Ninan
Senior Member
- Messages
- 526
http://mariasmetode.no/2013/11/update-haukeland-english/
12 fresh millions for the Rituximab study
The Stoltenberg administration (the former Government) did propose a continuation of the economic support to the studies of CFS/ME by Helse Vest. Helse Vest have been granted funds for a national clinical multi centre study of CFS/ME both in 2012 and 2013. The proposal is to continue the support pursuant to cap. 781, post 79. This is understood to imply that the two millions that are now granted by the government budget are for the Rituximab study at Haukeland Hospital, as the four millions that have been granted over the government budget at an earlier stage. There are no comments or signals that indicates otherwise. This means that in total six million NOK have been granted over the government budget.
Last week, the news was out that The Research Council had finally decided the spesific number of their contribution to be 10 million NOK. That means that it´s now 19 million NOK for the multi center Rituximab-study. 10 from The Research Council, 3 from MEandYou and 6 through the governmental budget.
Multi center study
The coming study is a multi center study. This means that several centers will, in accordance to a common protocol, treat a predetermined number of patients with Rituximab to study the effect. The datas with the results will be collected and treated at one location, with the participation of, and transparent to, all participating centers
Where will the studies take place?
As of today there are five centers that each will be in charge of a group of patients. Who will be part of the groups, and how many patients at each location, have not been decided yet. The locations are Oslo, Trondheim, Notodden, Tromsø and Bergen
When will the studies start?
When the studies will start at the various locations have not as of today been decided, but most probably during spring 2014. The researchers are in contact with each other and are doing the final work on the protocol for the study, in addition Forskningsrådet have not yet decided on how much their contribution to the study will be
What is a protocol?
A protocol describes in minute detail how the study is to be carried out. That the protocol is thorough and closes any holes that can be questioned at a later time are of uttermost importance. This takes time – but it pays to wait a bit extra to achieve a solid study that produces valid results
How many have applied to take part?
Don´t write more letters! We have received more than a thousand letters and referrals. So many, that it have been impossible for the researchers to reply individually. Your letter has been read even if you have not received a reply. All applications have been read, roughly classified by region, and will be forwarded to the nearest of 5 institutions
How many patients are needed?
It looks like 144 of this 100 will participate in the study. Half of these will receive medication, and the other half salty water (this is called placebo).
Who will be selected?
The decision is made by the institution as long as it is within the numbers that have been agreed upon. All the selected patients have to qualify according to the Canadian criteria, and have to be residents of Norway. Patients that have received Rituximab at an earlier time can not take part in the study. Although all the patients will be Norwegians, the results and knowledge found in this study, will be of benefit for both patients and doctors abroad.
What happens with those participiants who do not receive medication?
Half of the participants will not receive medication, but a small dose of salt water. This has no effect on the disease itself. At the same time we know that ME, over time in some patients, will improve without treatment. We want to control for this effect by the use of a placebo group in the study. If it turns out, after the study have been analyzed, that Rituximab have effect, and the cost of medications can be covered. those who received salt water will get Rituximab, possibly in a new study. That may only take place when the current planned study have been done and analyzed. This might take three years
How will I know if I have been selected?
Those who might be candidates will be contacted when the day of selection approaches. Then you will be called in for a pre-examination, then you will be notified whether you are selected or not
Do we need more studies after this?
For a medication to be approved for the use for a specific disease the use must be approved by «legemiddelverket» in Norway, and/or FDA in the US. If the result of this study turns out positive Rituximab will be much closer to approval. Whether the study is enough depends on the quality of the protocol – and consequently how reliable the result is. This is one of the reasons for the time and work spent on the reliability of the protocol.
How much time before we might receive treatment with Rituximab?
First all the patients have to go through the study, this will take two years starting when the last patient is included. All data will then have to be controlled, analyzed and published. FDA and the Norwegian «Legemiddelverket» will evaluate the data and decide wether there may be a new indication for Rituximab. This will at least take 4 years, possibly more. Rituximab will certainly not be a medication for all ME patients. As with any kind of illness or condition it is probable that different ME patients need different kind of treatments and medication
Work is done on symptom directed treatment
Do not despair! The researchers are aware of how horribly ill patiens are and how difficult life is for ME patients. Intense work is done paralell to the rituximab study to find symptom directed treatment for the patients as patients. Several different medications are being tried.
