Clinical Trials
The field of clinical research is beset with dwindling patient populations and decreasing retention rates. Finding the right partners to conduct all phases of a clinical study is the final and most important stage in bringing a new drug to market. Achieving success at this stage translates immediately into the approval of cutting-edge treatments to diseases, thus reaping the rewards of efforts, years and billions of dollars invested in the long journey of discovery and development.
Compliance with international laws, informed voluntary consent, access to diverse patient populations, targeting new investigative sites, clinical monitoring and study design are some of many variables that need to be factored into this process. The integration of technological tools that allow for digital data capturing and real-time reporting can speed up a trial significantly, while fulfilling all the requirements of the parties involved.
Pharmaceutical sponsors seek out CROs and organizations that can help them overcome the hurdles of the clinical research process by increasing awareness of all potential benefits and risks of participation to both physicians and patients. Ultimately, the impact yielded on human health is visible in the access provided by clinical studies to patients that are knowing and willing to become a part of the process.
Testing times for human research
How the pharmaceutical industry is striving to attract and retain volunteer
patients for clinical trials. By Julian Rogers
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Evaluating Challenges to Clinical Trial Execution
Evaluating Challenges to Clinical Trial Execution Garrett D. Smith,
Accelovance, Marketing & Patient Recruitment
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The impact of new media on patient recruitment
As sponsors rely more heavily on the web for clinical trial patient
recruitment support, Mary Schwarz, Vice President of New Media at leading
patient recruitment and retention firm MMG
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Revolutionizing Patient Recruitment Through Cross
Referring
Everyone talks about how much more efficient a properly executed centralized
patient recruitment process is over traditional patient recruitment
methods.
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Taking Trials Home
Timely patient enrollment remains the Achilles heel of drug development.
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Maximizing randomizations through referral response
Lost-to-follow-up is one of the greatest correctable barriers to completing
clinical study patient enrollment
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Safety reporting in clinical trials
There’s no time to wait, say Sentrx’s Ralph Bobo and Jill
Notte.
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'The Protocol Is At The Heart Of Every Clinical
Trial'
The protocol is used in selecting investigative sites and designing
the data collection tools; it describes how to treat and evaluate the
trial subjects; it serves as a reference for monitoring and auditing
trial conduct, and it conveys the plan for analyzing the data when the
study is complete.
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Safety reporting in clinical trials: no time to
wait
With the intense focus on drug safety, sponsors should separate the
time-sensitive process of suspected unexpected serious adverse reaction
(SUSAR) reporting from the long-term process of clinical data management.
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The ePRO evolution
Kurt Mussina is Vice President of CRF Inc. He has over 17 years of experience
spanning Research, Marketing and International Business Development
in the Pharmaceutical and Contract/Clinical Research Organization (CRO)
industries.
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The perfect partner
As more companies try to establish profitable relationships with external
clinical research experts, we asked Wyeth’s Ira Spector what companies
should look for in their ideal match.
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Looking beyond EDC
The global pharmaceutical industry is poised at the cusp of a new phase
in clinical development. The convergent forces of emerging technology,
financial pressure, and consumer demand are compelling our industry
to carry out drug development faster, better and cheaper.
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Pharma with a big I
In a move that is confirming its commitment to provide transparency
of clinical information, the IFPMA is to launch a new internet search
portal for clinical trials information. NGP spoke to Director General
Harvey Bale to find out more.
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Trial without error
We look at how, through a combination of interactive technology, support
and experience, each of the major challenges of a global clinical trial
can be addressed.
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