Category

Informed Patient

Minority Patients Recruitment in Clinical Trials

By | Clinical Trials, Diversity & Inclusion, Informed Patient, Patient Engagement, Patients | No Comments

The FDA has approved 22 new drugs in 2016, and there are 31,468 patients participated in clinical trials in total. We have been encouraging patients to join clinical trials by showing patients the benefits for them and future generations. However, we should also focus on the diversity of patients in clinical trials, rather than only increasing the total number of patients. Among all the patients participated in clinical trials in 2016, 48% were female patients and 24% were patients with color, which does not correlate with the population percentages of women and people of color in the nation. According to 2010 census, there are approximately 51% women and 30% people of color in the U.S. It is evident that women and people of color are under-presented in clinical trials, which could lead to different drug effects on women and people of color. Therefore, it is essential to encourage more minority patients to participate in clinical trials.

To recruit minority patients in clinical trials, there are serious barriers that need to be addressed. According to a Forbes report, the biggest obstacle is the lack of encouragement or support from the attending physician. Many doctors are either unaware of relevant clinical trials for their patients or not spending sufficient time on each patient. In a 2000 Harris Interactive survey, 80% of cancer patients were unaware of their potential clinical trial options. Additionally, in a 2013 Zogby survey, more than 50% of patients were still unaware of clinical trials, and only a quarter of patients learned of clinical trials from their physicians. Thus, raising the awareness of the existence and benefits of clinical trials is extremely necessary. One big reason that patients are not aware of clinical trials is due to their physicians failing to introduce clinical trials to their patients. Forbes pointed out that “with the increasing pressure to see patients more and more quickly, they simply don’t have the time to engage in lengthy discussions with patients.” However, as a physician, listening to their patients, asking for patients’ needs and helping patients as much as possible is crucial. Especially for minority patients, their diverse backgrounds may require special needs from their physician. Also, the effect of the same treatment can vary enormously across different patients. Therefore, it is vital for physicians to communicate properly with each minority patient. One communicating strategy is that doctors should transfer their language to one that different patients can understand, which will help awareness amongst minority patients. Besides, during the whole process of clinical trials, patients should decide how they want to be part of any of the processes, and physician takes the significant role of guiding and suggesting their patients. Another possible reason that stop minority patients from joining clinical trials are that many patients misunderstand and believe that an experimental treatment must be better than the standard, hence, they would rather take a placebo than finding a standard treatment through clinical trials.

We are a nation of immigrants and diversity is our reliable weapon to support society’s stability. To perfect our healthcare industry, we need to raise and spread the awareness of diversity and inclusion. Physicians are encouraged to engage with their minority patients, communicate with them, and provide the best treatments and clinical trials options for them. Physicians’ efforts can not only help minority patients at present but also benefit their future generations since there are biological changes as generations live and grow in our country. In the end, building trust and communication between physician and minority patients are the keys to recruiting more minority patients in clinical trials.

To further explore the importance of increasing minority patients recruitment in clinical trials, CHI is organizing 2nd Annual Breakthroughs in Healthcare Diversity Symposium on 1/9/18 in San Francisco, CA. The symposium is a leading collaborative symposium for patients, patient groups, clinicians, researchers, technologists, healthcare and life science executives, and diversity and inclusion advocates to discuss diversity and inclusion in healthcare. The symposium will discuss best practices, and exchange new ideas related to making healthcare more diverse, with a specific focus on understanding how to serve underserved patient groups, including racial and ethnic minorities, women, and the LGBT community. The symposium will also focus on helping provider, pharma, and other organizations who serve patients with the latest ideas and insights on how these organizations can become more diverse and inclusive in order to best understand the unique and diverse needs of the patients they serve. Attendees will learn the newest insights and ideas, discuss practical solutions, and meet industry and marketplace colleagues. Please click here for more information.

