Posts Tagged ‘clinical trials’
Posted by Andrew Smith on October 14, 2009
This is the Table of Contents of Clinical Research focus 20(10) issue for October 2009. Members of The Institute of Clinical Research can view the full text of each article by clicking the link and logging in with their username and password.
Global competition
Andrew Smith
Given that multinational (often ‘massively multinational’) trials are now the default position for anything beyond the earliest phase of clinical research, it is somewhat surprising that they still polarise opinion. To some, they are the only way to complete large studies even remotely on deadline and within budget. To others they are damaging to local professionals and research infrastructure and of limited clinical relevance to a medicine’s target patient population. In this extended editorial, Andrew Smith takes a look at the evolving bigger picture of globalising clinical research and suggests how we might find a new balance point to deliver global performance combined with local relevance.
Andrew Smith
There are many layers of perception and received opinion characterising the UK’s performance, with a basic view that we are not performing as well as we might in comparison to other countries (generally in terms of being slower and/or more expensive) and are losing business as a consequence. However, much of the evidence for this is anecdotal, and where metrics do exist they are often specific to an organisation, therapeutic area or part of the process (eg, final protocol to first patient visit). A one-day conference was held in September to discuss initial results of a 2-year study that looked across the entire research process, encompassing both commercial and non-commercial research in all therapeutic areas. Andrew reports…
Feature
Emily Scott
Conducting a clinical study takes a considerable amount of planning, resource, and commitment. But, after the last subject is out, the database has been cleaned, and the planned analyses have been done, what happens to the data that were collected? For interventional studies conducted in accordance with the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), data collected in a clinical study should be submitted to the authorities in a Clinical Study Report (CSR). Emily Scott provides an introduction to CSRs, how they should be constructed and how other study personnel should be involved.
Prof. development
Nicky Perry MICR
The ICR Research Nurse Special Interest Group (SIG) held their second forum on June 18th at the ICR office. Sixty research nurses attended. The agenda for the day was set following the training needs analysis conducted via questionnaire, which was sent out last year. The result of this survey highlighted that nurses wanted to know more about study management, especially how to cost a clinical study.
Iain Searle MICR CSci, Merryn Collard RICR & Jane Nathan RICR
ICR’s Trainers’ Forum generally holds three meetings each year, designed to address topical issues and challenges for those involved in training functions across health, pharmaceutical and life science industries and services. This event was prompted by the rapid development of remote delivery methods within our sector, with a wide range of solutions being implemented across the industry. The days’ agenda had been developed by the Steering Committee, which has a mission to support the interests and further development of trainers within ICR by providing topical meetings, with expert speakers from within and beyond the pharmaceutical industry.
Trial technology
Elena Skryabina
In the latest in our series of introductions to key topics, Elena Skryabina examines the use of infusion pumps for intravenous drug delivery in clinical trials. She demonstrates the amount of control that is possible in a single Phase I unit but also the care that should be taken in larger studies, where differing pumps at different sites can impact on the precision of study drug delivery.
Book review
Allan Gaw, reviewed by Andrew Smith
The rationale for this excellent little book is summed up by Mark Twain, quoted in the introduction: “The past does not repeat itself, but it rhymes.” Learning about the history of clinical trials helps us to understand why the present is the way it is, and this book provides insights into ways of thinking and working that many of us would otherwise simply take as given. It is written in a clear, readable style, with interpretation as well as factual account, highlighting the aspects of each topic that have had the most significant impact on the way clinical research is done today.
Regular update
Janette Benaddi MICR CSci
Like most organisations, the Institute has experienced a difficult operating environment this year, caused by the global recession. However, the Board of Directors and Senior Management Team (SMT) took early, proactive steps at the beginning of the year to manage us through the recession. These included a thorough overhaul of our operating costs and we are starting to see the benefits of these actions. Janette thanks you, our members, for your continuing support. We have received many communications from you supporting ICR over recent months, as we have gone through the change management process. The staff are extremely encouraged by this.
Compiled by Andrew Smith
Our regular look at the lighter side of clinical research, including some ideas for blockbuster movies involving clinical research, examples of “frontier science” in literary classics (and the new Dan Brown), and “Ten things that suggest global clinical research is starting to pick up again…”.
