The European Medicines Agency (EMA) recently released an addendum regarding International Conference for Harmonisation’s Guidelines on statistical principles for clinical trials (ICH E9) – with the addendum highlighting the importance of considering treatment effects when planning a clinical trial[1].
The new EMA addendum ‘aims to clarify the ICH E9 by elaborating on the choice of estimand and sensitivity analysis in clinical trials, providing a framework to align its planning, design, conduct, analysis and interpretation. The proposed framework aims to facilitate dialogue for the disciplines involved at the planning level of the trial; and also between sponsors and regulators regarding the treatment effects of interest that a clinical trial should address.’ [2]
“For physicians to best inform their patients on the medical choices available, it is crucial we have a clear means, language and accountability of describing the effects and efficacy a medicine may have. These descriptions are further complicated by the way each individual responds to treatment,” said Novotech CRO Associate Director of Medical Services Dr Radha Jha, “By agreeing at the start of clinical trial planning how the treatment effects of the product being investigated will be described (both efficaciously and non), we are providing a framework of how these effects can be recognised, statistically measured and assessed for safety during the trial.”
“At the start of each clinical trial, Novotech works closely with clients to implement an agreed system of identifying and measuring potential treatment effects, and how these will be accounted for statistically; as we understand the importance this may play in post marketing,” Dr Jha explained.
The EMA ICH E9 R1 Addendum will be open for comments until 28 February 2018.
More information about the EMA ICH E9 R1 Addendum can be accessed via the links below:
- ICH E9 statistical principles for clinical trials
- Draft ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials, step 2b - Revision 1
For more information on how Novotech can assist your upcoming clinical trial, contact us via www.novotech-cro.com/contact
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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] Regulatory Affairs Professionals Society, ‘EMA Opens Consultations of Two Revised ICH Guidelines’
[2] European Medicines Agency, ‘Draft ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials, step 2b - Revision 1’