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International Clinical Trials

Editorís Comment

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 Agencyís 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 Ďblinkeredí 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 trialís 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 donít 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 Speakersí 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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