Training and Harmonization Program for Research Centers for Multi-Site Trials

Multi-Site Clinical Trials, that is, those conducted simultaneously in more than one research center, present very interesting but also challenging peculiarities for clinical research in Brazil.

Taking into account the plurality of our country, with different habits, customs and cultures distributed across the various states/regions, the multi-site trial is capable of covering a greater part of this population diversity, increasing the of the study sample and, consequently, granting it greater “power”, since its results can be applicable to the general population. Furthermore, from a practical point of view, it facilitates the recruitment of research participants, reducing study time.

In our practice, it has been very common to hear comments, especially from research monitors, regarding the heterogeneity between research centers. This disparity is caused by different structures, management and conduct. This situation makes it difficult to develop a multi-site trial, resulting in recruitment problems, inclusion failures, follow-up losses and data inconsistencies, putting the development and results of the trial at risk.

We understand that a qualification and/or initiation visit alone, although a valid instrument, often does not allow for an adequate assessment of the potential of a research center. Likewise, the meeting with researchers also does not allow for a better assessment of the team's theoretical and practical knowledge in clinical research, as well as of a trial.

Technical and practical harmonization between sites that will execute the same trial protocol, in our opinion, is extremely important, especially with regard to the quality of a clinical trial.

With this objective, the Clinical Research Unit of the Isaia Institute is offering sponsors yet another activity in clinical research: the PROGRAM FOR TRAINING AND HARMONIZATION OF RESEARCH CENTERS FOR MULTI-SITE TRIALS.

Topics developed in the program:

• Analysis of a feasibility questionnaire;
• Calculation of recruitment potential of research participants for a given pathology;
• Recruitment strategies;
• The importance and management of source documents;
• Investigator’s File (Essential Documents);
• Responsibilities of the PI and study coordinator;
• Relationship between the research center and the sponsor;
• Relationship between the research center and CEP;
• Prevention and management of missing data;
• The Quality Manual of a research center;
• The development and management of Standard Operating Procedures for a research center;
• Standard Operating Procedures specific to a clinical trial;
• Internal monitoring;
• Training of a center’s clinical research team;
• The importance of a Continuing Education Program to maintain the training of a center’s clinical research team;
• The importance of properly conducting the informed consent and assent process;
• The clinical monitor as a quality agent in the research center;
• Management and control of the investigational product;
• Clinical monitoring and correct reporting of adverse events;
• Protocol deviations;
• Validation of research documents;
• Certification of instruments and devices used in a clinical trial;
• Mechanisms for research participant adherence to the trial;
• Structure of a research center.