Drug studies (clinical trials) are crucial in developing new medications to treat many illnesses. Pharmacy Technicians are increasingly working in facilities that conduct drug studies and have become important members of drug research and development teams. Read on to learn more about the expanding market for global drug studies and about how working as a Pharmacy Technician in a drug study program may be the right career fit for you.
Clinical Trials Projections for Market Growth 2018 to 2025
According to recent studies, the global clinical trials market which was valued at 40 billion dollars in 2016 is expected to grow by 5.7% by 2025.
In the United States in 2018 there were 101,165 registered drug studies that were studying many different experimental medications.
Spending on clinical trials in oncology (cancer treatment) are projected to increase significantly by 2025.
Spending on clinical trials in acute and chronic pain management especially involving the development of new NSAIDS (non-steroidal anti-inflammatory drugs) and acute pain medications are also expected to increase dramatically by 2025.
Other areas for projected increased spending on clinical trials by 2025 include autoimmune diseases/inflammation, diabetes, cardiovascular diseases, central nervous system diseases and obesity.
What are Pre-clinical Studies?
Pre-clinical studies are conducted prior to the beginning of clinical studies. During pre-clinical studies, the new drug is tested either in test tubes and cell cultures (in vitro) or on laboratory animals (in vivo).
In a pre-clinical study, different dosages of the experimental medication are used to determine levels of toxicity, therapeutic levels and the pharmacokinetics of the drug.
Pre-clinical studies will determine if it is financially feasible for a pharmaceutical company to advance an experimental drug to a drug study (clinical trial).
What is a Drug Study?
Drug studies which are also called clinical trials have 5 different phases which all must be successfully completed before a new drug can be brought to market. It is estimated that it takes approximately 12 to 18 years and 1 billion dollars from conception to final FDA approval for a new drug to be brought to market.
What are the Different Phases of a Drug Study?
There are 5 different phases of a drug study before a drug study is considered completed. These include phases 0 through 4.
What is Phase 0 of a Drug Study?
During phase 0 of a drug study, a small dose of the drug is given in a single dose to a small number of subjects (usually approximately 10 people) to determine if the drug acts the same way in humans as it does in laboratory animals.
What is Phase 1 of a Drug Study?
Before starting phase 1 of a drug study, the study investigators are required to submit an “Investigational New Drug Application” to the FDA detailing the results of their findings as to the effects of the investigational drug on cellular models and on laboratory animals (this was tested in phase 0).
During Phase 1 of a Drug Study, the drug is tested on human subjects for the first time. This phase helps determine the best dose of the medication, the safety and side effects profile and the best way of formulation to deliver the experimental drug.
In a phase 1 study, approximately 20 to 100 healthy volunteers or people with the disease or condition are given a range of doses of the drug being tested over several months to determine the safest dose, the tolerability profile and how the medication is metabolized and distributed within the body.
Study participants are also studied on the effects of taking the new medication with and without food to determine if there is any effect on the drug’s absorption.
Approximately 70% of drugs tested in phase 1 drug trials move on to a phase 2 clinical trial.
What is Phase 2 of a Drug Study?
In phase 2 of a drug study, once a range of applicable doses has been researched, a larger group of study participants (up to several hundred people) are studied over a period of from several months to 2 years to determine how effective a drug is (efficacy) and what toxic side effects (toxicity), if any, might prevent the drug research process from continuing.
In phase IIA, the drug is studied to determine if it has a significant biologic activity and can be clinically effective in patients at a certain pre-determined level of activity.
If this minimum threshold of biologic activity is met, the study can then progress to phase IIB where the optimal therapeutic dose with the fewest side effects can be ascertained.
Only a relatively small percentage (approximately 33%) of potential new drugs advance from phase II of clinical study to phase III (https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm).
What is Phase 3 of a Drug Study?
In Phase 3 of a drug study, approximately 300 to 3000 volunteers with the disease or condition being studied are evaluated over a period of from 1 to 4 years to determine the efficacy of a drug, the therapeutic dose and any potential side effects (adverse reactions).
Phase 3 of a clinical trial is usually the most expensive and most time- consuming phase of a drug study and usually 2 successful phase III trials are required by the FDA in order to obtain approval for a new drug.
Only about 25% to 30% of phase 3 drug studies are successful and go on to be approved by the FDA.
What is a Phase 4 of a Drug Study?
