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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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KITE’S CAR T-CELL THERAPY YESCARTA® (AXICABTAGENE CILOLEUCEL) FIRST IN EUROPE TO RECEIVE POSITIVE CHMP OPINION FOR USE IN SECOND-LINE DIFFUSE LARGE B-CELL LYMPHOMA AND HIGH-GRADE B-CELL LYMPHOMA
Stockley Park, UK – 16 September, 2022 – Kite, a Gilead Company, today announces that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Yescarta® (axicabtagene ciloleucel) for adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. If approved, axicabtagene ciloleucel will be the first Chimeric Antigen Receptor (CAR) T-cell therapy approved for patients in Europe who do not respond to first-line treatment. Although 60% of newly diagnosed LBCL patients will respond to their initial treatment, 40% will relapse or will not respond and need 2nd line treatment.
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White Papers |
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Crunch Time: The Impact of Serialisation Requirements on Packaging Operations
PCI Pharma Services
The deadlines for including unique product identifiers on prescription drugs is putting a strain on multiple parts of the industry, much of which is ill-prepared to meet the target. Here, we look to the experience of a company that is ahead of the curve for lessons on how to manage and ease the transition to serialisation.
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