Experts Suggest Ways to Increase Cancer Patient Participation in Clinical Trials

Clinical trials are the cornerstone of developing better cancer care. However, less than 5% of cancer patients participate in clinical trials. A recent meeting of cancer experts developed a list of recommendations for increasing clinical trial enrollment. Strategies at the patient and community level include involving patient advocates and community leaders in clinical trial recruitment, simplifying patient consent forms, and providing interpreters. At the physician level, electronic registries may help keep doctors informed about the availability of clinical trials for their patients. Doctors must also work on speaking to their patients about clinical trials in culturally sensitive ways. Finally, at the level of organizations that initiate clinical trials, institutions need to become more efficient about opening and conducting trials.


Experts Suggest Ways to Increase Cancer Patient Participation in Clinical Trials

Clinical trials are the cornerstone of developing better cancer care. However, less than 5% of cancer patients participate in clinical trials. A recent meeting of cancer experts developed a list of recommendations for increasing clinical trial enrollment. Strategies at the patient and community level include involving patient advocates and community leaders in clinical trial recruitment, simplifying patient consent forms, and providing interpreters. At the physician level, electronic registries may help keep doctors informed about the availability of clinical trials for their patients. Doctors must also work on speaking to their patients about clinical trials in culturally sensitive ways. Finally, at the level of organizations that initiate clinical trials, institutions need to become more efficient about opening and conducting trials.


Doctors Should Discuss Treatment Expenses with Patients

A recent editorial argues that doctors should talk about the issue of cost when discussing treatment options with patients. High out-of-pocket treatment expenses can cause severe financial hardship that may affect patients’ well-being. A study showed that over 60% of patients want to discuss treatment cost with their doctors, yet only 15% do so. Even though patients frequently want to choose the best treatment regardless of expense, sometimes there are viable lower-cost alternatives. Moreover, some patients may indeed be willing to trade potential medical benefits for less financial distress. Finally, even if patients do not change their treatment choices, discussing treatment costs can help them prepare financially for expensive procedures and learn about options for dealing with medical debt.


NIH Clinical Trials Severely Limited by U.S. Government Shutdown

Clinical trials at the National Institutes of Health (NIH), the U.S. national medical research agency, continue to enroll patients despite the U.S. government shutdown, but the scope and pace of enrollments have been drastically reduced. More than 13,000 NIH employees, about three-quarters of its workforce, have been forced to take unpaid leave. As a result, in the week since the shutdown, only 12 new participants were admitted to existing trials, compared to around 200 in a typical week. Only patients in imminent danger of dying are being enrolled, most of them cancer patients. No new trials are being started, and at least seven studies have been delayed since the shutdown began.


ClinicalTrials.gov Reopens Despite U.S. Government Shutdown

Numerous federal services in the U.S. have been suspended due to the ongoing government shutdown. Among the services affected was the federal registry of clinical trials, accessible via the website ClinicalTrials.gov. New trials were not being entered into the registry and made available for enrollment. As a result, many people, including patients with advanced cancer, were unable to enroll in studies offering potentially lifesaving experimental treatments. However, after a U.S. Congressman contacted the National Institutes of Health (NIH), which administers the database, a small number of furloughed workers was called back to reopen the website. While the website is not fully operational, processing of clinical trial registrations has resumed, along with updates of the most critical information.


ClinicalTrials.gov Reopens Despite U.S. Government Shutdown

Numerous federal services in the U.S. have been suspended due to the ongoing government shutdown. Among the services affected was the federal registry of clinical trials, accessible via the website ClinicalTrials.gov. New trials were not being entered into the registry and made available for enrollment. As a result, many people, including patients with advanced cancer, were unable to enroll in studies offering potentially lifesaving experimental treatments. However, after a U.S. Congressman contacted the National Institutes of Health (NIH), which administers the database, a small number of furloughed workers was called back to reopen the website. While the website is not fully operational, processing of clinical trial registrations has resumed, along with updates of the most critical information.


ClinicalTrials.gov Reopens Despite U.S. Government Shutdown

Numerous federal services in the U.S. have been suspended due to the ongoing government shutdown. Among the services affected was the federal registry of clinical trials, accessible via the website ClinicalTrials.gov. New trials were not being entered into the registry and made available for enrollment. As a result, many people, including patients with advanced cancer, were unable to enroll in studies offering potentially lifesaving experimental treatments. However, after a U.S. Congressman contacted the National Institutes of Health (NIH), which administers the database, a small number of furloughed workers was called back to reopen the website. While the website is not fully operational, processing of clinical trial registrations has resumed, along with updates of the most critical information.


UK Health Authority Issues Final Rejection for Cancer Drug Xalkori

The UK’s National Institute for Health and Clinical Excellence (NICE) confirmed its decision to reject using National Health Service funding to provide crizotinib (Xalkori) to patients. Xalkori is used for patients with previously treated non-small cell lung cancer (NSCLC) who have mutations in the ALK gene. While NICE acknowledges that Xalkori is effective in these patients, they do not consider its benefit substantial enough to warrant its high cost. Xalkori has been found to extend the time without cancer progression by an average of 5.1 months compared to standard chemotherapy; it is unclear whether it increases overall survival. UK patients can still take Xalkori, but would have to pay the full cost themselves (£37,512 – £51,579 for a complete treatment course).


Gilotrif to Be Commercially Available in the U.S. Soon

Afatinib (Gilotrif), a new drug for the treatment of some lung cancers, will become commercially available in the U.S. beginning the week of September 2. Gilotrif is approved as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who have certain mutations in the EGFR gene. A companion diagnostic, the therascreen EGFR RGQ PCR Kit, can detect these specific EGFR mutations, so-called exon 19 deletions or exon 21 (L858R) substitutions. The makers of the drug will offer a patient support program to provide financial and other support to help patients who might otherwise not have access to Gilotrif.