• The shortage of some cancer drugs is having a significant negative impact on current and future cancer clinical trials in the Cancer Cooperative Groups, which conduct their research primarily with public funding through the National Cancer Institute. Of the drugs on the most current shortage list, 22 are cancer agents. Approximately half of all active cooperative group cancer clinical trials have at least one drug on the shortages list. There are approximately 400 active studies across the Cooperative Groups at this time.
  • Many chemotherapy drugs on the list are older sterile injectables that are the standard-of-care treatment for various types of cancer (see supplemental chart). Such drugs are widely utilized in the Cooperative Group setting, mainly due to the fact that placebos (sugar pills) are rarely used in cancer clinical trials, and are never used alone if an acceptable treatment is available. The Cooperative Groups design and conduct randomized phase III, and large phase II, clinical trials, many of which compare the safety and efficacy of a potentially new treatment regimen against, or in combination with, standard treatment. For example, new radiotherapy approaches are being tested in combination with the standard chemotherapy paclitaxel, which is in short supply.
  • There are a number of new therapeutic approaches being evaluated throughout the Cooperative Group system, involving a variety of vaccines, new signal transduction agents, and biologic approaches. In most instances, such new approaches either build on existing therapies or are directly compared to available treatments. In either case, having access to agents which are well established in cancer care is essential to the design of these trials.
  • The unpredictable nature of the shortages makes it very difficult to quantify, predict and monitor the impact across the system. Multiple research sites participate in any given Cooperative Group study, ranging from large comprehensive cancer centers and academic medical centers to community hospitals and small oncology and radiology practices. When a drug utilized in a clinical trial is in short supply or is no longer being manufactured, it compromises the sites’ ability to enroll patients in trials. The impact of a shortage extends across this large network—there are nearly 1,800 research sites affiliated with the Cooperative Groups.
  • Large, randomized Cooperative Group trials enroll hundreds, sometimes thousands, of patients. When research sites affiliated with the Groups are unable to accrue patients into clinical trials due to lack of available drug, it delays the overall pace of the trial because it takes longer to accrue the necessary number of patients for the data collected in the trial to be statistically relevant.
  • It is NOT a common practice for a Cooperative Group to halt a clinical trial due to a drug shortage. Availability of drugs in short supply is a highly fluid situation across the Group-wide network, and the Groups seek to keep studies open so that physicians can enroll patients whenever drug is available.
  • Delaying accrual slows the pace of scientific research because the longer it takes to accrue the necessary number of patients onto a trial, the more it delays completion of the trial. Slowing the pace of cancer research wastes the investment made in the treatment, data management and time investment by the patients and clinical scientists participating in the study.
  • Patients may be denied the opportunity to participate in a trial for which they are eligible, due to lack of available drug. It is a common practice among research sites to ensure availability of drug before enrolling a patient onto a clinical trial. It is also a common practice to select an alternative, standard treatment when lack of drug would cause a delay in treatment for a patient. Treatment delays of days to months are critical in the life of a cancer patient and could limit their chances for a cure or remission of their disease.
  • Cooperative Groups address the impact of drug shortages on a trial-by-trial basis, in collaboration with the National Cancer Institute. A substitution of drug is permitted in some clinical trials, to allow for utilization of alternative regimens that were not part of the original protocol due to a shortage of the existing drug being used as part of the investigation. However, for other clinical trials, particularly those with FDA registration implications and requirements, substitutions of drugs used in the trial are not permitted.
  • Another residual impact of drug shortages is the delay in obtaining the data necessary to bring new cancer therapeutics to patients. With more than 400 cancer agents in various stages of development, it is imperative that cancer clinical trials continue uninterrupted in order to obtain the necessary data to seek approval of new anti-cancer drugs as soon as possible.

Coalition’s Participation in Congressional Testimony Submitted by the National Coalition for Cancer Research (NCCR).

American Society of Health-System Pharmacists for current shortage listings, bulletins, and other info.

FDA Frequently Asked Questions about Drug Shortages

House Energy and Commerce Committee Website. Hearing, Subcommittee on Health, Friday, September 23, 2011 “Examining the Increase in Drug Shortages.” Visit this website to watch archived video of the hearing, read witness testimonies, etc.