Preclinical and Clinical Trial Requirements
A brief overview of the situation regarding preclinical and clinical trial requirements in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
See [Regulatory, Pricing and Reimbursement Overview, Section 3 b)]; new medical products must undergo an evaluation of quality. In order to obtain a MA, the pharmaceutical company has to submit sufficient data regarding the quality of the medical product.
Clinical documentation, including results from clinical trials, is required as a part of an application for MA.
There is however not a requirement that the clinical trials must be conducted locally; but rather the requirement is that it can be documented that the clinical trial fulfills both research ethical standards/requirements and requirements for good clinical research practice under the Directive 2001/20/EC. Thus, if the clinical trial has been conducted outside the EEA, documentation for fulfillment of these requirement has to be submitted as a part of the application for marketing approval.
2. How are clinical trials funded?
There are several alternatives for financing a clinical trial. Usually clinical trials would not be funded as a part of the ordinary healthcare financial mechanism, but rather through regional, national or international research funds or funded and initiated by private industry.
It is required that the sponsor is seated or represented by an agent by proxy within the EEA. In the latter case the proxy must be documented to the NoMA. The sponsor shall ensure that the trial product/composition with possible associated equipment is made available for free.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
A pre-approval is required before the commencement of a clinical trial. Clinical trial can only be initiated if there is a prior approval from the Ethics Committee, and the NoMA does not object to the clinical trial. Thus, the protocol is subject to the assessment and approval of both the Ethics Committee
and the NoMA.
In examining the application, the Ethics Committee shall in particular
- the relevance and design of the clinical trial;
- whether the estimated risk and disadvantage has been weighed against the benefit of the individual subject and other current and future patients, and whether the conclusion is justified;
- the protocol;
- the suitability of the examiner and the other staff; the investigator’s brochure;
- the suitability of the test site;
- the relevance and completeness of the consent form and the information process related to obtaining informed consent;
- the justification for research on persons who are unable to give informed consent;
- the provisions for compensation or compensation if a subject suffers injury or dies as a result of a clinical trial;
- insurance or allowances to cover the liability of the examiner and sponsor;
- the size and the detailed rules for the payment of any fees or compensation to the examiners and subjects;
- the relevant clauses in any intended contract between sponsor and testing site; and
- how the subjects are recruited.
The Ethics Committee shall give its opinion to the applicant and to the NOMA no later than 60 days after the complete application has been received.
4. What are the requirements for consent by participants in clinical trials?
Before the commencement of a clinical trial, the participant/test subject shall be informed with regard to the purpose of the test, the benefit and risk associated with the trial participant’s participation, the conditions for conducting the trial and that the test subject may withdraw from the trial at any time.
Before the clinical trial is initiated, the test subject must give his / her (informed) consent to participate in the trial. Thus, the consent shall be given after the required information has been provided / received. If written consent cannot be given, the consent may be given orally. Oral consent must however be attested by an independent witness.
A consent to participate in a clinical trial may be revoked at any time. Patient data and biological material collected until the consent is recalled will be included as study data, but no further data will be collected.
5. May participants in clinical trials be compensated?
Compensation is neither prohibited, nor – similar to international guidelines – directly regulated in the national rules.The size and the detailed rules for the payment of any fees or compensation to the examiners and participants is, as set out under question 18 above one of the elements to be considered by the Ethics Committee.
Generally the participant is compensated for travel expenses and if applicable the time spent, (lost income). Any compensation exceeding coverage of the participant’s costs is generally limited. The approach is restrictive, as it is considered from a medical ethical point of view; the compensation should not induce the participant to be more willing to participate and/or continue to participate than without the compensation.
Patients participating in clinical trials may also be entitled to have travel expenses covered provided that the clinical study has been approved by the health enterprise. The clinical trial is then considered as medical treatment and travel expenses are covered according to current rules.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The sponsor is obliged to insure the test persons participating in the test satisfactorily against any damage that may occur during the test. As set out in the Product Liability Act, provides a special regulation for damages to natural persons caused by pharmaceuticals, also during trials (e.g. clinical trials).