Phase 4 (Post-Marketing Surveillance) of a drug study (this involves studying the safety and efficacy of the drug) occurs after the drug has received approval by the FDA for sale and is being used by the public.
During Phase 4 of a drug study, several thousand volunteers with the disease or condition being studied are evaluated while taking the drug for rare and adverse side effects over at least a 2-year period.
If serious side effects are discovered, the drug may be pulled from the market or restricted to only certain uses.
The Pharmacy Technician’s Role in Drug Studies
Pharmacy Technicians provide key roles assisting pharmacists in drug studies of new experimental drugs which are conducted throughout the United States at many major medical centers, hospitals and clinics.
At all times when working with a drug study group, you will work under the direct supervision of a Clinical Trials Pharmacist and under the supervision of senior and lead Pharmacy Technicians.
Licensure Requirements for Pharmacy Technicians Working in Drug Studies
Current licensure as a Pharmacy Technician and certification by the Pharmacy Technician Certification Board are required to work a Pharmacy Technician in a drug study. You may also be required to pass multiple drug study related competency modules which are related to the drug being studied.
Important Required Skills for Pharmacy Technicians Working in Drug Studies
Important required skills and abilities for Pharmacy Technicians working in drug studies include:
- Paying attention to details
- Having effective communication skills
- Possessing critical math skills including pharmacological computations and calculations
- Possessing excellent computer skills including the use of excel spreadsheets
- Possessing excellent communication and telephone skills
- Having the ability to meet deadlines and work under pressure
Important Work Abilities for a Pharmacy Technician Working in Drug Studies
Important work abilities for a Pharmacy Technician working in a drug study include:
- Having the ability to lift 20 pounds
- Having the ability to stand or sit for extended periods of time
- Having the ability to work well with other team members
The Multi-Disciplinary Drug Study Team
Depending on the phase of the drug study you are working with, you will be working with a multi-disciplinary team that usually includes:
- A consulting physician from the hospital, medical office or medical center
- Research workers from a pharmaceutical company
- Research nurses
- Pharmacy staff members
- Medical staff members
- Nursing staff members
- Quality Assurance staff
General Duties of a Pharmacy Technician Working in a Drug Study Group
The general duties of a Pharmacy Technician working in a drug study include:
- Answering phones
- Attending staff meetings
- Providing support to pharmacists
- Checking expiration dates on medications
Principal Duties of a Pharmacy Technician Working in a Drug Study Group
The principle duties of a Pharmacy Technician working in a drug study group under the direct supervision of a Clinical Trials Pharmacist will include:
- Dispensing inpatient and outpatient investigational prescriptions
- Entering prescription orders into the computer system
- Receiving investigational drug supplies
- Returning unused medications
- Removing investigation medications from stock for destruction after a completed drug study
- Removing study drugs returned by patients for proper destruction
- Conducting inventory and checking drug expiration dates
- Delivering investigational drugs to the sterile product technician coordinator for repackaging
- Contacting representatives from drug manufacturing companies to order new supplies of drugs as needed
- Acting as a liaison between the pharmacy, the drug company and the researchers
- Billing study fund for encapsulation of study medications
Additional Essential Functions of a Pharmacy Technician Working in a Drug Study include:
- Maintaining records and documentation of all investigational and outpatient transactions and procedures
- Meeting regularly with representatives of any applicable controlled substances drug destruction company
- Maintaining all records of the archival file
- Training new Pharmacy Technicians
- Maintaining records on freezer and refrigerator temperatures daily
- Contacting study coordinators for prescription clarifications
- Assisting study coordinators
- Assisting nursing staff
- Assisting patients who come to the pharmacy for research transactions
- Maintaining a database of protocols
- Writing letters to investigators on behalf of supervising pharmacists
The drug study market in many different therapeutic areas is projected to continue to expand providing well-paying and stable jobs for Pharmacy Technicians. Working as a Pharmacy Technician in a drug study program provides the opportunity for an exciting and rewarding career assisting in the research and development of new medications which can help save lives. Understanding how drug studies work can help you to decide if this specialty area of pharmacy fits with your personality and interests. State certification as a Pharmacy Technician along with PTCB certification are required to qualify for employment in a clinical drug study. An interest in drug research, having the ability to pay attention to details, having good computation skills and being able to work well with others are some of the skills necessary to be successful as a Pharmacy Technician working in the challenging drug study field.