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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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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Feb6

Expensive medicines and where it’s all going?

Aussie Blog Image2The Australian Commonwealth spending on PBS drugs is currently around $9 billion AUD per annum.  It is forecast to be over $15 billion by 2023. We are seeing this upward trend due to the increasing incidence of chronic illnesses and conditions, the ageing population of Australia and the cost of new PBS medications.

We know the hurdle to getting drugs listed on the PBS is higher than ever.  But when they get listed why are these medications so expensive for governments and should we listen to those criticising the Pharmaceutical Companies who discover, commercialise and manufacturer these medications?

Bruce Booth wrote an interesting article recently on Forbes.com where he looked at two very different calculations around the total cost of drug development.  All things equal, and dipping into a Tufts Centre for the Study for Drug Development, it looks like the cost is now upwards on $2 billion USD per drug.  That’s huge by anyones standards.  But consider the journey to approval.

  • It takes an average of 10 years to bring a discovery to the approval stage.
  • Only 8% of drug candidates make it from discovery to the market – and that’s regulatory approval not reimbursement.  Reimbursement is a further stumbling block.
  • The cost of failures is the largest part of the overall cost in this analysis.

70% of the calculated cost of developing a new drug is that cost associated with the failures along the way. In a good article, Booth suggests we need to do things better, faster and cheaper.

I tend to agree. New technologies and the digital world we live in should mean we can share new information, new clinical data and new treatments more rapidly. Most products in the drug-pipeline are now complex, highly technical and often target new pathways and therefor HCPs will need to have a more in-depth understanding of the mechanism of action and science behind these innovative compounds and classes of drugs.

The other question is how can the ‘Big Data’ we keep reading about help us develop the right products for the right patients in a healthcare landscape that is constantly changing and evolving?  A load of patient, HCP and product data itself won’t help us.  We need to be able to analyse and sift through it to find meaningful truths and insights that change the way we develop and commercialise new medicines.  This will make a difference.

 

Originally published on Ogilvy CommonHealth Australia’s blog: http://www.ogilvycommonhealth.com.au/blog

 

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Mar11

SXSW 2014: Technology and Health

SXSW_Logo_2013_BlackBG_CS

In Part 1 of his SXSW blog series, Robert Egert recaps some of the SXSW themes that are transforming the way the world looks at healthcare.

Massive—that’s the first thing you need to understand about the SXSW experience. At any given time, there are 30 to 50 events to choose from taking place in multiple locations throughout downtown Austin. This means that, unlike conventional conferences, each individual attendee cuts his or her own path through the events by selecting and reselecting from the nearly unmanageable array of keynotes, panel discussions, presentations, and workshops.

Events that feature celebrity speakers or that focus on hot topics can fill up quickly. Dashing from event to event, waiting in long lines, and striking up random conversations en route is part of the experience. Many events include audience QA, so if it suits your fancy you can become part of the public conversation, even if you aren’t an official presenter.

Here’s a highly personal recap of the themes, issues, and events that impressed, stimulated, and/or frightened me:

BIOMETRICS

The Idea: The pervasive collection of quantified biometric data will transform healthcare.

Wearable, implanted, and otherwise applied technologies will collect vast amounts of data on each of us throughout the day and night regardless of where we are or what we are doing. The collected data won’t only be sent to our phones—it will also be shared with physicians and aggregated into an ever-expanding library of health data.

This library can be used to evaluate the impacts of lifestyle choices on health and longevity (how much of what kinds of exercise must you do to reduce hypertension?). They can also measure the impact of pharmacologic therapies (which drug was more effective?), they can help identify disease patterns (what patterns around comorbidity should be looked at?), and they can provide real-time reports on just about anything you want to know about human behavior and health.

Why this is important:

If we combine biometrics with the predictive capabilities of DNA analysis, we’ll be able to obtain a detailed image of our individual health within the larger social context.

CROWD-SOURCED DRUG DISCOVERY

The Idea: Crowd-sourcing health studies and clinical trials.

Current approaches to drug testing and conducting health studies are expensive, slow, and cumbersome. What if we used crowd-sourcing to answer quantifiable health questions?

Jessica Richman, who is the founder of uBiome, a start-up that uses a crowd-sourced approach to collecting scientific health data, proposes that we dramatically change our approach to scientific inquiry. She suggests that with the right protocols and infrastructure in place, crowd-sourcing will be used to speed the evaluation of new products, measure the effectiveness and safety of products already in-market, and obtain quantifiable data on the health impacts of lifestyle choices.

