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DDCM: what are the points that generate the most demands at ANVISA (Part 2)?

To conclude the discussion of the most common requirements of the DDCM, according to the COPEC presentation that took place in May 2019, we discuss in this text the requirements related to the Clinical Development Plan for research projects.

The main requirements of the DDCM regarding the clinical part are concentrated in the design of the clinical study in approval and in the investigator's brochure, corresponding to 13% and 19% of all requirements in 2018, respectively.

The Clinical Development plan should bring all clinical studies planned to be carried out, even if there are still undefined data to be supplemented later, accompanied by a critical analysis in relation to the selected primary and secondary outcomes, in addition to their correlation with Medicine Based on Evidence for the disease or condition under study. The main questions related to the brochure, according to the presentation by ANVISA, refer to the complete description of the clinical studies already carried out for the product under development. Note: the posology of the proposed medication must be well established and justified.

The main requirements related to clinical protocols refer to the statistical part of the project, a point that does not bring much news. Regarding the statistical part, the lack of detail in the sample calculation, with missing formula, justification of the selected margins and references that support the statistical calculation are the main points of question.

One aspect that we evaluated as important in the development of the study - and is already highlighted in face-to-face meetings with ANVISA technicians - is to justify the selected clinical outcomes, especially when they are different from those recommended by the guidelines established by the Ministry of Health or other national guidelines and recognized international standards.

Safety aspects in the project also generate questions from ANVISA's technical team with some regularity, such as lack of a pharmacovigilance plan and adequate monitoring of adverse events. ANVISA also questions product suspension information in other countries and security alerts issued by other agencies, which must be described in the DDCM security information. Describe the regulatory status of the product in other countries with a wealth of safety information in these markets.

We believe that, despite the change in format, the points of questioning, and the attention of the technical team of clinical research management, have not undergone major changes in recent years, there is always a need to justify the clinical choices of the design and establishing a parallel with the care practice in the country and current treatment guidelines.

Finally, if your documents have been translated, make sure the translation and final presentation of these documents are reviewed before being sent. After all, you know in detail the potential of the drug in development, but the evaluating technician will formulate this judgment according to the neatness and clarity of the documents received.

See below the distribution of DDCM requirements by subject - evaluation for 2018.

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