Protecting Progress in Clinical Research

I am a social worker by academic training, and I worked at HCFMUSP and A.C.Camargo Cancer Center. From my perspective, the community resources offered by the State are very limited because the demand for social support is far greater than the resources available in healthcare.

Our vision is that, based on the diagnosis of each social condition, we must encourage society to become the transforming agent of that reality. The most effective way to help the people involved is through the principle of mutualism, which addresses social issues and the demands placed upon them.

Mutualism is the union of efforts and resources among people within a group to create a common financial fund that shares risks and covers losses or the unforeseen needs of individual participants.

The Clinical Research Law requires immediate and comprehensive assistance for research participants. I have no criticism of this requirement because, as social workers, we understand the importance of providing that level of care.

However, the reality of clinical research involves significant economic disparities among those conducting research. We have pharmaceutical companies and CROs with substantial financial resources alongside investigators conducting their own studies who are legally accountable under the law but have limited financial resources. Insurance helps place all of these stakeholders on more equal footing by providing access to the resources needed to meet their obligations.

We need to take a broader view of the situation. Brazil is a country of continental proportions, characterized by significant disparities in economic conditions and professional training. Clinical Research Insurance acts as a guarantor of resources by meeting specific requirements that ensure participant care.

My role as a social worker is to interpret this reality and, in my capacity as a broker, identify ways to further supplement the resources available to support clinical research.

Clinical research continues to introduce increasingly ambitious projects, and Brazil cannot afford to be left behind. As research becomes more complex, stakeholders increasingly need to share business risks with insurance companies.

When Insurance Lags Innovation

Various project formats are emerging today, and insurance providers are often unable to keep pace with these changes, resulting in coverage being declined.

The insurance market also faces its own constraints. Reinsurers set the rules that insurers must follow regarding risk acceptance.

Some insurers are unable to cover projects involving vaccines, while others cannot cover pediatric studies, among other areas.

We still have a long way to go. I have always worked with socioeconomic classifications, and I believe that, in the future, we should create more accessible insurance options based on a study's level of severity. For example, a study involving only medical record reviews should have lower insurance costs.

Since we work with Civil Liability Insurance, participants must always prove that damage occurred, even if they have signed the TECLE. The TECLE relates to establishing the causal link between the research and the damage.

Evaluating Risk, Ensuring Protection

I evaluate the study design, number of participants, study phase, active ingredient, primary objective, inclusion criteria, project duration, potential adverse reactions and adverse events.

I always ask about the potential severity of an adverse reaction and whether the client can estimate the expected duration of hospitalization and the associated costs.

Based on that information, I evaluate what insurance companies can offer.

I also assess the business risk by determining whether my client will be covered for 70 percent or 80 percent of the costs by the insurer and which insurance company offers the most suitable coverage.

Smarter Coverage through AI

With the help of AI, I believe it will become a fundamental tool for analyzing risks and actual loss events.

It will provide greater confidence to reinsurers and insurers when discussing the scope of risks to be covered and will help create new coverage options for new risk areas, keeping pace with the dynamics of the projects.

Putting People before Policies

As a pioneer in research insurance in Brazil, I adopted a more technical approach rather than a purely commercial one.

There is a very fine line between technical, consultative sales and purely commercial sales. A technical professional exercises greater caution when assessing risks and handling claims properly. I am also very concerned about the deductible amount clients may have to pay, especially for projects at public institutions where researchers often lack contingency funds. A commercial broker may not always highlight this cost.

My advice is that every professional should enjoy what they do and always remember that our clients are loved by someone. If we don't approach our work with that awareness, we could jeopardize someone's livelihood.