FDA agrees to IRB Waivers for Minimal Risk Studies
The FDA recently issued new guidance [1] to sponsors, investigators and institutional review boards that it did not intend to object to an IRB waiving informed consent requirements for certain minimal risk investigations. The new guidance provides clarity on what had previously been reviewed on a case by case basis by the FDA.
The positive effect of this new guidance will to facilitate sponsor and Investigator’s ability to conduct studies that may contribute to the development of products to diagnose, treat diseases, conditions or address unmet medical needs.
The FDA also outlined it does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters consent requirements meeting roughly the same criteria as for an IRB waiving some informed consent requirements [2]
International Conference for Harmonisation provides update for Planned Guidance on Collecting Safety Data
International Conference for Harmonisation (ICH) has released a concept paper and business plan regarding its upcoming Guideline ICH E19, on targeted approaches to safety data collection.
The Guideline will provide internationally harmonised guidance on when it would be appropriate to use a targeted safety data collection approach in specific late stage pre or post marketing studies and how to implement such an approach. The aim of targeted safety data collection approaches is to reduce burden on patients and investigators and increase the number of clinical trials and participants.
The ICH stated the Guideline will be consistent with existing practices, and that the ICH E19 business plan will be finalised by November 2019 and ready for implementation by June 2020 [3].
International Conference for Harmonisation Good Clinical Practice Revision 2 is now in effect
While the International Conference for Harmonisation (ICH) Good Clinical Practice (GCP) Revision 2 (ICH E6 R2) came into effect on 14 June 2017 [4], many biotechnology and drug development companies are still working to include the updated guidelines into their research activities.
The new guidance recognises that the scale and complexity of clinical trials has changed and that GCP needs to be modernised to include more efficient approaches to clinical trial management. Sponsors should focus on activities which have the greatest impact on patient safety and data reliability.
The top five ICH E6 R2 key points sponsors need to be aware of and accommodate for in future clinical trial plans are:
1) Inclusion of a new Quality Management section
This new section mirrors the ICH Q9 Quality Risk Management Guideline and must now to be applied in Clinical Trial GCP. This involves sponsors implementing a Quality Management System using a risk-based approach. Risks at both a system and clinical trial level need to be identified, reviewed and reported throughout the life of the trial.
2) Sponsors need to ensure contracted CROs have a robust system for managing sub-contractors
The revised ICH GCP requires sponsors to have oversight of any trial-related functions carried out on its behalf; including those sub-contracted to another party by contracted CROs.
3) Sponsors should implement a risk based approach when considering validation methodology and use of computerised systems
The ICH E6 R2 now provides guidance regarding the increase of electronic data capture, computerised systems and data management. SOP’s covering all aspects, such as installation and use, are now required.
4) A risk-based approach to monitoring is now required
Sponsors need to implement a systematic, prioritised, risk based approach to monitoring their clinical trials. Sponsors can choose on-site monitoring, centralized (remote) monitoring or a combination of both. Centralized monitoring allows sponsors to access an overall picture of developing trial data and provides the ability to identify inconsistencies, trends or a lack of variability – which may not have been noticed during a single on-site monitoring visit or when reviewing patient/subject data set one at a time.
5) Corrective and Preventative Action (CAPA) has been incorporated into GCP
Sponsors should perform a Root-Cause Analysis and implement appropriate CAPA for any significant non-compliance which may or has the potential to affectpatient safety or reliability of trial results. The sponsor and CRO are required to have processes in place which describe how non-compliance during the trial will be handled. This includes any non-compliances by the Investigator/study site and by Sponsor/CRO staff.
For more information on how Novotech can assist your upcoming clinical trial, contact us via www.novotech-cro.com
Headquartered in Sydney, Novotech is internationally recognised as the leading regional full-service contract research organisation (CRO). With a focus on clinical monitoring, Novotech has been instrumental in the success of hundreds of Phase I - IV clinical trials in the Asia Pacific region. Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia Pacific presence included running clinical trials in all key regional markets. Novotech also has worldwide reach through the company's network of strategic partners.
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[1] US Food & Drug Administration (FDA), IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects
[2] Source: The Association of Clinical Research Professionals (ACRP), FDA Gives Industry Green Light on IRB Waivers for Minimal Risk Studies
[3] Source: Regulatory Affairs Professionals Society (RAPS), ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data
[4]European Medicines Agency, ICH E6 (R2) Good clinical practice