Image courtesy of KROMKRATHOG at FreeDigitalPhotos.net

Mobile application developers are trying to simplify the trip between home and hospital.

However, these mobile developers might soon discover they’ve bitten off more than they can chew, as the FDA recently sent a letter to one software developer warning them that they needed FDA clearance to market their mobile application.

These are the two main distinctions you should know about the apps out there:

• Wellness- related applications

These applications are geared more towards general health and well-being than any particular disorder. Good examples of these are mobile pedometers, trackers of calories burned, or even sunscreen re-application reminders (more of these than you would think.)

• Disease-related applications

This class of applications are promoted as disease management applications. Examples include grocery store sorters, blood glucose readers for diabetics, Self-Care management apps that help the patient catalogue lab results, and even diagnostic apps that allow physicians to input symptoms and link them together to try to come up with an answer.

Wellness-related applications don’t have to be FDA regulated, but disease-related applications do. The motivation behind the stricter regulations of the disease-related applications is to make sure the devices actually perform their advertised function, as any misrepresentation in this class could harm patients.

In addition to the software itself, any accessory device plugged into the phone or tablet to help a disease-related application operate must also be regulated.

This all also open up some grey area as to where advice ends and disease or medical management truly begins. We suspect that as these applications begin to offer more robust interventions in the lives of patients, the distinctions will become more defined.

Contact ClinEdge if you’re interested in hearing more!

Reference: http://www.informationweek.com/healthcare/policy/fda-warns-mobile-health-apps-makers/240155716?cid=RSSfeed_IWK_healthcare

Image courtesy of posterize at FreeDigitalPhotos.net

Much recent research has focused on the purported health benefits of omega-three fatty acids. The agents within Omega-3′s are known as lipid-regulating agents, as they decrease the liver’s triglyceride level. Good sources of omega-3s include fish oil (the Omega 3 supplement that most commonly comes to mind), algal oil, krill oil, and even flaxseed oil. While there are some meta-analyses that protest the cardiovascular benefit of Omega-3’s, the majority of studies indicate positive effects.

However, the current #1 brand in the US is not in fact a fish oil. That coveted spot goes to Omega-3 Krill Oil. However, most popular Krill Oil supplements carry only 90mg of Omega-3 per softgel, compared to high end fish oil supplements that offer up to 900 mg. How can a product be outselling a competitor that offers 10 times more omega-3 per pill? Below, we break down some of the key differences, as well as some of the misconceptions, that can tip the scales regarding your choice of sea creature supplement.

•   ABSORPTION

Ultimately, the strength behind the marketing of Krill oil is that it is better absorbed into the body than fish oil.  The company NKO patented a process to gently remove Omega-3 from Krill. According to NKO’s own research, this process allows for the bond between the Omega-3 and phospholipid to remain intact, which allows for more efficient absorption into our cell membranes. Fish oil absorbs too, but the process isn’t as seamless.

• FISHY TASTE

One of the main marketing tactics behind the promotion of krill oil is its lack of fishy aftertaste. On one level, this can be easily explained by the fact that krill are not in fact, fish, but a crustacean! According to omegavia.com, the astaxanthin found in Krill oil does have e potential act as an anti-rancidity (antioxidant) agent, “but only if it is present in very high quantities.” Not all brands are equally protective, and heat can easily break down this protective factor.

• MISCONCEPTIONS

As Steve Rosenman of seekingalpha.com puts it, Krill Oil is “ highly volatile and spoils easily; it cannot be standardized consistently to Rx grade requirements; and there is no upper limit safety data.” Also, did you catch how we said that NKO was the only the original krill oil supplier for Mega Red? That’s right, they have since then switched away. And since NKO is currently the only company with the patented gentle removal Omega-3 process, which means you can’t be sure the supplements you’re taking carry the much-touted Krill oil absorption advantage!

• SO…WHY ARE THE KRILL BEATING THE FISH?

If you think about it, it looks like a self-sustaining cycle. The much-higher price of Krill Oil allows for a better advertising budget, which is in turn better able to emphasize the positive aspects of Krill oil!

While all Omega-3s can provide positive effects, it is important to research the differences between them.