Posted in "Clinical research", CRfocus, Pharmaceutical development | Tagged: "Clinical research", clinical trials, CRfocus, Magazine contents, medicine, Table of contents (TOC) | Leave a Comment »
Posted by Andrew Smith on August 20, 2009
The UK pharmaceutical industry is one of the most significant industries to make money for ‘UK plc’ and re-invest it back into UK-based R&D, within their own organisations, in universities and throughout the NHS. As many have said, the UK ‘punches above its weight’ in our sector. Despite this, we often feel unloved, in terms of both media and public opinion and increasing constraints on revenue (eg, prescribing decisions being led by NICE guidance while reimbursement rates have been cut under the successor to the PPRS). However, the counter-balance to this top-line constraint has come in the form of various initiatives to make more of a contribution in terms of investment in education and training, infrastructure and organisational processes. As a globalised industry has far less binding ties to doing its R&D in the UK than it did 30 years ago, this policy makes a great deal of sense. Over the past decade or so, these initiatives have come under the banners of PICTf, UKCRC and, now, the Office of Life Sciences (OLS) Blueprint, which was published over the summer.
The Blueprint set out 12 key action points, which have been agreed across government, industry, the higher education sector and the NHS. This expands to 10 pages of specific policy measures, complete with timelines and budgets. The Blueprint has been widely welcomed by industry and commentators alike, and certainly, every policy measure should have a positive effect.
The measure that has received the most coverage is the Innovation Pass, ring-fenced funding for time-limited use across the NHS without appraisal by NICE (although NICE will define the criteria for medicines that can take this short-cut). This will be piloted in 2010/11 with a budget of £25m. While initially portrayed by the media as bypassing NICE, this could be a valuable experiment in ‘live appraisal’ mirroring the ‘live licensing’ model proposed by PricewaterhouseCoopers in their Pharma 2020 reports.
The policy that will be of most interest to us in the clinical research sector is the “package of measures to improve the UK environment for clinical trials”. This includes ensuring the UK “fully exploits its potential to be a world leader in heath informatics” (ie, making electronic patient records finally happen!), underlining the duty for SHAs to promote R&D, adding metrics on patient in clinical trials to Trusts’ Quality Accounts, and creating a national framework for local management of research (ie, transforming NHS R&D departments). Significantly, the last three points are essentially reworking areas covered by PICTf nearly a decade ago…
The questions that need to be asked about all these measures, though, are “Will they be implemented as planned?”, “Will they result in improvements in the productivity of UK R&D and uptake of resulting products?” and “Are they sufficiently different from previous initiatives to justify the top-line reduction in reimbursement for medicines?” The many intelligent and powerful people close to this project evidently think so. Far be it from me to disagree, but the fact that this is the third major initiative in less than a decade suggests that its predecessors did not maintain momentum in their improvements (or, more cynically, that pharma are getting increasingly itchy feet in the light of increasing competitiveness overseas).
To sound another small note of scepticism, the UK is less than 12 months from a general election, with a change of government far more possible than at any time since 1997. Although many measures in the Blueprint can be implemented almost immediately, many will take time to demonstrate success, and none will be immune from reversal under a new government.
So, I would like to raise two cheers for the OLS Blueprint: it talks a good game and will certainly have some success, but will it be enough to steady ship of UK competitiveness or just the latest in a series of defences against an insuperable drift to merely “punching our weight”? We will see…
Posted in "Clinical research", Editorials, Pharmaceutical development, pprs | Tagged: "Clinical research", clinical trials, Drug development, Health economics, pharma, Pharmaceutical development, Pharmaceutical Pricing Regulation Scheme (PPRS) | Leave a Comment »
Posted by Andrew Smith on July 23, 2009
You can tell it’s summer! In the latter part of July, large parts of the clinical research establishment evidently winds down for a summer recess. In the past few days, three substantial and (to a greater or lesser extent) significant reports have thudded onto my desk (metaphorically, of course – I read them as PDFs…)
I would like to be able to give a detailed analysis of each of these documents, discussing which of their many recommendations seem to be the most feasible and/or helpful. However, arriving so close together (and as we’re getting the August issue of CRfocus to print) I have only had time to skim them so far, so the best I can do is suggest that you take a look at them yourself.
