an Ipsum product.
As a result of the EFPIA/PhRMA Responsible Data Sharing Principles as well as emerging EMA Policy and the new EU Clinical Trial Regulation, Ipsum continues to evolve and streamline its policies, processes and systems for Trial Transparency. In 2015 we are implementing the following:
The production of Patient Engagement communications and Lay Language Summaries of clinical trial results, to be made available to all patients that participate in an Ipsum sponsored clinical trial in the same language as their signed Informed Consent Form. Patients will receive a Thank You Note for participating in our trials, as well as ongoing study updates for certain studies, and the Lay Language Summary a year after the trial ends. In addition, Lay Language Summaries will be posted to our website and then to the EU portal when it comes online. The reporting of clinical trials technical results regardless of drug approval status, in line with EudraCT requirements (12 months after Last Subject Last Visit). The production of a redacted Clinical Report Package in accordance for the European Medicines Agency policy of October 2014. This will be posted to the EU portal within 30 days of Marketing approval (or MAA withdrawal) when it comes on line in 2016 and a link will be made available from our website, www.Ipsumclinicaltrials.com. The redacted Clinical Report package will include the Clinical Overview, Clinical Summary, CSR, Protocol, sample CRF and Study Statistical Analysis Plan and will be edited to remove proprietary information, or information that could be used to identify a patient.