This approach promises to allow us to quickly and efficiently collect larger data sets than ever before. But with this comes the responsibility to maintain processes and checks to maintain scientific integrity.

Why this is important:

It can dramatically reduce the cost of conducting health and drug studies, and it can generate libraries of data for ad hoc inquiry and analysis.

SXSW Series:

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Mar15

Expanding Universe: Centers of Excellence

Expanding UniverseThe success of most pharmaceutical products and medical devices is in part based on the expertise of learned physicians in designing and conducting clinical trials, interpretation of data from these trials, and eventually in educating healthcare providers. Historically, these esteemed physicians are the most recognized names at the highest-ranked medical schools and affiliated teaching hospitals. More recently, a new trend has begun to emerge: the rise and expansion of private research centers that are quickly rivaling their traditional academic counterparts. This phenomenon is a consequence of two significant developments over the past few decades.

Since the 1980s, industry funding for biomedical research by pharmaceutical and medical device manufacturers has surpassed the investment by the federal government. PhRMA estimates that member companies in 2011 invested $50 billion in the discovery and development of drugs. This amount, even without counting the investment by medical device manufacturers, is significantly higher than the $31 billion spent by the National Institutes of Health.

A second development is an increase in media and legislative scrutiny of relationships between industry and physicians. Many media stories brought questionable interactions into the spotlight, and legislators at state and federal levels began to put rules in place to increase transparency and minimize perceived undue influence of industry on healthcare providers. As the industry developed guidelines for interactions with healthcare providers, academic institutions began implementing their own rules limiting interactions.

The dwindling federal research dollars and ever stricter institutional rules are beginning to drive some investigators to switch their affiliations to private health organizations or start their own research centers. Early indications are that the quality of research at these nontraditional research centers is likely to be as good as that performed at major medical centers. In fact, a 2012 article by researchers from Harvard Medical School reported that “academic and nonacademic sites are equally effective in their ability to identify and retain appropriate study participants.” If the current trends continue, we can expect more industry-funded clinical research to be conducted at these private research facilities.

Many of the physicians at these centers are already well-known in their respective therapeutic areas due to their prior research and publications. Their personal reputations may translate into their new centers’ prestige, as they continue their contributions through congress presentations and peer-reviewed publications. In time, younger researchers from these centers may indeed grow into future thought leaders, just as those from academic research centers have done historically.

Emergence of these potential new “centers of excellence” presents opportunities and challenges for the manufacturers and for communication agencies. As the nonacademic research centers are managed by investigators who have expertise and interest in working with industry in various capacities as investigators, advisors, and educators, they may be more open to collaboration than the experts at academic institutions. They will also continue to maintain high ethical standards to protect their own reputations among their peers. However, there may be a need for the industry to educate them regarding the latest guidelines issued by PhRMA or AdvaMed, and the constantly evolving regulations at the federal and state levels, since these centers may lack the compliance infrastructure of the major academic centers. As communicators who facilitate interactions among industry, researchers, practitioners, and patients, it behooves us to keep an eye on this trend to better serve our clients.

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Dec4

Fighting the Stigma of Mental Illness

Even with our medical knowledge of the neurobiologic causes of mental illness, prejudice and discrimination against people with mental illness is not decreasing (according to a study published by Indiana University and Columbia University).

The World Health Organization (WHO) reports that there are 450 million people worldwide who suffer with mental illness but fewer than half receive care (caused by limited resources and stigma). While the WHO is taking action, by assisting governments with better access to healthcare and training healthcare workers to recognize the signs of mental illness, the WHO cannot fight stigma alone.

Many people with mental health concerns hide their illness or decide not to seek help because of what others “think.” They are often plagued with shame and agonize over with whom to share (family, friends, colleagues) their diagnosis. Worst of all (in my opinion), people with mental illness often “self-stigmatize” (internalize the public’s perception) and limit the amount of success they think they can attain or deserve.

Could you imagine how different our lives and nations would be if society knew that Abraham Lincoln or Winston Churchill had a mental illness? Or worse, if these two men held themselves back because they felt they didn’t deserve to succeed?

Mental illness is no different than any other illness, but because it manifests in the characteristics that make us human, it is more difficult to understand and often feared. In some cultures, superstition also contributes to how people are treated or viewed among a productive society.