 

References:

Stone, Judy. “How Can We Encourage Participation in Clinical Trials?” Forbes, Forbes Magazine, 8 Jan. 2015, www.forbes.com/sites/judystone/2015/01/06/how-can-we-encourage-participation-in-clinical-trials/#1146b57c4d0c.

Tate, Wendy. “Diversity in Clinical Trials: Recruiting Women and Minorities in Research.” Forte Research Systems, Forte Research Systems Inc., 12 Apr. 2017, forteresearch.com/news/diversity-clinical-trials-women-minorities-research/.

Creating Stakeholder Dialogue Around Drug Pricing

By | Drug Costs, Healthcare Costs, Healthcare Value, Informed Patient, Rising Cost, Uncategorized | No Comments

The increase in prescription drug pricing and spending has been one of main factors contributing to the high costs of healthcare in the United States. In fact, according to a 2015 report by the National Center for Health Statistics, the national health expenditure for prescription drugs made up 10.1% of the total national health expenditure that reached $3.2 trillion that year [1]. Certain measurements of drug pricing villanize manufacturers an industry with outrageous cost and spending of prescription drugs. For example, patent exclusivity, research and development efforts, and competition in the market are generally blamed for the initial price increases. However, these measurements also cause skepticism and inaccuracies, thus shining a negative light on pharmaceutical companies. Therefore, the outliers misrepresenting pharmaceutical companies and the number of failed drugs need to be addressed in order for patients to have a better understanding on drug pricing.

Two outliers that don’t represent the overwhelming amount of biopharmaceutical companies are Mylan and Turing Pharmaceuticals. In 2007, Mylan Pharmaceutical acquired EpiPen, a handheld device that injects epinephrine to an individual with life-threatening allergic reactions, and increased the price of the drug by 500% [2]. The price rose from $100 to $600 in 2008 without any justification [3]. To no surprise, the company came under fire by the media for its unethical approach. The price increase can be attributed to Mylan’s patent use which allowed them to profit off of the drug without facing competition from a generic drug for a period of time [4]. In a similar situation, Martin Shkreli, founder and CEO of Turing Pharmaceuticals, raised the price of the drug Daraprim from $13.50 to $750 a tablet overnight [5]. What were once ‘affordable’ drugs became unaffordable for the vast majority of users causing outrage and shaming for pharmaceutical companies. Again, there are outliers that don’t represent the overwhelming majority of pharmaceutical companies that are developing new and novel drugs.

According to the 2017 Edelman Trust Barometer, the trust in the healthcare industry is slowly increasing compared to last year [6]. The trust in pharma in the U.S. seems to be “neutral.” With pharmaceutical companies like Mylan and Turing, it’s understandable why Americans might not be fully invested in pharma. When pharmaceutical companies make the headline in the news, it usually is unfavorable.

Furthermore, research and development is key when it comes to developing new drugs and used as justification for drug pricing. As we know, the process of creating a drug involves a lot of trials and errors where high costs are incurred in order to satisfy regulations imposed by the Food and Drug Administration (FDA); thus, it can create opportunities to price the drug even higher than it actually cost to get it out to the market. According to the 2017 Edelman Trust Barometer, 8 out of 10 people believe the pharmaceutical industry puts profit over people [7]. In reality, pharmaceutical companies only realize 39% of initial gross drug expenditures [8]. In addition, companies like Gilead are helping subsidize the cost of its drug, Epclusa, in Australia, which will help approximately 200,000 Australians that face the challenges of hepatitis C [9]. For example, Merck created an HPV vaccination program for cervical cancer in Rwanda [10]. Despite the media’s negative coverage, several other pharma companies have partnered with organizations like the Gates Foundation and UNICEF to provide medications for the developing world [11].

