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International Clinical Trials
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Developing new drugs, or old drugs for new indications, is all about
running clinical trials. It is widely acknowledged that the current
process is at best inefficient and, for the future economic health of
the pharmaceutical industry, is in dire need of improvement. That being
said, over the last 25 years, we have seen very little progress in the
conduct of studies. What developments there have been have come as a
result, to some extent, of electronic aids for design, management and
reporting.
In this edition of ICT, we have a number of
contributions which touch upon the impact of what one might call
electronics in clinical trials. Evjatar Cohen at Appian discusses how
mobility and collaboration might be key to ensuring high quality in
studies. He highlights how mobile devices have become embedded in our
daily lives; but, while the industry is committed to transforming trials
electronically, only 14% report that they are fully migrated in all
areas. Marc Desgrousilliers and Eric Morrie at ClinCapture regard
digital technology as a way of streamlining data collection,
transmission and monitoring, and review what is available on the market
today. Dr Chris Watson at Exco InTouch also explores what sponsors and
CROs can gain by implementing electronic technology advances.
Some
time ago, a colleague of mine noted that the failure of a particular
clinical trial in the US was due to the fact that the inclusion and
exclusion criteria for the study meant that there were a total of only
six eligible patients in the whole of the US. Tigran Arzumanov, Bernhard
Bodenmann and Le Vin Chin at Clinerion compare the search for patients
with suitable profiles to participate in clinical research with the
proverbial search for the needle in the haystack. In their paper, they
examine how electronic health records (EHRs) can significantly aid this
process: companies that have access to such records are more capable of
carrying out feasibility studies, and better at identifying patients and
recruiting them. The challenge in such utilisation of EHRs is one of
data protection, and I have noted a recent debate where patients seem
more willing to share personal data on Facebook than they do when
altruistically participating in clinical research.
Patient
retention is always a challenge in clinical trials, even when enrolment
has gone smoothly. As many as 30% of participants may drop out before
the study is complete, according to Franc Jeffrey at EQ Travel. He
observes that the logistics of travel and expense reimbursement to
patients is yet another area of clinical trials which is beginning to be
outsourced. He further claims that improved travel management can help
reduce the number of patients that drop out of studies.
One of
the reasons subjects may drop out is an unacceptable adverse event. The
accurate identification and reporting of such events is a crucial part
of the drug development process – it is little wonder, therefore, that
the FDA has placed this area under increased scrutiny in the form of
stricter pharmacovigilance (PV) regulations supported by inspections. Dr
Mitchell Gandelman at Sciformix Corporation points out that failure in
PV can have serious consequences for all stakeholders in the drug
industry. Thus, all partners in the drug development process need to
play an active role in PV. Dr Brian Edwards and Olga Björklund at NDA
Group further reveal that the FDA is not satisfied with the quality of
data in clinical trials, and they report on how the new FDA PV guidance
is impacting on clinical safety data. What is more, a system-wide buy-in
and implementation of guidelines is required to ensure efficient PV.
In
this issue, we also have interesting contributions on clinical trial
design for biosimilar testing and standard operating procedures. I hope
you enjoy your summer reading.
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News and Press Releases |
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CPhI expert forecasts ‘huge growth in Middle East manufacturing with Europe a medium-term target’
CPhI Middle East & Africa (CPhI MEA) expert Madhukar Tanna, Chief
Executive Officer of Pharmax, a United Arab Emirates (UAE) based branded
generic manufacturer, says favourable conditions in the UAE are
resulting in a boom of pharmaceutical manufacturing throughout the
region. Government incentive schemes to increase domestic production,
coupled with a brand friendly environment and rising healthcare needs is
fuelling surging demand – with many new companies and plants launching
in the last two years alone.
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White Papers |
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Extractables and Leachables Testing: A Risk Based Approach
RSSL
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime.
Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance.
Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure.
This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events |
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World Pharma Week 2019
17-20 June 2019, Seaport World Trade Center, Boston
World
Pharma Week will bring together a unique and international mix of large and
medium pharmaceutical and biotech companies, CROs, leading universities and
clinical research institutions, emerging companies and tool providers—making it
a perfect meeting-place to share experience, foster collaborations across industry
and academia, and evaluate emerging technologies.
More info >> |
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