As always, feel free to come to ClinEdge with any questions you might have, but remember to consult your primary care physician before starting to take a dietary supplement like fish or krill oil.

Sources:

http://seekingalpha.com/article/1472941-the-future-of-omega-3-based-lipid-management-all-eyes-on-amarin?source=yahoo

http://www.omegavia.com/krill-oil-vs-fish-oil/

http://www.ncbi.nlm.nih.gov/pubmed/15656713

Although opinions range (and rage) over the extent to which dual enrollment occurs within clinical trials, it is more universally accepted that subjects simultaneously taking part in multiple clinical trials can jeopardize both patient safety and the validity of the trial’s results. While there are procedures and regulations that disallow subjects from this prohibited behavior, the problem persists.

Here are the top three reasons to be wary:

• Mixing Medications

Subjects who tend to double enroll in several studies may be motivated by a desire to attain more comprehensive healthcare. However, exposure to combinations of experimental drugs that have unknown interactions with each other can have unknown risks that can jeopardize participant safety as well as trial data.

• Whodunit?

In April, Dr. Gary Zammit, President and CEO of the CRO Clinilabs used a database solution to combat the problem of dual enrollment in its trials (click here for the full article). They determined that “eleven percent of subjects provide[d] false identi[ties] to the research sites to attempt to avoid taxes on research subject stipends.” If subjects are willing to fake personal health information, more complex identification methods may have to be used to verify if a study’s inclusion/ exclusion criteria is being met.

• The Big Ifs

A subject who is willing to enroll in several concurrent studies, and especially one who is willing to give out fraudulent personal health information, should raise some fundamental questions for investigators. Are there assurances such a subject honestly meets the inclusion/ exclusion criteria for the studies at hand, that they are faithfully following study protocols, or that they are reporting accurate information instead of just saying what they think the researchers want to hear?

While the effects of dual enrollment are harmful, there are thankfully multiple methods to identify such subjects, as well as limit them from being considered for enrollment in the first place. What should be most important in the minds of sponsors and CROs is creating a Standard Operating Procedure (SOP) for all of their studies, and making sure that all relevant employees are properly informed.

Whether the resulting procedure be stricter internal regulations or an outsourced database program, the whole team working on it together results in smarter research and safer results.

Image courtesy of imagerymajestic / FreeDigitalPhotos.net

Successful clinical trials need participant enrollment.  But it is getting increasingly harder for most investigators to recruit and retain patients.

A couple of the many reasons are: first, less than 5% of Americans know where to find info about clinical trials; and second, 75% of the general public say they have little or no knowledge of the process.  Sound tactics for patient recruitment are therefore essential, especially as competition intensifies in the industry.

ClinEdge’s marketing and patient recruitment team knows how to analyze protocols and identify key enrollment barriers early, to remove them before they hurt participation. We leverage our operational strengths on a site-by-site basis, to generate relevant analyses and achieve maximum success for our clients.  This empowers our clients to focus more on their investigations, rather than worry so much about outreach.

To connect patients with clinical study opportunities, ClinEdge integrates a range of branding, traditional & interactive marketing, and patient engagement services, such as:

• advertising–reaching out to new prospective patients through media buys, radio/TV spots, traditional print ads, and more.  ClinEdge designs, launches, and manages the ads.

• branding–standing out from the crowd.  ClinEdge expresses meaningful and effective messages at the right time.

• PR and community engagement–generating healthcare publicity.  ClinEdge brings careful planning, good timing, and a clear message to these efforts.

• graphic design–effectively merging images, words, and ideas to convey information.  ClinEdge creates branded landing pages for each and every online campaign.  These websites quickly convey the most important facts about a study and capture potential patient information.

• marketing–building personable relations with prospects.  ClinEdge specializes in regular, low-cost communications, including providing patient resources on websites, social media, and mobile apps.  For example, we leverage the fact that most depressed patients browse the internet for solutions.  Through online campaigns alone, we recruit an average of 20 potential patients for each depression study.

• newsletter marketing–reaching a target audience through cost effective newsletter campaigns.  ClinEdge’s recruitment team has noted a 32% conversion rate through newsletter outreach.

