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Ethics
attrition:
Unacceptable
levels of attrition in the clinical stage of development are driving
profound changes in the architecture, design, and analysis of clinical
trials. The majority of respondents to our survey said that reduction in
patient numbers, less exposure to study drug, and drops in overall trial
duration were key points in favor of adaptive designs; however, a
majority also had specific concerns with adaptive trials―concerns
that involved methodological, logistical, and regulatory uncertainties:
Herman Mucke, Adaptive
Clinical Trials: Innovations in clinical trial design, management and
analysis,
Insight Pharma Reports, 2007 Bayesian clinical trials: Clinical Informatics clinical
auditing: Regulatory agencies’ changing focus and
expanding expectations regarding GCP compliance will be addressed at the
Second Annual Clinical Auditing Forum. Attendees can
expect presentations on auditing best practices, strategies, and
techniques to ensure that solid GCP compliance and scientific and
ethical standards are maintained throughout the conduct of clinical
trials. Clinical Auditing Forum June 6-7, 2012 • Boston, MA Program | Register | Download
Brochure
Clinical
Quality Risk Management
conference will focus on meeting the emerging regulatory expectations
for a quality systems-based approach to GCP compliance. FDA compliance
officials are increasingly speaking about the importance of sponsors’
quality systems in clinical research, and of the shifting expectations
for sponsors’ clinical trial oversight, in particular to a quality
risk management approach in trial oversight. European regulators have
also expressed interest in the topic, and are reportedly working on a
risk-based quality management approach for clinical trial conduct and
supervision. Clinical
Quality Risk Management June 4-5,
2012 • Boston, MA Program | Register | Download
Brochure clinical
trial monitoring:
Mastering
Clinical Trial Monitoring
conference will focus exclusively on the changing role and expanding
expectations of the experienced clinical trial monitor. Building on the
overwhelming success of previous events, thought leaders will share
their experiences related to implementing risk-based monitoring plans,
enhancing the monitor’s job performance with hands-on techniques and
tips, and improving site performance and data integrity. Themes
throughout the conference will be building risk-based monitoring plans,
monitoring global clinical studies, incorporating the latest regulatory
requirements and expectations into your monitoring activities, and
meeting the challenges of monitoring in an electronic environment. Mastering Clinical Trial Monitoring
June 4-5, 2012 • Boston,
MA Program | Register | Download Brochure The
NIH defines a clinical
trial
as a prospective biomedical or behavioral research study of human
subjects that is designed to answer specific questions about biomedical
or behavioral interventions (drugs, treatments, devices, or new ways of
using known drugs, treatments, or devices). Clinical trials are used to
determine whether new biomedical or behavioral interventions are safe,
efficacious, and effective. Behavioral human subjects research involving
an intervention to modify behavior (diet, physical activity, cognitive
therapy, etc.) fits this definition of a clinical trial. Human subjects
research to develop or evaluate clinical laboratory tests (e.g. imaging
or molecular diagnostic tests) might be considered to be a clinical
trial if the test will be used for medical decision making for the
subject or the test itself imposes more than minimal risk for subjects.
Biomedical clinical trials of experimental drug, treatment, device or
behavioral intervention may proceed through four phases:
CenterWatch
http://www.centerwatch.com/
A listing of more than 41,000 industry- and government- sponsored
clinical trials as well as new drug therapies recently approved by the
FDA. CRO: An organization that conducts all or some of the clinical research involved in the drug or product development process on behalf of pharmaceutical research companies. An overview of drug development, Barnett/Parexel, 2000 http://www.barnettinternational.com/EducationalServices_Publication.aspx?p=6464&id=97141 Contract
Research Organization or Clinical Research Organization. Clinical trials
are increasingly being run by outsourcing to these groups. developmental
site agreements: Companies
work with hospitals to develop instrumentation and clinical research
applications. drug
development Latin America:
operations
data: 2012.
Topics to be discussed include
Utilizing
portals: Integrating data, enabling communications, and optimizing
clinical trial operations methodology, Clinical Trial Operations and
Clinical Data Integration: Building data warehouses to integrate clin
ops and clinical data across studies, data mining …. Integrating
and Leveraging Clinical Trial Operations Data February
8-9, 2012 • Miami, FL Program | Register
| Download Brochure patient:
People
with a specific disease or condition, particularly those being treated
by a health professional.
patient
recruitment: Patient
recruitment and retention are critical to drug development programs.