So what is the tie-in with why I picked this blog topic and Fast4wD Ogilvy? Fast4wD has been at the center of global communications for clinical research for the past 10 years. While our therapeutic area of expertise is broad, the majority of our business has fallen under CNS. In addition, since 2003, my career has coincidentally focused on mental health research. I say coincidental because several of my immediate family members and very close friends have struggled with these concerns. I’ve learned a lot through my personal and professional experiences, but the most heartbreaking learning I’ve had is that a double standard exists. From a scientific and medical professional perspective, the “support” is there (just look at the list below of common or well known disorders currently open on ClinicalTrials.gov), but the dialogue behind the scenes isn’t always very nice or compassionate when it affects the immediate business.

ClincalTrials.gov lists the following open clinical trials:

  • 2005 depression trials
  • 1505 anxiety disorder trials
  • 594 schizophrenia trials
  • 475 ADD and ADHD trials
  • 472 eating disorder trials
  • 351 post-traumatic stress disorder (PTSD) trials
  • 296 bipolar trials
  • 158 trials listed collectively for obsessive compulsive disorder (OCD), panic disorder and Tourette’s syndrome

As the National Alliance on Mental Illness (NAMI) says, “Stigma erodes confidence that mental disorders are real, treatable health conditions. We have allowed stigma and a now unwarranted sense of hopelessness to erect attitudinal, structural and financial barriers to effective treatment and recovery. It is time to take these barriers down.”

We can start by looking for ways to help make a change.

  • Be compassionate and be careful of what you say:
    • “Tard”
    • “Psycho”
    • “Did you take your meds today?”
    • “Just snap out of it!”
  • Participate in a nonprofit like NAMI at some level:
    • Memberships
    • Volunteering your time
    • Join fundraisers (walks, runs, etc.)

My challenge to you is to add to my list above of how we can help make a change. I want to hear from you.

 

 

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Aug30

A Common Goal for Clinical Trial Participants

The Olympics opening and closing ceremonies allowed us to reflect upon and appreciate the diverse world we live in. Watching the procession of athletes was proof to us all that Olympians come from all corners of the world, in very many different shapes and sizes!

The same can also be said for clinical trial participants.

By their nature, global clinical trials can be considered an oxymoron. From a patient perspective, their participation in a clinical trial is a very personal decision. Many patients choose to enroll in a clinical trial for access to a medication that might give them a few more weeks or months to live, or the possibility of improved quality of life. Other patients may choose to participate as they want future generations to have the opportunity to live life to the fullest, something that might have eluded them. The list can go on.

As an agency when we look at patient participation, we need to remember that the probability of two patients on the same study knowing each other is very slim, so there will never be the coming together of a group of likeminded individuals on a given clinical trial. Likewise, we want to avoid the possibility of patients discussing their study experiences for fear of un-blinding themselves, but we want them to embrace the fact that they are not alone.

There are many different tactics we can use to bring a sense of community, or belonging, to patients in clinical trials. The biggest hurdle to overcome is creating a program that can be inclusive to all patients. Of course, the answer here is that a) that’s impossible, and b) that’s not a smart solution.

Thinking back to the Olympic athlete procession, the mix of cultures and values on show reflected the diversity of a group, but together with a common goal, to win gold.

In clinical trials, we want patients to have that same sense of a common goal, of purpose. However, the way we share that message is very different. For some patients, they just require clear instruction from their study team and feel confident that they know their commitment to the study. For others, they want to receive regular bites of information, telling them how many patients have been recruited, which countries are taking part, etc.

The tactics that we implement to inform patients about a clinical trial and then to keep them motivated to continue in the trial are not off-the-shelf ticket items. We know that each patient recruited will bring his or her own set of beliefs and information needs. In business, we often use Myers-Briggs as a way to build teams and recognize the differences among us. We embrace those differences and slowly learn how to work within our structure. We must do the same when communicating with patients globally about their health and their decision to volunteer to be a research study participant.

Crafting solutions can be challenging. In these cost-conscious times, sponsors are looking for the most cost-effective way to get their message across. As an agency working in these lean times, we are moving forward with new technologies and communication channels to reach all patients. London 2012 showed what can be achieved in tough economic times. The athletes have proved that regardless of ethnic background or values, there was a common goal and everyone has been part of the greatest sports day the world will see for another four years.

The same sense of belonging can be achieved for clinical trial participants; you just need to know what makes them tick….

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Jul31

Affordability of Medicines—the New Kid on the Block

You know the feeling: you pop into the shop and see something you want to buy, but times are tight and you simply can’t afford it. You want the best, but you feel compelled to consider all your spending priorities and choose to go for the less expensive brand—it’s a question of affordability.

In today’s environment, this is a challenge facing healthcare systems throughout the world. Coupled with this, more healthcare resources are being consumed as people are living longer with increasingly complex health problems. Add to this the increased complexity of how national health systems are assessing a medicine’s value, and you have the perfect storm.

