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May 4, 2015

REMS Update
Modifications and Revisions on the FDA Guidance

A Risk Evaluation and Mitigation Strategy (REMS) is a required risk management plan that uses tools beyond the prescribing information (the package insert) to ensure that the benefits of certain drugs outweigh their risks.

In the current regulation the FDA stated that any proposed modification to an approved REMS, including proposed changes to materials that are appended to the REMS document, must be submitted as a proposed REMS modification in the form of a prior approval supplement (PAS), and must include a REMS assessment. The guidance states that the proposed modification(s) may not be implemented until approved by the FDA.

FDASIA (Food and Drug Administration Safety and Innovation Act) amended the REMS modification provisions under section 505-1(g) and (h) of the FD&C Act. Section 505-1(h), as amended by FDASIA, requires the FDA to review and act on proposed minor modifications, as defined in guidance, within 60 days It also requires the FDA to establish, through guidance, that certain modifications can be implemented following notification to the FDA. In addition, FDASIA requires the FDA to review and act on REMS modifications to conform the strategy to approved safety label changes, or to a safety label change that the FDA has directed the application holder make pursuant to section 505(o)(4) of the FD&C Act, within 60 days. Finally, FDASIA specifies that proposed REMS modifications no longer require submission of a REMS assessment; instead, proposed modifications must include an adequate rationale for the proposed changes.

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Faster Clinical Trial results reporting
Using TrialScope Convert can help you speed up your clinical trial results – and it is free!

TrialScope Convert is a free online service that uses a results xml file as input source and converts it to the xml format required for EudraCT results reporting. If you are up against the July 21, 2015 deadline for submitting clinical trial results, TrialScope Convert could help to speed up your process.

TrialScope Convert reduces data entry by as much as 85%. It also enables sponsors to take advantage of data that was previously reviewed, QC'd and approved for submission to One sponsor who previewed the service estimated that they would save 5-8 hours per study on data entry alone!

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Providing patients with outcomes of clinical trials
Initiatives to informing patients after their participation in a clinical trial of the outcome

According to surveys conducted by the Boston-based Center for Information and Study on Clinical Research Participation (CISCRP) and published in 2012, over 90% of clinical trial participants never hear back—they receive no oral, written or digital communication—about the trials they contributed to (Exp. Rev. Clin. Pharmacol., 5, 149–156, 2012). Historically, and in the majority of cases even today, there are no promises made about making trial results available to participants. But a 2013 survey conducted by CISCRP of more than 5,600 volunteers found that the prospect of receiving results was one of the top five reasons for people to participate in trials at all. So even though there are no promises made by study investigators, participants do come in with an expectation of receiving results.

Now a growing number of researchers, disease foundations and advocacy organizations are working to improve patient access to data from clinical trials in which they participated.

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WHO Statement on Public Disclosure of Clinical Trial Results
Ethical imperative and timeframe definitions

Before any clinical trial is initiated (at any Phase) its details are to be registered in a publicly available, free to access, searchable clinical trial registry complying with WHO’s international agreed standards. The clinical trial registry entry should be made before the first subject receives the first medical intervention in the trial. But this is only the first step. According to WHO standards it is also required to updating clinical trials postings regularly and to report on the main findings and key outcomes in a pro-active way.

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Clinical Trial Oversight Summit Boston
Peter Schiemann to speak at the Clinical Trial Oversight Summit, Boston, MA, June 1-3, 2015

The first topic Peter will cover is focusing on the changes in the relationship(s) with your CRO(s) when you implement a Risk-based Monitoring (RbM) approach and how you need to prepare for this new challenge. The second presentation will be about the fundamentals of implementing RbM, e.g.

  • What is the reason for the difficulties that sponsors face when implementing a risk-based approach to monitoring?
  • How can we overcome these difficulties? What are the key elements that need to be considered?
  • How come most of the sponsors cannot realize the cost saving potential that risk-based monitoring promises?
  • What needs to be done to make it happen?
  • With monitoring focused where it really matters, how can we detect real quality improvements?

As registered recipient of our newsletter you are eligible for a discount: Mention key code “SPK00” when registering online and you will save $200 off a commercial conference registration / $100 off an academic, hospital or government affiliated registration to any conference at the Clinical Trial Oversight Summit. If you register before May 8th, you are eligible for the lowest conference rate.

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Endpoint Adjudication Methods used in Clinical Trials for 69% of the NMEs approved by FDA and 41% by EMA (phase III in 2013/14)
Beat Widler with Ken Getz from Tufts University and colleagues from our partners published a research article on DIA’s Therapeutic Innovation & Regulatory Science, Journal

The objective of that paper was to analyze how often adjudicated methods across efficacy and safety assessments were used in drug approvals in the European Union and United States in 2013 and early 2014. Methods: A total of 35 new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) and 88 European Medicines Agency (EMA) approvals in Europe were included in this analysis.

A goal of this publication was to contribute to more robust processes and approaches in the adjudication of endpoints what should allow better protecting patients’ safety and data integrity.

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