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 Clause 13 - Clinical Trials and Non-Interventional Studies of Marketed Medicines

13.1 Companies must disclose details of clinical trials in accordance with the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature.

13.2 A non-interventional study of a marketed medicine is defined as a study where the medicine is prescribed in the usual manner in accordance with the terms of its marketing authorization. The assignment of the patient to a particular therapeutic strategy is not decided by a study protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.

13.3 Companies must publish the summary details and results of non-interventional studies of marketed medicines in a manner consistent with their parallel obligations with respect to clinical trials.

13.4 Non-interventional studies that are prospective in nature and involve the collection of patient data must be conducted for a scientific purpose. They must comply with the following criteria:

  • there must be a written protocol and written contracts between the health professionals and/or the institutes at which the study will take place and the pharmaceutical company sponsoring the study, which specify the nature of the services to be provided and the payment for those services
  • any remuneration must be reasonable and reflect the fair market value of the work
  • in countries where ethics committees are prepared to review such studies, the study protocol must be submitted to the ethics committee for review
  • data protection legislation must be complied with
  • the study must not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicine
  • the company’s scientific service must approve the protocol and must supervise the conduct of the study
  • the study results must be analysed and summaries must be made available within a reasonable period of time to the company’s scientific service, which service shall maintain records of such reports; the summary report should be sent to health professionals who participated in the study. If the study results are important for the assessment of benefit/risk, the summary report should be immediately forwarded to the relevant competent authority
  • sales representatives may only be involved in an administrative capacity and such involvement must be under the supervision of the company’s scientific service which will also ensure that the representatives are adequately trained for the role; such involvement must not be linked to the promotion of any medicine.

Clause 13 Supplementary Information

Clause 13 Good Pharmacovigilance Practices

Attention is drawn to the ‘Good pharmacovigilance practices’ page on the European Medicines Agency website. (www.ema.europa.eu)

Clause 13.1 Details of Clinical Trials

This clause requires the provision of details about ongoing clinical trials (which must be registered within 21 days of initiation of patient enrolment) and completed trials for medicines licensed for use in at least one country. Further information can be found in the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 2009 and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature 2010, both at http://clinicaltrials.ifpma.org.

Companies must include on the home page of their website information as to where details of their clinical trials can be found.

Details about clinical trials must be limited to factual and non-promotional information. Such information must not constitute promotion to health professionals, appropriate administrative staff or the public.

Clause 13.3 Publication of Details and Results

This requirement applies to non-interventional studies completed on and after 1 May 2011 with which a UK company has had any involvement. Companies are, however, encouraged to publish details and results of such studies completed prior to that date.

Clause 13.4 Other Studies Covered by Clause 13.2

Companies are encouraged to comply with Clause 13.4 for all other types of studies covered by Clause 13.2, including epidemiological studies and registries and other studies that are retrospective in nature. In any case, such studies are subject to Clause 18.7.

Clause 13.4 Approval and Supervision

The approval and supervision of non-interventional studies are dealt with in Clause 22.2.

Clause 13.4 Date of Implementation

Companies must comply with Clause 13.4 in relation to noninterventional studies that are completed on or after 1 July 2008. Companies are encouraged to comply in relation to studies completed prior to that date.