Cancer Patients Face Treatment Disruptions Come June; Immediate and Severe Funding Cuts May Curtail Access to Cancer Clinical Trials

“The nation’s cancer clinical trial network, which provides care to thousands of patients across the United States, may have no choice but to abandon life-saving and life-extending research studies, including support for patients participating in those studies, due to crippling proposed budget cuts. For decades, federally-supported clinical trials have produced critical advances in the fight against cancer, representing one of the greatest returns on research investment anywhere. But this progress could soon grind to a halt due to far-reaching—and largely unnoticed—budgeting decisions that are happening in plain sight.”

Editor’s note: Clinical trials are not only important for testing the safety and effectiveness of new drugs; they also provide an avenue for patients who cannot benefit from standard treatment options to access new, cutting-edge treatments that could help them. In fact, our founder’s life was saved by his involvement in a clinical trial.


Cancer Patients Face Treatment Disruptions Come June; Immediate and Severe Funding Cuts May Curtail Access to Cancer Clinical Trials

“The nation’s cancer clinical trial network, which provides care to thousands of patients across the United States, may have no choice but to abandon life-saving and life-extending research studies, including support for patients participating in those studies, due to crippling proposed budget cuts. For decades, federally-supported clinical trials have produced critical advances in the fight against cancer, representing one of the greatest returns on research investment anywhere. But this progress could soon grind to a halt due to far-reaching—and largely unnoticed—budgeting decisions that are happening in plain sight.”

Editor’s note: Clinical trials are not only important for testing the safety and effectiveness of new drugs; they also provide an avenue for patients who cannot benefit from standard treatment options to access new, cutting-edge treatments that could help them. In fact, our founder’s life was saved by his involvement in a clinical trial.

April 16, 2014 update: The NCI has released a letter to allay concerns about clinical trial funding come June. From the letter: “As in the past, full funding for all research activities required to carry out approved studies will be provided.” Read the full letter here.


Implementation of the NCI’s National Clinical Trials Network

“The National Cancer Institute is launching a new clinical trials research network intended to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year.  The new system, NCI’s National Clinical Trials Network (NCTN), will facilitate the rapid initiation and completion of cancer clinical trials based on improvements in data management infrastructure, the development of a standardized process for prioritization of new studies, consolidation of its component research groups to improve efficiency, and the implementation of a unified system of research subject protection at over 3,000 clinical trials sites.  Grants to fund the program will be awarded early in the spring of 2014…

“NCTN employs an inclusive process for generating studies and conducting clinical trials using broad representation from the oncology field, including academic researchers, as well as professional organizations, patients, and advocates.  In particular, community-based clinical trials play an important role in expanding the implementation of research findings to encompass all phases of cancer care delivery.  A new system to support clinical trials research in the community setting, the NCI Community Oncology Research Program (NCORP), which will play a critical, complementary role to the NCTN, is being launched later this year and will involve both cancer treatment and cancer care delivery research.”


Implementation of the NCI’s National Clinical Trials Network

“The National Cancer Institute is launching a new clinical trials research network intended to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year.  The new system, NCI’s National Clinical Trials Network (NCTN), will facilitate the rapid initiation and completion of cancer clinical trials based on improvements in data management infrastructure, the development of a standardized process for prioritization of new studies, consolidation of its component research groups to improve efficiency, and the implementation of a unified system of research subject protection at over 3,000 clinical trials sites.  Grants to fund the program will be awarded early in the spring of 2014…

“NCTN employs an inclusive process for generating studies and conducting clinical trials using broad representation from the oncology field, including academic researchers, as well as professional organizations, patients, and advocates.  In particular, community-based clinical trials play an important role in expanding the implementation of research findings to encompass all phases of cancer care delivery.  A new system to support clinical trials research in the community setting, the NCI Community Oncology Research Program (NCORP), which will play a critical, complementary role to the NCTN, is being launched later this year and will involve both cancer treatment and cancer care delivery research.”


