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    Knowledge Is Power: Understanding Your Cancer to Inform Treatment

    Know Your Cancer While it’s easy to put different types of cancers under one umbrella, the reality is, no two cancers (and no two people living with cancer) are the same. That’s why getting tested for both inherited mutations and biomarkers can help us understand the unique characteristics of each type of cancer, guiding us to make informed decisions about our care. 1 For Maryland-based Ethel, understanding her genetic mutations has been able to help better inform her treatment journey through ovarian cancer. Ethel is an avid volunteer and participant at her local synagogue, and her involvement is not only a big part of her life, but it also played a role in a major health change. In 2017, after experiencing intense pelvic pain, Ethel learned that she had Stage 3 ovarian cancer. Having  learned about BRCA mutations at her synagogue, she decided to get tested and learned she had inherited the mutation. Inherited mutations are identified through genetic testing and passed down from parent to child. 2 For example, mutations in the BRCA 1 and BRCA 2 genes increase the risk of certain cancers, including breast, ovarian, prostate and pancreatic cancers. 3 In fact, 5-15% of ovarian cancers are caused by inherited mutations. 4 On the other hand, unlike inherited mutations passed down from generation to generation, biomarkers are indicators of cancer that convey unique aspects of a tumor’s behavior, development and progression — all important factors that can greatly impact treatment decisions. 4 Advances in precision medicine, a highly individualized way of implementing health care that considers both the genetic makeup, biomarker profile, and lifestyle of an individual, means we no longer need a “one-size-fits-all” approach to treating cancer. Now, our ability to target specific biomarkers and genetic mutations has allowed physicians to address the complexities of each subtype of cancer and make informed decisions about treatment. 4 “Fewer than one in five individuals with a history of breast cancer or ovarian cancer have undergone genetic testing, but we now have therapeutic options for women with certain mutations. 5 It’s critical for women to know their BRCA status early and do tumor testing if they have cancer,” shared Dr. Sharyn Lewin, Director of Gynecologic Oncology at Holy Name Medical Center. “We have learned so much about personalized medicine that women are able to advocate for themselves to ensure they’re receiving all of the information possible to inform their course of treatment.” When a person is diagnosed with cancer, genetic testing can provide information that may improve patient care and enable access to certain types of targeted therapies. 1 This information may help family members too as they can gain knowledge about their own risk of developing the disease by understanding the heritability of a certain cancer. 1 Genetic testing can let someone with ovarian cancer know whether they possess an inherited mutation in one of the BRCA genes, which can influence the patient’s decisions about care. 1 Beyond knowing she is Ashkenazi Jewish, a risk factor for ovarian cancer, Ethel’s knowledge of her family history was limited. “ After learning about my BRCA2 mutation, my oncologist recommended my daughter get tested. We learned that she also has the BRCA2 mutation ,” Ethel shared. “We thought it was important to have all of our family members get tested because I have a granddaughter now and we want to be prepared.” The Importance of Biomarkers in Cancer Treatment While genetic testing is a critical part of informing a treatment journey, other tests may also be recommended by a doctor to provide important information about a person’s disease. Biomarker testing looks for genes, proteins, and other substances that provide useful information about how a specific type of cancer behaves. For example, biomarker testing for a trait known as homologous recombination deficiency (HRD) can provide important information after an ovarian cancer diagnosis. HRD impacts how well DNA can be repaired and may be the root cause of the cancer. About half of the people living with advanced ovarian cancer have tumors that test positive for HRD, which can help guide treatment decisions and determine if a woman may be eligible for certain targeted treatment options. 6 Targeted Treatment to Optimize Care Armed with information about their genetic makeup and tumor characteristics, patients can work with their care teams to make informed decisions about treatment, which may include options such as PARP inhibition therapy. LYNPARZA ® (olaparib) is an oral targeted PARP inhibition therapy for certain types of cancer. 7 PARP is a protein that repairs DNA damage in cells so they can survive. In cancer cells, you want to stop this repair so they can’t survive. LYNPARZA helps kill cancer cells by preventing PARP from repairing them. PARP is also found in healthy cells, so LYNPARZA may affect them too. 8 After achieving a complete response from chemotherapy, Ethel started taking LYNPARZA as maintenance therapy. Once beginning LYNPARZA, Ethel was able to complete her treatment regimen after two years. Because of her BRCA 2 mutation, Ethel continues to see an oncologist every six months since she is at risk for other cancers. Depending on the type of cancer, LYNPARZA can be used as maintenance therapy, an active treatment or an adjuvant therapy (treatment after surgery). In advanced ovarian cancer, LYNPARZA is used as maintenance therapy after platinum-based chemotherapy to help prevent the cancer from growing or returning. It’s also approved in the 1st-line maintenance setting after response to platinum-based chemotherapy for BRCA m advanced ovarian cancer and in combination with bevacizumab for HRD positive patients after response to platinum-based chemotherapy. 