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Clinical research in Brazil – New horizons, new challenges

On this 6th episode, we are discussing the future of clinical research and how ANVISA has organized itself to overcome post-pandemic challenges.

Claudiosvam Martins

Claudiosvam is the current coordinator of the clinical research area for medicines and biological products at Anvisa.

He is pharmacist with a master's degree in the field of clinical pharmacology, he was the manager of new synthetic drugs’ sector at Anvisa, and a full member of CONITEC.

Anvisa is a relatively new agency compared to other agencies we already know. And Anvisa has been built over time. Before the pandemic, we were also very committed to changing legislation and implementing new regulations. In 2015 we had our milestone when we published a resolution, which is the RDC-9 of 2015. Therefore, it has changed significantly, giving a lot more clarity to the criteria, to the requirements for conducting clinical research in Brazil. Ever since, we've been mostly improving the deadlines. We are clear that this is a vital issue, since it is crucial in the regulatory environment, especially for clinical research, but that's not all. We have seen an improvement in the quality of our processes, the quality of our analysis, to the point where we are recognized worldwide as a very active, very respected agency. Therefore, before the pandemic, we had already done it, we had been increasing, implementing some new procedures, some manuals, we had some interactions with the associations of the productive segment to discuss, building together the necessary improvements. And it has been that way ever since. We always discussed, shared ideas, while paying attention to all entities, everyone who is involved in clinical research. Hence, I would like to highlight here that just before the pandemic we held an event with the regulated sector, based on a survey we carried out, to understand a little bit of the overview, the situation of the processes that were submitted. And we did this by looking at what generated most demands, brought up the greatest doubts, the greatest number of doubts. And so, this was an important kickstart, because then we had the bigger picture; we called all the associations to show what we had found. Calling them, inviting them in, to find ways to minimize all these issues that end up impacting and extending deadlines. With each requirement that is made, each request for supplementing a document or information, there is an extra deadline, which ends up postponing and greatly increasing the deadlines for regulatory decisions. I’ll give you examples. We made a publication of an important resolution as well, which was for the recognition of the reviews done by other regulatory authorities, founding members, and permanent members of the ICH. As Brazil knows... Anvisa has been a member of the ICH since 2019, now it is part of the management committee. And then we published an OS, a service orientation, from which we started to recognize the analysis by the INPD part that we call, which is the quality part of the great clinical development dossier that we call the DDCM. So, in reality, if this part had already been approved by one of the ICH member agencies that we recognized, it helps speed up our analysis. Another very important matter, just to conclude, we also overviewed and modified the 2015 RDC-9, which was a demand of the sector, of the sponsors, of the entities involved in clinical research, which was the proof that the clinical research was registered in international banks and platforms, such as Clinical Trials or Eudra in Europe. The sponsors saw this requirement in submission as a barrier, since clinical research is competitive and, being competitive, those who move faster end up attracting the research, taking the research to their country. Therefore, we also made this modification of the RDC and put this receipt for presentation a little later, so that it would not mean an impediment, risking the loss the opportunity. Brazil would lose the opportunity to enter, to have, to carry out clinical research.

ANVISA after 18 months of pandemic

The emergence of the pandemic in March 2020 was disruptive, as they say, it was and has been a massive challenge, not only because it affected us personally, but mainly in terms of therapeutic options, of vaccines. Until now, we found ourselves in a very complex situation, complicated in many aspects. First, because the researches that had already been approved, and were underway, were severely affected by the restrictions imposed in the pandemic scenario. Professionals and participants could not leave their homes, and the delivery of the medication was impaired. That was our first challenge. If we recall, there was an impact on transportation, consequently the import of investigational products was absolutely impacted. We had participants in Brazil who participated in research in the United States and vice versa. Therefore, it was a very complicated, and right from the start our first measure was precisely to flexibilize, because today, any substantial change made to a clinical protocol must be approved by Anvisa. At first, what we did was to do a risk assessment, to assess exactly the impact of the changes at that moment, in order to allow them to be implemented quickly, given that situation. We did this with a lot of pioneering spirit because it was already in the first two weeks of the pandemic. We then set up a Covid committee that we call the Covid-19 Committee under General Medicines Management. And at that time, as therapeutic alternatives were sought, and obligatorily went through clinical research, Copec, in particular, was affected in a significant way, and this committee then brought people together, servers, specialists, in different areas of GGMED - even areas outside the GGMED. We started discussing, to jointly analyze the processes that we received, mainly about vaccines. It is very complicated, not only because of the vaccine development process, which is very complex, but also because it is not a common product. It is not. It's very complex. And at that moment, we started to receive processes, for example, phase 1, phase 2, phase 3 development at the same time. Therefore, there were many challenges, all at once. And the speed, without a doubt, the haste, the agility that I needed to give answers to society. It was a substantial challenge, but at the same time, we had never exchanged, shared, discussed with our peers, other regulatory services, as much as we did due to this scenario. It was arduous. We are still in a somewhat difficult situation, but I believe that this more acute phase, after the vaccines, now that the studies have already ended, the vaccines are being administered in the population; I think that we have gone through this more acute moment and now we are evaluating vaccine research as well, more research on antiviral drugs and other therapeutic alternatives. But we've learned a lot for sure.

Has the storm has passed?

Let's say we still have a light rain, but with less thunderstorms. And the moment, from the beginning, and with this politicization of the emergence of fake news, all of this created a very complicated environment for us as a regulatory agent, because we were not only now evaluating and approving vaccines and other clinical research, but also dedicating a substantial amount of time to clarify and undo the gigantic amount of mismatched information, whether intentional or not. And today we have the urgency of the pandemic, of public health, of approving research, but also the urgency of the media. So, we spend a lot of our time responding to the media. And we understand, this is not a criticism, but it also takes a long time to be able to respond, clarify, and give transparency to our activities.

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