Aug21

Helping Clients Navigate Compliant Communications for FDA-regulated Products

Helping Clients Navigate Compliant Communications for FDA-regulated Products IMAGE_EDVANITY URLS: Google Paid Search Engine Marketing (SEM) Changes
• Redirecting ad changes effective January 12, 2016
• Prohibiting ads where vanity URLs are utilized and dramatically different from the destination URL

Google has announced significant changes in their paid search engine advertising policies with regard to pharmaceutical products. The change that we are addressing here deals with vanity URLs, and their respective redirecting ads, that will take place in January 2016. The bottom line is that Google will no longer allow vanity URLs in an effort to provide consumers with more “clarity and transparency.”

Google has a long-standing policy prohibiting any ads where the destination URL differs dramatically from the display URL. Please note, this prohibition is not exclusively for pharmaceutical products—it has been Google’s practice across the board. Up until now, the pharmaceutical industry had been the exception to the rule. The reason for the exception was because in many cases, information seekers will not know the name of a drug, but will understand and know the symptoms/disease state information.

FDA background information
Previously, the FDA never objected to marketers utilizing vanity URLs and/or redirecting ads. These URLs/ads typically do not directly promote the name of a prescription product. Instead they lend themselves more to a disease state or descriptive nature, and then redirect users to another location or URL where they will see branded information specific to the prescription drug and/or disease state. Vanity URLs/redirecting ads are not exclusive to online SEM use, and are also used in print ads, television commercials, billboards, postcards, and more.
In March 2009, the FDA sent out 14 violation letters regarding search engine marketing practices of 48 brands. Thirteen of those violations referred to SEM ads running on Google. The FDA noted four types of violations in 2009:

  1. Omission of risk information, failure to meet requirements of 21 CRF 202.1(e)(5)(ii)
  2. Inadequate communication of indication
  3. Overstatement of efficacy
  4. Failure to use the required established name

Google’s reaction—what exactly is Google implementing?
Beginning in January 2016, Google will not permit pharmaceutical advertisers to have vanity URLs (such as “TreatmentforConditionX.com”) that redirect users to a BrandName.com website.

Pharmaceutical marketers will have the following options for vanity URLs:
Option 1

ConditionSymptomsGoogle-01

Sample ad showing company name as URL

Option 2
They can add “.com” to the company name.

ConditionSymptomsGoogle-02

Sample ad showing company name plus .com as URL

Option 3a (for prescription drugs, biologics, and vaccines)
They can display the phrase “Prescription treatment website” as the display URL.

ConditionSymptomsGoogle-03

Sample ad showing prescription treatment display URL

Option 3b (for medical devices)
They can display the phrase “Prescription device website” as the display URL.

ConditionSymptomsGoogle-04

Sample ad showing device display URL

All of these ads will be able to drive to pages on the brand.com or brandhcp.com website.

At the present time, this change has been instituted by Google only, and doesn’t lend itself to print, television, or other advertising mediums.

What does this mean for our clients?
Review and reassessment of live and proposed Google SEM campaigns where clients utilize vanity URLs need to be completed as soon as possible. New campaigns need to take these new rules into consideration during the tactical planning phase. Funds can be shifted to Yahoo and Bing, however there is the possibility that they may also follow suit.

Google has indicated a willingness to work with pharmaceutical clients to minimize potential negative impact to paid search campaign performance. Testing of the new formats will determine which type of units work best with various campaigns.

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Aug14

The Client’s Always Right…Except When They Aren’t

Darlene Dobry Med Mktg Blog Image EDIn a service industry, many of us live and die by the mantra, “The client’s always right.” We have long understood and served our role as agency partners and know that we need to passionately support our clients’ efforts.

But is it acceptable to challenge the clients’ wisdom and tell them from time to time that the path they want to take will not result in the best outcomes? That they should take greater risks and push themselves and their brands to greater heights? That they should not accept mediocre results when they can achieve greatness? That they should stop doing what the others are doing and break away from the pack?

