INVESTOR NEWSLETTER ISSUE N°3
automation of the FDA review environment will be one of the biggest and best things that they can do for themselves and that this is enabled by eStudy Data Standards.
She went on to discuss DataFit, explaining that it is moving along now and that they were pleased with its progress. This project was spearheaded by Dr. Chuck Cooper and is an initiative that evaluates data in submissions/validates standardized data. Ms. Slack closed by stating that clinical study data standards are an international need and asset; the standards need to be flexible, sustainable, and used to realize their full value. Much progress has been made, but there is still much to do.
Dr. Ron Fitzmartin, Senior Advisor for the Data Standards Program at FDA, started his presentation by saying that they would not be where they are today without Dr. Chuck Cooper (who represented FDA at last year’s CDISC Europe Interchange but has since moved on to a new career and is also a member of the CDISC Board of Directors). In 2004, FDA indicated its support for CDISC standards for eSubmissions; 10 years later, FDA posted a Position Statement about CDISC standards. Data standards are at the foundation supporting the regulatory review process. Standards have a major impact on data quality.
Dr. Fitzmartin showed a slide entitled: “How do the standards support regulatory review?” Shown were five pillars: Predictability, Traceability (Provenance), Reproducibility, Communication, and Common Tools.
Dr. Fitzmartin explained that FDASIA states that FDA has the authority to require electronic submissions in the format needed. FDASIA Reauthorized PDUFA V, section 12, which discusses the development of clinical data terminologies through open standards development (i.e. CDISC). The draft binding Guidances and Technical Guide are out for review. They reference the Data Standards Catalog (DSC).
Dr. Fitzmartin closed with responses to two questions. Q: Will there be waivers? A: No (except for some granted to use retired versions of the standard). And, Q: Can FDA refuse to file? A: Yes. The data must conform to the DSC.
He also presented later in the afternoon in the CFAST session. Please refer to page 2, “The Glass Half Full with CFAST” for more on this topic.
Dr. Fergus Sweeney, head of Compliance and Inspection Sector at the European Medicines Agency (EMA) presented on Thursday afternoon, 10 April. He gave an overview of what EMA is doing in terms of standards and eData. He
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mentioned that EMA published in 2010 their Guidance on eSource, which includes 12 requirements from the CDISC eSource Data Interchange document and is intended to encourage use of eSource to streamline research.
He commented on the EMA data strategy around medicinal products, investigator site information and datasets that can be used across various stakeholder systems. He spoke about pro-active pharmacovigilance through signal detection. EMA received 1.2 M ICSRs (Individual Case Safety Reports) last year, 200 of which were discussed at advisory meetings and ~ 50% resulted in label changes or other steps to protect the public.
He also mentioned the EMA’s pro-active Clinical Trial Data Publication Policy. There will be a final round of consultation with stakeholders in May this year and there was a press release out the prior evening (9 April) on this topic. The final policy is to be submitted to their board for endorsement in June with final implementation after that. Dr. Sweeney emphasized that the EMA is committing to the full sharing of data. This was reinforced by the clinical trial legislation voted in the week prior to the Interchange by parliament in a nearly unanimous vote (over 500 for, only 17 against, with 13 abstentions).
He mentioned that there will be legislation that includes the need for a system at EMA that will take care of full registration and submission results. There will be one application dossier to EMA, regardless of the number of member states involved, and one decision to be posted following review. He stated that they need standards for structured data for registration of the trial, substance, product, organization, structured documents for results reporting and other areas. He stressed that they certainly did not want to reinvent the wheel, and accordingly would be looking to CDISC for assistance in the future.
Dr. Sweeney closed by saying: “Good data supports good decision-making.” Patients should be able to make decisions for themselves based on knowledge.
“Good data supports good decision-making.” - Dr. Fergus Sweeney, EMA
During the closing panel, there was an interesting discussion initiated by Dr. Kalra, who quoted PWC Pharma 2020: “Information about patients and the medicines they need will become as important as the medicines they need,” after which he challenged the pharma industry to prepare for this
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