As one early aside, it might be worth considering the OLS Blueprint (an action plan to re-energise and optimise the UK’s innovative pharmaceutical industry) in the context of PICTf, which was a series of reports, workstreams and metrics that ran in the first half of this decade. Much of what has made UK clinical research what it is today had its source in the PICTf work programmes, so it remains to be seen how much of the Blueprint builds on those developments, and how much re-addresses topics that PICTf initiatives didn’t quite manage to resolve. Also, with a UK General Election less than a year away, and a change of government certainly not beyond the realms of possibility, it might be interesting to wonder how many of the report’s 12 key action points would withstand a shift from Labour to Conservative.
Perhaps more likely to maintain its relevance should the Conservatives win power next year is the report by Professor Sir Iain Kennedy’s report on how NICE might better handle the valuing of innovation in its analysis of the economic impact of new health technologies. Although it sticks with the basic ICER/QALY framework, it makes some strong recommendations on what further research is needed and on a pilot scheme for innovation might be rewarded. This chimes with the “Innovation Pass” idea in the OLS Blueprint, which was initially portrayed in the media as something of a snub to NICE, but is perhaps more an anomoly of publication timings.
If these two reports are quite UK-specific, the middle one is definitely global in scope. Commissioned by the ACRO (the US trade body for CROs, representing the head offices of many of the world’s major contract research organisations) the report aims to demonstrate that clinical research in the “pharmerging” countries is of a comparable standard of safety and ethics of the traditional countries (ie, USA, western Europe etc.) and speed, scale and reduced cost present a compelling case for embracing the shift of larger clinical trials to these new regions rather than railing against it. From my initial reading of the report, this seems something of a tautology: because the studies are commissioned by western sponsors, often conducted by local affiliates of western CROs and designed to collect data to support western registration with the FDA, EMEA etc. is it really surprising that the standards achieved are broadly similar. Still, it’s important for the rest of society to recognise this if they hadn’t already (much of our industry realised this some years ago).
For all three reports, there is then the question of momentum. By the time the world starts getting back to speed in September, we might have had time to ponder some of their more complex recommendations, but others might have forgotten about them entirely! So, let’s make the effort and read them now…
Posted in "Clinical research", Pharmaceutical development, Quick thoughts | Tagged: "Clinical research", clinical trials, Drug development, Health economics, Outsourcing, Pharmaceutical development | Leave a Comment »
Posted by Andrew Smith on June 3, 2009
CRfocus 20(06) – June 2009
This is the Table of Contents of Clinical Research focus 20(06) for June 2009. Members of The Institute of Clinical Research can click on the links to read the full text of each article.In previous years, we have endeavoured to publish reports on all conference sessions in this issue. However, due to constraints on page space and available reporters, we have decided to publish a balanced selection of reports in print, with others (and extended versions of printed reports) becoming available here during June.
Conference photo-gallery
Plenary sessions
- Niall Dickson, Prof. Karol Sikora, Prof. Nick Bosanquet, Francis Crawley & Colin Miller FICR CSci
- Reporter: Suheila Abdul-Karrim MICR Csci
- Kate Moss
- Reporter: Andrew Smith
Lively Debates & Votes: Day Two Plenary Sessions [online only, coming soon]
Sharing knowledge
- Prof. David Jefferys & Paul Wathall MICR
- Reporter: Wendy Tomlinson MICR
- Prof. Peter Andrews & Prof. Malcolm Alison
- Reporter: Jane Pelly MICR Csci
- Rebecca Sergeant & Sarah Watts
- Reporter: Judit Varkonyi-Sepp MICR Csci
Electronic Data Capture (EDC): Issues & Practical Solutions [online only, coming soon]
The A-Z of Adaptive Study Design [online only, coming soon]
Fundamentals of PIPs [online only, coming soon]
Therapeutics
- Prof. Angus Dalgleish, Prof. Nicholas James, Prof. Jonathan Waxman & Prof. Will Steward
- Reporter: Shethah Morgan MICR Csci
- Dr Mike Mullen & Dr Marcus Flather
- Reporter: Sue Jackson RICR
The Heart of Cardiology [extended version, online only coming soon]
Organ Transplantation: Past, present & future [online only, coming soon]
Raising standards
- Eva Nilsson Bagenholm MD & Bev Holt MD
- Reporter: Rachael Winter RICR
