Trek Therapeutics co-founder Robert Hindes, MD was previously a member of the faculty at Yale University in Connecticut. A consultant with a strong background in the pharmaceutical industry, Robert Hindes, MD consults with drug manufacturers on clinical trials for new drugs.

1. The Four Phases of Clinical Trials
Before Market Approval
Robert Hindes

2. Introduction
• Trek Therapeutics co-founder Robert Hindes, MD was previously a member of
the faculty at Yale University in Connecticut. A consultant with a strong
background in the pharmaceutical industry, Robert Hindes, MD consults with
drug manufacturers on clinical trials for new drugs.
Clinical trials are performed to collect data on the efficacy and safety of new
medications. Clinical testing happens over several phases with pharmaceuticals
required to report to the FDA after every phase for approval to move to the next
phase. Typical four-phase clinical includes:
1. Phase 0. Researchers give the new drug to a small group of healthy people
(less than 15). The drug is given in small doses. Researchers monitor how the
drug is metabolized and tolerated to know if it is safe.
2. Phase I. Investigators work with a larger group of about 20-80 healthy people.
The drug is administered in small doses that are increased progressively. The
aim is to identify an appropriate dosage for administration, one that is
efficacious but without major side effects. This phase takes several months.

3. Clinical Trials
• 3. Phase II. Investigators take hundreds of people who have the
condition the drug seeks to treat and gives them the medication.
They then monitor these participants for several months or years,
gathering information on the drug's effectiveness and associated
toxicities or side effects. Data gathered in this phase helps
investigators plan for the crucial phase III.
4. Phase III. Researchers take an even bigger sample (up to 3,000
people) for this phase. The participants in the study all have the
medical condition targeted by the drug being investigated.
However, not participants receive a new drug. Some may be given
existing medication or treated with a placebo. Neither the
participants nor the investigators know who has received the
study drug. The goal is to remove bias when monitoring drug
efficacy. This phase generally lasts 1 or more years. After the
conclusion, a report is sent to the FDA for review. If the agency is
satisfied following a careful review of all data, it approves the
marketing of the drug.