Lastly, it’s critical to address the failed formularies that ultimately lead to higher pricing as these costs must be recouped. The price to develop a drug is over $500 million [12]. According to the Tufts Center for the Study of Drug Development, the cost to develop and win marketing approval for a new drug is $2.6 billion [13]. The variance in the two aforementioned distinguish by fourfold, but it’s really expensive. Aside from this statistic, during clinical research phase studies, only 25-30% of initial drugs move to phase 4 where the drug is trialed by volunteers with the disease of interest [14]. The development of a drug can take a long time, especially when it comes to illnesses like cancer or HIV. During this time, the initial fund to conduct these studies starts to deplete. As patients, we need to understand that these are factors that even pharmaceutical companies have no control over.

As we wait for a viable healthcare reform under the current administration, it’s important to push for one that restores the well-being and decreases the burden of millions of Americans. During the process, there needs to be increased dialogue between patients and providers, such as pharmaceutical companies. All to avoid situations like that of Mylan and Turing. If drug pricing continues to increase, the biopharmaceutical industry will face more scrutiny. There will be increasing tension between patients, pharmaceutical companies, and pharmacy benefit managers (PBM). It’s important for all stake holders to be open and transparent in order to resolve these issues successfully. In an ever changing environment, we must learn to understand the process in order to appropriately resolve issues plaguing our society. We are ever changing.

To further explore the drug pricing trends, CHI is organizing the 5th Annual Healthcare Executive Roundtable on October 12, 2017, in Manhattan, New York. The Center for Healthcare Innovation’s “Understanding Value in Consumer-Orientated, Patient-Centric Era” Roundtable is an intimate, invitation-only, expert roundtable discussion for healthcare executives, key opinion leaders, and patient groups to discuss how stakeholders throughout the healthcare ecosystem can address critical issues related to healthcare value, quality, and cost. This year’s Roundtable will focus on several key market forces that affect the current state of healthcare in the U.S. Please visit http://chisite.org/roundtable/ for more information.

Work Cited

[1] Health Expenditures. Centers for Disease Control and Prevention. https://www.cdc.gov/nchs/fastats/health-expenditures.htm. Accessed September 14, 2017.

 

[2] Mylan Raised EpiPen’s Price Before the Expected Arrival of a Generic. The New York Times. https://www.nytimes.com/2016/08/25/business/mylan-raised-epipens-price-before-the-expected-arrival-of-a-generic.html?mcubz=3. Accessed September 14, 2017.

 

[3] Mylan finalizes $465 million EpiPen settlement with Justice Department. CNBChttps://www.cnbc.com/2017/08/17/mylan-finalizes-465-million-epipen-settlement-with-justice-department.html. Accessed September 14, 2017.

 

[4] Mylan Raised EpiPen’s Price Before the Expected Arrival of a Generic. The New York Times. https://www.nytimes.com/2016/08/25/business/mylan-raised-epipens-price-before-the-expected-arrival-of-a-generic.html?mcubz=3. Accessed September 14, 2017.

 

[5] Drug Goes From $13.50 a Tablet to $750 Overnight. The New York Times. https://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html. Accessed September 20, 2017.

 

[6] Trust in Healthcare: Making Progress. Edelman. https://www.edelman.com/post/trust-healthcare-making-progress/. Accessed September 20, 2017.

 

[7] Trust in Healthcare: Making Progress. Edelman. https://www.edelman.com/post/trust-healthcare-making-progress/. Accessed September 20, 2017.

 

[8] Majority of Drug Revenue Not Going to Pharmaceutical Companies. The American Journal of Pharmacy Benefits. http://www.ajpb.com/news/majority-of-drug-revenue-not-going-to-pharmaceutical-companies. Accessed September 20, 2017.

 

[9] New Hepatitis C Drug to be subsidized in Australia. The Pharma Letter. https://www.thepharmaletter.com/article/new-hepatitis-c-drug-to-be-subsidized-in-australia. Accessed September 25, 2017.

 

[10] Even Pharma’s Good Deeds Are Criticized. Forbes. https://www.forbes.com/sites/johnlamattina/2013/05/06/even-pharmas-good-deeds-are-criticized/#612c29ec4cd3. Accessed September 20, 2017.

