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

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Clinical Research and Development in the Pharmaceutical and Biotechnology Industry

Robert Anderson, MHA, CCRA, CCRCP

Director, Clinical Trials Administration 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

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Physician Biotechnology Industry







Healthcare Industry Players

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Target Selection Biotechnology Industry

Target Validation

& lead


Proof of Concept

Clinical Trials



Proof of ConceptOutcome

2 – 4 Years

4 – 7 Years

Clinical Phases I, IIIII, IIIB*



FDA Approval

Marketing (Phase IV

Clinical Trials)

*Key variable guiding development time

Marketing Introduction

Drug Discovery Process


(5,000 – 10,000)



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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).

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Sponsor Biotechnology Industry






The Players in Clinical Research

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Phase II Biotechnology Industry

End of Phase II


Pre-IND Meeting

IND Application



Drug Approval

Phase III




File NDA

Clinical Trials Process andAssociated Regulatory Process

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Phases of Clinical Trials Biotechnology Industry

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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

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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?

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Clinical Trials Benefits & Risks Biotechnology Industry

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Clinical Trial Standard Language Biotechnology Industry

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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.

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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.

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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.

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Other Issues in the Clinical Research Process Biotechnology Industry

  • National Institutes of Health

  • Special populations

  • Data Safety Monitoring Boards

  • Orphan drugs