12 fresh millions for the Rituximab study
The Stoltenberg administration (the former Government) did propose a continuation of the economic support to the studies of CFS/ME by Helse Vest. Helse Vest have been granted funds for a national clinical multi centre study of CFS/ME both in 2012 and 2013. The proposal is to continue the support pursuant to cap. 781, post 79. This is understood to imply that the two millions that are now granted by the government budget are for the Rituximab study at Haukeland Hospital, as the four millions that have been granted over the government budget at an earlier stage. There are no comments or signals that indicates otherwise. This means that in total six million NOK have been granted over the government budget.
Last week, the news was out that The Research Council had finally decided the spesific number of their contribution to be 10 million NOK. That means that it´s now 19 million NOK for the multi center Rituximab-study. 10 from The Research Council, 3 from MEandYou and 6 through the governmental budget.
Multi center study
The coming study is a multi center study. This means that several centers will, in accordance to a common protocol, treat a predetermined number of patients with Rituximab to study the effect. The datas with the results will be collected and treated at one location, with the participation of, and transparent to, all participating centers
Where will the studies take place?
As of today there are five centers that each will be in charge of a group of patients. Who will be part of the groups, and how many patients at each location, have not been decided yet. The locations are Oslo, Trondheim, Notodden, Tromsø and Bergen
When will the studies start?
When the studies will start at the various locations have not as of today been decided, but most probably during spring 2014. The researchers are in contact with each other and are doing the final work on the protocol for the study, in addition Forskningsrådet have not yet decided on how much their contribution to the study will be
What is a protocol?
A protocol describes in minute detail how the study is to be carried out. That the protocol is thorough and closes any holes that can be questioned at a later time are of uttermost importance. This takes time – but it pays to wait a bit extra to achieve a solid study that produces valid results
How many have applied to take part?
Don´t write more letters! We have received more than a thousand letters and referrals. So many, that it have been impossible for the researchers to reply individually. Your letter has been read even if you have not received a reply. All applications have been read, roughly classified by region, and will be forwarded to the nearest of 5 institutions
How many patients are needed?
It looks like 144 of this 100 will participate in the study. Half of these will receive medication, and the other half salty water (this is called placebo).
Who will be selected?
The decision is made by the institution as long as it is within the numbers that have been agreed upon. All the selected patients have to qualify according to the Canadian criteria, and have to be residents of Norway. Patients that have received Rituximab at an earlier time can not take part in the study. Although all the patients will be Norwegians, the results and knowledge found in this study, will be of benefit for both patients and doctors abroad.
What happens with those participiants who do not receive medication?
Half of the participants will not receive medication, but a small dose of salt water. This has no effect on the disease itself. At the same time we know that ME, over time in some patients, will improve without treatment. We want to control for this effect by the use of a placebo group in the study. If it turns out, after the study have been analyzed, that Rituximab have effect, and the cost of medications can be covered. those who received salt water will get Rituximab, possibly in a new study. That may only take place when the current planned study have been done and analyzed. This might take three years
How will I know if I have been selected?
Those who might be candidates will be contacted when the day of selection approaches. Then you will be called in for a pre-examination, then you will be notified whether you are selected or not
Do we need more studies after this?
For a medication to be approved for the use for a specific disease the use must be approved by «legemiddelverket» in Norway, and/or FDA in the US. If the result of this study turns out positive Rituximab will be much closer to approval. Whether the study is enough depends on the quality of the protocol – and consequently how reliable the result is. This is one of the reasons for the time and work spent on the reliability of the protocol.
How much time before we might receive treatment with Rituximab?
First all the patients have to go through the study, this will take two years starting when the last patient is included. All data will then have to be controlled, analyzed and published. FDA and the Norwegian «Legemiddelverket» will evaluate the data and decide wether there may be a new indication for Rituximab. This will at least take 4 years, possibly more. Rituximab will certainly not be a medication for all ME patients. As with any kind of illness or condition it is probable that different ME patients need different kind of treatments and medication
Work is done on symptom directed treatment
Do not despair! The researchers are aware of how horribly ill patiens are and how difficult life is for ME patients. Intense work is done paralell to the rituximab study to find symptom directed treatment for the patients as patients. Several different medications are being tried.
