What Does Early Access Mean?

What Does Early Access Mean

Early access in cancer care refers to cancer patients who receive treatment with a drug that is still in the approval process by the FDA. Treatments currently used in standard care for cancer patients at one point went through the approval process of the FDA by performing clinical trials.

In order for a pharmaceutical company to have a drug approved for commercial use by the FDA, clinical trials must complete 4 phases.

Phase I: Smaller study consisting of 50 participants of various cancer types. This is the first-time humans will be monitored using the drug. The safest dosage and method of taking the drug are determined, as well as side effects are observed.

Phase II: Several cancer types are selected to observe unique responses. Side effects are also observed for the slightly larger group of over 100 participants.

Phase III: Consisting of hundreds or sometimes thousands of participants, 1 or 2 cancer types are focused on. The new treatment is compared to the standard treatment. Once this phase is completed, pharmaceutical companies can request FDA approval for marketing and selling the drug to consumers.

Phase IV: Sometimes with less participants than Phase III, the long-term side effects and treatment results are observed. Once this phase is completed, the drug can be taken off the market or new restrictions are placed depending upon the findings and results of the study.

Should I Get Early Access Treatment?

Access to these treatments requires pre-screening and enrollment to be completed prior to receiving the treatment. Sometimes, there are many qualifications (eligibility criteria) for patients to be enrolled in a clinical trial. Nearly 3 out of 4 cancer patients who don’t enroll in clinical trials is because they fail prescreening due to not meeting eligibility criteria. Some individuals are reluctant to enroll because of lack of human testing, but drugs are researched for an average of 6 years before clinical trials begin. Participation in these trials is important for the development of these drugs in order to ensure safety before commercial use. Each individual who participates helps the drug become one step closer to being administered to other patients.

There are many different types of clinical trials offered for cancer patients including treatment (most common), prevention, screening, supportive and palliative care trials. For treatment cancer clinical trials, many aspects of cancer care can be tested including:

  • Drugs
  • Vaccines
  • Approaches to surgery or radiation therapy
  • Combination of treatments to boost immune system and fight the cancer

Only approximately 3% to 5% of adult cancer patients participate in clinical trials, and 85% of cancer patients are being treated in community practices where research access is very limited or non-existent. At these community practices, clinical trials are most often not mentioned or are not considered seriously.

Of those that do enroll in clinical trials, many find positive results. According to NCI, “A survey of oncologists in community cancer clinics found that most agreed that clinical trials provide high quality care (87%) and benefit enrolled patients (83%).” Those who fail first-line therapy, experience constant side effects from current treatment, and those who have specific biomarkers relating to their cancer, may benefit from cancer clinical trials.

There are 135,000 total clinical trials listed on clinicaltrials.gov, 37,000 of which are for cancer patients. Did you know, In the past 10 years nearly 300 forms of medicine have been approved by the FDA to help people with hard-to-treat diseases? So far in 2020,21 drugs specifically for cancer have been approved.

Sources:

NCI https://www.cancer.gov/

ACS https://www.cancer.org/

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