Patient recruitment, if not adequately planned for, can extend your
development timeline by a number of years. Retention of patients
throughout the life of a clinical trial is essential in order have
complete data sets for your analysis and subsequent filings. Topics to be discussed include in 2012 include Designing and implementing
a clinical enrollment plan: Strategy development, plan implementation
and contingency planning … Patient
Recruitment and Retention in Studies and Registries
February 8-9, 2012 • Miami, FL Program | Register
| Download Brochure personalized
therapy clinical trials: Executive
Summit: Driving Innovation in Clinical Development Sept 19-21, 2012 •
Washington, DC Program | Register | Download Brochure Phase
I: The
main aim of this phase is to determine drug safety. At this stage, drugs
are tested in a small group of healthy volunteers to determine the
drug’s activity. Phase
II: These
trials are aimed at identifying the optimal dose to be used in Phase III
trials and, ideally, they identify drugs that will not make it through
the next phase of testing. Typically, Phase II trials are double-blinded
and have placebo controls. Phase
IIa and b: Some pharmaceutical companies further differentiate this
phase into phases IIA and IIB. Clinical studies designed to evaluate
dosing are referred to as Phase IIA and studies designed to determine
the effectiveness of the drug are called phase IIB. Design and
Analysis of Clinical Trials Shein-Chung
Chow, Jen-pei Liu phase
II risk reduction: See Chemistry glossary backup
compounds
Phase
III: These
studies, which take several years, can involve thousands of patients at
multiple trial centers. They are aimed at definitively determining the
drug’s effectiveness and its side- effect profiles. These studies are
also typically double- blinded and placebo- controlled. Phase
III success rates for the pharmaceutical industry are low, but recent
advances in simulation & modeling, clinical trial design,
proof-of-concept, and pre-clinical decision making are set to reduce the
attrition rate. Phase III Clinical
Trials March 12-13, 2012 • Philadelphia, PA Program | Register | Download Brochure Phase IV/ postmarketing surveillance: At this stage, after a drug has been launched, pharmaceutical companies may conduct further studies of its performance, often examining long- term safety. See also Regulatory Affairs Phase Zero, also known as microdosing placebo
non- responders: Non-
responders on placebo] define a group that would never improve their
condition unless given the drug. They may be a group that, if we could
identify them, could be used to reduce clinical trial size. Using this
group in a proof- of -concept, it may be possible to test a drug even
without a comparative placebo and determine whether it is likely to be
active. placebo
responders: Most
people think of the placebo response as a true response. But much of it
is actually regression to the mean. Clinical trial subjects with
more extreme symptoms are often selected because it is desirable to see
a dramatic effect upon treatment with the drug.
pragmatic
trials: Pragmatic
trials measure effectiveness—the benefit the treatment
produces in routine clinical practice Martin Roland, David J
Torgerson, Understanding controlled trials: What are pragmatic trials?
BMJ 316: 285 24 January, 1998 http://www.bmj.com/cgi/content/full/316/7127/285 randomized
clinical trials RCTs: A
study in which the participants are assigned by chance to separate
groups that compare different treatments; neither the researchers nor
the participants can choose which group. Using chance to assign people
to groups means that the groups will be similar and that the treatments
they receive can be compared objectively. At the time of the trial, it
is not known which treatment is best. It is the patient's choice to be
in a randomized trial. National Cancer Institute Dictionary of
Cancer Terms http://www.cancer.gov/Templates/db_alpha.aspx?CdrID=45858
randomized controlled clinical trials: Are the gold standard for determining the efficacy of therapeutic interventions. However, medical practice has not evolved around the concept of randomized trials, but around the idea of careful observations, (anecdotal) case studies and the evaluation of retrospective data. Interventions discovered by these means and taken forward into clinical practice became standard practice as they continued to be superior when compared with prior or alternative types of treatment. Back to the future: why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine, Frueh FW. Pharmacogenomics. 2009 Jul;10(7):1077-81 http://www.ncbi.nlm.nih.gov/pubmed/19604080 risk
ratio: The
ratio of risk in the treated group (EER) to the risk in the control
group (CER). This is used in randomised trials and cohort studies and is
calculated as EER/CER. [Glossary of EBM Evidence Based Medicine]
Terms, Centre for Evidence Based Medicine, Mt. Sinai Hospital, 2000 http://www.cebm.utoronto.ca/glossary/
Single
Controlled Trial SCT: Since
1998, the FDA has allowed drug developers to use what is known as the
single controlled trial (SCT) to support their drug approval
applications. The SCT provision allows applicants to prove the
effectiveness of new drugs by submitting data from only one controlled
clinical study instead of multiple studies. site management organization: Wikipedia http://en.wikipedia.org/wiki/Site_management_organization site
performance: In today’s environment, effective site management
requires not only core organizational abilities, but also a series
of unique, more sophisticated skills to effectively manage productivity.
Barnett International/CHI’s forum on Site Performance Management
focuses on these critical site management skills, providing clinical
research professionals with a series of tools, techniques, best
practices, and examples of what has and has not worked in the management
of effective sponsor/site relationships. Particular attention will
be paid to the role of the clinical research associate, who
often serves as the “face” of the sponsor, while also
focusing in on the important role played by each clinical research
team member in effective site management. Site Performance Management October
3-4, 2011 • Cambridge, MA Program
| Register
| Download Brochure site
selection: Topics to be
discussed in 2012 include Designing and implementing a clinical
enrollment plan: Strategy development, plan implementation and
contingency planning … Global
Site Selection, Feasibility Assessment, Operations & Site Management
February 7-8, 2012 • Miami, FL Program
| Register
| Download Brochure stratification-
clinical trials: The FDA has
been cautious in forwarding any policy on genotyping and clinical
trial stratification, while at the same time trying to engage the
industry in discussions on the subject.
streamlined
clinical trials : subject:
People
being studied as part of clinical trials or other investigation,
including those serving as controls.
vendor
management: With growing regulatory expectations for a quality
systems-based approach to GCP compliance, sponsors must be certain that
their third party vendor partners are “inspection ready. Vendor
Management in Clinical Trials June 6-7, 2012 • Boston, MA Program | Register | Download
Brochure Bibliography Clinical
trials Conferences http://www.chicorporate.com/Conferences/Search.aspx?k=&r=&s=CTL |