7 LYNPARZA is also approved in breast, prostate and pancreatic cancer. 7 Based on results from the SOLO-1 trial, safety profile was in line with that observed in prior clinical trials. The most common adverse events (AEs) ≥20% were nausea (78%), fatigue/asthenia (64%), vomiting (40%), anemia (40%) and diarrhea (35%). The most common ≥ grade 3 AEs were anemia (22%) and neutropenia (9%). 9 Indications for certain mutations or biomarkers can help determine where a patient is on their treatment journey and further inform if and when to start LYNPARZA. The better we understand the cancer, the greater chance we have to maximize patient outcomes. Dr. Lewin commented, “ Our goal as physicians is to keep women with ovarian cancer in remission for as long as possible. Treatment with PARP inhibitors such as LYNPARZA as a monotherapy or a combination of Lynparza plus Avastin for women with germline and somatic BRCA mutations and HRD has allowed us to reach women using personalized medicines that are meant to target the specific behaviors of their tumor type to optimize care.” So, What Comes Next? Understanding our familial risk and the unique makeup of cancer tumors provides crucial information to help us make smarter decisions about cancer treatment. With a biomarker-driven approach to treating cancer, it is the hope that patient care teams can work to potentially enhance treatment plans with targeted therapies, treat patients more effectively, and ultimately, improve outcomes. 8 Since completing her treatment with surgery, chemotherapy, and LYNPARZA, Ethel and her husband are enjoying their first grandchild, traveling, and exercising, and she is excited to continue her volunteer activities at her synagogue. “I feel like I’ve become a different person. I’ve become much more grateful and thankful after experiencing all the support from my family and friends all the way from chemotherapy up until I finished taking LYNPARZA,” she shared. Visit www.LYNPARZA.com to learn more and talk to your doctor about genetic and biomarker testing after a cancer diagnosis. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS There are no contraindications for LYNPARZA. WARNINGS AND PRECAUTIONS Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The median duration of therapy in patients who developed MDS/AML was 2 years (range: 10 years). All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy. Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed. Pneumonitis: Occurred in 0.8% of patients exposed to LYNPARZA monotherapy, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately. Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment. Females Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose. Males Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time. Venous Thromboembolic Events: Including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated. ADVERSE REACTIONS—First-Line Maintenance BRCA m Advanced Ovarian Cancer Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary tract infection (13%), thrombocytopenia (11%), and stomatitis (11%). Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%). ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab Most common adverse reactions (Grades 1-4) in ≥10% of patients treated with LYNPARZA/bevacizumab compared to a ≥5% frequency for placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%). In addition, the most common adverse reactions (≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%). In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%). Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%). ADVERSE REACTIONS—Maintenance Recurrent Ovarian Cancer Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%). Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%), and dyspepsia (20%). Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%). ADVERSE REACTIONS—Adjuvant Treatment of g BRCA m, HER2-Negative, High-Risk Early Breast Cancer Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: nausea (57%), fatigue (including asthenia) (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%), and stomatitis (10%). Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: decrease in lymphocytes (77%), increase in mean corpuscular volume (67%), decrease in hemoglobin (65%), decrease in leukocytes (64%), and decrease in absolute neutrophil count (39%). ADVERSE REACTIONS—g BRCA m, HER2-Negative Metastatic Breast Cancer Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%). Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%). ADVERSE REACTIONS—First-Line Maintenance g BRCA m Metastatic Pancreatic Adenocarcinoma Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%). Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%). ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%). Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%). DRUG INTERACTIONS Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment. CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA. USE IN SPECIFIC POPULATIONS Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose. Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients. Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C). Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min). INDICATIONS LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: First-Line Maintenance BRCA m Advanced Ovarian Cancer For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated (g BRCA m or s BRCA m) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: a deleterious or suspected deleterious BRCA mutation, and/or genomic instability Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. Maintenance Recurrent Ovarian Cancer For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Adjuvant Treatment of g BRCA m, HER2-Negative, High-Risk Early Breast Cancer For the adjuvant treatment of adult patients with deleterious or suspected deleterious g BRCA m, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. g BRCA m, HER2-Negative Metastatic Breast Cancer For the treatment of adult patients with deleterious or suspected deleterious g BRCA m, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. First-Line Maintenance g BRCA m Metastatic Pancreatic Cancer For the maintenance treatment of adult patients with deleterious or suspected deleterious g BRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. Please see complete Prescribing Information , including Medication Guide . References American Cancer Society. Tests for Ovarian Cancer. Available at https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/how-diagnosed.html . Accessed July 2022 American Cancer Society. What Causes Ovarian Cancer? Available at https://www.cancer.org/cancer/ovarian-cancer/causes-risks-prevention/what-causes.html . Accessed July 2022 Petrucelli N, et al. BRCA1- and BRCA2-Associated Hereditary Breast and Ovarian Cancer. 1998 Sep 4 [Updated 2022 May 26]. In: Adam MP, Mirzaa GM, Pagon RA, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2022. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1247/ Zheng, QiongFei Mda, et al. First-degree family history of prostate cancer is associated the risk of breast cancer and ovarian cancer, Medicine: January 29, 2021 – Volume 100 – Issue 4 – p e23816 doi: 10.1097/MD.0000000000023816 Childers CP, Childers KK, Maggard-Gibbons M, Macinko J. National Estimates of Genetic Testing in Women With a History of Breast or Ovarian Cancer [published correction appears in J Clin Oncol. 2018 Feb 1;36(4):432]. J Clin Oncol . 2017;35(34):3800-3806. Panagiotis A. Konstantinopoulos, Raphael Ceccaldi, Geoffrey I. Shapiro, Alan D. D’Andrea; Homologous Recombination Deficiency: Exploiting the Fundamental Vulnerability of Ovarian Cancer. Cancer Discov 1 November 2015; 5 (11): 1137–1154. LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. Rose, Maddison. PARP Inhibitors: Clinical Relevance, Mechanisms of Action and Tumor Resistance, Frontiers in Cell and Developmental Biology, 2020 Volume 8 https://www.frontiersin.org/articles/10.3389/fcell.2020.564601 Moore K, Colombo N, Scambia G, et al . Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med . 2018;379(26):2495-2505.

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    Debunking 5 Clinical Trial Myths You May Have Heard

    There’s a good chance you’ve heard the term “clinical trial” before, whether it came up in your doctor’s office, in an advertisement, or even on this very website. But as common as this phrase is within the medical field, its meaning may not be entirely clear to someone who is not a health care professional or who works in the health care industry. So, what is a clinical trial? Let’s start at the beginning: At its core, a clinical trial is a study that answers specific research questions related to an investigational medicine or treatment. Clinical trials are integral to health care, as they allow scientists to better understand health conditions and determine whether new drugs, diagnostics, medical implants, or other treatments are safe and effective. Even if you’re new to clinical research, it is not uncommon to find that your initial perception of them is shaded with uncertainty. That’s because, despite the importance of clinical trials, there is an alarming amount of misconceptions surrounding them. The best way to determine whether clinical trials make sense as part of your health story is by demystifying them. For Blood Cancer Awareness Month, we discussed clinical trials with Brandon Blue, MD, an expert in health disparities and multiple myeloma, to look at a few common myths and learn the facts, as well as the role these trials play in the future of Oncology—and across medicine in general. Myth #1: Clinical trials are not safe. Researchers, along with the pharmaceutical companies, academic organizations, and research hospitals that sponsor clinical trials, must follow strict rules and ethical guidelines. In the United States, these guidelines are set by the Food and Drug Administration (FDA), a government agency charged with regulating trials and approving therapies or diagnostics before they become available to the public. Additionally, each clinical trial is reviewed and monitored by an Institutional Review Board (IRB), which is an independent panel of qualified, unbiased health care providers and researchers. The purpose of an IRB is to help ensure that trials are conducted ethically and that the rights, safety, and welfare of trial participants are protected throughout the process.