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Using trial examples provided by the workshop participants, the instructor will demonstrate the process of identifying opportunities for increasing clinical trial efficiency and minimizing the risk of a failed trial, by applying adaptive design principles. By using actual examples, modified to whatever extent is required by considerations of confidentiality, the focus will be on solving real challenges facing those working on the development of innovative pharmaceuticals, biologics, or medical devices. Logistical and implementation challenges associated with the proposed designs, and their solutions, will be discussed as well.

Many discussions of adaptive clinical trial design and analysis are largely theoretical and may be difficult for attendees to apply to the challenges they face in their own work. This workshop is intended to fill the gap between typical presentations and each attendee’s own area of application, allowing the attendees to accurately assess whether adaptive design approaches may be of benefit in their own work.

Workshop programme

13:00 Registration & Coffee

13:30 Opening

Roger Lewis

Roger Lewis, MD, PhD, Senior Medical Scientist , Berry Consulting

 

·         Review of the “toolbox” of adaptive techniques that can commonly be applied
·         Advantages, challenges, and regulatory considerations in the choice of adaptive techniques to be considered
·         Evaluation and “stress testing” of proposed adaptive designs

14:00 Identification and Evaluation of Opportunities for Increasing Clinical Trial Efficiency

Roger Lewis

Roger Lewis, MD, PhD, Senior Medical Scientist , Berry Consulting

 

·         Interactive discussion of clinical trial examples provided by workshop participants
·         Identification of opportunities for increased statistical and operational efficiency
·         Discussion of simulation and other evaluation methods for determining the operating characteristics of proposed designs

15:00 Tea / Networking Break

15:30 Logistical and Implementation Considerations

Roger Lewis

Roger Lewis, MD, PhD, Senior Medical Scientist , Berry Consulting

 

·         Discussion of logistical challenges and implementation methods for multicentre trials incorporating the adaptive approaches discussed in the workshop
·         Discussion of experiences (both successful experiences and adverse experiences) associated with the implementation of adaptive clinical trials

16:30 Oversight and Monitoring of an Adaptive Trial

Roger Lewis

Roger Lewis, MD, PhD, Senior Medical Scientist , Berry Consulting

 
  • Approaches to the oversight and monitoring of adaptive clinical trials
  • Considerations in the formation of Data and Safety Monitoring Boards (DSMBs) and their operation
  • Methods to ensure ongoing trial integrity and the acceptability of final trial results to regulators
  • 17:00 End of workshop

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    Holiday Inn Regents Park

    Carburton Street
    London W1W 5EE
    United Kingdom

    Holiday Inn Regents Park

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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