Expanded Access Versus Right-to-Try

McGinley L . FDA to make it easier for doctors to get unapproved cancer drugs for patients. The Washington Post. https://www.washingtonpost.com/health/2019/06/03/fda-make-it-easier-doctors-get-unapproved-cancer-drugs-patients/?utm_term=.726e5a27402e. Published June 3, 2019. Accessed August 20, 2019.

Turney T . FDA In Brief: FDA takes new steps to broaden patient participation in cancer clinical trials, advancing policies to promote inclusion of pediatric patients and patients with medical conditions that can occur alongside cancer. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-takes-new-steps-broaden-patient-participation-cancer-clinical-trials-advancing. Published March 12, 2019. Accessed August 20, 2019.

FDA News Release. FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer. https://www.fda.gov/news-events/press-announcements/fda-announces-project-facilitate-assist-physicians-seeking-access-unapproved-therapies-patients. Published June 3, 2019. Accessed August 20, 2019.

Loftus P . FDA to ease some cancer patients’ access to experimental drugs. The Wall Street Journal. https://www.wsj.com/articles/fda-to-ease-some-cancer-patients-access-to-experimental-drugs-11559566800. Published June 3, 2019. Accessed August 20, 2019.

Project Facilitate. Assisting healthcare providers with expanded access requests for investigational oncology products. https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate. Published August 1, 2019. Accessed August 20, 2019.

Marchion M . US aims to help more cancer patients try experimental drugs. Associated Press. https://apnews.com/5b449037e11649219c45b663d9b7337f. Published June 3, 2019. Accessed August 20, 2019.

Shoemaker D Barber K Whitney K . Right-to-try or right to ask? Rho White Paper. https://www.clinicalleader.com/doc/right-to-try-or-right-to-ask-understanding-right-to-try-and-fda-s-expanded-access-programs-0001 Published 2019. Accessed August 20, 2019.

Brennan Z . Right to Try One Year Later: Limited Patient Involvement but More FDA Clarity Coming. https://www.raps.org/news-and-articles/news-articles/2019/5/right-to-try-one-year-later-limited-patient-invol. Published May 30, 2019. Accessed August 20, 2019.

McGinley L . “Right to try” legislation heads to the White House. The Washington Post. https://www.washingtonpost.com/national/health-science/right-to-try-legislation-heads-to-the-white-house/2018/05/22/64795536-5dea-11e8-a4a4-c070ef53f315_story.html Published May 22 2018. Accessed August 20 2019.

ERC-USA. ERC-USA initiates therapy under Right to Try law with first patient In California using investigational compound ERC1671 for treatment of glioblastoma. GlobeNewswire. https://www.globenewswire.com/news-release/2019/01/08/1682156/0/en/ERC-USA-Initiates-Therapy-Under-Right-to-Try-Law-With-First-Patient-In-California-Using-Investigational-Compound-ERC1671-for-Treatment-of-Glioblastoma.html. Published January 8, 2019. Accessed August 20, 2019.

Florko N . Prominent “right-to-try” advocate is getting treatment under the new law. https://www.statnews.com/2019/02/05/one-right-to-try-advocate-is-getting-treatment-under-the-new-law/. Published February 5, 2019. Accessed August 23, 2019.

US Government Accountability Office. Investigational Drugs: FDA and Drug Manufacturers Have Ongoing Efforts to Facilitate Access for Some Patients. https://www.gao.gov/assets/710/701243.pdf. Published September 2019. Accessed September 12-20, 2019.

Mezher M . GAO Reports on FDA, Drugmaker Efforts to Boost Access to Investigational Drugs. https://www.raps.org/news-and-articles/news-articles/2019/9/gao-reports-on-fda-drugmaker-efforts-to-boost-acc. Published September 10, 2019. Accessed September 12-20, 2019.

Right to Try. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try. Published May 28, 2019. Accessed August 22, 2019.

Wong CH Siah KW Lo AW . Estimation of clinical trial success rates and related parameters. Biostatistics. 2019;20(2):273-286.