¹ It’s also important to note that all treatments available to the public today started out in clinical trials. Dr. Blue emphasized that even when the pace of drug development is particularly fast, as it is in his area of specialty, Oncology — “every day a new cancer drug is either getting developed or approved,” he noted—the clinical trial process helps ensure that safety is prioritized. Dr. Blue emphasizes “all [approved] medications needed to be tested in order to know that they are safe and that they work.” Speaking specifically to someone who believes that clinical trials are not safe, Dr. Blue would note that “it is important for patients from diverse backgrounds to participate in clinical trials, so we know how these investigational medicines may work for the patients that will use them, especially those of color.” Taking part in a clinical trial may be the right choice for some cancer patients. If you choose to participate in a clinical trial, you should be informed of what to expect, the potential benefits and risks of participating, and why the research is being conducted. If you enroll in a trial, you can change your mind and withdraw at any time. Myth #2: Diversity in clinical trials is not important. Over the years, we’ve learned how important it is for cancer clinical trials to include people of different sexes, ages, races, and ethnicities. This is because our bodies may react differently based on these factors. In the United States, research has shown that racial and ethnic minorities, particularly Black Americans, have worse outcomes in multiple types of blood cancer.² As Dr. Blue points out, “Many times this is due to the fact that for many cancers, minorities get diagnosed at younger ages and at more advanced stages than others. 3,4 However, minority groups have the lowest clinical trial enrollment numbers.” It’s imperative that clinical trials reflect the diverse population of people with the health conditions they’re studying in order to help researchers understand how effective and safe a treatment is for those who need it. It must be acknowledged that historical failings in the clinical research field, including the infamous Tuskegee Study run by the U.S. government from 1932 to 1972, have contributed to continued public mistrust in the research process. Though the ethical standards lacking in the past have seen tremendous overhauls over the past decades, including stronger regulations and the creation of the Office for Human Research Protections , the medical community and pharmaceutical industry are committed to continuing to rebuild meaningful trust with patient communities. 5 Knowing the importance of transparency and building trust in achieving diversity, equity, and inclusion (DE&I) in clinical trials, the Diversity, Equity and Inclusion in Clinical Trials (DEICT) team at Janssen Pharmaceutical Companies of Johnson & Johnson strives to be a leading force in educating the public on the clinical trial process and why diversity and inclusion is important in clinical trials. Their “Research Includes Me” program focuses on reaching underrepresented and underserved communities by meeting them where they are and addressing barriers to clinical trial participation. To learn more about the clinical research process and why diversity is so important to the future of medicine, visit ResearchIncludesMe.com . Myth #3: Clinical trials are not developed with people like me in mind. The need for representation in clinical trials has become much more apparent in recent years, and there are many different efforts underway to deliver on that need. So that everyone has a seat at the table in clinical research, government agencies, including the FDA and the National Institutes of Health in the United States, have expanded their efforts to promote inclusivity in clinical trials. Included among the medical community’s DE&I efforts is placing an emphasis on ensuring that the staff administering clinical trials – including Oncology clinical trials – are more reflective of the populations they serve. Dr. Blue underscores the importance of having diverse populations develop and lead cancer clinical trials, noting that “Culture is key! You cannot teach culture in medical school; it’s something that is passed down from your family and life experiences.” As representation grows across the medical field, especially in positions of power and among medical professionals leading research projects, a patient’s sense of feeling seen and heard in the clinical trial process will grow with it. 6 Through the program, Better Trials . Made Together., Janssen is co-creating better trial experiences by facilitating deeper connections among patients, investigators, and others. By asking and listening, they’ve found there are commonalities for both patients and investigators across their trial experience, regardless of geography or disease state. And these commonalities (or voices) have helped them change how Janssen approaches, plans, and executes clinical trials for underrepresented and underserved communities. Myth #4: The only way to participate in a clinical trial is waiting to be recruited into one. It is true that many researchers actively seek out participants, and it is also true that some people enter trials on the recommendation of their doctor. However, patients are also able to seek out relevant clinical trials on their own and request information to see if the study would be a good fit for them. There are many trial search tools that are free and easy to use. If you are interested in searching for suitable clinical trials in your area, you can search ClinicalTrials.gov . At any given time, there are thousands of clinical trials actively