 

[11] Even Pharma’s Good Deeds Are Criticized. Forbes. https://www.forbes.com/sites/johnlamattina/2013/05/06/even-pharmas-good-deeds-are-criticized/#612c29ec4cd3. Accessed September 20, 2017.

 

[12] R&D Costs For Cancer Drugs Are Likely Much Less Than Industry Claims, Study Finds. NPR. http://www.npr.org/sections/health-shots/2017/09/11/550135932/r-d-costs-for-cancer-drugs-are-likely-much-less-than-industry-claims-study-finds. Accessed September 20, 2017.

 

[13] Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion. Tufts Center for the Study of Drug Development. http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study. Accessed September 28, 2017.

 

[14] Step 3: Clinical Research. U.S. Food & Drug Administration. https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm. Accessed September 20, 2017.

 

Improving Healthcare Transparency to Build Trust and Engagement

By | Global Healthcare Trends, Healthcare Access, Healthcare Technology, Informed Patient, Patient-Driven Healthcare | No Comments

Throughout the healthcare industry, there is a growing demand for greater transparency. Today’s healthcare consumer is savvy and well-researched, so the days when a doctor, hospital, or pharmacy could dictate medication recommendations and treatment methods and expect a patient to blindly follow advice are mostly over. Patients also have a variety of options, so supplying valuable information can help a brand to stay competitive.

Medical Billing Transparency

Medical billing transparency is in high demand. Customers expect to know what they will have to pay for a doctor’s appointment, medication at a pharmacy, or treatment ahead of time. Since procedures and medications can vary widely in price, even within the same locale and network, detailing pricing points up front can help a practice to attract and retain customers. By working closely with insurance companies, practices can help customers discern complete out-of-pocket costs ahead of time and plan for those costs.

Health Information Accessibility

Since healthcare practices are required to make meaningful use of electronic health records (EHRs), these records are more easily shareable now than in the past. Making it possible for patients to view these records online at their convenience can help to drive better healthcare outcomes and can create an atmosphere of trust between healthcare providers and patients. When patients can view their own information and do research about conditions and other health factors, it can also drive engagement.

Online Presence and Familiarity

Having a company website or app can help a patient to feel familiar with a practice office, hospital, or pharmacy before visiting. Showing pictures of the building, waiting office, and possibly medical equipment or rooms can help a patient to feel comfortable when arriving at the location. Supplying a bit of information about doctors and staff can help patients to feel greater trust and reassurance about the quality of care that they will receive.
Setting Patient Expectations In Advance
No patient enjoys arriving to a scheduled appointment on time and then having to wait for hours to see a doctor. Allowing patients to download, print, and fill out patient forms ahead of time can help to expedite appointments and save on office crowding, enhancing the patient experience and making the best use of staff time. Any further information that can be furnished to help patients know what to anticipate, such as standard wait times and average length of time for certain procedures, will further develop patient expectations and improve satisfaction with services.

 

References:
Why Price Transparency Matters Now / Healthcare financial Management Association http://www.hfma.org/content.aspx?id=28785
Meaningful Information for Better Healthcare / The Network for Regional Healthcare Improvement http://www.nrhi.org/work/multi-region-innovation-pilots/center-healthcare-transparency/

What Changing U.S. Demographics Mean for Clinical Trials

By | Clinical Trials, Diversity & Inclusion, Healthcare Access, Informed Patient, Patients | No Comments

The Food and Drug Administration has declared a renewed focus for 2016 exploring diversity in clinical trials. [1] Data gathered from FDA shows that there is still a significant lack of patient diversity in clinical trials.  “While African-Americans/Blacks represent 12% of the total U.S. population, they comprise just 5% of clinical trial participants. Hispanics account for 16% of the total population but just 1% of trial participants.” [2]

 

