Issues in early phase research
Timing of First-in-Man Studies
John Kolthammer HonFICR
There are, of course, many issues relating to early phase (clinical) research (EPR); but, an often-neglected perspective is that of the process for deciding when is the right time to start the first studies in man; inevitably, but not always, in young, healthy volunteers. This article focuses on the scientific issues which affect the decision process to start the first studies in man.
The Role of Method Development Studies in Aiding Clinical Drug Development
Jim Growcott & Andrew Hughes
Developing a therapeutic agent is a significant investment with significant associated business risks. The inability to translate promising pre-clinical data through to clinical realisation is a common frustration. This paper looks at how, in the oncology setting, translational science conducted in pre-clinical model systems and development of methods to be used in clinical trials are married to help support early decision-making in clinical development.
At the Cutting Edge of Early Phase: An Interview
Liz Allen FICR
Liz has been involved in early phase research since 1982, designing, conducting and reporting on clinical trials in both academic and CRO settings. Since 1989, she has worked at Guys Drug Research Unit and has been Director of Scientific Affairs since 2001. She took time out of her busy schedule to discuss her work in early phase research and some of the topics at the cutting edge of the sector.
Features
Impact of the Human Tissue Act on UK Clinical Research
Shethah Morgan RICR & Chris Womack
The UK Human Tissue Act 2004 provides a regulatory framework that includes research activities undertaken by pharmaceutical companies using human cell-containing samples obtained from research subjects. This legislation enters an environment that is already heavily regulated and has a strong research ethical basis. The authors describe some of their experiences in working with the provisions of this Act.
Stuart Redding MICR
Stuart reports on a discussion forum, held at the PCMG 2007 Annual Conference, on when and how project managers should be included in the processes of handing over and managing outsourced clinical trials. He mentions the need for handover training, when keeping a named project manager is important and how frequent, open communication is vital.
John L Allinson & Ray Briggs
We are pleased to launch this new series in which experts provide introductions to topics that are becoming increasingly important, and that clinical research professionals will need to know more about in the coming years. We start with biomarkers, which have a powerful role to play as surrogate endpoints, but raise issues of qualification and analytical technology.
People
Communicating the Human Side of Science & Technology: An Interview
Judith Hann
Judith Hann is well known as a science broadcaster, but has also made a career in writing about science and training scientists to deal with the media. She will be giving the closing keynote address at ICR’s Annual Conference. We spoke to Judith to give prospective delegates an idea of what to expect from this interesting, informative and inspiring session.
Viewpoint
Andrew Smith
The Editor of CRfocus discusses the changes launched in this re-designed issue of CRfocus, and some of the editorial changes that have been building up to this over the past few months.
Regular update
Susan Ollier MICR
In the first of a new series of monthly messages from the Chair of ICR, Susan Ollier welcomes you to this new-look issue and outlines some of the principles guiding the Board of Directors in their strategic planning of ICR’s activities: innovation, inclusion and interaction.
Preview: 29th Annual Conference & Exhibition
Andrew Smith
Andrew gives a brief preview of the ICR Annual Conference, taking place in Birmingham on April 8th and 9th. He discusses highlights of the conference programme, regular favourites such as the exhibition and Gala Dinner, an expanded poster competition and new events for this year’s meeting, including “Speed Networking” and “Sue’s Surgery”.
A SIG for All Seasons: Introducing the Innovative Medicines Special Interest Group
Frances Sanders RICR & Pauline Iredale MICR
Innovative approaches and novel techniques are increasingly important in drug development. The ICR Innovative Medicines SIG (formerly the Genetics Research SIG) have assessed the needs of members in this area, and set out how they plan to address them.