recruiting patients across the United States alone. Available trials can vary across a wide range of health conditions, age groups, study lengths, and geographic regions, so even if there is not a clinical trial that immediately suits your circumstances, it is worth checking periodically as availability may change. If you would simply like to learn more about the clinical trial process and familiarize yourself with patient rights, more information can be found on ResearchIncludesMe.com . Learn More Myth #5: My participation in a clinical trial doesn’t really make a difference. Clinical research impacts us all, even if we aren’t immediately aware of the advancements they drive. From life-saving medical technologies and medications to products like sunscreen, you have clinical trials to thank! Given the nature of research, there are no guarantees that a trial will bring about the desired results, but each study contributes to a wider pool of medical knowledge that can benefit current and future patients across the globe. To those considering a clinical trial, Dr. Blue says, “Thank you for not only considering yourself but the future of the medical field. The only way that we will find a cure to cancer is if everyone thinks of others. I would also say the information we learn today could help one of your family members in the future, and your involvement could teach us something that could save that person’s life.” Whether you are considering a cancer clinical trial for you or your loved ones, the decision to participate in any research study is a highly personal one. That places extra importance on accurate information—participants need to be aware of everything that happens during the clinical trial process, their rights, and how to determine if a trial is a good fit for each individual, based on their own health condition and other factors. One resource that can help in this process is Janssen’s clinical trial fact sheet , designed to help patients speak with their health care professionals. Click the button below if you are interested in further information that can help educate and assist you in making decisions about clinical trials: explore more with janssen References ¹ What Are Clinical Trials and Studies? National Institutes of Health. https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies . April 9, 2020. Accessed August 2022. ² Cancer Disparities. National Cancer Institute. https://www.cancer.gov/about-cancer/understanding/disparities . March 28, 2022. Accessed September 2022. ³ Age At Cancer Diagnosis For Blacks Compared With Whites In The United States. Journal of the National Cancer Institute. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326308/ . January 29, 2015. Accessed September 14, 2022. 4 A collaborative study of differences in the survival rates of black patients and white patients with cancer. Cancer. https://pubmed.ncbi.nlm.nih.gov/1562983/ . May 1, 1992. Accessed September 14, 2022. 5 The U.S. Public Health Service Syphilis Study at Tuskegee: Research Implications. Centers for Disease Control and Prevention. https://www.cdc.gov/tuskegee/after.htm April 22, 2021. Accessed August 2022. 6 Diversity & Inclusion in Clinical Trials. National Institute on Minority Health and Health Disparities. https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html . February 7, 2022. Accessed August 2022.

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    Debunking 5 Clinical Trial Myths You May Have Heard

    There’s a good chance you’ve heard the term “clinical trial” before, whether it came up in your doctor’s office, in an advertisement, or even on this very website. But as common as this phrase is within the medical field, its meaning may not be entirely clear to anyone who doesn’t work in the industry. So, what is a clinical trial? Let’s start at the beginning: At its core, a clinical trial is a research study that answers specific research questions related to a medicine or treatment. Clinical trials are integral to health care, as they allow medical researchers to better understand health conditions, develop and test new treatment options, and find cures. Even if you’re new to clinical trials, it is not uncommon to find that your initial perception of them is shaded with uncertainty. That’s because, despite the importance of clinical research, there is an alarming amount of misconceptions surrounding them. The best way to determine whether clinical trials make sense as part of your health story is by demystifying them. Let’s take a look at a few common myths and learn the facts. Myth #1: Clinical trials are not safe. Researchers, along with the pharmaceutical companies, academic organizations, and research hospitals that sponsor clinical trials, must follow strict rules and ethical guidelines. These guidelines are set by the Food and Drug Administration (FDA), a government agency charged with regulating trials and approving medicines before they become available to the public. Additionally, each clinical trial is reviewed and watched over by an Institutional Review Board (IRB), which is an independent panel of qualified, unbiased health care providers and researchers. The purpose of an IRB is to ensure that trials are conducted ethically and that the rights, safety, and welfare of trial participants are protected throughout the process. If you choose to participate in a clinical trial, you should be informed of what to expect, the potential benefits and risks of participating, and why the research is being conducted. If