Summer 2003

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Day 5

On Friday morning, we traveled by bus to the Clinical Research Center. The Center is one of only 80 NIH-supported centers for performing clinical research, testing possible new drugs, and human health studies.

Once we arrived at the Clinical Research Center, Joy Lilljedahl prepared us for the morning and gave us the schedule. We first met Mr. and Mrs. Foster, who gave us a patient's perspective on clinical trials and what it's like to be involved.

After that, Dr. Boisaubin told us about informed consent and the other factors of his job as a patient's advocate. He explained the evolution of the concept and legal boundaries of consent. Informed consent consists of disclosure, understanding, volunteering, competence, and consent.

Dr. Pablo Okuysen discussed how clinical trials are carried out, the difference between industry-initiated and investigator-initiated trials, and how new drugs are developed and tested.

Clinical trial patients are recruited by physicians, by invitation to hospital patients, or by volunteering.

In drug development, a pool of possible compounds is identified. A target disease is chosen and tested for positive reactions. Next is a pre-clinical test for toxicity in animals. In phase 1 of clinical trials (pilot study) healthy volunteers are tested for toxicity. In phase 2, the safety and effectiveness of the compound is studied in 30-40 patients with the targeted disease. In phase 3, large-scale studies are carried out. Finally, in phase 4, post-market studies are done to check for side effects. It takes up to 12 years and between $4 and $20 million dollars to develop one drug.

Next, Joy came back and explained how they administer research studies, track grants, and do all the necessary paperwork to assure that everything is done in a safe and responsible way as laid out by regulations and laws.

Finally, Dr. Nai-Hui Chiu gave us a brief tour of the facility.

Websites and resources for this presentation:

U.T. Houston General Clinical Research Center U.T. Houston GCRC General Information ClinicalTrials.gov - Information on Clinical Trials and Human Research Studies Search Clinical Research Studies Protocol Database Welcome to the Centerwatch Clinical Trials Listing Service!

Friday afternoon, Dr. Franklin returned and presented on the cognitive development of the adolescent brain.

She presented on developmental changes through time, including sensorimotor (birth - 2 years), peroperational thought (2 years - 7 years), concrete operational thought (7 years - 12 years), and formal operational thought (12 years - adulthood).

She also examined changes in language, memory, gross motor skills, fine motor skills, and gender development in middle and late childhood.

The biggest surprise was that adolescence is a 10-15 year transition period rather than an overnight accomplishment.

Finally, in implications to education, consider developmental stage when planning lessons. Also, be aware of the child's current state of knowledge. What the child knows already will determine what new information he/she is able to absorb. Next, cognitive advances are optimized when new material is only slightly different from what the child already knows. Finally, active learning promotes deeper and longer lasting enduring understanding. 

Websites and resources for this presentation:

Adolescent Medicine - Cognitive Development Adolescent Development Resources Adolescent Cognitive Development Cognitive Development Adolescent DevelopmentA Physical, Cognitive, & Psychosocial Perspective

 

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