Clinical trial results, whether favourable and unfavourable

Today's post is authored by Tim Garnett, Lilly's Chief Medical Officer and Senior Vice President, Medicines Development Unit.

Put simply, our goal is to make life better for people around the world. Sharing the results of our clinical trials and ensuring this information is available to the people who need it is part of that goal.  There are important public health benefits to be gained from open access and transparency of clinical trial information. That’s why Lilly is committed to register all our trials and to disclose the results of the company’s clinical trial data.

To benefit patients and healthcare professionals, sharing clinical research, trial outcomes and safety information has to be done with care. This is imperative for any data released to ensure that it is not misinterpreted or misused. Protecting individual patient privacy is a vital component of that. We also need to protect our intellectual property, including commercially confidential information and contract rights, which support our continued innovation.

Here are 7 ways in which we are committed to responsibly disclose our clinical trial data results for the benefit of patients and future research:

  1. Whether favourable or unfavourable, Lilly posts the results of all Lilly-sponsored Phase II, Phase III and Phase IV clinical trials of Lilly marketed products conducted anywhere in the world that were initiated on or after October 15, 2002.
  2. Results from all Phase III clinical trials and any clinical trial results of significant medical importance are submitted for publication. We don’t just do this for medicines that have met their clinical goals and been approved for use – we also disclose results for investigational medicines whose development have been discontinued.
  3. We register all Lilly-sponsored Phase II, Phase III and Phase IV clinical studies, conducted anywhere in the world, that were initiated on or after October 15, 2002, on www.clinicaltrials.gov.
  4. Lilly also registers all Phase I clinical studies commencing on or after October 1, 2010 on www.clinicaltrials.gov.
  5. Lilly, along with the industry as a whole, has started posting results to the European database www.clinicaltrialsregister.eu. Our first results were submitted on 21 July 2015. We are updating results for trials conducted in the EU on our marketed products back to trials from 2004.  This is a 2 year process and will be completed in 2016.
  6. Lilly discloses results of Lilly-sponsored clinical trials for compounds whose development terminates on or after October 1, 2009. This includes Lilly-sponsored Phase I clinical trials in patients that initiated on or after October 1, 2009 and Lilly-sponsored Phase I clinical trials in healthy volunteers that initiated on or after October 1, 2010.
  7. We have an online portal to facilitate requests from legitimate researchers for clinical trial data here: www.clinicalstudydatarequest.com 

We are not alone in these efforts, and continue to support industry-wide initiatives.The EFPIA/PhRMA Joint Principles for Responsible Clinical Trial Data Sharing, implemented on 1 January 2014, underscore the pharmaceutical industry’s commitment to disclosing clinical trial data. In the UK, recent research found that 91% of clinical trial results for medicines approved in 2012 had been disclosed within 12 months of regulatory approval or trial completion, up from 71% in 2009. This clearly demonstrates that real progress is being made.

Delivering increased transparency and responsible data sharing is a process of continuous development, set to be enhanced by the availability of real-world data from patient registries, hospitals and general practitioners. All healthcare stakeholders, from the pharmaceutical industry through to policy makers and healthcare professionals, have a role in working together to develop systems that can maximise the potential of big data while ensuring we continue to protect the identities and confidentiality of the patients who make our research possible.