Tag Archives: Roche

Clinical research community celebrates excellence at PharmaTimes awards

The cream of the European clinical research community came together in London last night to celebrate excellence at the PharmaTimes International Clinical Researcher of the Year awards. Sadly, due to a diary clash, ClinDev was unable to take up an invitation to attend, but we’re pleased to bring you the winners of the awards, as announced on the PharmaTimes twitter feed:

  • 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.

Ex-Pfizer head criticizes Roche over negative bitopertin study results

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.”


Portal launched to aid trial data transparency

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:

  • Boehringer Ingelheim
  • GlaxoSmithKline
  • Roche
  • Sanofi
  • ViiV Healthcare

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.

Updated webinar on clinical trial transparency running through September

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.

To find out more, and to book your place, visit https://clinicaltrialtransparency.eventbrite.co.uk/

EFPIA & PhRMA discuss transparency amid allegations

Pharmaceutical industry trade bodies in the EU (EFPIA) and USA (PhRMA) have published a joint statement setting out their principles of responsible data sharing for clinical research.

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.

This comes at a time when the EMA guidelines on data release are still under public consultation, but it is not clear whether this week’s statement goes any further than the system that is expected to come into place from 2014.

The announcement comes days after an EFPIA email was leaked by The Guardian newspaper, setting out a proposed strategy that includes “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data“. This proposal was attacked by the AllTrials.Net campaign, and representatives of both GSK and Roche were reported to have distanced themselves from the strategy.


Select Committee hears further evidence on clinical trial transparency

House of Commons logoIn 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.

Institute of Medicine to develop consensus study on strategies for sharing clinical trial data

The Institute of Medicine (IOM) recently held a workshop on Sharing Clinical Research Data. Following on from this event, the IOM has announced plans to develop a consensus study on strategies for sharing clinical trial data. The IOM is currently organizing a planning activity that will focus on developing an independent study that would provide guidance. A small planning meeting for potential sponsors and key stakeholders will be held in the near future.

The news has been welcomed by a group of pharma companies including AbbVie, AstraZeneca, Serono, GSK, Roche and Novartis.

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.

Glivec ruling frustrates Novartis, raises questions about pharma investment in India

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.