- Alison Messom MICR & Andrew Borrisow
- Reporter: Wendy Tomlinson MICR
- Prof. Richard Gray & Joan Perou HonFICR
- Reporter: Suheila Abdul-Karrim MICR Csci
- Fergus Sweeney & Gunnar Danielsson
- Reporter: Judit Varkonyi-Sepp MICR CSci
Putting a Price on Patient Value [online only, coming soon]
Inspectors: Why Do They Do It? [online only, coming soon]
Developing professionals
Medical Devices Workshop [online only, coming soon]
Image in Business: It’s Personal [online only, coming soon]
Project Management Workshop [online only, coming soon]
Leadership Workshop [online only, coming soon]
Regular updates
- Janette Benaddi MICR Csci
Posted in CRfocus | Tagged: clinical trials, conference, CRfocus, Declaration of Helsinki, Drug development, ICR, Magazine contents, medicine, Pharmaceutical development, stem cells, Table of contents (TOC), World Medical Association (WMA) | Leave a Comment »
Posted by Andrew Smith on April 29, 2009
This is the Table of Contents of Clinical Research focus 20(05) for May 2009. Members of The Institute of Clinical Research can click on the links to read the full text of each article.
Features
John Poland FTOPRA
The Declaration of Helsinki was developed to underpin the ethical conduct of human clinical research. Eight years after its previous major update, which prompted two clarifications on contentious points, the Declaration was revised late in 2008 after a process lasting nearly 2 years. John Poland provides a detailed view of the latest revisions, which have provoked mixed responses from regulatory, ethics and clinical communities.
Nicky Dodsworth MICR CSci & Efraim Roe
An increasing number of studies are being performed in parts of the world whose first language is not English. There are challenges in translation and communicating science in a multilingual world dominated by the de facto language of English. Nicky and Efraim look at the issues surrounding translation of the patient information and informed consent forms.
People
Richard Tiner
Richard Tiner steps down as Medical Director of the Association of the British Pharmaceutical Industry (ABPI) at the end of May, after nearly 13 years in the post. Over that time, he has been a prominent speaker at ICR events, and was the first person we interviewed for CRfocus. As he prepares to move on, he reflects on the changes in the UK clinical trials landscape since the mid-1990s, in which he has been instrumental.
National update
Mary Mumford RICR
Mary reports on the October 2008 meeting of the ICR Scottish Forum. At the meeting, Dr Janet Messer, Deputy Director of the NHS R&D Forum, gave an overview of the initiatives to integrate and streamline R&D activities throughout the NHS, while Brian Rae, R&D Manager of the Greater Glasgow & Clyde NHS Trust, spoke about the successes and challenges in developing world-class clinical research structures in one of the most health-challenged regions of the UK.
Professional development
Shanoo Singh
Being interviewed can be a nightmare. Interviewing skills have been rapidly and continuously changing over the past decade. Having been both a candidate and an interviewer on many occasions, Shanoo reaches out to everyone, particularly those seeking their next strategic positions, and offers some tips on how to perform at your best in an interview situation.
Viewpoint
Andrew Smith
When the economic upturn comes, the individuals, organisations and indeed countries that will be best placed to succeed will be those that have continued developing through the lean times. As an industry, we’ve become very good at working costs out of our processes. However, focusing solely on this risks neglecting importance of creating additional value for companies, shareholders and society as a whole. The relative risk of trying to leap ahead through strategic innovation is actually lower now than in ‘boom’ years, those that innovate and survive will secure their place at the forefront of the industry for a generation.
John Kolthammer HonFICR
To recognise that our new Chair of the ICR Board of Directors has a background in medical device development, John Kolthammer, former CEO of ICR, offers a respectful and somewhat light-hearted reminiscence to draw attention to the some of the interesting issues that have always been present at the interface between pharmaceuticals and medical devices.
Regular update
Janette Benaddi MICR Csci
Janette inspires us to remain optimistic and look harder than we have ever done for opportunities, despite any current financial insecurities or media-fuelled gloom. To add personal despondency to this will surely reduce our individual ability to cope, and will probably also make the wider recession both longer and deeper. It’s challenging to look on the bright side, but she believes that there is a bright side for many of us, if we care to search for it.
