Developing just one cancer drug can cost sponsors as much as US$648 million. Although these costs can be reduced with the help of a contract research organization’s (CRO’s) specialized expertise and resources, it’s still a hefty investment and it is not guaranteed that the medication will reach the market. The approval of novel therapies depends heavily on their Phase I human clinical trial, the results of which determine whether a drug is safe enough to be investigated further. Perhaps more so than other indications, Phase I cancer trials are especially crucial because promising treatments have the potential to qualify for the Food and Drug Administration’s Accelerated Approval or Breakthrough Designation fast-track pathways.
The success of Phase I oncology clinical trials hinges on the quality of the selected research sites because this stage requires, especially rigorous patient safety monitoring. To avoid common mistakes when running a clinical trial, sponsors must choose oncology sites that have the right experience and facilities to ensure their trial’s success. Read on to learn more about the top five highly qualified Phase I oncology sites in the U.S. which are equipped with the experience and resources to help your early-stage cancer trials run smoothly from the start.
1 | Mary Crowley Cancer Research (Dallas, Texas)
This early-phase oncology site was founded in 1997 by Mary Crowley, a survivor of cervical cancer, to drive fundamental change at the time in patient access to innovative cancer treatments. As a specialized cancer research site, patients at Mary Crowley are offered access to new investigational therapies through numerous Phase I and Phase II clinical trials in collaboration with leading global pharmaceutical companies. Since 1997, Mary Crowley Cancer Research has conducted over 740 clinical trials, 129 of which were first-in-human studies, partnered with nearly 300 sponsors, and contributed to the approval of 18 cancer drugs by the Food and Drug Administration.
2 | The Angeles Clinic and Research Institute (Santa Monica, California)
With a team of eleven leading board-certified oncologists specializing in a variety of tumor types, the Angeles Clinic has an established reputation for delivering cutting-edge therapeutic options for cancer patients. To dedicate further resources to the development of innovation in oncology, this research site has expanded to include Experimental Therapeutics (Phase I) and Drug Development programs on-site. Their specialized Phase I cancer clinic has experienced study staff who deliver quality care to patients with different diagnosis types who have not responded to traditional treatments. The Angeles Clinic and Research Institute offers extensive site resources to support early-phase cancer studies with a wide range of indications, from neuro-oncology and gastrointestinal cancer to skin and lung cancers, among others.
3 | Highlands Oncology (Arkansas)
For 26 years, Highlands Oncology has been serving patients across Arkansas and Oklahoma as the only community-based Phase I oncology clinical trial center in the state of Arkansas. Their Research Department offers sponsors and their CRO’s teams full-service certified study staff who operate multiple clinical trials in oncology and hematology. Currently, Highlands Oncology is actively conducting over fifty trials, including 17 Phase I studies, across more than 25 categories of cancers. This clinical research site is equipped with the latest diagnostic imaging technologies, as well as a large team of medical oncologists, radiation oncologists, surgeons, and supportive care physicians to deliver the highest quality standard of cancer care.
4 | NEXT Oncology (U.S. & Spain)
NEXT Oncology is a dedicated Phase I oncology clinic headed by co-founder and world-renowned medical oncologist, Dr. Anthony Tolcher, that delivers the latest clinical trials of new cancer therapies. This site is well-equipped to support global multi-center trials across its six clinical sites located in Austin (TX), San Antonio (TX), Austin (TX), Fairfax (VA), Barcelona (Spain), and Madrid (Spain). Dr. Tolcher sees every clinical trial as an opportunity to provide a breakthrough in cancer treatment and recognizes the role technology plays in this innovation. To streamline their site efficiency, sponsors and CROs can expect quality data and patient management from NEXT Oncology through the use of digital tools such as proXimityTM and Noona.
5 | The START Center for Cancer Care (U.S. & Spain)
For 35 years, the START Center has been a global leader in Phase I oncology research, with its extensive GCP-certified, oncology-specialized clinical team having helped bring 28 cancer drugs into the market. Their locations span two sites in Madrid, Spain, as well as three states, including Utah, Texas, and Michigan, providing a large pool of patients for clinical trial recruitment. This site is currently supporting clinical trials for cancers of the bladder, breast, colon, kidney, lung, prostate, and skin. In addition to offering 13,000 square feet of world-class facilities, the START Center also contains a dedicated Phase I Clinic, Regulatory Affairs Department, and Pharmacokinetics Department.
Vial, Working with Top Phase I Oncology Sites
Vial is a full-service CRO that recognizes the importance of advancing digital technology to drive innovation in today’s oncology drug development landscape. Vial’s Oncology CRO provides streamlined workflows, site startup in 30 days or less, and relationships with the top clinical sites. To discover more highly sought-after investigators and Phase I sites to ensure the success of your cancer clinical trials, visit https://vial.com/investigators/ and contact a Vial Oncology CRO representative today.