Absolutely—this is our job, this is what true client partners should want and expect. We cannot simply nod our heads in approval if we truly care about our clients and the brands we support. We need to tell the truth―backed up with data, customer insights and market knowledge—and state it with conviction. When it’s out, the client will ultimately determine which direction to proceed, but they will do it knowing the potential “watch outs” or barriers to its success, and we can then work together to be armed with the ultimate plan.

It has been my experience that clients do appreciate partners who show passion, conviction and a commitment to doing what they believe is right. Most are not looking for order-takers or yes-men (and if they are, you may want to consider working with a new client).

In my office, I have a sign that says, “I’d agree with you, but then we’d both be wrong.” It’s not there to remind me that I’m always right—it’s a daily reminder to stand up for the brand and what you believe…always, even if it’s not necessarily popular. Of course, it’s critical to be able to back it up and deliver with diplomacy, grace and experience. In the end, the client drives the ultimate decision, and as their partner, we align, support them and drive to deliver the very best.

My best client relationships have been based on trust, truth and transparency, and respecting that it works both ways. There is immense power, transformative ideas and inspired problem solving that come from collective diverse thinking and challenging the status quo. Remember, in the words of David Ogilvy, “We only get a spark when the stone and flint are moving in opposite directions.”

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Aug5

Immunotherapy: Has the Answer to Cancer Been Inside Us All Along?

Immunology Blog Image EDThis year over 1.6 million Americans will be diagnosed with cancer and nearly 600,000 people will die from the disease. That’s over 1600 people each day. The need for innovative therapeutic approaches to treat cancer has never been higher. To help fight the tumor, oncologists are literally looking within at new immunotherapeutic approaches aimed at unleashing the body’s own natural defenses.

The idea of immunotherapy isn’t a new one. Since the first studies of antibodies began in 1891, researchers have continued to investigate the potential of the immune system. But the idea held little more than promise.

But all that has changed.

Numerous breakthrough advancements in immunotherapy, with unprecedented results, have propelled the entire class forward. At this year’s Annual Meeting of the American Society of Oncology (ASCO), immunotherapy took front and center. Thousands upon thousands of oncologists crammed the educational sessions for just a glimpse of some of the new data being presented, CNN ran headline news stories from the congress, and even patients are aware and asking their physicians about the new therapies being researched.

Across the board, the pharmaceutical industry has started to mobilize behind the potential of immunotherapy unlike anything else seen before. Most of the major pharmaceutical companies already have one or more new drug candidates in development—and if they don’t, they are aggressively exploring opportunities to catch up.

Over 800 Clinical Trials With Immunotherapy Products
At present there are 844 ongoing or completed clinical trials with immunotherapy drugs across a wide range of tumor types. These trials include some of the most challenging cancers associated with the worst prognoses, like lung, stomach, brain, and melanoma. And new trials with new products and new regimens are added almost daily.

$35 Billion in Projected Sales
Analysts believe that annual sales for immunotherapy products in oncology will reach $35 billion a year.

60% of Cancers Will be Treated With Immunotherapy

Researchers believe that immunotherapy may become the dominant form of treatment in oncology, with nearly two out of every three cancer patients receiving some form of immuno-based therapy within the next decade.

While these numbers are staggering, the greatest benefit may be for the patients diagnosed with cancer. The early results from the emerging next-generation immunotherapy agents have rightfully captured the hopes of both patients and oncologists. With continued research and a little luck, these treatments may provide more than a treatment for a cancer, they may offer a cure.

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Also posted in clinical trials, Healthcare Communications, Medical Education, Medicine, Pharmaceutical, Physician Communications, Strategy | Tagged , | 1 Response
Jul2

Does Size Always Matter?

How Pharma Engages With Its Followers Online

Social Network Blog Image_EDPharma is investing more heavily in social media than ever before; tweets are up 530% since 2013 and Twitter followers have increased by nearly 300%. So far, so good. Because more followers means more opportunities to get involved, and the more impact you make online, right?

