In this interview, Dr Alison Messom, Chairman of The Institute of Clinical Research, reflects on the latest ICR event, at which around 30 academic and commercial clinical research professionals explored the state of the art in clinical trial operational metrics, how to define them, collect them, analyse them and act on them.
Ultimately, she concludes that well-formed metrics are a valuable tool that should be used by any forward-looking manager and organisation, but they should only aid decision-making rather than drive it entirely, with analysis in the correct context being vitally important.
In this interview, Dr Arun Bhatt explains the context of recent developments in India, where a legal ruling has required all patients considering taking part in a clinical trial to have their informed consent recorded on video.
In the 9-minute interview, Dr Bhatt explains:
- How the idea of filming informed consent arose and how it came to be part of a legal ruling
- Practical aspects of filming the informed consent process
- Whether he expects any impact on patient recruitment rates as a result
- Whether this development might be taken up in other countries
This interview was conducted via Skype, so the audio quality might make it difficult to hear the entire conversation clearly. A transcript will be added to this page shortly.
A few days ago, I appeared as a panellist on a webinar discussing the results of a recent survey on patient awareness of clinical trials within the hepatitis C patient community, hosted by Tudor-Reilly. We discussed how to raise awareness of HepC clinical trials, some of the issues around conducting studies in this therapeutic area, and how these findings might be applied to patient engagement in clinical research more generally.
The webinar was led by Peter Coe, Chairman of Tudor-Reilly, and the other panellists were:
- Dr Matthew Foxton, consultant hepatologist
- Andrew Langford, CEO of the British Liver Trust
- Karen Donovan, principal of healthcare consultants Health Business Group
The audio and slides from the webinar are now available [here].
In this interview with Nicky Dodsworth, we discuss the recent EFGCP Workshop on risk-based monitoring.
At the conference, speakers from industry, academia and regulators shared their perspectives on how to adapt the oversight and monitoring of a clinical trial, and of individual sites within a study, according to their risk profile relating to patient safety and the quality of resulting study data. The risk profile is based on the novelty and complexity of the study, and the capability and quality of the site performance.
Here is an interview I recorded with Richard Scaife, Chairman of the Pharmaceutical Contract Management Group (PCMG) ahead of their Annual Conference to be held in Budapest early in June 2013. At the time of writing, final delegate places are still available.
We talked about some of the hot topics in the outsourcing of clinical development, which will be explored in more detail at the conference:
- Whether clinical trial outsourcing has become too elaborate
- Payment schedules, and whether pharma is paying too much, too early for outsourced trials
- The possibility of benchmarking or standardising elements of outsourcing contracts
- How the balance of power between sponsors and CROs is shifting
The Institute of Clinical Research held its latest Project Management Forum last Friday, with over 50 delegates meeting to discuss issues around oversight of clinical research projects where outsourcing is involved. Following the meeting, I spoke with Ian Gravenor about the presentations and the interactive session.
The next ICR Project Management Forum will be held in the Autumn. To find out more, visit http://www.icr-global.org/community/forums/project-management-forum/
Here is an interview I recorded with Geoff Taylor, Director of Clinical Quality Assurance at Eisai Product Creation Systems.
Geoff will be giving the keynote presentation at a conference on Risk-Based Approaches to Clinical Trials, held in London on April 24-25, 2013. I am also pleased to confirm that the conference organisers have offered a 15% discount off the full delegate rate for all ClinDev readers. Simply use the code CQ4173ClinDev when registering.
We discuss a variety of topics, including:
- The challenges around senior management buy-in to make the up-front investment in time and resources to move to a risk-adaptive approach
- The changing balance of activities between data managers, central monitors and field-based monitors
- The potential for the field-based monitor role to take a more active approach to site relationship management, and the possible shift in skills for the next generation of monitors
- How quickly risk-adaptive monitoring could be as ubiquitous as EDC is today
The conference will cover all of the key factors which must be taken into consideration when making the transition to a risk-based approach – with the aim of improving efficiency whilst remaining compliant and without impacting deliverables. It is estimated that sponsors can save 23% of trial costs with a risk-based approach… but as Geoff points out, there’s far more to risk-adaptive monitoring than simply cutting costs!
Other speakers at the conference will include:
- Miguel Valenzuela, Bayer (also interviewed for ClinDev)
- François Beckers, GSK Vaccines
- Patricia Eriksson, Sanofi Pasteur
- Natalia Zurita, Almirall
- Marc Buyse, IDDI & CluePoints
- Daniel Milikowski, AstraZeneca