Indeed, just as you weigh up whether you can afford to pay for something, those who pay for medicines (termed “payers”) all have affordability at the forefront of their minds. Governments are addressing the issue by driving further healthcare reforms, while payers are aggressively managing costs, limiting therapy choice, and shifting more of the cost burden to consumers.

However, if industry is to effectively support payers in their informed decision-making, it is important that they are viewed as investors in their community’s health and not simply gatekeepers of the budget.

As investors in health, payers deploy a variety of instruments to support medicines’ cost control. These can be broadly divided into supply-side and demand-side approaches.

Demand-side instruments include:

  • National-level price negotiations/price cuts
  • Reference pricing systems–using the cost of other similar drugs to set the price
  • Health technology assessments–assessing the value of a medicine using a range of tools including cost- and comparative-effectiveness
  • Promoting generic medicines and parallel imports–parallel imports refer to the practice of importing a medicine from another market where the medicine is cheaper

Supply-side instruments include:

  • Patient co-payments–this is the practice where patients will pay a certain percentage of the medicine’s cost
  • Reimbursement restrictions–restricting the money paid for a particular drug
  • Delisting–removing a product from a list of drugs that will be paid for
  • Prescribing budgets–setting financial budgets for the prescribing of medicines
  • Formularies and guidelines–a list of medicines that have been approved to be prescribed, or their incorporation within guidelines that should be adhered to

To date, the pharmaceutical industry has focused predominantly on communicating about cost and cost-effectiveness to secure optimal pricing and reimbursement for their brands at a market level. Arguably, more needs to be done to demonstrate the true benefit of treatment to patients, the communities in which they live, and society at large.

Some solutions to help demonstrate the true value of a treatment include:

  • Evaluating and demonstrating the longer-term patient outcomes
  • Demonstrating and communicating the economic value across all stages of a product lifecycle
  • Supporting payers to identify which patient segments would benefit most from treatment
  • Relating the outcomes demonstrated through clinical trials to local demographics

There is no doubt that the industry continues to go through a challenging time, while the economic crisis faced by many countries is only likely to get worse. In this environment, the issue of affordability is higher up on governments’ and payers’ agendas. However, by understanding and meeting the needs of payers and their communities, the industry will be better placed to ensure patient access to their medicines.

 

 

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Jun12

BATMAN, SIESTA and AWESOME

An apology to fans of Gotham as this blog post isn’t about the awesome Batman having a siesta prior to launching an attack on the Joker but on the (often somewhat fudged) acronym names given to clinical trials in the pursuit of creating a captivating trial identity.

So which clinical trials were betrothed with BATMAN, SIESTA and AWESOME?

BATMAN:  Bisphosphonate and Anastrozole Trial – Bone Maintenance Algorithm AssessmeNt

SIESTA:  Snooze-Induced Excitation of Sympathetic Triggered Activity

AWESOME:  Angina With Extremely Serious Operative Mortality Evaluation

I also have to mention other enchanting clinical trial name acronyms that caught my eye:  ASTRONAUT, CABG Patch Cardioplegia Substudy, EUROSTAR, REDHOT and BLIND-DATE.

A catchy identity based on an acronym of the title of the clinical trial is memorable. The acronym can resonate with both the clinical trial participant and the trial investigator. And an unforgettable acronym doesn’t need to be as complicated as a superhero.

I asked an oncologist friend for a memorable clinical trial name and their response was: SCOPE—Study of Chemoradiotherapy in Oesophageal cancer Plus or minus Erbitux. Their reasoning being that not only is SCOPE an acronym of the trial title but it is also strongly associated with using an endoSCOPE to examine the oesophagus.

It is proving increasingly difficult to come up with unique acronym-based clinical trial names for our clients as indicated by SMART (at least 25 trials lay claim to this name), HOPE (five trials) and CURE (six trials). To get around this, some clients opt to use a name that symbolizes the tone and goal of the research as opposed to an acronym. However, The New England Journal of Medicine reported that compared with clinical trials without acronym names, acronym-named trials enrolled five times as many patients (but were not more likely to report positive results).1

Either way, naming a clinical trial, whether using an acronym or otherwise, gives the trial an unforgettable identity and provides a creative platform for communications and messaging. The identity engages clinical trial participants and investigators, optimizing the recruitment and retention of participants in clinical trials.

 

1Acronym-Named Randomized Trials in Medicine — The ART in Medicine Study

N Engl J Med 2006; 355:101-102, July 6, 2006

 

 

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