But engaging in genuine, meaningful conversations about a corporate brand isn’t easy, and it’s important to ensure we don’t fall into the trap of focusing too much on numbers and not enough on engagement. Companies need to ensure they don’t build followers just to push out messages to anyone willing to pay attention. While people are increasingly more open to finding new knowledge on social media, they don’t want to wade through hundreds of pages of information, images or tweets to do so.

The balance between community size versus engagement is becoming more and more of a priority, and formed one of the focus areas for a recent report published by Ogilvy Healthworld, part of Ogilvy CommonHealth Worldwide (the health behavior specialists of Ogilvy & Mather).The report, Connecting the Dots: Which Pharma Companies Are Succeeding in the Social Media Space?, was the first of its kind to provide insights into which pharma companies are leading the way in integrated social media marketing strategies.

“We know that some pharma companies have been cautious in their approach to social media, but our report clearly demonstrates a dramatic and successful increase in activity,” said Rebecca Canvin, Social Media Manager at Ogilvy Healthworld, adding: “Social media has changed the way pharma companies communicate—it allows them to build corporate reputation and engage in genuine, meaningful conversations with audiences. For companies who want to stand out from the crowd, it’s time to be brave, get personal, educate and integrate social media into their wider marketing strategy.”

Interestingly, companies that ranked most highly in the audit weren’t necessarily those with the largest communities, but those who engaged their audiences through frequent activity. And it’s not hard to understand why the more active companies enjoy the most engagement with their followers—after all, social media in its very nature demands participation and interaction. But the companies that do it well manage to create content that is less about the organization and more about connection points or interests that followers share.

The report highlights that although the focus for pharma companies is still on building brand profile, the priority is turning to attracting, keeping and engaging with loyal followers. And to do this, the onus needs to shift to “quality over quantity.” It’s more powerful to engage with a small group of passionate followers, whether they’re consumers, doctors or media, than to blast one message to 10,000 followers and “see what sticks.”

And loyal followers will reward companies who engage continuously in this way—so really, shouldn’t we all be asking, how much does size matter?

Connecting the dots - infographic UK Post

To find out more on Connecting the Dots: Which Pharma Companies Are Succeeding in the Social Media Space? please visit: http://bit.ly/1P5R5Ws

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Jun11

The Next Phase of Pharmaceutical Value Propositions Needs to Include the Real Meaning of Synergy

Synergy Blog ImageExpress Scripts recently issued a report on drug spending that made some headlines in the business press.[1,2] This compelling report shows that, from the perspective of a pharmacy benefit manager (and its pharmacy claims database), evidence confirms the trends of increased drug spending, particularly in the subset of patients that consumes at least $100,000 worth of drugs annually:

• The population of patients that takes at least $100,000 worth of drugs has almost tripled from 2013 to 2014
• Compounded drugs were the 3rd highest driver of the trend, behind HCV antivirals and oncolytics
• 9 out of 10 patients with drug costs over $50,0000 used specialty medications
• Men and baby boomers (those aged 51-70) make up the majority of those with high drug costs
• Comorbidities and polypharmacy were prevalent among patients with high drug costs

Glenn Stettin, MD, the SVP of Clinical, Research, and New Solutions, outlines in this report implications and recommendations, most of which are feasible for a PBM to consider:

• Eliminate wasteful spending and improve medication adherence
• Manage specialty and traditional medications together
• Pioneer new approaches in cancer care that both offers patient access and sustains payer affordability

While these are important recommendations, there is an opportunity for pharmaceutical manufacturers to consider extending and enhancing the value propositions of their drugs, and it relates to the “comorbidities and polypharmacy” finding in this report, which is pretty remarkable. The report shows that:

• Among patients whose drug costs reached $100,000, more than one-third were treated for more than 10 conditions
• More than 60% were taking more than 10 medications
• One in four patients had prescriptions from at least 4 different prescribers
• More than half of patients with $100,000 in drug costs were prescribed medications by physicians from at least 4 difference specialty areas

Now, as we read daily in the business press, the drug industry is facing pushback about its pricing of newer agents (specifically HCV antivirals and oncolytics). This resistance from customers is normal, and has taken various forms of stricter precertifications and/or formulary requirements.[3] Recently, legal patent challenges have surfaced; in some countries, various advocates are asking that patents on drugs be voided, so that generic competitors can appear earlier.[4] Nonetheless, evolving industry forces, such as comparative effectiveness research, constrained health care budgets of some payers, and new competitors have started to create a new equilibrium between sellers and buyers, and these forces are helping to more quickly vet winners and losers. It is encouraging to see the manufacturers (particularly of HCV and cancer drugs) refine the value propositions of their drugs, which now include cures for some patients.[3]

But disease is multifactorial (and, as the ESI report shows, multiple diseases are, too), and treatments often need multiple approaches. Manufacturers may need to extend the current value proposition of “one drug that treats one disease at one time” and add it to the complicated heath care mix that includes other variables, for example:

• Combination therapies (with other drugs, including competitors and/or generics, and with other modalities such as devices, diet, surgery, etc.)
• Timing or sequence of treatments (ie, phase of the disease)
• All of the factors in “care coordination” (ie, different physicians, different specialties, different settings)

In other words, manufacturers need to demonstrate the synergy produced by their drugs. “Synergy” is often misused, but I like the Merriam-Webster definition of synergy as “a mutually advantageous conjunction or compatibility of distinct business participants or elements (as resources or efforts).”[5] Certainly some treatment guidelines, pathways, and medical policies attempt to address these multiple variables in health care. But manufacturers can bring their significant credibility in clinical research and patient experience to identify, define, and demonstrate the specific opportunities that optimize their drugs’ performance. They are best-suited to do so, and the customers are receptive to that type of message. (Note: as this heads to posting, 2 manufacturers are reported to have taken this approach and are studying their oncology drugs in combination.[6])

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Footnotes:

1. Super Spending: US trends in high-cost medication use. May 2015. http://lab.express-scripts.com/insights/drug-options/super-spending-US-trends-in-high-cost-medication-use. Accessed May 19, 2015.

2. Growth of patients with $50K annual drug tabs skyrockets. Fierce HealthFinance. May 17, 2015. http://www.fiercehealthfinance.com/story/growth-patients-50k-annual-drug-tabs-skyrockets/2015-05-17). Accessed May 19, 2015.

3. Gilead’s $1,000 Pill Is Hard for States to Swallow. The Wall Street Journal. April 8, 2015. http://www.wsj.com/articles/gileads-1-000-hep-c-pill-is-hard-for-states-to-swallow-1428525426. Accessed May 21, 2015.

4. High Cost of Sovaldi Hepatitis C Drug Prompts a Call to Void Its Patents. http://www.nytimes.com/2015/05/20/business/high-cost-of-hepatitis-c-drug-prompts-a-call-to-void-its-patents.html. Accessed May 20, 2015.

5. Merriam-Webster Online. http://www.merriam-webster.com/dictionary/synergy. Accessed May 21, 2015.

6. AstraZeneca and Lilly to test new cancer drug combination. Reuters. May 29, 2015. http://www.reuters.com/article/2015/05/29/us-astrazeneca-eli-lilly-cancer-idUSKBN0OE0HU20150529. Accessed May 29, 2015.

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May28

Satisfying Patient Needs Across Generations via Patient Portals

When it comes to healthcare, patients from the “Greatest Generation” to Millennials want three things: 1) a strong patient-physician relationship, 2) easy-to-understand healthcare information, and 3) this information? preferably in a digital format. How do we accomplish all three? Before we answer that question, let’s take a look at how different generations access healthcare information.

