Blog Tag: foreign clinical studies

European Commission Proposes Stronger Cooperation for Health Technology Assessment

On January 31, 2018, the European Commission adopted a legislative proposal with the aim of strengthening EU cooperation among Member States when conducting a Health Technology Assessment (HTA) of new medicines and certain new medical devices. The European Commission Fact Sheet explains that HTA is a procedure for assessing the added value of new medicines and medical devices, for example, assessing whether a new scanner will lead to a better diagnosis or whether a new surgery will improve the patient’s treatment.

BEUC, the European Consumer Organization, explained in a press release that at the moment, around 50 national and regional HTA authorities provide Member States with clinical data, however, work carried out by one authority is often replicated by another, leading to inefficiency in EU health systems.

The Commission’s proposal establishes four areas of joint work between Member States at EU-level:

  • Joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients;
  • Joint scientific consultations, or “early dialogue,” whereby developers can seek advice from HTA authorities;
  • Identification of emerging health technologies, commonly referred to as ‘horizon scanning’, to identify promising technologies early; and
  • Voluntary cooperation on other areas.

In a press release, the Commission added that “manufacturers will no longer have to adapt to different national procedures.” Not all work will be done jointly, the Commission’s press release indicates that individual EU countries will continue to be responsible for assessing non-clinical (e.g. economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement. Thus, device manufacturers will still need to work with each Member State to determine pricing and reimbursement.

The Commission’s Q&A on the proposal explains that the joint clinical assessments will not affect market approval as they will only occur after the medical devices have obtained a CE mark. The Q&A also notes that HTA does not interfere with the conformity assessments of medical devices.

The Commission asserted in the Q&A that those benefiting from cooperation would include:

  • Patients, who may benefit from a faster uptake of promising innovative technologies;
  • Member States, whose national authorities will be able to pool their expertise and avoid duplication of efforts on clinical assessments, making better use of human and financial resources; and
  • Industry, including SMEs, who will benefit from clearer rules and greater predictability for their business planning, and cost savings.

In a statement to EURACTIV.com, Yannis Natsis, Policy Manager for the European Public Health Association, cautioned:

A European approach must improve on the current system and deliver meaningful innovation and affordable treatments. There must not be the slightest doubt that cooperation would weaken it or make the assessments less rigorous.

A timeline proposed by the Commission indicates that the proposal could be adopted by the European Parliament and the Council of Ministers in 2019, become applicable three years later, and then have a further three-year transitional period to allow for Member States to phase-in the new system.  The Q&A provides an example of a phase-in, suggesting the system could perform 10 to 15 joint clinical assessments in the first year of operation and reach around 65 assessments towards the end of the transitional period.

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices.  In view of the “increasingly global” nature of clinical research, the FDA issued the guidelines to clarify the standards under which foreign clinical data will be accepted.

Under the FDA’s existing framework, and in particular for Premarket Approvals (PMA), the FDA will accept foreign clinical data if it conforms with the 1983 version of the Declaration of Helsinki, or the local rules of the country in which the clinical study was conducted.  If using the local rules, the sponsor must detail any differences between the local rules and the Declaration, and explain why the local rules are more protective of human test subjects.  One of the proposed rules would require that foreign clinical studies used to support PMAs, Investigational Device Exemptions (IDEs), Humanitarian Device Exemptions (HDEs), and 510(k)s be conducted according to good clinical practice (GCP).

The FDA also states that, for many device premarket applications, like 510(k)s, PMAs, and de novos, foreign clinical data “can be used to support clearance or approval of the application” as long as the data constitutes valid scientific evidence under 21 CFR 860.7.  The FDA encourages sponsors to submit the foreign clinical studies for review through the FDA’s Pre-Submission process, before using the studies to support an application.

The draft guidance document further lists three special considerations that may be applied to foreign clinical studies to ensure that they satisfy FDA standards, namely (1) differences in clinical conditions, (2) differences in study populations, and (3) differences in regulatory requirements.  These special considerations are intended to identify whether the results of a foreign clinical study can be generalized to apply to US clinical practices, the US population, and FDA  requirements, respectively.  To illustrate application of these special considerations, the FDA has provided 7 examples and explains the outcome of applying the special considerations to the examples.

According to the Federal Register, public comments on the draft guidance document must be submitted to the FDA by July 20, 2015. Comments may be submitted online to Regulations.gov, or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.