Sarah Alwardt, PhD
As cancer treatment shifts from broad chemotherapy to highly personalized therapies, drug development in oncology is also evolving. There are currently some 71,000 oncology trials listed on ClinicalTrials.gov, with new studies being added every day. Although the trials may involve varied forms of disease or new modalities such as cell and gene therapies, all share 1 thing in common: They are competing with one another to recruit patients.
According to the National Cancer Institute, standard of care is defined as treatment that experts agree is appropriate, accepted, and widely used. If a study is comparing new treatment options with a standard treatment that has not changed for years, why not use historic RWE as the control? If multiple biopharma companies are developing new drugs for the treatment of renal cell carcinoma, and each is conducting trials with nearly identical control groups, the possibility exists for all to draw data from the same control group. This may present some risk to the biopharma companies but could be a major boost for patients in the form of faster access to promising new therapies.
Wide Spectrum of Potential Uses of RWD/RWE in Clinical Studies (Click to Enlarge)
Formalize a 2-Step Regulatory Approval Process
Under the FDA’s expanded access program, patients with an immediately life-threatening condition or serious disease may gain access to investigational drugs for treatment outside of clinical trials when no alternative therapy options are available. For patients who have exhausted approved options for treatment, participating in the expanded access program may be worth the risk of using an unapproved drug.
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