EMA Launches Public Consultations to Revise Three Scientific Guidelines

Public consultations concern revision of the guidelines on evaluation of anticancer medicinal products, multiplicity issues in clinical trials and investigation of drug interactions

The European Medicines Agency (EMA) has recently launched three public consultations for which the feedback is expected by 30 June 2017.

EMA launches a public consultation on the concept paper to revise the guideline on the evaluation of anticancer medicinal products

The EMA has launched a public consultation on the concept paper on the need to revise the guideline on the evaluation of anticancer medicinal products in man. The EMA scientific guideline on the clinical evaluation of antineoplastic and immunomodulating agents was revised in 2010 and included a disease specific guidance. This guidance was later expanded to constitute a separate appendix: the Appendix 4. The concept paper on the need to revise the guideline on the evaluation of anticancer medicinal products in man describes and discusses the basis for the revision of the Appendix 4 in relation to the use of minimal residual disease (MRD) as a clinical endpoint in multiple myeloma (MM) clinical studies.

Indeed, MRD has been recognised as potentially important clinical endpoint in MM and other haematological malignancies. Several clinical trials have reported that non-detectable MRD status is prognostic for both progression-free survival and overall survival in MM. In addition, in 2016, the International Myeloma Working Group published consensus criteria for response and MRD assessment in myeloma. Thus, there is a need to reflect on the utility of MRD in the development of medicinal products for treatment of MM as primary intermediate efficacy endpoint.

The concept paper is available here. The comments should be sent to ONCWPsecretariat@ema.europa.eu by 30 June 2017.

EMA launches a public consultation on the guideline on the multiplicity issues in clinical trials

The EMA has launched a public consultation on the guideline on the multiplicity issues in clinical trials. This guideline is intended to provide guidance on how to deal with multiple comparison and control of type I error (the probability to reject at least one out of several true null hypotheses) in the planning and statistical analysis of clinical trials.

The main scope of this guideline is to provide guidance on the confirmatory conclusions which are usually based on the results from pivotal phase III trials and, to a lesser extent, on phase II studies. The guideline mainly discusses the issues in decision-making for a formal proof of efficacy. The guideline does not attempt to address all aspects of multiplicity but mainly considers issues that have been found to be of importance in European marketing authorisation applications.

The guideline is available here. The comments should be sent to multiplicity-gl@ema.europa.eu by 30 June 2017.

EMA launches a public consultation on the concept paper for the revision of the guideline on the investigation of drug interactions

The EMA has launched a public consultation on the concept paper for the revision of the Guideline on the investigation of drug interactions. The concept paper proposes a further update to reflect recent scientific knowledge and experience in applying the guideline since it came into force.

The first revision of the Guideline on the investigation of drug interactions was adopted by the EMA’s Committee for Medicinal Products for Huma Use in June 2012.

Now, the EMA aims to provide further recommendations on the in vitro and in vivo study designs. There are a series of articles stating that cancer drug resistance remains a major cause of death of cancer patients. To this end, some members of the academia note that there is a clear need to develop clinically-relevant and novel in vivo models and technologies to test and attempt to predict drug sensitivity and the likelihood of resistance.

The concept paper is available here. The comments should be sent to PKWP@ema.europa.eu by 30 June 2017.