Clinical Research Site: University Hospitals Coventry and Warwickshire NHS Trust
Clinical Research Team: PPD
Clinical Research Associate: Victoria Hawkins, PRA International
Clinical Trial Administrator: Lara Edmondson, Chiltern International
Project Manager: Amy Sweet, Roche Products
Team Leader: Greg Trevelyan, Roche Products
Clinical Company: PRA International
ClinDev would like to echo the congratulations of the judging panel and all the attendees at last night’s gala dinner – this is a multi-stage competition with increasing numbers of entrants from across Europe, so these winners really are the “best of the best”!
Update: In my haste to publish this post, I confused the Clinical Research Team award, which was won by PPD, with the Clinical Company award, which was won by PRA International. My apologies to all concerned for the mix-up, and my thanks to Tom Poole of PPD for spotting my error.
Writing on the Forbes website, former Pfizer president John LaMattina criticized Roche for issuing a press release stating that its developmental drug bitopertin was no better than placebo in treating negative symptoms of schizophrenia in two phase III clinical trials, while four further clinical trials are still in progress. While he found the degree of transparency noteworthy, LaMattina is concerned that the announcement could have an influence on patients, particularly in a case like this, where the studies relate to measuring moods and emotions.
In the piece, he quotes Dr. Steven W. Ryder, former head of Clinical Development at Pfizer, who added “Bias influencing both arms may dampen, augment or leave unchanged the difference between trial arms. One thing for sure: Roche will likely have to perform an analysis of data gathered before and after the announcement.”
ideaPoint, Inc. has announced a new portal providing a secure system for researchers to request access to anonymized, patient-level clinical trial data provided by sponsor organizations. Sponsors who have committed to provide data through the site currently include:
In addition to research proposals to request data from clinical trials already listed on the site (clinicalstudydatarequest.com), researchers can also submit inquiries to some study sponsors to ask about the availability of data from studies not yet listed. Following approval by the Independent Review Panel, researchers are asked to sign a Data Sharing Agreement. A summary of the requirements in this agreement and an agreement template are provided on the site.
I’ve updated my 60-minute webinar to reflect the latest changes to policy around clinical trial transparency. Running on multiple dates through September, ClinDev subscribers and ICR members can save £20 on the standard delegate rate.
Under the new commitments, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients, and members of the public.
Patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and European Union will be shared with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information. Researchers who obtain such clinical trial data will be encouraged to publish their findings.
Companies will work with regulators to provide a factual summary of clinical trial results to patients who participate in clinical trials.
The synopses of clinical study reports for clinical trials in patients submitted to the Food and Drug Administration, European Medicines Agency (EMA), or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.
Biopharmaceutical companies have also reaffirmed their commitment to publish clinical trial results regardless of the outcome. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication.
In a few minutes’s time, the UK Commons’ Science & Technology Select Committee will hear oral evidence in its inquiry into clinical trials and data transparency. The proceedings will be reported here tomorrow, but you can watch the session live here. It should also be possible to watch a recording of the proceedings from the same page.
Contributions will come from:
Dr Catherine Elliott, Director, Clinical Research Interests, Medical Research Council
Sharmila Nebhrajani, Chief Executive, Association of Medical Research Charities
Professor Peter Johnson, Chief Clinician, Cancer Reasearch UK
Nicola Perrin, Head of Policy, Wellcome Trust
Dr Bina Rawal, Director of Research, Medical and Innovation, Association of the British Pharmaceutical Industry
Dr James Shannon, Chief Medical Officer, GlaxoSmithKline
William M. Burns, Member of the Board of Directors, Roche
Dr Ben Goldacre, Wellcome Research Fellow in Epidemiology, London School of Hygiene and Tropical Medicine
This session will look into issues around the sharing of clinical trial data, continuing from the first session, which took place on March 13th.
Discussions at the IOM workshop has moved the conversation around clinical trial data sharing from whether it should occur, to how it can be enabled, which also mirrors the view of the European Medicines Agency. As data holders are beginning to individually generate policies for clinical trial data access, better alignment among stakeholder actions will be necessary to harness the full potential of data sharing.
The decision today by India’s Supreme Court to deny Novartis a patent for its cancer drug Glivec® (imatinib mesylate) has been welcomed by Indian patient activists and generics manufacturers. However, it causes concern for the Swiss pharma company, along with Pfizer, Bayer and Roche, who are currently challenging patent decisions in India for their drugs Sutent, Nexavar and Pegasys respectively. The implications for pharma investment in R&D in India will also be worrying for the growing India CRO sector.
The Supreme Court ruled that the patent application was an example of “evergreening” – making a small alteration to an existing drug in order to gain additional patent protection. The compound is based on a drug originally patented in 1993, and its patent in the USA was granted an extension to expire in 2015. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited, stated that “Novartis has never been granted an original patent for Glivec in India” and that the company “provides Glivec free of charge to 95% of patients prescribed the drug in India, currently more than 16,000 patients”.
The ruling also raises questions around global pharma’s willingness to invest in India, which has a massive population although many of them cannot afford conventional drug prices. Issues around protection of Intellectual Property have dogged India for many years, with pharma patenting only being introduced in 2005. Novartis has previously said it needs legal certainty if it is to plan further investment in drug research in India, and other companies will doubtless be considering this when distributing their global R&D investment.