Law 14.874/24 - Post-trial Access Plan

Post-Study Supply Planning: Ensuring Continuity of Treatment in Clinical Trials

The development of new drugs and therapies is a complex and rigorous process that involves multiple phases of research and clinical trials. Within this context, the protection and well-being of participants are absolute priorities. A critical issue that emerges at the end of a clinical trial is the continuity of treatment for those who benefited from the experimental drug. This is not an issue exclusive to Brazil, but it is a fact that the regulations practiced in the country are most likely among the most widespread globally, sometimes in a very objective and calm manner and other times generating some debate. This does not prevent clinical research from being carried out and, under the rules of the new clinical research law, it gains contours of predictability and consistency that protect researchers, sponsors and participants.

But like all regulations, it requires qualified technical support for correct navigation.

And it is in this scenario of the new law that the Post-trial Access Plan comes into play, an instrument that aims to clarify the need to implement a program or not, taking into account the course of the disease, type of innovation, individuality of the participant and finally the judgment of the researcher responsible for the research and the participants. The text of the law is clear. There is no need to question fundamental points and criteria that have been established.

What is the Post-trial Access Plan?

The Post-trial Access Plan is a formal document that details the guidelines and procedures for providing the investigational drug to participants who need it after the clinical trial has ended. This plan is required by law, specifically by Law 14.874, which regulates the continuity of experimental treatment for the health and safety of participants. This document must be produced locally, in collaboration between the PI and the Sponsor and/or its Representative.

Importance of the Plan

The plan ensures that the transition to the post-study period is carried out safely, with continuous monitoring and assessment of the need for experimental treatment. It also provides for the appropriate documentation of all adverse events and communication with regulatory authorities to ensure that the supply of the drug continues in accordance with current regulations and ensures the transition to the post-study period when this becomes necessary.

Regulatory Compliance and Approval

In order for the Post-trial Access Plan to be implemented, it must be submitted to and approved by regulatory authorities prior to the end of the clinical trial. This process ensures that any changes or adjustments to the plan are made transparently between the parties.

Conclusion

The Post-trial Access Plan becomes part of the project documentation. Implementing a well-structured plan that complies with legal standards is essential for clinical trials to be conducted responsibly and in compliance with regulations. Each project must have its own plan, and the various stakeholders involved in the research will work on its development. Below is a suggested structure for the plan based on the law. It is worth noting that plans submitted in studies are the responsibility of each proponent and sponsor, and that the principles shared here are mentioned for informational and educational purposes.

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Post-Treatment Access Plan for [Name of Investigational Drug]

Sponsor: [Sponsor Name] Principal Investigator: [Principal Investigator Name] Research Site: [Research Center Name] Protocol: [Clinical Study Protocol Number] Version: [Plan Version]

1. Purpose and Context

General Purpose: [Describe the purpose of the plan, addressing the need to ensure continuity of treatment with the investigational drug after the study]

Study Description: [Include a summary of the clinical study, highlighting the phase, number of participants, objectives and duration]

2. Justification for Continued Access

Reasons for Continuation: [Explain whether or not there is a need to continue providing the medication, considering factors such as the severity of the condition, the therapeutic alternatives available, and the benefits observed during the study]

Evaluation Criteria:

• Severity of condition: [Specify how this criterion will be analyzed]

• Availability of other therapies: [Describe what other therapeutic options are available]

• Unmet medical need: [Determine whether the investigational drug addresses a clinical need not met by other therapies]

• Risk-benefit analysis: [Evaluate whether the benefits of continued use of the drug outweigh the potential risks]

3. Post-Treatment Access Program

Program Goal: [Describe the goal of the program, focusing on the importance of ensuring there are no interruptions in participants’ treatment]

Inclusion Criteria: [Establish the criteria that will define which participants will be able to continue receiving the medication post-study]

Monitoring Plan:

• Ongoing monitoring: [Detail how regular monitoring will be carried out to ensure the safety and effectiveness of the treatment]

• Duration of Post-Treatment Access: [Indicate how long the medication will be made available to participants under the program]

Transition Procedures: [Explain how the transition to the aftercare access program will be accomplished, ensuring there is no interruption in participants’ treatment]

4. Individualized Treatment Assessment

Evaluation Process: [Describe the procedure that will be followed by the investigator, with the support of the sponsor and in consultation with the participant, to determine whether treatment should continue]

Documentation and Recording: [Explain how decisions about continuing or stopping treatment will be documented and how these decisions will be justified]

5. Responsibilities of the Parties Involved

Investigator Roles: [Specify the investigator's responsibilities, including formally requesting the sponsor to initiate post-treatment provision]

Sponsor's Roles: [Define the sponsor's obligations, such as ensuring free provision of the medicine and necessary support to participants]

Functions of the Research Center: [Describe the responsibilities of the research institution, focusing on coordinating the plan and providing necessary care to participants]

6. Procedures for Suspension of Supply

Conditions for Suspension:

• Participant Decision: [Document the process to be followed if the participant wishes to discontinue treatment]

• Cure or new therapeutic options: [Explain how the cure or introduction of therapeutic alternatives will be documented and how this will affect the continuity of treatment]

• Lack of benefit or new risks: [Describe how the lack of benefit or identification of new risks will be assessed]

• Adverse reactions: [Detail how adverse reactions that prevent continued use of the medication will be treated]

• Technical or safety difficulties: [Document the actions to be taken if technical or safety difficulties arise in manufacturing or obtaining the drug]

Justification: [Explain the justification process and submission to the CEP for approval in case of a need for supply interruption]