Preclinical and Clinical Trial Requirements
Preclinical and Clinical Trials in Bolivia – an overview. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, 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, it’s not a set condition. Studies issued by other countries are accepted.
2. How are clinical trials funded?
The interested party is responsible for financing the studies.
3. What are the requirements for pre-clinical and clinical trial protocols? Who must approve the protocols?
All protocols must be issued and presented in Spanish including these basic pieces of information:
- General information
- Justifications and objectives
- Type of study
- Statistic analysis
- Selection of target
- Description of treatment
- Study development and evaluation of response
- Adverse reactions
- Ethical aspects.
- Practical considerations
- Annex I Data recollection
- Annex II Investigators Manual
- Annex III Standard Procedures
- Annex IV Analytical information of the samples to be utilized
4. What are the requirements for consent by participants in clinical trials?
In the case of minors and patients with disabilities a written consent is needed either by their parents of legal representative. All patients will be provided with information on each clinical study that they must consent to.
The basic information that must be provided to them are:
- Treatment to be administered.
- Benefits expected.
- Adverse reactions.
- Alternative treatments that are available.
- The possibility to retire from the study in any phase of the treatment.
- Information of the people that will access to the patient’s information.
- Economic compensation and treatment in case any harm during the treatment.
- The investigator that will be conducting the study.
5. May participants in clinical trials be compensated?
Yes, they can be economically compensated.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Before the study is initiated the promoter must have an insurance in favor of the patient.