Compiled by Andrew Smith
Our regular look at the lighter side of clinical research, including “Ten innovations that won’t add value to sponsors, shareholders or society” and engaging with patients in language that is a bit more “street”…
Posted in CRfocus | Tagged: "Clinical research", clinical trials, CRfocus, Declaration of Helsinki, Drug development, Ethics, interview, Magazine contents, medicine, Table of contents (TOC), World Medical Association (WMA) | Leave a Comment »
Posted by Andrew Smith on April 1, 2009
CRfocus 20(04) – April 2009
This is the Table of Contents of Clinical Research focus 20(04) for April 2009. Members of The Institute of Clinical Research can click on the links to read the full text of each article.
Weathering the storm
Andrew Smith
In the current economic climate, it’s easy to reach the conclusion that the recent high-profile mega-mergers (eg, Pfizer/Wyeth, Merck/Schering-Plough etc.) are simple industry consolidation. But, as we’ve pointed out in CRfocus previously, the link between the global economic turmoil and the changes in the pharmaceutical industry is perhaps less direct than one might think. Andrew explores…
Tim Ewbank
The past 12 months have seen economic turbulence on a scale no-one could have predicted. So how has this impacted on the pharma and biotech sectors? Harten Group’s seventh annual industry survey takes a look at the facts behind the headlines. Tim Ewbank presents some of the findings of this research.
Jonathan Hart-Smith
Following a recent survey at the beginning of 2009, jobseekers within the UK pharmaceutical and biotechnology industries have a very positive outlook. Their positivity is a breath of fresh air in stark contract to the general mood for the economies of Western Europe and the USA. Jonathan Hart-Smith presents the findings of this survey.
Research integrity
Nigel Crossland FICR Csci
A for-cause audit is defined as an independent and objective examination of a clinical research study in order to confirm the circumstances of a reported incident of serious non-compliance. In this article, Nigel describes some of the principles and practicalities involved in ‘for-cause audits’ and shares some examples of their findings.
Andrew Smith
This year’s EFGCP Annual Conference, held in Prague at the end of January, aimed to provide a European perspective on integrity in the conduct and publication of clinical research. Andrew was there, and presents commentary on selected presentations, as previously reported on the CRfocus blog.
Book review
Reviewed by Debbie Early MICR
Prof. development
Judi Eaton
Judi reports on the latest ICR CTA workshop, aiming to give CTAs everywhere ‘Tools & Updates’ as part of the ‘Maximise Your Potential’ series. Topics included the draft CTA Handbook, a regulatory and ethics update and the ongoing development of the Integrated Research Application System (IRAS).
Regular updates
Janette Benaddi MICR Csci
In her first message as Chair of ICR, Janette pays tribute to her predecessor, Susan Ollier, and sets out her vision for the coming year. During difficult times, it is important that we continue to support you in your careers and ensure that we are meeting your expectations. Janette explains that we are going to embrace these challenging, changing times and continue to add value to the services we provide for members of ICR.
Andrew Smith
Our regular look at the lighter side of clinical research, including “Ten things we hope sales & marketing won’t say to clinical” and engaging with patients in a “hip hop stylee”…
Posted in "Clinical research", CRfocus | Tagged: clinical trials, conference, CRfocus, Drug development, Magazine contents, pharma, Pharmaceutical development, Recession, Table of contents (TOC) | Leave a Comment »
Posted by Andrew Smith on March 5, 2009
Making up for the delay with February’s Table of Contents, here is the Table of Contents for the March issue of Clinical Research focus 20(03). Members of The Institute of Clinical Research can click on each link, and log in to read the full article. If you want to become a member of ICR, visit www.icr-global.org/membership for more information.
Patient recruitment & retention
Sherry Armstrong-Wilkinson MICR
If you want recruitment and retention to succeed, then it’s time to adjust the focus on where investment is made. When selecting and training CRAs, how much time and investment do we put into developing skills and expertise that will allow them to support sites fully in the development of robust and strategic recruitment strategies? Sherry explains how a strong, dynamic relationship between investigators and CRAs is crucial for optimal site management and is vital for devising and implementing successful site-specific strategic recruitment and retention plans.