Implementation of the NCI’s National Clinical Trials Network

“The National Cancer Institute is launching a new clinical trials research network intended to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year.  The new system, NCI’s National Clinical Trials Network (NCTN), will facilitate the rapid initiation and completion of cancer clinical trials based on improvements in data management infrastructure, the development of a standardized process for prioritization of new studies, consolidation of its component research groups to improve efficiency, and the implementation of a unified system of research subject protection at over 3,000 clinical trials sites.  Grants to fund the program will be awarded early in the spring of 2014…

“NCTN employs an inclusive process for generating studies and conducting clinical trials using broad representation from the oncology field, including academic researchers, as well as professional organizations, patients, and advocates.  In particular, community-based clinical trials play an important role in expanding the implementation of research findings to encompass all phases of cancer care delivery.  A new system to support clinical trials research in the community setting, the NCI Community Oncology Research Program (NCORP), which will play a critical, complementary role to the NCTN, is being launched later this year and will involve both cancer treatment and cancer care delivery research.”


‘Early Access’ Scheme Unveiled for Innovative Medicines

“People with advanced cancer and other serious illnesses like dementia could soon benefit from early access to innovative and promising treatments.

“The Early Access to Medicines scheme would enable safe and promising drugs to be ‘fast tracked’ into the NHS before they have even been granted a licence for use.

“The new scheme will allow patients without other treatment options to be given experimental drugs that have not yet been licensed but that have been deemed safe and effective through clinical trials.

“Experts will carry out a rapid analysis of the treatment before labelling it a ‘promising innovative medicine’.

“The Medicines and Healthcare products Regulatory Agency (MHRA) will then offer a scientific opinion based on a medicine’s risks and benefits. If the benefits are found to outweigh the risks, doctors will be given the green light to offer the drug to patients.”

Editor’s Note: This UK program is similar to a program already in place in the US that allows patients to request access to drugs still being tested in clinical trials. Even though so-called “compassionate access” is possible, the process can be quite difficult for patients. Learn more about it  from our blog feature on the topic.


‘Early Access’ Scheme Unveiled for Innovative Medicines

“People with advanced cancer and other serious illnesses like dementia could soon benefit from early access to innovative and promising treatments.

“The Early Access to Medicines scheme would enable safe and promising drugs to be ‘fast tracked’ into the NHS before they have even been granted a licence for use.

“The new scheme will allow patients without other treatment options to be given experimental drugs that have not yet been licensed but that have been deemed safe and effective through clinical trials.

“Experts will carry out a rapid analysis of the treatment before labelling it a ‘promising innovative medicine’.

“The Medicines and Healthcare products Regulatory Agency (MHRA) will then offer a scientific opinion based on a medicine’s risks and benefits. If the benefits are found to outweigh the risks, doctors will be given the green light to offer the drug to patients.”

Editor’s Note: This UK program is similar to a program already in place in the US that allows patients to request access to drugs still being tested in clinical trials. Even though so-called “compassionate access” is possible, the process can be quite difficult for patients. Learn more about it  from our blog feature on the topic.


‘Early Access’ Scheme Unveiled for Innovative Medicines

“People with advanced cancer and other serious illnesses like dementia could soon benefit from early access to innovative and promising treatments.

“The Early Access to Medicines scheme would enable safe and promising drugs to be ‘fast tracked’ into the NHS before they have even been granted a licence for use.

“The new scheme will allow patients without other treatment options to be given experimental drugs that have not yet been licensed but that have been deemed safe and effective through clinical trials.

“Experts will carry out a rapid analysis of the treatment before labelling it a ‘promising innovative medicine’.

“The Medicines and Healthcare products Regulatory Agency (MHRA) will then offer a scientific opinion based on a medicine’s risks and benefits. If the benefits are found to outweigh the risks, doctors will be given the green light to offer the drug to patients.”


Not Enough Cancer Patients Enroll in Clinical Trials

Around 10% of mid- and late-stage clinical trials of cancer treatments end prematurely because not enough patients enroll, a recent analysis shows. This lack of participants slows the development of new cancer medications and wastes considerable amounts of money invested in these trials. The authors of the analysis hope to focus attention on possible reasons why too few patients enroll in clinical trials. Doctors may not always encourage their patients enough to participate, and some insurance plans do not cover the costs associated with clinical trials. Patients may also hesitate because they fear receiving only a placebo instead of treatment. However, in modern clinical trials, new cancer drugs are tested against the current standard therapy, so that all participants receive treatment.