The Clinical Research Industry Flashcards
What is Clinical Research
A branch of healthcare science that determines the safety and effectiveness (efficacy) of medication, devices, diagnostic products and treatment regimens intended for human use.
These maybe used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
Clinical Trials
- A study done in human subjects to investigate a potential new drug, device or biologic product
- The mainstay for bringing new drugs to market
Clinical Trial Conduct
There are 3 primary groups involved in the conduct of a clinical trial
- Sponsor
- Principal Investigators
- IRB’s
Sponsor
- Pharmaceutical company
- Requires the expertise and the help of a CRO to hopefully bring their product to market
- 90% of Sponsors use CRO’s b/c Sponsor’s specialty is creating the drug and developing new products as well a better treatments.
- A CRO helps the Sponsor write the protocol,
- submit the data to the FDA
- and monitor the site throughout the study
- medical monitor
- CRO handles all communication with the sites
Industry Sponsors
- Merck
- Pfizer
- Norvatis
- Johnson & Johnson
- GlaxoSmithKline (GSK)
Contract Research Organization (CRO)
- Provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
- Ranges from large, international full service organizations to small, niche specialty groups.
- Help companies conduct the extensive test on experimental drugs, biological, and medical devices that government regulators require before they will consider these products.
CRO Companies
- Covance
- Syneos Health (previously INC Research)
- Precision for Medicine
- Iqvia
- PPD
- Parexel
- Medpace
- PRA Health Services
- Worldwide
- ICON
- Advanced Clinical
- Premier Research
- Chitern
Principal Investigator (PI)
• Personally conduct or supervise the research
. Ensures each person whom a task is delegated is qualified by education, training and experience to perform each delegated tasks
• Protect the rights, safety, and welfare of the participants who will be under their care. To do this they agree that the research
. Is in accordance w/ all federal regulations requirements, IRB approval plan, and will assure accuracy, security and integrity research data and subsequent analysis of that data
Institutional Review Board (IRB)
- Independent body that reviews, evaluates, and decide on the scientific and ethical aspects of the clinical trial protocol as well as the benefits and risk to the study participants
- Main purpose is to protect the rights, safety and well being of subject who participate in the trial
- Members must be qualified to review and evaluate science, medical aspects, and ethics of proposed trials
- Conducts initial continuing review of trials
IRB - Central
ROLE
. Used by (Pharmaceutical company or CRO) that don’t have internal IRB’s
. Provides supervision for different sponsors across VARIOUS study sites
BENEFITS
. Saves time and money
. Reduce delays in enrollment
EXAMPLE
. WIRB (Western Institutional Review Board
. Advarra
IRB - Local
ROLE
. Internal group that supervises research at ONE location
. Used for internally funded, investigator initiated trials
. Present at most academic institutions
BENEFITS
. Can review multiple studies onsite; internally/externally funded trials
. Better understanding of local customs and standards of care w/in the community.
. Speed of research is locally controlled
. Familiarity amongst members and investigators
