Facilitated by: Niall Dickson
Panellists: Professor Karol Sikora, Professor Nick Bosanquet, Colin Miller FICR CSci & Francis P Crawley
Reporter: Suheila Abdul-Karrim MICR Csci
Keywords
Conference, Declaration of Helsinki, Discussion, Globalisation, Pricing, Voting
The 2009 ICR Annual Conference started with a refreshing alternative to the stereotypical conference. Instead of the usual keynote speaker, delegates were treated to thought-provoking statements that set the scene for 2 days of explorative learning. Members of the panel were asked to comment, and the audience had the opportunity to question and add their concerns/comments.
Morning discussions
The morning session started with the facilitator, Niall Dickinson, asking members of the panel to reflect on these statements, provide their views, then engage the audience to provide their opinion. These topics would also be echoed through the day’s parallel sessions and, at the end of the day, the closing plenary session would discuss the topic further and provide another opportunity to vote, to see if the days’ learning had perhaps brought about a change of view or opinion.
The statements put forward were:
- Diverse local requirements, contracts, inspections etc. will drive multinational studies to fewer, larger countries (eg, USA, India, China, Russia)
- The 2008 revision of the Declaration of Helsinki will have a significant impact on the conduct of clinical research
- Any attempt to rationalise decisions on acceptable pricing of healthcare is doomed to failure
Professor Karol Sikora started by raising the obvious fact that given the current recession, it would be difficult to support statement 1 since we are now in the phase where past results are not a way of predicting the future. While it could lead to serious competition, countries like the USA will still have work because in a way research can be recession-proof in that if you have a child that needs an antibiotic or vaccine you are going to get it for your child irrespective of the situation the country is in.
In terms of statement 2, he felt that the Declaration of Helsinki (DoH) 2008 will not have a significant impact on the way clinical trials are conducted. With regard to statement 3, Professor Sikora reiterated a valuable fact that pricing plays a major role: healthcare is not like a supermarket, it gives the payer more authorization and ultimately the customer decides whether they are willing to pay a particular price or not.
Audience participation
The audience was then asked to raise their concerns, questions and comments.
Andrew Smith (Editor of CRfocus) commented that statement 1 was less about cost but rather more about the speed of getting through the studies and that this would ultimately determine where studies will be conducted. Suheila Abdul Karrim MICR CSci (ICR member) commented that even while one does look at going to developing countries, it has to be taken into account that these countries would have to be provided with equipment etc. and so you would not really be rationalizing and your spend would actually be more. Prof Sikora added to this by stating that from his experience in conducting a trial in Kazakhstan, the sponsor company just kept providing all the equipment right up to CT scanners.
Adam Jacobs FICR CSci (Dianthus, and also a member of an ethics committee) commented that he was somewhat disappointed with the 2008 revision of DoH as it seems to have ‘watered-down’ the post-trial access for patients. Prof Sikora agreed that it would be quite ruthless to stop concern about the patient at the end of the study. Jo Burmester RICR (Pharmaschool) said that the DoH was important when it was first introduced but is now superseded by ICH GCP and hence it would be highly unlikely that the legislation would change in Europe and UK based on the new version of DoH. Susan Ollier HonFICR CSci (QED Partnership and outgoing Chair of ICR) stated that it would depend on whether the new version of DoH was acceptable to the UK and other developing countries. Suheila Abdul Karrim then added that it is country-dependant, using South Africa as an example where the Regulatory Authorities adopted DoH (2004) and some companies chose not to bring their studies into South Africa due to the cost of post-trial access not being factored into the initial budget.
The audience was then asked to vote and in so doing provided their opinion on these statements. Refer to Table 1 (below) for results of the morning session votes.
Afternoon discussions
The afternoon session had a different panel, that provided their opinions on the same statements. It started off with Professor Nick Bosanquet stating that in terms of statement 1, trials would go to those countries that would be able to deliver good quality data regardless of the complexity of the trial. This does not place Europe in a bad situation, but certainly increases the competition facing the UK compared to a decade ago. As for statement 2, he felt that, while the new version of DoH would not have any effect on trials, it does put forward a strong case for EMEA to take the lead in terms of setting a standard, so that there could be one system used across Europe. As for pricing (statement 3), he highlighted the reality that healthcare spending will increase by at least 1% every year and it was time to have to face up to the fact that one had to ensure that you were getting value for that money.
