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Types of Clinical Research Studies at CLICMI

At the Clinical Research Center for Innovative Medicines (CLICMI), we conduct various types of clinical studies aimed at developing innovative treatments and improving patient health. The types of studies vary depending on their objective, the stage of drug or treatment development, and the study design.

1. By Stage of Drug Development:

• Phase I: Evaluates the safety of a new drug, determines the appropriate dosage, and identifies possible side effects in a small group of volunteers, usually healthy or with specific conditions. For example, a new diabetes medication may be tested in healthy volunteers.
• Phase II: Assesses the drug’s effectiveness against a specific disease, collects additional safety data, and adjusts the optimal dosage. For example, testing whether a treatment reduces symptoms of rheumatoid arthritis.
• Phase III: Confirms safety and effectiveness in a larger population, compares the new treatment with current standards, and monitors adverse effects. For example, comparing a new hypertension medication with existing therapies.
• Phase IV: Post-marketing studies that monitor long-term safety and effectiveness of an already approved drug, identifying additional benefits or rare effects in broader populations.

2. By Study Design:

• Randomized Controlled Trials (RCTs): Participants are randomly assigned to different groups (new treatment, standard treatment, or placebo) to ensure objective and comparable results.
• Double-Blind Studies: Neither participants nor researchers know who is receiving the active treatment or placebo, minimizing bias and ensuring reliable data.
• Open-Label Studies: Both participants and researchers know the treatment being administered, allowing access to innovative therapies and specialized medical care.
• Crossover Studies: Participants receive different treatments at different times, serving as their own control, which increases accuracy when comparing treatments.

At CLICMI, safety and ethics are top priorities. We protect participant well-being through:

1. Regulatory Compliance

• Strict adherence to Good Clinical Practice (GCP) guidelines from the International Council for Harmonisation (ICH) and other international frameworks, such as the Declaration of Helsinki.
• Full compliance with local Mexican regulations established by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS).
• Continuous oversight by independent Research Ethics Committees (RECs) that review and approve each protocol for ethical and scientific validity.
• Regular monitoring, audits, and inspections by regulatory authorities and sponsors to detect and correct any procedural deviations.

2. Staff Training

• Ongoing education and training for CLICMI staff to ensure all procedures are conducted with the highest standards of quality and professionalism.

3. Data Protection

• Participant personal and medical data are handled with strict confidentiality, in compliance with the Mexican Federal Law on Protection of Personal Data Held by Private Parties and international standards such as the General Data Protection Regulation (GDPR) when applicable.

4. Ethical and Human-Centered Care

• Guided by medical ethics principles: autonomy (respecting participants’ decisions), beneficence (maximizing benefits and minimizing risks), and justice (fair treatment).
• Clear and detailed informed consent process, where participants receive full information on the study—objectives, procedures, risks, benefits, and rights—with sufficient time to ask questions.
• Ongoing support and specialized medical care during both scheduled and unscheduled visits, ensuring participant safety and well-being throughout the study.

At CLICMI, studies are designed for people with specific health conditions related to the treatment under investigation, such as diabetes, cancer, or cardiovascular diseases. Each study has defined eligibility criteria in its protocol that determine who may participate.

Before joining a study, interested individuals go through an informed consent process where they are clearly informed about:

• The study’s purpose and procedures.
• Possible risks and benefits.
• Their rights, including the freedom to withdraw from the study at any time without consequences.

This process ensures participants make informed decisions and feel supported throughout their involvement.

Yes. CLICMI partners with key stakeholders to advance clinical research and improve access to innovative treatments:

1. Universities

• Collaborating with academic institutions to generate scientific knowledge and train students and researchers in clinical trial conduct, shaping highly qualified professionals.

2. Hospitals

• Establishing partnerships with hospitals and medical specialists to promote clinical research and provide patients with access to investigational treatments that may be more effective than those currently available.

3. Pharmaceutical Industry

• Working with pharmaceutical companies to conduct clinical trials, recruit participants, administer innovative treatments, and collect data rigorously. All processes are conducted in strict compliance with national and international regulations, ensuring transparency and quality.

4. Conflict of Interest Management

• All collaborations with the pharmaceutical industry are managed under strict ethical controls to avoid conflicts of interest, ensuring participant well-being always remains the top priority.