Tag Archives: Clinical trial data

US Institute of Medicine backs clinical data transparency

The US Institute of Medicine has published its report into transparency around clinical trial data. Somewhat behind policy developments in Europe on this topic, the US body first announced its intention to review the area in April 2014 and issued a discussion framework in January 2014.

In response to 23 public- and private-sector sponsors in the United States and abroad, the Institute of Medicine (IOM) assembled a committee to develop guiding principles and a practical framework for the responsible sharing of clinical trial data. In its report, Sharing Clinical Trial Data: Maxi­mizing Benefits, Minimizing Risk, the committee concludes that sharing data is in the public interest, but a multi-stakeholder effort is needed to develop a culture, infrastructure, and policies that will foster responsible sharing—now and in the future.

Specific recommendations in the report include that:

  • Data sharing plans are registered with the trial registration before the trial begins
  • Summary results are published within a year of a trial’s end
  • Full data sets from a clinical trial should be shared within 18 months of the trial’s end
  • Data sharing initiatives should be overseen by independent panels of experts and the public, and should be as transparent as possible.

The AllTrials campaign welcomed the report, but commented that its recommendations could have been stronger if they had included clear pathways to implementation and calls for audits of compliance.

EMA clinical data publication policy comes into force

On 1 January 2015 the new EMA policy on publication of clinical data entered into force. Under this policy, the Agency proactively publishes the clinical reports submitted as part of marketing-authorisation applications for human medicines. Since 2010 the Agency has been releasing clinical-trial reports on request, under its access-to-documents policy.

The policy will apply to clinical reports contained in all marketing-authorisation applications submitted after that date. The reports will be released as soon as a decision on the application has been taken.

The Agency embarked on this process because it believes that the release of data is about establishing trust and confidence in the system, because it will allow the public to better understand the Agency’s decision-making. In addition, academics and researchers will be able to re-assess data sets. The publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines.

EMA begins final steps on clinical trial data transparency policy

The European Medicines Agency (EMA) has announced that it will launch a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of and access to clinical-trial data at the beginning of May. This will give key stakeholders and the Agency the opportunity to address any outstanding issues before the final policy is presented to the EMA’s Management Board for endorsement in June 2014.

This consultation is meant to clarify and fine-tune specific aspects and achieve the broadest possible consensus and understanding of the policy. The targeted discussions will focus on the presentation by the EMA of the principles set for the possible redaction of the clinical study reports to be published. If applied, the redactions will be based on the criteria identified by the Agency for those parts ofclinical trial data that exceptionally contain commercially confidential information. They will also aim to clarify how the concerned data-owners (e.g. marketing authorisation holders) will be consulted before publication of their clinical study reports, and user-friendly technical measures to make the data accessible under the new policy including their terms of use.

Clinical Trials Regulation adopted by EU Council of Ministers

On April 14th, the Council of Ministers, representing the governments of member states of the European Union, formally approved a draft regulation aimed at facilitating and speeding up the authorisation procedure of clinical trials, following its agreement by the European Parliament in earlier in April.

This means that the regulation is now adopted. It will enter into force 20 days following its publication in the Official Journal of the European Union and apply six months after a EU portal for the submission of data on clinical trials and a EU database identifying each clinical trial have become fully functional (but not earlier than two years after the regulation’s publication).

The Regulation is expected to be published in the Official Journal early in May. This will begin an adoption/transition period that will last for just over over 5 years.

Novartis extends transparency initiative to patient-level data

Novartis has announced additional steps to further its transparency around clinical trial data. Researchers can also now request access to patient level data on newly approved innovative medicines in 2014 through the ideaPoint portal.

Novartis has long supported data transparency and was the first company to publish positive and negative study results of its innovative medicines within one year of the study completion further enabling clinical research while protecting patient privacy.

To date, Novartis has registered 2,720 trials on ClinicalTrials.gov and published 559 trial results on the same site as well as 1,777 clinical study summaries (known as “redacted clinical study reports”).

US Institute of Medicine issues discussion framework on clinical data sharing

The high-profile debate throughout Europe on clinical trial data transparency has been mirrored in the US, particularly within the Institute of Medicine.

In follow up to its October 2012 workshop, the IOM is conducting a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data. A discussion framework has been issued, outlining preliminary thoughts on guiding principles that underpin the responsible sharing of clinical trial data, defines key elements of data and data sharing activities, and describes a selected set of data sharing activities. One goal of this framework is to facilitate identification of the numerous complicated issues that the committee might need to take into account in the strategies and practical approaches to sharing of clinical trial data that will be recommended in the committee’s final report.