As researchers aim to understand how a drug’s effectiveness can vary in different patient groups, it is important to consider how U.S. demographics have begun dramatically shifting. According to the U.S. Census Bureau’s latest projection “It is predicted that by 2043, the U.S. will be a majority non-white nation. [3] White Americans will have gone from comprising 85% of the U.S. population in 2012 to just 43%. Hispanic and African Americans/Blacks will have grown substantially over that period, together making up 45 percent of the population with Hispanics being one of the fastest growing groups making up 31%.”[4] Therefore the inclusion of minorities in clinical trials will only become more critical. To demonstrate the safety and effectiveness of a new treatment, healthcare industry leaders should ensure the inclusion of a diverse population in clinical trials. Underrepresentation of minorities can skew vital trial and treatment data.

 

Some causes for lack of diversity and inclusion in clinical trials stem from lack of trust in trials, lack of awareness of what trials are, and barriers to participation of minority population in trials. For example, based on the history of medical research in the Tuskegee study, an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service studying the natural progression of untreated syphilis in rural African-American men in Alabama under the guise of receiving free health care from the United States government, there is a fear of exploitation in medical research.[5] Second, there is often a lack of misunderstanding about the process of clinical trials. Third, there are barriers to participation or feasibility for minority populations to enroll in clinical trial.

 

To attempt solve these complex diversity and inclusion issues, it is critical to go beyond the current one-size fits all approach and raise awareness, build trust, and reach out to under-represented population. Increased diversity in the population pool of clinical trials might just even result in greater confidence in the results and benefits of drugs to the population.

 

The Center for Healthcare Innovation’s Diversity, Inclusion, & Life Sciences Symposium on June 22, 2016 will address these issues in-depth. The Symposium is the leading annual, collaborative event for life sciences and healthcare executives, physicians, HR professionals, clinical trial professionals and patients, entrepreneurs, patient groups, researchers, academics, and diversity and inclusion advocates to discuss diversity and inclusion in healthcare. Please visit chisite.org/education/diversity-symposium/ for more information.

 

 

References

  1. 2016: The Year of Diversity in Clinical Trials | FDA Voice. http://blogs.fda.gov/fdavoice/index.php/2016/01/2016-the-year-of-diversity-in-clinical-trials/.
  2. Bridging the Diversity Gap in Clinical Trials | Thought leadership and innovation for the Pharmaceutical Industry – EyeforPharma. http://social.eyeforpharma.com/clinical/bridging-diversity-gap-clinical-trials.
  3. Census: White majority in U.S. gone by 2043 – U.S. News. http://usnews.nbcnews.com/_news/2013/06/13/18934111-census-white-majority-in-us-gone-by-2043.
  4. A Study On The Changing Racial Makeup Of “The Next America.” http://www.huffingtonpost.com/2014/04/13/changing-racial-makeup-_n_5142462.html.
  5. https://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment

 

How Can We Boost Patient Engagement?

By | Healthcare Innovation, Healthcare Quality, Informed Patient, Patient Engagement, Patient-Driven Healthcare, Patients | No Comments

Young smiling doctor consoling patient sitting on wheel chair outdoor

Many industries today focus on strengthening consumer engagement with their products and services. Whether it’s via social media, websites, mobile apps, video media, or televised commercials, companies across the globe know the importance of marketing their products, services, and technological advances in maintaining profit margins and consumer satisfaction levels. The healthcare industry would be wise to follow similar industry strategies in order to strengthen patient engagement.

There are a numerous views on what exactly defines patient engagement. Broadly speaking, patient engagement is defined as the degree to which patients are involved in their own care. A generally accepted, comprehensive definition provided by HIMSS Analytics states “An organization’s strategy to get patients involved in actively and knowledgeably managing their own health and wellness and that of family members and others for whom they have responsibility. This includes reviewing and managing care records, learning about conditions, adopting healthy behaviors, making informed healthcare purchases, and interacting with care providers as a partner.1 Essentially, patient engagement refers to the tools and technologies healthcare organizations use to engage patients before or after acute episodes of care and during the time between in-person visits.