Elaine Ward, Julia Miller & Brendan Delaney
As government policy is encouraging a larger number of patients to be seen by clinicians in the community, more clinical research studies require some recruitment in primary care. The Research Recruitment Methods Group came together in 2007 in a bid to begin to tackle recruitment barriers in primary care. Between them, the members of this collaborative group have had considerable experience of research conducted in general practice settings. Their aims are to improve delivery of clinical trials by exploring the factors which affect recruitment and then to develop a programme to systematically test the impacts of those factors. The authors discuss this group’s past, ongoing and future activities.
Gaynor Anders, Mary Schwarz & Jake Perez
Most are aware that the role of digital media, particularly the internet, in recruiting patients for clinical trials has been steadily expanding in both availability and acceptance worldwide. But, what has driven the emergence of digital outreach for patient recruitment and where is it headed? The authors take a brief look at how we arrived at the present use of digital media in patient recruitment and look ahead to its future applications. They also consider the driving forces for both the past and future evolution of digital outreach for patient recruitment and the implications for the clinical trial landscape.
Missy Orr
Missy Orr is Executive Director, Sites and Patients Services at PPD. Missy joined PPD in 2003 and oversees the global operations of patient recruitment activities. In this interview, we break down the component parts of patient recruitment, discuss why an approach might be successful in some places but not in others, and consider that patient retention doesn’t get the attention it deserves. An audio version of the complete interview is available to download.
Features
Samantha Marshall
Traditionally, ‘real world’ observational research has been criticized for lacking the robust scientific methodology of RCTs. However, with the shift in NHS requirements, the focus of clinical development needs to change to ensure a well-rounded development plan that includes not only RCTs but also more pragmatic research in real clinical practice. Samantha explores…
Alan Jones
Alan gives us our regular update on the latest developments in Health Technology Assessment, how it impacts on reimbursement for the medicines and devices we help develop, and how its importance will only increase for people designing and conducting clinical trials. This extended version of the article includes more detail on both the NICE and EUnetHTA conferences than was possible in the printed version.
Viewpoint
Andrew Smith
Were ‘cellist’s scrotum’, ‘guitarist’s nipple’ and the PIGPEN study on the treatment of headlice simply a bit of light relief for overworked physicians, or dangerous distortions of the scientific record… or even disease mongering? Andrew eschews his usual humorous streak to suggest that unacknowledged hoaxes in primary medical journals might not be a great idea…
Regular update
Susan Ollier MICR Csci
Susan Ollier, Chair of ICR until she reaches the end of her term of office at the Annual General Meeting on March 17th, looks over some of our recent achievements, thanks those who have made it all possible, and says a fond farewell to the colleagues and friends she has met along the way.
Posted in CRfocus | Tagged: "Clinical research", clinical trials, CRfocus, Drug development, Health economics, Magazine contents, medicine, Patient recruitment, pharma, Pharmaceutical development, Table of contents (TOC) | Leave a Comment »
Posted by Andrew Smith on February 27, 2009
A little late in the month once again, I’m afraid, but here is the Table of Contents for February’s issue of CRfocus, 20(02). Members of The Institute of Clinical Research can click on each link, and log in to read the full article. If you want to become a member of ICR, visit www.icr-global.org/membership for more information.
Enhancing NHS research
Susannah Radford
The Integrated Research Application System was designed to facilitate a more streamlined approach to gaining approvals for clinical research in the UK. Susannah interviewed users from mid-November to early December 2008 to find out how they were finding version 1.0 of system. She also reports on some of the changes made in IRAS 2.0, launched late in December.
Jill Dhell & Mark Lewis
In recent years, collaboration between the NHS and both the pharmaceutical and medical technology manufacturing industries has been high on the agendas of the Departments of Health and the UK industry trade associations. The publication of the model Clinical Investigation Agreement for studies carried out in the NHS is the latest development of this type. Jill and Mark explain…
Brian Thomson & Darren Clark
Andrew Smith interviews Dr Brian Thomson, Director of R&D at Nottingham University Hospitals NHS Trust, and Dr Darren Clark, CEO of Medilink East Midlands about initiatives to build capacity and capability for clinical research in the Nottingham area.