Comments may be submitted to the committee at either of two forthcoming public workshops, or via the committee’s project website. Comments will be most useful if submitted by March 24, 2014. The committee expects to release its final report with findings and recommendations on strategies and practical approaches to responsible data sharing in late 2014.

Janssen to share clinical trial data with Yale Open Data Access project

Johnson & Johnson has announced that its subsidiary, Janssen Research and Development, LLC, has entered into a novel agreement with Yale School of Medicine’s Open Data Access (YODA) Project that will extend its commitment to sharing clinical trials data to enhance public health and advance science and medicine.  Under the agreement, YODA will serve as an independent body to review requests from investigators and physicians seeking access to anonymized clinical trials data from Janssen, and make final decisions on data sharing. This is the first time any company has collaborated with a completely independent third party to review and make decisions regarding every request for clinical data.

“Sharing anonymized data from clinical trials is critical to advance public health because it furthers our understanding of diseases, expands the base of knowledge needed to develop new treatments, and generates new insights and more complete evidence to enable better healthcare decisions for patients – all while protecting patient privacy and confidentiality,” said Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson. “We are pleased to collaborate with YODA to ensure that each and every request for access to our pharmaceutical clinical data is reviewed objectively and independently.  This represents a new standard for responsible, independent clinical data sharing.”

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.

EMA restates commitment to publishing trial data

The European Medicines Agency (EMA) has announced that it has now reviewed all comments received on its draft policy on publication and access to clinical trial data. It has also updated its policy statements on “Release of data from clinical trials” and “Publication and access to clinical-trial data: an inclusive development process”.

While the comments received showed that there is large support for the Agency’s plans to allow access to clinical trial data submitted as part of marketing authorisation applications, they also highlighted that there is a need for further analysis and clarification of certain aspects.

The Agency will continue to work with stakeholders, including industry, academia and civil society organisations, to further clarify and fine-tune the proposed rules to achieve the broadest possible consensus. This work will be guided by a set of key principles that were agreed with the Agency’s Management Board on 12 December 2013. The policy on publication of and access to clinical-trial data and an implementation plan will be discussed at the March 2014 Management Board meeting.

The key principles include a stepwise approach for implementation with, as a first step, preparation for the publication of clinical study reports redacted as appropriate, the development of a methodology for de-identification of patients, and the definition of a standard format for the submission of data. The principles also foresee the introduction of preliminary steps prior to data access designed to address the risk of possible unfair commercial use of data while ensuring proactive and non-selective access (‘use control’ not ‘access control’).

The Agency reiterates its firm commitment to pursuing the objective of full transparency regarding clinical trial data. The Agency will continue to monitor progress in the Court cases brought by two pharmaceutical companies against the Agency and the on-going discussions on the new European clinical trials legislation. It recognises the need for consistency in the general approach to access to documents by EU institutions and bodies, while recognising the specificity of documents in the possession of the EMA and the Agency’s primary duty to protect and foster public health.

The Agency’s draft policy has prompted broad debate among an unprecedented range of stakeholders, including the important focus on the benefits to patients, and more generally to society of giving access to clinical trial data and on the best approach to achieve this. It has been the catalyst for various initiatives from the pharmaceutical industry, funding bodies and academia centres in this direction.

The Agency has embarked on developing its plans for the proactive publication and access to clinical-trial data because it believes that the release of data is about establishing trust and confidence. The Agency is also firmly of the opinion that wider availability of data broadens the scientific knowledge base, fosters innovation and encourages investment in the development of medicines and ultimately benefits public health.

HRA publishes guidance on registration of UK clinical trials

The Health Research Authority (HRA) has published practical guidance to clarify how the registration of all trials, required from 30 September, will work. All applications that receive a favourable ethical opinion from a Research Ethics Committee (REC) will, as a condition of that favourable opinion, be required to be registered in a publicly accessible trial register.

Accepted registers include the

 

The expectation is that all studies are to be registered before the first participant is recruited. However, research awarded a favourable opinion from a REC after 30 September 2013 will not be considered to be in breach of the favourable ethical opinion if the study is registered within 6 weeks of the first participant having been recruited (or, for medical device studies, within the timeline determined by the current registration and publication decision trees).