Why Clinical Trials Are Essential for Advancement in Ovarian Cancer Treatment
Women who have ovarian cancer need to understand that the best hope for improved screening methods and more effective treatments lies within their participation in clinical trials. Research is the cornerstone of improved medical advances, but work needs to be done at every level and for every stage in order to make sure that more, and better, research opportunities continue to become available.
In her presentation at the 20th Annual Ovarian National Conference in Chicago on July 8, 2017, Dr. Carol L. Brown said that there is not a single major advance in the screening and treatment of ovarian cancer that did not come from a clinical trial.
At the same conference, Dr. John Moroney of the University of Chicago Medicine repeated the sentiment, saying that the only way that progress can continue is if there is an expansion and improvement of clinical trials that focus on gynecologic cancers.
Statements on the importance of expanding the entire practice of clinical trials on gynecologic cancers continued through the meeting. Dr. Brown and Dr. Morony both stated that there is a growing crisis in the lack of available clinical trials for women with gynecologic cancers. The doctors both pointed out the crisis of there being a 90 percent reduction in participating patients who enrolled in gynecologic cancer clinical trials between 2011 and 2016.
Drug trials
Dr. Brown, the associate cancer center director for diversity and outreach and a gynecologic oncologist at the Memorial Sloan Kettering Cancer Center, stated that cancer researchers generally already have quite a bit of confidence in a drug if it is being tested in a phase 1 trial. Generally speaking, if a drug has made it to phase 1 trials, there is a high likelihood that it will provide at least some benefit to cancer patients. Dr. Brown also said that it is important for patients to understand that it is rare for a drug that has made it to phase 1 testing to be deemed as not beneficial at all to cancer patients.
The goal of the research in phase 1 trials is to understand the safety of administering a drug, the drug's maximum tolerated dose, and how the body will react and process the drug. Phase 1 trials are usually quite small, however, and generally only involve 20 to 40 patients who will receive the trial treatment.
Phase 2 trials are substantially larger than phase 1 trials. It is in phase 2 that the majority of the advances have been made. Phase 2 trials have become larger than phase 1 trials over recent years, have begun to occur more rapidly, and researchers have been working very hard to make them more accessible.
Phase 2 trials have also begun to move outside of the specialized cancer centers. Whereas phase 1 trials are still usually conducted in cancer centers, phase 2 trials have moved out into the community more. According to Dr. Brown, there was a time when it was completely unheard of for phase 2 trials to be done outside of cancer centers. With the number of participants decreasing, researchers became desperate to continue their efforts. They finally realized that many patients did not want to travel to the large cancer centers and that the best way to ensure participation was to bring the trials directly to the patients.
The phase 3 trial results are crucial to a drug's success. The Food and Drug Administration considers the phase 3 findings when they are deciding whether or not to approve a drug for safe use. This third phase is often considered the "gold standard" of clinical trials. It is in the third phase that researchers will usually compare two treatments that have already proven themselves effective. While comparing the two drugs to determine how effectively they work, researchers will also consider any associated side effects that may have adverse effects on the quality-of-life of patients. Some of these side effects may include neuropathy, hormonal changes, and even the cost of the drug.
Why clinical trials are so important
Dr. Brown said that when women with ovarian cancer participate in clinical trials, they are not only contributing to the larger good and helping other women who have ovarian cancer or will be diagnosed with it in the future, but they are also benefiting themselves. By participating in a clinical trial, the participants gain access to new drugs and treatments long before they become available to the general public. While other women may have to wait several years for a drug to become approved and distributed amongst the general population, participants may get an early jump start on combating their ovarian cancer with the latest treatment options.
Women who participate in clinical trials receive other benefits in addition to access to a new drug. They also get closer observation from the team of research doctors than they would if they were not participating in the clinical trial. When a woman participates in a clinical trial, she receives closer attention from some of the leading gynecologic cancer physicians available and gets additional scans, screenings, and checkups from doctors or nurses that help determine the progress of the cancer versus the treatment.
Dr. Brown continued her lecture by citing a vast range of advances that have helped to change the course of ovarian cancer treatment options. All of the advances mentioned were the results, both directly and indirectly, of clinical trials and included making available a range of targeted anti-ovarian cancer therapies, such as the oral PARP inhibitors, Rubraca and Lynparza, as well as the discovery and optimization of less toxic anti-cancer drugs, such as carboplatin and paclitaxel.
Dr. Brown went on to discuss how advanced ovarian cancer trials had become within the last three years with the discovery of four new, and more effective anti-ovarian cancer drugs, as compared to only four new drugs within the previous 15 years. Every time one new screening or treatment method is discovered, it opens the door for additional or better methods to be researched. Research is not only gaining ground in the fight against ovarian cancer, but it is picking up pace and accelerating more than ever before. As long as the trials continue at the same pace, a master cure for ovarian cancer may be just one more clinical trial away, and to stand in its way would be nearly criminal.
It is unfortunate that even in light of the rapid recent advances in clinical trials in the fight against ovarian cancer, optimism has been tempered with an even more recent trend in the reduction of trials. Dr. Brown blames this decrease in ovarian cancer trials not only on a reduction in participants, but even more so on reductions in federal and private funding for research. Brown stated that a vast majority of federal funding has been diverted away from ovarian cancer research as a whole and more towards smaller studies that focus primarily on biomarkers. This diversion of funds may be largely due to a recent trend in the reorganization of oncological cooperative group research and more towards smaller, private research groups. This diversion of funds and reallocation of information will only hurt and slow down ovarian cancer research and possibly prevent new screening and treatment methods.
Women with ovarian cancer, as well as concerned individuals who do not have cancer, can help improve the future of ovarian cancer research trials by contacting their elected representatives and advocating aggressively for the funding needed for clinical research trials. One such source of contact and support can be found through the Society of Gynecologic Oncology's Legislative/Congressional Ambassadors Program. This program helps to increase the support for the National Cancer Institute which works tirelessly combat cancers such as ovarian cancers. By contacting these programs, patients can learn both how to effectively communicate with their elected officials and also how to find the latest clinical trials that they can participate in.
Increasing awareness, increasing funds, and increasing participation may be the three keys to improving clinical trials and finally curing ovarian cancer.
References
Green, L. (2017, July 09). Clinical Trials Are the Way Forward for Ovarian Cancer, but They Need Advocates at Every Level. [Web]. In Cure Today. Retrieved from: http://www.curetoday.com/conferences/20th-ovarian-national-conference/clinical-trials-are-the-way-forward-for-ovarian-cancer-but-they-need-advocates-at-every-level
