Clinical Research

What are clinical trials?

After a new drug has been thoroughly tested for safety and effectiveness in the lab, the developers get FDA approval to conduct research with human volunteers. This research — clinical trials — includes three phases that each focus on obtaining specific information.

The new drug must successfully pass each phase before moving on to the next one:

• Phase 1: safety and dosage — includes 20-100 volunteers; study runs several months
• Phase 2: efficacy and side effects — up to 100 volunteers; study runs up to two years
• Phase 3: ongoing effectiveness and monitoring of adverse reactions — includes 300-3,000 volunteers; lasts one to four years

Drugs that pass all three phases are approved for use and sold on the market, but an ongoing fourth phase recruits several thousand volunteers. This group continues to be monitored for the drug’s safety and effectiveness.

Can you participate in a clinical trial?

Drs. Shaikh and Dharma offer patients of Southwest Family Medicine Associates the opportunity to participate in ongoing clinical trials. The FDA-regulated clinical trials they conduct focus on different objectives, such as:

• Comparing effectiveness of a new medication to an existing medication or a placebo
• Comparing effectiveness of different doses of the same medication
• Determining whether a medication produces specific results
• Determining the incidence of adverse events in patients taking specific medications
• Assessing the safety of long-term use of specific medications
• Identifying ways to predict which patients may be at risk for relapsing while on medication

Each clinical trial defines the type of medication involved, the goal of the study, and the specific health condition targeted. Drs. Shaikh and Dharma recruit volunteers with a variety of health conditions for their clinical research.

This list below gives you an idea of the health conditions they study, some of which still need volunteers. The doctors continuously begin new clinical trials as existing trials end, so they may need volunteers with other health concerns.

• Heart failure
• Hypertension
• Diabetes
• Influenza
• High cholesterol
• Asthma
• Chronic obstructive pulmonary disease
• Depression

What are the advantages of volunteering for clinical research?

You have the benefit of trying out cutting-edge investigational products while helping to advance medical science. All of your research visits and lab work are free of cost, so you essentially get free checkups and learn more about your health condition along the way.

Volunteers who participate in clinical research are compensated for their time and travel. Appointments are made to accommodate your schedule, and Dr. Shaikh is available 24/7 for her research patients. Contact Southwest Family Medicine Associates today.