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International Clinical Trials
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Welcome to the 25th edition of International Clinical Trials.
Crowdsourcing is a concept that is new to me and forms the basis of one
of the papers in this issue. Crowdsourcing is a process that involves
outsourcing tasks to a distributed group of people, and can occur both
online and offline. The difference between crowdsourcing and ordinary
outsourcing is that a task or problem is outsourced to an undefined
public, rather than a specific body, such as paid employees. Tomasz
Sablinski of Transparency Life Sciences discusses how crowdsourcing,
data transparency, patient centricity and telemedicine are emerging as
the future of drug development (page 36). Investigators and participants
in clinical trials have hands-on, user experience of the benefits and
risks of novel clinical treatments, but also experience the
effectiveness of the trials data generation and collection mechanisms.
Even the Food and Drug Administration (FDA) believe, according to Janet
Woodcock, Director of the Agency’s Centre For Drug Evaluation and
Research, that there has been a shift from medically-defined assessment
of treatment to patientassessed impact, and the FDA now talk about
patient-centred drug development as a key objective. Crowdsourcing is
being applied in some instances to protocol design where the world in
general can help to produce an optimal, patient-centred design, rather
than one produced by ‘blinkered’ academics or pharmaceutical company
physicians. Apparently outsourcing is fed by data transparency, which is
difficult to sell to companies who are often unwilling to publish
negative trial results.
In order that clinical trial data be transparent, it must be traceable.
For clinical information, traceability means knowing where your data is
located, how information is derived and from which data, and furthermore
how conclusions are reached. As research organisations cope with the
tsunami of data derived from increasingly large clinical trials,
traceability is becoming a challenge. This is reflected in the article
on non-response of clinical trials by Andrew Grannell of Statistical
Solutions (page 46). He notes that missing or incomplete responses are
common features in many clinical trials and particularly in
observational studies, and he worries about how these missing data
values will affect the validity of the trial’s conclusions.
Patient recruitment is key to the success of a clinical trial, and the
use of social networking sites in connection with this, as well as a
variety of approaches to patient recruitment are discussed by Rahlyn
Gossen of Rebar Interactive (page 18) and Aaron B Fleishman of BBK
Worldwide (page 24), respectively. If some of the suggested changes in
the conduct of clinical trials and patient recruitment become
widespread, one can almost feel sorry for regulators trying to keep up
with these modern trends.
Twenty years ago, the FDA had a massive backlog of reviews of new drugs,
and the Prescription Drug User Act was introduced to help fund enhanced
reviewing; it has since been through several modifications. The latest
update of the act should, in theory, come into force this coming
September and Nina Baluja, George K Hemworth, Mehri Hezari-Adam, Pat
Mann and Henrietta Ukwu at PPD have provided an overview of the upcoming
changes in legislation (page 60). Whether these will address increased
patient involvement remains to be seen. They conclude, however, that
careful planning and a well thought-out submission strategy will help
companies to navigate the goals and initiatives set out in this new user
fees act.
In this wide-ranging edition of ICT we also have articles addressing
South America, India and China, as well as perhaps more mundane, but
vital issues, such as training and reporting of serious adverse events.
We thank all our contributors for their stimulating submissions.
International Clinical Trials is proud to be a media sponsor of ICSE
2012, taking place in Feria de Madrid on the 8th-10th October. Bringing
together pharmaceutical decision makers from over 140 countries, the
event is a unique forum for business development, networking and
education. Make sure that you don’t miss the Pre-Clinical Trials,
Clinical Trials Stages 1-4, CRO, and Clinical Data Management zones. To
meet a member of the ICT team, visit the Speakers’ Corner, sponsored by
Samedan Ltd. Looking ahead to the November 2012 issue, we will be
investigating how a growing number of major collaborations point to the
evolution of a new CNS research environment based on shared knowledge,
data and operational resources among drug developers. We will also be
featuring our annual survey on central and eastern Europe, which will
assess the benefits and pitfalls of operating in the region. If you have
an idea for an article, get in touch |
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News and Press Releases |
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