The time between visits is a particular challenge in patient engagement. During provider-patient visits, discussions with care providers and increased involvement with the patient tends to lead to higher levels of engagement. As months pass after visits, active participation is no longer necessary and engagement becomes less of a priority. The result is often forgotten instructions provided during the visit. The effectiveness of continuous engagement with patients after their treatment was tested with a program that delivered text messages three days a week to 700 gastroenterology patients who were trying to lose weight during a six month period from November 2012 to April 2013. The objective was to analyze the effectiveness of prolonged engagement by comparing the success of the treatment between those who received texts and remained engaged with a control group who was left alone. The results showed that patients who received the text messages dropped 0.5 more on the Body Mass Index (BMI) than patients who did not participate.2 This simple example of increased communication depicts the drastic impact that engagement can have on the patient’s long-term, perceived value of the treatment and instructions given.

The ability to remain in contact with patients through text messaging is an example of how changes in technology offer new opportunities to increase patient engagement. Yet, despite numerous new systems used today, raising patient engagement remains a challenge. In part, this is due to the complexity and scope of effective long-term engagement. According to Dan Housman, Director at Deloitte, the biggest challenges of the historically accepted model of provider and patient relationships stem from assumptions which fail to account for the uniqueness of the individuals involved. These assumptions include that a patient must be obedient and that a physician should act with authority.3 This way of thinking undermines patient-centricity and fails to develop a healthy relationship which promotes patient engagement. By addressing the flaws in the traditional model and revising those to better reflect trending patient-focused values, healthcare providers can more effective communicate the value of continued patient engagement, which ultimately results in its increase.

IBM Watson Health is an example of one of the countless companies in healthcare making efforts to change this model and enhance patient engagement initiatives. This September, they launched a population health program, expanding their online cloud capabilities to provide a more accessible, relevant platform for accessing industry-specific trends and innovations. It is staffed with a team of professionals that engage with users, answering any questions very quickly. This results in more informed patients and addresses the issues with the assumptions in the traditional provider-patient relationship model. Furthermore, the program promotes and records user feedback on treatment which can be used to further improve the methods of care and provide tangible results in healthcare outcomes. Michael Rhodin, Senior Vice President of IBM Watson Group, stated in a press release “This newest expansion of the IBM Watson Health Cloud makes it an even more robust and flexible platform for the life sciences and healthcare industries and explains its rapid adoption among leading organizations in these fields.4 The value added to the interaction helps to promote further patient engagement over time.

Patient engagement is an important aspect the healthcare. It leads to better health outcomes for patients by increasing their understanding of the value in instructions from providers and promotes adhering to suggested preventative measures. Healthcare providers must continuously reach out to patients, keeping them motivated and increasing both parties understanding of the other. CHI will be further exploring patient engagement and its challenges in today’s dynamic healthcare industry at its upcoming Healthcare Executive Roundtable on October 15, 2015 in Manhattan. For more information, please visit http://www.chisite.org/education/healthcare-executive-roundtable.

References

  1. Noteboom, Michelle Ronan. “From Patient Engagement to Telehealth, What Does It All Mean?” Healthcare   IT News. 18 Sept. 2015. Web. 2 Oct. 2015
  2. Fellows, Jacqueline. “Meeting the Challenge of Patient Engagement.” HealthLeaders Media. 26 Aug. 2015. Web. 2 Oct. 2015
  3. Gruessner,Vera. “What Obstacles Stand in the Way of Patient Engagement? ” MHealth Intelligence. 16 Sept. 2015. Web. 2 Oct. 2015
  4. Gruessner, Vera. “Could a Population Health System Improve Patient Engagement?” MHealth Intelligence. 14 Sept. 2015. Web. 2 Oct. 2015.