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 USD 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 industry. According to the Act on Drugs, a sponsor is an individual or a legal person who manages and finances the 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 (the “Representative”; this is usually a contract research organization); nevertheless, the sponsor remains responsible for the performance of the clinical trial in accordance with the Act on Drugs. 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, statistic consideration and organization of the clinical trial, 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 to be able to obtain an approval of the State Institute for Drug Control, the relevant Ethics Committee must issue a positive opinion on the clinical trial.
4. What are the requirements for consent by participants in clinical trials?
The participants in a clinical trial should be first thoroughly advised on the scope, nature, potential consequences and risks of the clinical trial. An informed consent of a participant of a clinical trial (i) must be made in writing, (ii) must contain the signature of the participant and date of such signature, (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?
The participants of the clinical trials may be compensated for expenses related to the participation in the clinical trial, such as travel or food expenses. The compensation must not exceed the costs incurred by the participant. Healthy participants may be remunerated for the participation, and the amount of remuneration must be consistent with the nature of the clinical trial. Financial incentives are prohibited in the case of minors and adults who are not legally capable of giving informed consent. When reviewing the application for an approval of the clinical trial, the relevant Ethics Committee reviews also the compensation and remuneration arrangements.
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 is the existence of an insurance policy covering the civil liability of the sponsor and the investigator for any damage caused to a participant as a consequence of the clinical trial. According to the Act on Drugs, the sponsor is responsible for the conclusion of this insurance policy. Also, when reviewing the application for the opinion on the clinical trial, the relevant Ethics Committee also reviews the insurance policy concluded by the sponsor covering the liability for damage in cases of the health of the participant being damaged or the participant dying as a consequence of the clinical trial.
Generally, the clinical trial insurance does not cover claims arising due to actions in deviation from the clinical trial protocol and claims arising due to unprofessional treatment or negligence in providing healthcare services. However, claims arising due to unprofessional or negligent provision of healthcare services should be covered by mandatory insurance of the healthcare provider operating the respective clinical trial site.