Colin Miller felt that statement 1 was more about recruitment being the issue and not the country size. There are countries outside the US that recruit very fast and still provide good quality data. Although some regulatory authorities in these countries can pose delays of 90–180 days in getting study drug imported to the country, they still make up for this with rapid recruitment, and clients are willing to take them on. He then went on to stress the fact that the FDA in the US was not even considering the new version of the DoH (statement 2). He said that, currently, the UK set-up was a good model when viewing pricing(statement 3) and that it has to be remembered that, due to the litigious environment we live in, people still want the best and will go for the best in order not to be sued.
Francis Crawley argued that recruitment was only part of the issue for statement 1 and that one needs to consider government investment in clinical trials in Europe. Only 10% of (non-commercial) trials in Europe are managed by Brussels and the rest is managed by the member states. Trials are also driven by the market and if the market is open, it then opens opportunities for research. He expressed concern that there is no real clarity from (or for) ethics committees as to which version of DoH should be used (statement 2). There is a dire need for good ‘fleshed-out’ guidelines on ethics and the use of the term “clinical trials” instead of “clinical research” in the new version of DoH was of concern. In terms of statement 3, he felt that, while there will be a lot of discussions around the issue of pricing, these discussions in themselves will not be rational, due to the diversity in Europe and globally.
Discussion & voting
Delegates were again asked to raise their questions or concerns.
A comment raised by Eric Boelema (CDR Ltd) concerning statement 1 was that inspections will not drive studies to a particular country, because everyone wants to improve and implement GCP. The fact remains that wherever the trial goes, the inspectors will follow.
Voting was conducted once more after discussion on each question and the results were compared to those of the morning session. In addition, delegates who had voted that morning were asked if they had changed their opinions after attending the days’ sessions. Refer to Table 1 (below) for results.
| |
Statement 1: Diverse local requirements, contracts, inspections etc. will drive
multinational studies to fewer, larger countries (eg, USA, India,
China, Russia) |
Statement 2: The 2008 revision of the Declaration of Helsinki will have a significant impact on the conduct of clinical research |
Statement 3: Any attempt to rationalise decisions on acceptable pricing of healthcare is doomed to failure |
| Morning session |
(139 responses)
|
(135 responses) |
(131 responses) |
| Strongly agree |
8%
|
1% |
6% |
| Agree |
40%
|
4%
|
42% |
| Neither agree nor disagree |
17%
|
14% |
23% |
| Disagree |
31%
|
61% |
25% |
| Strongly disagree |
4%
|
19% |
4% |
| Afternoon session |
(74 responses)
|
(73 responses) |
(72 responses) |
Strongly agree
|
3% |
1% |
4% |
| Agree |
24%
|
3% |
32% |
| Neither agree nor disagree |
12%
|
22% |
13% |
| Disagree |
45%
|
60% |
49% |
| Strongly disagree |
16%
|
14% |
3% |
| Change in opinion |
(56 responses)
|
(53 responses) |
(51 responses) |
| Yes |
21%
|
13% |
22% |
| No |
79%
|
87% |
78% |
Table 1 Interactive voting results from Day 1 of the ICR 2009 Annual Conference.
While the results were varied in terms of demographic data, ie, the various roles people are involved in with regard to clinical research, it seemed that they had a clear idea of what they wanted to accept as a viewpoint.
Summary
Not only did this refreshing alternative to starting and ending the day stimulate discussion and participation amongst delegates, it also created an awareness around issues that are part of clinical research on a daily basis.
While some had already made up their minds and left with their opinions unchanged, others who have grown to accept things in a particular manner still held on to their opinions but left aware of different angles of viewing aspects of research, and yet others left refreshed with a whole new view, and possibly thinking about challenging these aspects of research in the future should the need arise.
Niall Dickson is Chief Executive of the King’s Fund.
Professor Karol Sikora is Professor of Cancer Medicine and honorary Consultant Oncologist at Imperial College School of Medicine.
Professor Nick Bosanquet is Professor of Health Policy at Imperial College, London.
Colin Miller FICR is Senior Vice President, Medical Affairs at Bio-Imaging Technologies.
Francis P Crawley is Executive Director of the GCP Alliance.
Suheila Abdul-Karrim MICR CSci is an independent consultant providing CRA services and training within the pharmaceutical industry in South Africa.