Monica Wong Blog Image

The “Greatest Generation” (Age 65+)
While almost 60% of people ages 65 and older use the Internet on a daily basis, this generation of patients are heavily influenced by their doctors when it comes to recommendations, health information and referrals. However, children and caretakers of this generation, Baby Boomers, may also play a role in making these decisions on behalf of the “Great Generation.”

Baby Boomers (Age 45-65)
While this generation is also influenced by physicians, Boomers are more likely than the “Greatest Generation” to research their options, challenge assumptions and rely on peer-to-peer conversations to make their healthcare decisions. 79% of Baby Boomers go online every day or almost every day. A Google/Nielsen Boomer Survey also reported that 78% of Baby Boomers have searched for health information after seeing something on TV. Baby Boomers also influence healthcare decisions of their Gen X and Millennial children.

Gen X (Age 30-45)
According to research done by Smith & Jones Healthcare Marketing, Gen X are only moderately responsive to healthcare advertising. Since this generation is the first to experience the digital age, Gen X shops for healthcare like they do for retail goods and services. They are partial to TV and in-office messages compared to other forms of marketing channels, but they also have a tendency to search for ratings and reviews online, as experience matters to them.

Millennials (Age 20-30)
Like Gen X, Millennials highly value positive patient experiences. They are young and healthy and as a result, they mainly use healthcare for primary care, urgent care and OB/GYN. Online advertising, TV and in-office messages are the best ways to reach them close to the care decision. Millennials seek information from a variety of sources, including online, social networks and word of mouth.

Satisfying Patient Needs Across Generations With Patient Portals
What do these generations of patients all have in common? They want positive patient experiences with their physicians. They want information they can easily understand and they want easy access to it online. So how do we satisfy these needs? Patient portals. Why? Because increasing positive patient outcomes and experiences begins with making physicians more accessible when patients have concerns. Physicians can distribute timely and relevant information to their patients on a digital platform that can be accessed 24/7. According to the American Academy of Family Physicians, 41% use portals for secure messaging, 35% use them for patient education, and 30% use them for prescribing medications and scheduling appointments.

How Can Marketers Leverage Patient Portals?
By repurposing existing healthcare marketing material and creating a depository for digital assets, these resources can be made available to HCPs who can then share these assets with their patients. Their patients will likely be more receptive to information as it is coming from a trusted source, their physicians, and through a channel they have easy access to. However, there are limitations.

Opportunities to Take Patient Portals to the Next Level
For elderly patients, additional features like the ability to increase portal font size is a simple fix. For digital natives, mobile-optimized portals can facilitate prescription refills and requests as well as schedule appointments. For non-native English speakers, portals available in different languages can dramatically improve patient services. But for those who do not have access to the Internet, we’ll have to find a way to close that gap. If you have any thoughts, please share in the comments below.

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May19

Wearable Wonder: Will They Improve Patients’ Quality of Life?

LeanneLakeBlogImageSizedClearly wearables are “all the buzz” in our industry. Soon our Fitbits, watches and the like will become an essential part of connected healthcare, monitoring our bodies and feeding important data about our health to the cloud to be analyzed by our healthcare professionals. More data in, better outcomes come out—it’s fantastic news. But what if these devices can go the next step and actually respond to the data they are monitoring? Can you envision a future where a wearable device can improve our body’s function and a person’s quality of life in real-time? I recently learned about one that just might.

It’s called the WAK, short for the Wearable Artificial Kidney. This wearable innovation has the potential to be truly life-changing for the more than 400K patients with end stage renal disease who are currently undergoing hemodialysis every day in our country.

For the majority of these patients, treatment is their lifeline, but it can also take over their life. Hemodialysis patients receiving treatment in centers spend on average 4 hours a day, 3 days a week completely immobile—tethered to a chair, tied to a machine. Much like chemotherapy, the treatment that is saving them often makes them sick for hours afterward. In the absence of a successful transplant, they will undergo dialysis until the end of their life.

