Clinical research and development in the pharmaceutical and biotechnology industry
Download
1 / 17

Clinical Research and Development in the Pharmaceutical and Biotechnology Industry - PowerPoint PPT Presentation


  • 212 Views
  • Uploaded on

Clinical Research and Development in the Pharmaceutical and Biotechnology Industry. Robert Anderson, MHA, CCRA, CCRCP Director, Clinical Trials Administration www.cratraininginstitute.com Houston Texas. Objectives. To understand the drug development process

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Clinical Research and Development in the Pharmaceutical and Biotechnology Industry' - vita


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Clinical research and development in the pharmaceutical and biotechnology industry l.jpg

Clinical Research and Development in the Pharmaceutical and Biotechnology Industry

Robert Anderson, MHA, CCRA, CCRCP

Director, Clinical Trials Administration

www.cratraininginstitute.com Houston Texas


Objectives l.jpg
Objectives Biotechnology Industry

  • To understand the drug development process

  • To understand the phases and components of the clinical research process

  • To appreciate the history behind the regulations in the clinical development process

  • To understand the current regulations involved with the clinical research process


Healthcare industry players l.jpg

Physician Biotechnology Industry

InsuranceCompany

Patient

Care

Hospital

Pharmaceutical

Industry

Healthcare Industry Players


Drug discovery process l.jpg

Target Selection Biotechnology Industry

Target Validation

& lead

optimization

Proof of Concept

Clinical Trials

Pre-clinicalPhase

CompoundSelection

Proof of ConceptOutcome

2 – 4 Years

4 – 7 Years

Clinical Phases I, IIIII, IIIB*

Drug

Registration

FDA Approval

Marketing (Phase IV

Clinical Trials)

*Key variable guiding development time

Marketing Introduction

Drug Discovery Process

(250)

(5,000 – 10,000)

(5)

(1)


Clinical trials what are they l.jpg
Clinical Trials: What Are They? Biotechnology Industry

  • An organized research study designed to investigate new methods of preventing, detecting, diagnosing, or treating an illness or disease (such as cancer).


The players in clinical research l.jpg

Sponsor Biotechnology Industry

InvestigatorSite

Patient

IRB

CRO

SMO

The Players in Clinical Research


Clinical trials process and associated regulatory process l.jpg

Phase II Biotechnology Industry

End of Phase II

Meeting

Pre-IND Meeting

IND Application

PhaseI

PhaseII

Drug Approval

Phase III

Pre-NDA

Meeting

PhaseIV

File NDA

Clinical Trials Process andAssociated Regulatory Process


Phases of clinical trials l.jpg
Phases of Clinical Trials Biotechnology Industry


Tasks involved to develop support clinical trials l.jpg
Tasks Involved to Develop/Support Clinical Trials Biotechnology Industry

  • Protocol development

  • Volunteer recruitment

  • Clinical conduct (management)

  • Monitoring

  • Data management

  • Clinical statistics

  • Medical writing

  • Quality assurance


What is involved in a clinical trial l.jpg

File IND application Biotechnology Industry

Sites enroll patients

Develop protocolSubmit to FDA for comment or no action

Patients cycle through study Capture: Adverse events, vital signs, study drug adherence, QOL questionnaires captured on Case Report Forms

Select investigational sites based on # of patients needed for the study

Patients exit study

  • Regulatory requirements for each trial at each site

  • 1571 or 1572

  • PI’s CV

  • Financial disclosure forms

  • Informed consent

  • IRB approval

Data collected and cleaned

Sites closed

Write study report

Add study to NDA

Initiate site(s)

What is Involved in a Clinical Trial?


Clinical trials benefits risks l.jpg
Clinical Trials Benefits & Risks Biotechnology Industry


Clinical trial standard language l.jpg
Clinical Trial Standard Language Biotechnology Industry



History behind regulations of clinical trials l.jpg
History Behind Regulations of Clinical Trials Biotechnology Industry

  • Regulations often result in response to abuse of human research subjects and concerns about the validity of data and conclusions from clinical trials.

  • The primary vehicles for human subject protection are IRBs and informed consent.

  • The Declaration of Helsinki and the Belmont Report are critical documents for the protection of human subjects in research.

  • The FDA, by means of PDUFA and FDAMA, has made significant gains in speeding the process of making new drugs available for patients who need them.

  • Current problems with clinical trials and trial oversight may well lead to increased regulation.


Regulations for clinical trials l.jpg
Regulations for Clinical Trials Biotechnology Industry

  • The FDA regulations pertaining to clinical trials are found in 21 CFR Parts 11, 50, 54, 56, 312 and 314.

  • The ICH Guidelines for Good Clinical Practice should be followed in clinical trials.

  • The FDA publishes many guidelines and information sheets pertaining to the appropriate conduct of clinical trials.

  • Good clinical practices are the ethical and clinical standard for designing, conducting, analyzing, monitoring and reporting on clinical trials.


Health outcomes l.jpg
Health Outcomes Biotechnology Industry

  • Health outcomes studies examine the clinical, economic and quality-of-life outcomes of pharmacotherapy.

  • Health outcomes research expands upon the FDA-mandated efficacy and safety endpoints to give a fuller picture of the outcomes experienced by a patient. It is a relatively new discipline that combines a number of fields of study, including medicine, epidemiology, statistics, economics and psychometrics.

  • Early in development, companies may be interested in documenting the epidemiology and cost burden of a particular disease state.

  • As a compound moves through to Phase II and II, behavioral, humanistic and economic endpoints may be incorporated into registration trials.

  • Concurrently, economic models may be created to quantify the economic benefit of the new therapy.

  • Once a compound is launched, a variety of research services may be utilized, including registries, Phase IIIb/IV comparative studies and claims analyses.


Other issues in the clinical research process l.jpg
Other Issues in the Clinical Research Process Biotechnology Industry

  • National Institutes of Health

  • Special populations

  • Data Safety Monitoring Boards

  • Orphan drugs


ad