Adaptive pathway seeks to maximize the positive impact of new drugs on public health by balancing timely access for patients, with the need to provide adequate evolving information on benefits and risks.

Adaptive pathways can be defined as a proactively planned, adaptive approach to bringing drugs to market. This approach enables a medicinal product to be authorised for use in a controlled/limited patient population, during which additional clinical evidence is collected and assessed. The authorisation may then be applied to a larger patient population. The approach allows an expedited access to medicines in unmet medical need areas, while still shielding the more general public from risks associated with the product until further data can be assembled.

The purpose of the Adaptive pathways is to use the regulatory procedures within the current EU legal framework, including scientific advice with Regulators and/or HTA bodies, compassionate use programs, conditional marketing authorisation, marketing authorisation under exceptional circumstances, risk management plans, patient registries, etc.

Adaptive pathways in the EU

Adaptive pathway is based on the three principles defined by EMA:

  1. Iterative development,
  2. Gathering of evidence through real-life data to supplement clinical trial data and
  3. Involvement of patients as well as Health Technology Assessment (HTA) bodies/Payers in the product development design.

Latest Glossary Definitions

Monitoring Plan

Describes the monitoring methods, responsibilities, and requirements for the trial. It includes a brief description of the study, its objectives, and the critical data and study procedures.

The plan describes the reference policies and procedures to follow.

Project Management Plan

The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide guidance on a specific project.

EUDAMED

Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

ISO14155

International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

Redaction

In relation to Policy 70, the process of permanently obscuring CCI or PPD in the clinical documentation submitted to EMA by the applicant/MAH before the documents are published. Tthe redaction should appear as a light blue box with a black 'PPD' label or as a black box with a red 'CCI' label.

Protection of personal data (PPD)

In relation to Policy 70, “Personal data” is any information relating to an identified or identifiable natural person; an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his

Informed Consent Form (ICF)

Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent before participating in a clinical trial.

Lay person summary (of a clinical trial)

The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of clinical trials in a format understandable to laypersons. These lay person summaries will be made available in the EU Portal and Database.

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