The WAK is designed to help patients get out of the chair and back into life. It is a miniature battery-powered dialysis device that is worn like a tool belt. It is connected to the patient by a catheter, weighs approximately 10 pounds and offers dialysis 24/7. Some experts believe that in a perfect world, more frequent dialysis would yield better control, however this comes with a tremendous burden to the healthcare system. If proven successful, the WAK could improve outcomes and deliver new hope for patients, reducing their time in the chair and giving them the mobility to go about activities of daily life—a more “normal” existence. The FDA fast-tracked the WAK, and it is currently undergoing its first human trial in the United States. Human clinical trials conducted in Italy and London already concluded successfully.

For me, following the progress of this wearable technology is personal. I lost my dad to end stage renal disease and its complications three years ago this June. During the five years he “survived” on dialysis, I watched his body and spirit wear thin. Early on, the dialysis center gave him the personal connection he needed to share with patients having a similar experience, but soon after getting into the three-day-a-week routine, he and my mom longed to get back the flexibility that every retired person deserves. The ability to hit the driving range with his buddies on a Tuesday, attend his grandson’s football game on a Thursday, or even make the trek to NJ to visit me and my family on a Saturday afternoon.

Looking back, I wonder how the WAK would have changed my dad’s dialysis experience and the burden it placed on both him and my mom.

What’s your wearable wonder?

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Also posted in adherence, Apps, behavior change, Culture, Data, Design, Digital, Healthcare Communications, Patient Communications, Self-monitoring, Technology, Wearable Health Technology | Tagged | Leave a comment
May12

Product Launch Made to Work

Product Launch Blog ImageIntroducing a new product into the highly diluted pharmaceutical market is no easy feat. Our industry spares no time for coming up short of flawless, where the barriers to entry are a proverbial North Korea for the inexperienced and unprepared. The road to success is windy and narrow, but once achieved, the view is unmatched.

In today’s marketplace, suppliers are red-flagged for doing things the way they have in the past, and the competitive edge gained is in the ability to differentiate completely in some cases, and only partially in others.

How can we differentiate ourselves?

For a baseline, any transaction within the pharmaceutical space is a complex sale. The traditional model of selling a product, handling the logistics, and looking forward to a reorder does not cut it. As suppliers, we must adapt to the notion that we are no longer offering or launching a product, but rather have entered the era of solution-based selling. We must come to terms with the reality that being “geared” toward a client or industry is no longer acceptable, and complete customization comes at little or no extra revenue.

Make no mistake: selling a product is still physical, but an in-depth understanding of the customers’ base is now essential to the sale of a creation. The utilization of that understanding is to align our goals to match the customers’ needs. The result of a properly executed alignment is the transformation of the supplier into the partner. By outgrowing the paradigm of being the wholesaler, and embracing a newfound cooperative mantra, trust becomes the foundation of our rapport.

But trust isn’t just a way in, and a share of the market isn’t the only measure of our success. We have to continually push the limits of our capabilities to stimulate fresh ideas, and remain at the forefront of innovation to our clients. The growth driven from market advancement is what will allow us to maintain our business and simultaneously cultivate new opportunities. With trust, our new partners will expect us to act on our promises and will be more critical of our deliverables. We are no longer reacting to a signed Statement of Work (SOW) or Request for Proposal (RFP), we are building a proactive and cooperative plan of action. Suppliers cannot simply provide a product; they must also act as consultants.

The stigma of “Big Pharma” having deep pockets and quick trigger fingers is far from the truth. Pricing is critical and partners will expect us to eat a slice of the risk pie when entering into an agreement (you are a partner now, why wouldn’t you?).

We optimize the product for the consumer experience through the ability to launch a solution directed toward a specific client and their void. This style is undoubtedly the wave of the future, and the relationships formed via this approach will be more personal, more customized, and ultimately, more lucrative.

Differentiation begins with common interest, and results in great success.

