Preclinical and Clinical Trial Requirements
The key requirements for conducting preclinical and clinical trials in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, 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. INVIMA accepts clinical trials conducted abroad, if they sufficiently demonstrate safety and efficacy of the drug product.
2. How are clinical trials funded?
In Colombia, clinical research on humans is currently regulated primarily by Resolution No. 8430/93, that determines the scientific, technical and administrative standards for health research in Colombia.
Resolution No. 2378/08 incorporates the Good Clinical Practices drafted by Technical Working Groups appointed by the member countries of the Pan American Network for Drug Regulatory Harmonization (PANDRH), focused on requirements to be met by health institutions performing clinical research in humans.
Access to human genetic resources or sampling of biological material of minor ethnic groups or members of indigenous communities is also regulated through Resolution 3283/97.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
INVIMA has the responsibility to evaluate and approve the clinical research protocols to be carried out in Colombia. Any change in a protocol already approved should be notified to the Sanitary Authorities.
4. What are the requirements for consent by participants in clinical trials?
In Colombia this is called informed consent and it must be signed by two participating witnesses and the medical investigator. No ambiguity will be tolerated and the information will be provided according to the socio-cultural level of each one of the volunteers. In the same way, an informed consent is required for genetic samples, wherein aspects such as usage of said samples, conservation time and confidentiality should be explicit. The informed consent must contain:
- Rationale and goals of the research.
- Procedures to be implemented and their purpose, including identification of experimental procedures
- Expected discomfort and risks.
- Potential benefits.
- Alternative procedures that may be advantageous for the subject.
- A guarantee of getting answers to any questions, clarifications to any doubts about procedures, risks, benefits and other matters related to the research and treatment of the subject.
- Freedom to withdraw his/her consent at any time and retire from the study, without prejudice to further care and treatment.
- The insurance that the subject’s identity will not be revealed, and that all information concerning his/her privacy shall be kept confidential.
- A commitment to provide the subject with updated information obtained during the study, even if this may affect his/her willingness to continue the study.
- Availability of the same medical treatment and compensation to which the subject would be legally entitled, in case of damages caused by the research directly affecting him/her, on the part of the researching institution.
- In case additional costs arise, they shall be covered by the research budget or that of the responsible institution
5. May participants in clinical trials be compensated?
Compensation for participating in clinical trials is not forbidden, nor specifically regulated under Colombian law, therefore it is possible to agree on compensation in exchange for participation in a clinical trial. According to Resolution 2378/2008, sponsors must submit the clinical trial budget for the participating center, specifying, among other items, the budget for participants.
The compensation should be considered as a supportive incentive for expenses due to participation in the trial (transportation, food, work absences).
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Contractual agreements with insurance clauses. In the absence of such agreements, extra contractual responsibility rules would apply for indemnification, having the patient bear the burden of proof on any damages suffered as a consequence of the clinical trial.