Preclinical & Clinical Trial Requirements
Want to know about preclinical and clinical trial requirements in Peru? Read on! Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, 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?
Peruvian law only regulates clinical trials conducted locally.
2. How are clinical trials funded?
Clinical trials are funded by a sponsor.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
The preclinical and clinical trial protocols must file the following documents for authorization:
- Application for the authorization of the clinical trial
- Copy of the registration of the authorized research centers.
- Copy of the document approving the investigation protocol and the format for the informed consent.
- Affidavit by the sponsor signaling the compliance of the responsibilities in the local regulation.
- Affidavit by lead investigator signaling the compliance of the responsibilities in the local regulation.
- Affidavit by the lead investigator and the sponsor signaling that there are no financial conflicts of interest.
- Affidavit by the lead investigator and the sponsor regarding the conditions of the research center.
- Copy of the insurance policy.
- Affidavit of the sponsor signaling that he counts with a financial fund that can guarantee immediate attention and free treatment if any subject were to suffer an adverse effect.
- Clinical protocol in Spanish and original language (if other)
- Updated Investigator’s brochure
- Information regarding the quality of the product being investigated
- Copy of the document that certifies the capacitation in Good Clinical and Ethical Practices in Investigation in human beings of the entire investigation team which must be at most 3 years old.
- Total national budget of the clinical trial.
- List of the supplies needed for the development of the clinical trial.
4. What are the requirements for consent by participants in clinical trials?
The Executive Office of Technology Transfer and Training (OGITT in Spanish), which is attached to National Health Institute must approve the clinical trial after the evaluation of the protocol by DIGEMID which is binding.
Prior to obtaining consent, the research subject must be provided clear information regarding the clinical trial both verbally and written. Verification that the research subject understood is needed. Furthermore, enough time must be given to the subject before a decision is made and all his questions must be solved.
Informed consent is required previously to even verify eligibility criteria and it must be submitted in the appropriated format. Informed consent requires Approval by a Research Center of the Institution where the clinical trial will be conducted and must be redacted both in Spanish and the research subject’s native language.
Finally, it must include the following information:
- The object, justification and purpose of the trial.
- Treatments of the clinical trial.
- Procedures to be used and their purpose.
- Number of research subjects both locally and worldwide
- Expected time of participation
- Inconveniences and expected and unforeseen risks.
- Expected benefits.
- The existence of alternative procedures that could be advantageous to the research subject.
- Contact information of the lead investigator and the President of the Research Center as corresponds (as a guarantee to receive an answer to questions or doubts regarding the clinical trial, risks, benefits)
- Insurance that the research subject will not be identified and that information regarding privacy will remain private.
- That the research subject is granting the Research Center access to his clinical history
- Reasons why the trial or the subject participation may end.
- Availability of the medical treatment and the compensation to which the subject would have a legal right for damages by the investigation, indicating the insurance hired by the sponsor.
- Detail of economic compensation for additional expenses such as transport, housing, communication and food if applicable.
- Potential risk in pregnancy if applicable.
- Information regarding how and when the research subject will receive information regarding the clinical trial results.
5. May participants in clinical trials be compensated?
They can receive a reasonable compensation for extraordinary expenses and the lack of productivity arising from their participation. Compensation will be monitored per case to ensure that it does not improperly influence the participant’s consent.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The principal investigator and the sponsor are responsible for providing attention and free medical treatment to any participant that suffers any damage as a result from the trials. Furthermore, the sponsor is responsible to provide compensation to the participant for damages during the trial.