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Apr15

ResearchKit: A Medical Research Revolution?

Research Kit Blog Image SizedIn what boils down to crowd-sourcing medical information, Apple’s ResearchKit promises to turn the iPhone into a powerful tool for medical research. But will it live up to that promise?

Apple is putting the power of clinical trials in our pockets with ResearchKit, the open-source software framework designed for medical and health research. It will help doctors and scientists gather data more frequently and more accurately from clinical research participants using iPhone apps, enabling faster insights at lower cost.

ResearchKit leverages the sensors and other capabilities of the iPhone to track movement, take measurements and record data. When granted permission from the user, ResearchKit can access data from Apple’s HealthKit app such as weight, blood pressure and glucose levels, which are measured by third-party devices and apps. ResearchKit can also request access from the user to access the accelerometer, microphone, gyroscope and GPS sensors to gain insight into a user’s gait, motor impairment, fitness, speech and memory.

Several world-class research institutions have already developed apps with ResearchKit for studies on asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease. Using the built-in templates for informed consent, users decide if they want to participate in a study and how their data—and which parts of their data—is shared. Participants can perform activities and generate data wherever they are, providing more objective information than simply filling out forms for their activities.

More data will be generated through these apps for researchers to analyze than ever before. For example, just four days after its release, Stanford University School of Medicine’s MyHeart Counts app was downloaded 52,900 times, with over 22,000 users consenting to the study. But more data isn’t necessarily better data.

On the surface, ResearchKit sounds like the long-awaited answer to ongoing issues in traditional clinical trial processes, including limited participation due to proximity to institutions running trials, frequent data entry and the integrity of that data and limited data collection.

Apple has created three customizable modules to address the most common elements across different types of clinical studies: surveys, informed consent and active tasks. Programmers can use these modules as they are, build upon them or even create new modules of their own.

ResearchKit initially includes five active task modules that invite users to perform activities under semi-controlled conditions, while iPhone sensors actively collect data. The tasks can be a simple ordered sequence of steps or dynamic, with previous results informing what is presented. In this way, researchers and programmers can create custom apps for their relevant disease states. These modules simply record the data and pass it on to the researchers; Apple does not store it or track it in any way.

Since ResearchKit resides on the iPhone, it will be easier to recruit participants for large-scale studies, accessing a broad cross-section of the population. The data that it collects mostly comes from sensors and other apps; there is little chance of error in the measurements as compared to patients recording their data in paper-based diaries. Even the data that patients will enter themselves into ResearchKit apps will be more accurate: programmers can put limits on that data so that it fits within proper parameters.

Although ResearchKit solves many issues with clinical trials, it also creates some of its own.

Patient population

Apple promises access to a diverse, global population through ResearchKit, but that population might not represent the population as a whole.

IPhone users are more wealthy and educated than the general population, and minority groups are underrepresented in its user base. Additionally, ResearchKit is only available on iPhone 5 and newer models and the latest generation of iPod touch, which excludes a large segment of iPhone users.

On top of that, the patient populations for ResearchKit apps will be largely self-selected: those using the apps are already likely to be interested in their own health. So can the results generated from this narrowly defined population be extrapolated to the population as a whole?

Another point to consider with the self-selected patient population is that app desertion rate can be high, so researchers won’t have complete data from those who don’t finish the trial. This will also bias the data toward better outcomes since those who actually finish the trials are more motivated to see a positive outcome.

Data Validation

There is no validation that participants have a specific condition before they can enter a trial. This lack of verification can further skew the results of the trials. Going forward, tighter controls on who can enroll in each trial by verifying their basic information will lead to better qualified participants and more robust trial data.

Secure Communication

Verifying participants’ information might be hampered by the current lack of secure communication mechanisms between ResearchKit apps and their researchers’ servers.