you enroll in a trial, you can change your mind and withdraw at any time. Myth #2: Diversity in clinical trials is not important. Over the years, we’ve learned how important it is for clinical trials to include people of different sexes, ages, races, and ethnicities. This is because our bodies react differently based on these factors. It’s imperative that clinical trials reflect the diverse population of people with the health conditions they’re studying, in order to help researchers understand how effective and safe a treatment is for those who need it. It must be acknowledged that historical failings in the clinical research field, including the infamous Tuskegee Study run by the U.S. government from 1932 to 1972, have contributed to continued public mistrust in the research process. Though the ethical standards lacking in the past have seen tremendous overhauls over the past decades, including stronger regulations and the creation of the Office for Human Research Protections , the medical community still carries the continued responsibility of rebuilding that trust. The Janssen Pharmaceutical Companies of Johnson & Johnson have long prioritized diversity, equity, and inclusion (DE&I) in clinical trials, with the goal to advance health equity and create a better future for all patients. Knowing the importance of building trust in achieving those aims, Janssen strives to be a leading force in educating the public on the clinical trial process through their “Research Includes Me” program, which is focused on reaching underserved communities by meeting them where they are — listening to patient concerns, building trust through safety, and addressing barriers to clinical trial participation. To learn more about the clinical research process and why diversity is so important to the future of medicine, visit ResearchIncludesMe.com . Myth #3: Clinical trials are not developed with people like me in mind. The need for representation in clinical trials has become much more apparent in recent years, and there are many different efforts underway to deliver on that need. To ensure everyone has a seat at the table in clinical research, governmental agencies, including the FDA and the National Institutes of Health , have expanded their efforts to promote inclusivity in clinical trials. Included among the medical community’s DE&I efforts is placing an emphasis on ensuring that the staff administering clinical trials are more reflective of the populations they serve. As representation grows across the medical field, especially in positions of power and among medical professionals leading research projects, a patient’s sense of feeling seen and heard in the clinical trial process will grow with it. Another way Janssen is leading the charge for more diverse, inclusive, and equitable clinical trials is through routinely capturing insights of underrepresented communities in a program called “Patient Voice.” This program works to gather key insights from patients to help form clinical trials to serve the needs of the community. Myth #4: The only way to participate in a clinical trial is waiting to be recruited into one. It is true that many researchers actively seek out participants, and it is also true that some people enter into trials on the recommendation of their doctor. However, patients are also able to seek out relevant clinical trials on their own and request information to see if the study would be a good fit for them. There are even many trial search tools that are free and easy to use! If you are interested in searching yourself for suitable clinical trials near you, you can search Janssen’s Global Trial Finder . At any given time, there are thousands of clinical trials actively recruiting patients across the United States alone. Available trials can vary across a wide range of health conditions, age groups, study lengths, and geographic regions, so even if there is not a clinical trial that immediately suits your circumstances, it is worth checking periodically as availability may change. If you would simply like to learn more about the process and familiarize yourself with patient rights inside of clinical trials, more information can be found on the Research Includes Me website. [ Learn More ] Myth #5: My participation in a clinical trial doesn’t really make a difference. Clinical research impacts us all, even if we aren’t immediately aware of the advancements they drive. From life-saving medical technologies and medications to products like sunscreen, you have clinical trials to thank! Given the nature of research, there are no guarantees that a trial will bring about the desired results, but each study contributes to a wider pool of medical knowledge that can benefit current and future patients across the globe. Whether you are considering a clinical trial for you or your loved ones, the decision to participate in any research study is a highly personal one. That places extra importance on good information—participants need to be aware of everything that happens during the clinical trial process, their rights, and how to determine if a trial is a good fit for each individual, based on their own health condition and other factors. One resource that can help in this process is Janssen’s clinical trial fact sheet , designed to help patients speak with their health care professionals. Click the button below if you are looking for further information that can help educate and assist you in making decisions about clinical trials: [ Explore More with Janssen ]