Impact of the EU Directive
Andrew Smith
Industry and academia alike are calling for the EU legislative environment to be changed; however, there had not been a formal assessment of its practical impact across all stakeholder groups. The Impact on Clinical Research of European Legislation (ICREL) project has produced these metrics, and Andrew Smith reports from a conference held to present and discuss the project’s preliminary results.
Ingrid Klingmann
Shortly after the ICREL conference, Andrew interviewed Ingrid Klingmann, who coordinated the project. She explains some more of the background, discusses some of the more unexpected findings and looks at the potential next steps.
Ten Things…
Harriet Wibberley MICR & the ICR Clinical Pharmacology SIG
In this series, experts provide introductions to topics that are becoming increasingly important. This month, we provide ‘bite-sized’ guidance on Phase I clinical trials. If you want to request a topic to be covered, or submit your own “Ten things…”, please email editorial@crfocus.org.
Prof. development
Caroline Bedford MICR & Sheila Hodgson MICR
Pharmacy staff do much more than ensure safe storage of clinical trials supplies. Because of their training and experience, pharmacists and pharmacy technicians are well placed to pursue a career in clinical research. Caroline and Sheila, both members of the ICR Pharmacy SIG, explain some of the career paths and options for pharmacy technicians and pharmacists.
Lynn Seeley MICR & Irene Lee MICR
Delegates gave positive feedback after attending this workshop, hosted by the ICR CRA Special Interest Group (SIG) at Birmingham City University on September 25th 2008. Speakers represented the Medicines and Healthcare Products Regulatory Agency (MHRA) inspectorate, United Kingdom Clinical Research Network (UKCRN), research nurses, study site managers, pharmacists and Clinical Pathology Accreditation (CPA) Ltd. Lynn and Irene report…
Viewpoint
Andrew Smith
A recession can actually be a great time to be innovative and entrepreneurial. If this can (and does) happen in the wider sphere of business, Andrew argues it can (and should) also happen in the development of new medicines.
Regular update
Susan Ollier MICR CSci
In her message this month, the Chair of ICR explains how we will be working with our newly-appointed President, Lord Howe and the All-Party Parliamentary Group on Medical Research to ensure that the issues that are important to you are raised at the highest political levels, and how we aim to appoint a Vice-President with a similar remit outside the UK.
Posted in "Clinical research" | Tagged: "Clinical research", clinical trials, CRfocus, Drug development, EU Clinical Trials Directive, Magazine contents, Patient recruitment, Patient retention, Pharmaceutical development, Table of contents (TOC) | Leave a Comment »
Posted by Andrew Smith on February 24, 2009
Following on from the last presentation of the morning session, the speakers came back to discuss the morning’s topics.
Initial discussion concerned lists and flowcharts to summarise what needs to be done and what data needs to be collected at which visit. Sue Mackay agreed that this would be useful, but some sponsors prefer to avoid duplication wherever possible. This is precisely the kind of thing that the CDISC standard discussed earlier would resolve.
A delegate followed up by asking what sort of aid site staff use to schedule visits and activities. This varies according to the type of study (eg, patient types, working hours etc.) but Sue Mackay said she tries to create a schedule as far as possible. Adam Jacobs said that including this in the protocol would be beneficial. Another delegate said that this could cause confusion over which document is the source document for GCP purposes. In many cases, patient notes are used; eCRFs are being increasingly used, although these can be restrictive if patients report additional information.
Another delegate raised the issue of global trials, where practical issues differ between regions. Sandra Waechter mentioned that some units make local protocol amendments to accomodate local differences in care.
Adam Jacobs discussed the pros and cons of detailed protocols vs broad protocols with more detailed appendices. One delegate questioned whether we could ever reach a ‘perfect’ protocol when it needed to meet the requirements of such a diverse set of stakeholders. Adam stressed the importance of having time to do the job properly: the situations in which his team have had problems have been when time pressure (eg, to meet an ethics deadline etc.) has been extreme. Although as little as 3 days is required to do the actual writing of the protocol, he agreed with the earlier speaker that 3 months would be an appropriate period to allow for the discussion, reviewing and negotiation processes.
Posted in Reportage | Tagged: "Clinical research", clinical trials, Drug development, medical writing, medicine, panel discussion, pharma, Pharmaceutical development, protocol development, Reportage | Leave a Comment »