This is up to the app developers to implement, as is HIPAA compliance and compliance with international research regulations. Even if secure communications are implemented properly by app developers, sharing personal medical information is a sensitive subject—especially with current data breaches. There will likely always be privacy concerns, especially in participants who don’t fully understand how their health data will be used.

Big Data

ResearchKit trials could potentially have hundreds of thousands of participants, each one with the potential to have inaccurate data. How will researchers separate the signal from the noise with such large amounts of data?

Cleaning that data will be a huge job, and further making inferences from that data to the general population could be difficult. Building trust in the trial results in light of the challenges listed here could be an uphill battle with the general public. More thought needed here.

Going forward, simple improvements such as data validation will go a long way toward more qualified patient populations and more robust trial outcomes. But how can ResearchKit be made available to a more representative patient population?

The answer could lie in the open source framework of ResearchKit. Researchers will have the ability to contribute to specific activity modules in the framework, like memory or gait testing, and share them with the global research community to further advance what we know about disease. And since it’s open source, there is the opportunity to expand into the Android realm as well.

On a global scale, Android is the far more popular operating system, and its user base is more representative of the population as a whole. It would benefit these clinical studies if users across platforms could use these apps.

That said, Android has a fragmented operating system with disparate hardware platforms that have differences in their sensors (accelerometers, GPS, gyroscopes), and even in chipsets from device to device. Researchers would have to account for all of these differences and build and test apps across platforms, which is nearly impossible on their limited budgets.

While ResearchKit is not the perfect solution for clinical trials research, it is a good first step, especially when it comes to to clinical trial recruitment, which has been the bane of the healthcare industry for far too long. Results of the pioneering ResearchKit apps—for asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease—will reveal the true utility of such a mobile, global medical research solution.

This article was originally published in Medical Marketing & Media.

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Apr8

An Observer’s View of the Cancer Wars

Cancer Word Cloud BlogWith the National Cancer Act of 1971, President Nixon officially declared that the US was at war with cancer. The goal of this war is to defeat cancer as a major cause of death through a better understanding of cancer biology and the development of more effective treatments.

In the 40+ years since the act’s inception, how much progress have we actually made?

Cancers overall still remain a major cause of death, however significant progress has been made in early detection, prevention and treatment:

• In December 2014, the American Cancer Society reported a 22% drop in cancer mortality over the last two decades, with a corresponding increase in the survival rate of all cancers in both men and women
• The completion of the Human Genome Project in 2003 made it possible to test the value of genomic approaches and identify underlying genetic changes that lead to cancers
• Emerging data since 2003 have significantly changed the way cancers are researched and have led to the development of new diagnostics, therapies, preventive measures, and early detection
• Research direction is currently focused on combining new compounds and diagnostics to help increase efficacy and reduce toxicity through the use of agents that target specific tumor pathways most relevant to a patient’s own disease
• Scientific advances in treatment have also been born out of our growing ability to harness the immune system to fight cancer

These scientific discoveries have led to a shift from an organ-based to a molecular-based approach, and the results are already having a profound impact on the way cancer is being treated and treatments are being personalized to patients. Personalized medicine is an ideal that is driving much of the future of cancer research. The hope is that tailoring treatment to patients’ individual needs based on their genetic data will improve outcomes and reduce adverse side effects. With our increasing knowledge of the human genome, this is steadily becoming a real possibility, and the advent of immuno-oncology brings another layer of individualized therapy into the clinic.

While many battles against cancers have been hard fought and won on several fronts, the “cure” to cancers still seems elusive, largely because cancer is a cluster of many diseases. Looking to the future, one of our greatest challenges may be translating our recent discoveries into treatments that address patients’ individual mutation profiles and truly treat the patient instead of the disease.

One of our biggest questions may be whether our healthcare system can afford the cost of “high-quality” cancer care. Most likely the answer will be no, but to address this challenge, the onus will be on the healthcare community (providers, payers, insurers) to determine how we will use our growing understanding of individualized cancer therapy to advance the quality and effectiveness of cancer care.

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