Pharma

Interview with Violeta Ristic

by Fleming. Team

Read the interview with Agency for drugs and medical devices' GCP Inspector, Violeta Ristic.

1. What is the most sensitive part of a clinical trial and why?


"The most sensitive part of a clinical trial is the process of obtaining the informed consent form from the patients who have previously acquired knowledge about a particular pharmaceutical product still being studied for safety and efficacy. This part of the clinical trial is time consuming, since it requires a lot of time and patience by the investigator, who at the same time, is walking a fine line between standard medical practice and the research. The process of obtaining the informed consent form from the patient is an interactive process – one that varies from patient to patient and from one clinical trial to another, regardless of the fact that the same indications might apply. Successful completion of this process is essential to the realization of the clinical trial. Needless to say, this process lasts through the full duration of the clinical trial, or as long the patient is an active participant. Therefore, the investigator must stay alert during the clinical trial and must constantly “keep an eye” on the patients, making sure they understand the risks, benefits or their rights during the trial. In addition, the investigator is required to document his observations as much as possible."


2. What is the reality of the sponsor’s responsibilities to the study team and patients?


"Regardless of the part of the world he comes from, a sponsor, one who designs the idea of a clinical trial and who organizes the complicated procedures therein, must adapt his relationships first with the members of the study team and, last but not least, with the patients."


a) Study Team – The sponsor must provide an experienced and highly motivated investigator who will lead the optimum number of the team members all following his directions and acclimating to the needs of the study protocol. The sponsor must adapt his research to applicable national regulatory requirements, which are sometimes overly demanding (especially in the third world countries that represent bigger patient pull). In situations like this, the sponsor must be understanding and responsive in his compliance to the seemingly “unrealistic” demands of the said site.

b) Patients are humans who must be protected at all times – A sponsor must be honest and fair when it comes to verifying that the participating members of a clinical trial are well-educated about the safety and efficacy of the drug being tested. He must oversee that the given information is presented in a familiar language, as well as the procedures and schedules. A wise man said “When in doubt, read the Declaration of Helsinki.”


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3. Can you give an example/recent case where you observed a huge difference between the books/manuals and the real situation? What was the outcome from the case and what were the lessons for the future?


"In clinical trials, we often see a discrepancy between well-defined policies written in the guidelines and manuals and the real situation, including adaptation of instructions given to a clinical research team by their investigators. These discrepancies and adaptations can be said to be present in more or less every clinical trial. The sponsor and the investigator should recognize them and proactively take control of the relevant change. We must remember that many of the world’s great discoveries have happened by accident. If our goal is to successfully promote good clinical practice and to sustain it, new models of practice must be designed, tested and defined. Therefore, we should be open minded and adopt new procedures that could refine the quality of clinical trials in exclusion of neglect at the rest of the sites – a cascading process of quality improvement."

"I will give you an example of a clinical trial that had discrepancies in the following local regulations and international guidelines, not to mention the problem of signing ICF or even implementing new amendments. The clinical team was untrained and without a clear understanding of the importance of said clinical trial. Needless to say, this was the team’s first clinical trial. So you wonder what the outcome was? To make a long story short, the data of that clinical trial were inadmissible, as expected, but we didn’t give up on the team. The team was educated and informed about what was expected of them, and the sponsor was informed of local regulations and his duties and responsibilities toward the local center, team and patients. The clinical trial was not repeated, per se, but continued after the first one. This time strictly following protocol and under the stern guidance of the Agency, it had a different protocol number. The outcome was flawless, with all endpoints in place. This is a great example of the role the Agency should play: to educate and to implement the steps which are important to follow in a clinical trial."


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