Preclinical & Clinical Trial Requirements
Preclinical & clinical trial requirements in Czech Republic – an overview. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No, clinical trials may be also conducted abroad. If a clinical trial was conducted in a country outside of the European Union, an affidavit confirming that the clinical trial met the ethical requirements of the European Union is required and forms a part of the marketing authorization application.
2. How are clinical trials funded?
In the Czech Republic, clinical trials are usually funded by sponsors from the pharmaceutical or medical devices industry. A sponsor is an individual, a company, an institution, or an organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. A sponsor may be represented on the basis of a power of attorney by an individual or a legal entity in matters related to the clinical trial (known as the Representative; this is usually a contract research organization). The sponsor, or its Representative, must be a resident of (if the Representative is an individual), or have its registered seat in (if the Representative is a legal entity), an EU member state. The financing arrangements of the clinical trial are generally regulated by a separate agreement between the sponsor and the investigator as well as the healthcare provider.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
A clinical trial protocol is a document describing the aim, arrangement, methodology, statistical consideration, and organization of a clinical trial for drugs, including any potential subsequent versions and amendments thereto. The clinical trial protocol (along with other documents) must be submitted to, and approved by, the relevant Ethics Committee and the State Institute for Drug Control. In order for the clinical trial to qualify for an approval from the State Institute for Drug Control, the relevant Ethics Committee must issue a positive opinion regarding it.
A clinical investigation plan is a document describing the rationale, objectives, design, methodology, monitoring, statistical considerations, organization, and conduct of a clinical investigation for a medical device. The clinical investigation must be approved in advance by the State Institute for Drug Control. On the other hand, clinical investigations of medical devices that are CE marked or that are used within an investigation for its originally designated purpose require only a 30-day prior notification to the State Institute for Drug Control. The clinical investigation plan (along with other documents) is a mandatory part of the application for approval of the clinical investigation. In order for the clinical investigation to qualify for an approval from the State Institute for Drug Control, the relevant Ethics Committee must issue a positive opinion on it.
4. What are the requirements for consent by participants in clinical trials?
The participants in a clinical trial should be first thoroughly informed of the scope, nature, potential consequences, and risks of the clinical trial. The participant’s informed consent (i) must be made in writing, (ii) must include the participant’s signature and date of signing, (iii) must be granted voluntarily, (iv) must be adequately documented, and (v) must be granted by an eligible person or his/her representative. If a participant is unable to write, oral consent must be given in the presence of at least one witness and a written record must be made of such oral consent. The informed consent must be drafted in a language easily understandable for the participant of the clinical trial.
5. May participants in clinical trials be compensated?
Participants in clinical trials may be compensated for expenses related to their participation in the clinical trial, such as travel or food expenses. Com-pensation must not exceed the costs incurred by the participant. Healthy participants may be remunerated for participating in a clinical trial, and the amount of remuneration must be consistent with the nature of the clinical trial. Financial incentives (other than compensation of costs) are prohibited in the case of minors and adults who are not legally capable of giving informed consent. The relevant Ethics Committee will also review the compensation and remuneration arrangements when providing its opinion on the application for approval of the clinical trial.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
One of the statutory conditions for conducting a clinical trial/investigation is the existence of an insurance policy covering the civil liability of the sponsor for any damage caused to any participant as a consequence of the clinical trial. The sponsor is responsible for concluding this insurance policy. When providing its opinion, the relevant Ethics Committee will also review the insurance policy taken out by the sponsor covering liability for damage in the event a participant’s health is negatively affected or if he/she dies as a consequence of the clinical trial/investigation.
Generally, insurance for a clinical trial/investigation does not cover claims resulting from actions that deviate from the clinical trial protocol/clinical investigation plan or from unprofessional treatment or negligence in providing the healthcare services. However, claims arising from unprofessional or negligent provision of healthcare services should be covered by the mandatory insurance of the healthcare provider operating the respective clinical trial site.