Grupo Loeffler-Russek ENSURING SAFE DRUG DEVELOPMENT WITH REGULATORY COMPLIANCE

In an interview with CIOReview Latin America, Enrique Blanco, director of operations, Grupo Loeffler-Russek, sheds light on the importance of understanding and adhering to clinical trial laws and regulations and advocating for patient safety and ethical practices in the life science space.

In light of your experience and expertise, what sense do you get of the challenges and the trends that are taking place in the life science space?

In my professional opinion, the current situation regarding clinical trials in Mexico poses certain challenges due to the requirements set forth by the regulatory authority, COFEPRIS Similar to the FDA in the United States, COFEPRIS has established guidelines and norms that must be followed when conducting clinical trials. However, there are certain issues within the current regulations that need to be addressed.

One of the challenges I have encountered in my experience relates to clinical trials conducted during the phase three of drug development, particularly for stock products. In these cases, regulations commonly dictate that the sponsor of the study is responsible for the well-being of the study subjects, which include patients with specific illnesses or healthy individuals.

It is crucial to include informed consent as part of the process. However, in some instances, the guidelines do not provide sufficient detail in this regard. This is an area that requires careful attention within the industry to ensure patient safety.

 ​It is anticipated that in the coming years, countries will strengthen their efforts to protect their citizens and enforce regulations regarding clinical trials 

In the event of any problems, especially adverse effects, it is essential to understand the implications for both the medicine and the patient, as well as the responsibilities of the sponsor. While the guidelines state that the sponsor is responsible, it is necessary to clearly define these responsibilities, including the requirement for comprehensive insurance coverage. This is particularly important for protecting the patients and the sponsoring company. Explicitly establishing this requirement in the guidelines is essential for Mexican clinical trials.

When it comes to generic drug products, it is necessary to compare their clinical behavior with the reference product according to the guidelines. The guidelines specify which molecules or active ingredients must be compared using these studies. In this case, as the sponsor responsible for the quality of the product and the patients involved in the clinical trial, it is crucial to ensure proper insurance coverage. This coverage should protect both the company and the patients.

As human biology varies, some patients may exhibit sensitivities to certain ingredients, which must be carefully monitored. It is the sponsor's responsibility to determine whether adverse reactions are solely due to their product, the molecule's performance, or whether they occur with both the reference and generic products.

To perform these clinical trials, it is necessary to work with a third-party company authorized by the authorities to conduct the equivalent studies. This company needs to be authorized by COFEPRIS, and the clinical trial protocol must be submitted to COFEPRIS for approval. Once approved, the sponsor has the authorization to proceed with the clinical trial.

How do you see the evolution of the life sciences recruitment phase or overall the clinical trial space in the coming years?

In the coming years, it is anticipated that countries will strengthen their efforts to protect their citizens and enforce regulations regarding clinical trials. This is a natural progression considering the historical events and incidents that have highlighted the importance of safeguarding human rights. There have been instances reported where clinical studies were conducted in certain populations without adequate protection, offering rewards or incentives that infringed upon human rights.

As a result, countries are likely to impose stricter legal requirements and regulations governing the conduct of clinical trials. This will make it more challenging for companies to perform trials, necessitating their compliance with the evolving rules and standards. It will be essential for companies to review and reinforce their protocols, informed consent processes, and sponsoring responsibilities to align with the changing landscape.

Addressing the gap in insurance coverage should be a priority, as historical evidence and ethical declarations have emphasized the need to prioritize patient well-being and protect the interests of the companies conducting these trials. Proper documentation is of importance to ensure that valuable patient data is appropriately reported, preventing instances where healthcare professionals may overlook certain details.

To enhance future practices, it is crucial for pharmaceutical companies to actively engage in the review process to ensure protocols are well-structured and meet ethical standards, fostering collaboration with healthcare professionals. This collaboration will contribute to obtaining accurate and reliable results while reinforcing the understanding and accountability of the physicians involved.

What is your advice for your peers in the industry?

It is essential for professionals to be knowledgeable about the laws and regulations governing their field. These laws exist because of past incidents and serve as a framework for ethical conduct. By understanding historical failures like the Tuskegee experiment or the unethical studies conducted during World War II, health professionals involved in clinical studies can contribute to a better future. They must be aware of the objectives of their studies and take measures to protect both the participants and their organizations from potential risks. This necessitates a thorough understanding of the law and a commitment to ethical practices.