The Ten Biggest Challenges Facing Irish Clinical Oncology Research In 2003.
Brian Moulton, CEO, Irish Clinical Oncology Research Group1.
COMPETITIVE INTERNATIONAL ENVIRONMENT:-
The single biggest fact that we all must take on board on this Island is that there are queues of developing countries, some our near neighbours who are doing all they can to encourage the Pharmaceutical industry to choose their hospitals etc to develop their new compounds.
In recent years many of the Baltic countries and other former soviet union states have improved their quality systems and rekindled the interest of the Pharmaceutical industry. These nations have looked at their internal systems critically and have made important changes in order to facilitate the initiation of clinical research. The result is a more streamlined process of study start-up and in a world where the clock is ticking from the day the company developing a drug patents the compound this is an important advantage. These competitors have also recognised the importance of high quality data and have put in place systems to improve this to a level now comparable to EU countries. Our key advantage of the past has been eroded.
Every person involved in the set-up process for oncology and other clinical trials in their region or hospital must be mindful of these changes. All Ethics committee Chairs and administrators, hospital management representatives and department heads should endeavour to process all clinical trial paperwork as quickly as possible after decisions have been made. They must not in any way reduce the quality of their review but should expedite it and ensure that we in Ireland can continue to be attractive to the pharmaceutical industry. The alternative of dwindling levels of research
is very real now that our competitors are stronger.
We welcome the support of our Department of Health and Children, at a time when they are through the NCI all-Ireland agreement launching one of their many investments in new clinical trial infrastructure at St James’s Hospital last November 2002.
" Through clinical trials programmes, Irish patients can have quick access to these new treatments and so receive optimum treatment"
"Clinical trials are an essential part of developing better cancer prevention and therapeutic strategies and are acknowledged worldwide as the best way to advance patient care at the bedside"
ICORG this year plans a widespread review of our quality systems both centrally and at investigator sites, this has been initiated for a number of reasons but the importance of maintaining our reputation as a provider of quality data is the primary consideration.
2. EMPLOYMENT OF NEW RESOURCE
Nine sites country wide have been successful in their quest to obtain Ireland/Northern Ireland/US cancer consortium grants. These centres now have the challenge of employing this resource. This will entail in some cases the task of finding high quality people and in just about all cases the initiation of many new studies, often in new oncology disease areas in order to achieve the key elements of their grant proposal.
The second resource challenge will be the push for the provision of key staff not central to most of the initial grant applications. As research activities expand it will be necessary for other key members of the research team to be recruited, staff such as research pharmacists, research radiologists, pathologists and research registrars will be necessary.
3. ICORG SUB-GROUP DEVELOPMENT –
At the ICORG AGM on January 19th it was decided that a key element of the future success of ICORG and its investigators was the development of more sub-groups as well as the formalising of those sub-groups that are already in existence. This will enable us to broaden the range of studies underway and therefore improve the access of patients presenting at these investigators sites.
Sub-group development will also indirectly help the sites to meet the accrual targets that were central to the grant applications. ICORG will in the coming weeks be contacting all investigators to encourage their active participation in these newly formed sub-groups.
4. INITIATION OF THE AICG
The all-Ireland cancer network was formally launched on February 8th by Dr Andrew von Eschenbach , Director of the US National Cancer Institute (NCI). This will be a project of ICORG and the Belfast Clinical Research Support
Group (CRSC). The principal role will be to initiate and co-ordinate all Island clinical trials.
The key message from this initiative is that with the help, backing and support of the NCI the Departments of Health North and South have for the first time formally recognised the importance of clinical trials and a research orientation to the provision of top quality cancer care. The challenge for all involved in the cancer research arena is to make this investment a success and thereby ensure that this funding is continued.
Dr von Eschenbach congratulated all involved when launching this element of the initiative and guaranteed his continuing support.
Among the many different challenges this will present will be for example the implementation of a unified computing standard for clinical trial management in all active units throughout the Island.
5. INCREASED LEVEL OF AUDIT
As many of ICORG’s investigators are aware when you apply for Irish Medicines Board (IMB) regulatory approval to participate in a clinical trial you at the same time agree to participate in a process whereby you must be open to audit by the IMB. There are many indications that the level of audit is on the increase particularly in the area of oncology.
It is therefore more important then ever for each investigator to look carefully at their own research standards and procedures and be prepared for an audit at any time. ICORG will be putting in place many new working procedures to help all sites to improve and maintain their quality standards and in this way be as prepared as possible for IMB audit.
6. EU CLINICAL TRIAL DIRECTIVE
The European Commissions standards for clinical trials have up until this year been a theoretical quality level to which everyone involved in research could aspire, if they so wished. The more familiar name to most is Good Clinical Practice (GCP). This directive will very soon no longer be a
suggested standard it will become law in those EU countries that have
decided to be early implementers. Ireland is in the group of countries that
are due to implement in May 2003.
There are other elements to this legislation that have not been discussed widely and that may be in practice flawed in the world of oncology. One such element is the provision that all clinical trials would have to provide the medications under investigation for free to patients. Understandably this has received some high level criticism and there are indications that at this late stage the EU is looking again at some elements of the legislation. Professor Francois Meunier, Director of the EORTC has recently stated publicly that
"It would be extremely detrimental if the implementation of the Directive within national legislation is not taking into account the network of investigators conducting strategies trials with registered drugs. At a time when the European Commission and the European Parliament wish to boost cancer research, to maintain existing expertise in Europe and to promote our international visibility, any serious drawbacks and threats to the competitiveness of European research should be avoided at all costs," she said.
If implemented in Ireland in the current format it may introduce many new challenges to the initiation of many of the types of studies in which ICORG has been involved in the past.
7. DEVELOPMENT OF PATIENT ADVOCACY
Ireland has very underdeveloped patient advocacy groups in the oncology area. It is in the interest of all in oncology that these important parts of the overall picture be encouraged.
In other countries these group have helped empower patients to be more in control of all elements of their care and importantly they have created a voice for these patients. This voice could prove, in the future, to be an important part in the decisions making process on questions such as whether research funding should be increased or continued.
The challenge is to encourage those that are starting to form these groups to continue with their work and believe and understand the importance of their role in the overall process.
8. BROADEN RESEARCH EDUCATION –
ICORG has initiated a program aimed at providing GCP training free for a broader base of health care professionals involved in the research process. The aim is to have at least two training days at each active hospital in 2003. The obvious target of the program is to increase the understanding of the research process in more areas of the hospitals the challenge is to convince those it targets to find the time in already very hectic schedules. To date the training days have been very well attended with an average of more then 20 attending each course.
9. DEVELOPMENT OF RESEARCH TEAMS
The development of an inclusive research team within the oncology units, which have recently expanded their research numbers, will be a big challenge for the principal investigators at those sites. The model of success at those sites that have been most active in recent years is for the development of a strong team spirit at the centre with a gradual spread of enthusiasm and understanding of the high quality research requirements amongst all of the staff in the area.
This will in some cases be the biggest challenge for the principal investigators involved and may be the key to their achievement of the goals of their grant, and have a big impact in its renewal.
10. CONTINUE TO GROW OUR KEY PARTNERSHIPS WITH OUR LOCAL PHARMACEUTICAL AFFILIATES.
ICORG’s success to date has been in a large part due to the belief and support of many key people in the local Irish affiliates. These relationships are now even more important then ever, while there may be alternative sources for the funding of some of the research post around the country these relationships will be central to the expansion of ICORG’s study portfolio. This will also enable ICORG to increase the profile of these local affiliates internationally.