ClinEdge always creates huge interest and enthusiasm for participation in clinical trials. We recruit beyond the standard profiles (i.e. those who are very sick and those who want to make money) by rapidly identifying and reacting to new cohorts and trends. We have made a name for ourselves, literally and figuratively, by giving an edge to our clients.

Resource: See ClinEdge’s Marketing and Patient Recruitment infographic

The early developmental stages of a clinical study are oftentimes fraught with the excitement associated with groundbreaking research, but also with unpredictable stressors and rapid deadlines.

To begin with, clinical trials are constantly shifting as protocols are updated and adapted, making it difficult for a site to keep up with the expectation criteria for a particular study or even keeping the right timetable in mind while trying to effectively conduct top-tier research.

ClinEdge’s strategy to help its clients overcome these challenges is to simultaneously streamline and expedite the site selection process of any given trial by acting as the primary point of contact between the sponsor and the site, and by managing the organization of the necessary documentation to emphasize clarity and precision. Our process pipeline breaks down as follows:

1) Studies:

ClinEdge independently identifies upcoming research opportunities and discusses available study material with the Sponsor/ CRO

2) Selection:

Sites within ClinEdge’s network are selected via the Site Matching Process. This process includes, but is not limited to: extent of PI experience, patient populations regularly seen at site, site equipment, and site marketing strategy

3) Consideration:

A list of potential sites is submitted to the Sponsor/ CRO contact for consideration

4) Documents:

The Sponsor/ CRO sends documents directly to the site OR to ClinEdge for distribution.

5) Review:

Site candidates review the relevant information. ClinEdge discusses trial needs with site representatives in depth to ensure all questions are addressed before the completion of a feasibility.

6) Completion:

ClinEdge ensures the site sends completed documents to ClinEdge before designated deadlines; the information is reviewed and then forwarded to the Sponsor/ CRO

7) Communication:

ClinEdge continues to monitor communication with the sponsor and site until the study is either awarded or unawarded.

If awarded, the research sites individually manage contracting and budgeting for the study, although ClinEdge is available to assist the site in patient recruitment if necessary.

ClinEdge’s thorough vetting and assessment processes not only maximize a site’s exposure to studies ideally suited to their capabilities but also minimize the chances of costly timeline slips that can rob a site of research opportunities and revenue.

Each site within ClinEdge’s network has been awarded a minimum of two studies per quarter, and 101 study opportunities were rooted in our CRO/ Sponsor partnerships in Q1 of 2013.

Contact ClinEdge to hear more about how we can help you put your best foot forward on the path to a successful clinical trial.

Image courtesy of Nutdanai Apikhomboonwaroot / FreeDigitalPhotos.net

Do you have MS and look online for information about possible treatments? You are not alone. According to a patient survey conducted by Extrovertic and WEGO Health, MS patients have an “insatiable appetite” for online information about treatments, particularly new oral treatments. A majority of the respondents said that they would ask their specialist to switch them to one of the new oral medications if they knew for sure the efficacy of the new drug would be no worse than their current medications. When asked about specific brands, patients said they were most interested in learning about Biogen-Idec’s BG-12 (68%), followed by Genzyme’s Aubagio (65%), Lemtrada (59%), and Novartis’ Gilenya (57%).

Extrovertic had originally expected to hear a lot more grumbling about side effects, but instead found that only 21% of respondents included that topic within their top three topics for online discussion. “Health activists are so driven to find an efficacious product in this category that they were able to put the side effects in perspective and balance that tradeoff,” said Extrovertic. Patients go online more to talk to other patients about personal issues, like challenges of living with MS, fears about disease progression, symptoms, future treatments, and relationships with family and friends.

This survey suggests that marketers should offer information about their products in the form of videos, news releases, and viral-ready blurbs that can be shared or re-tweeted, since more and more MS patients are corresponding online with each other about the disease.  “This community loves to pass on information,” said Extrovertic.  So, newcomers to the MS pharmaceutical market should try to pave the way for patients to change from injections to oral treatments, according to Extrovertic, because “while many are comfortable talking to their specialist about it, even with the injectable-to-oral switch, they’re not going to do it automatically – they’re going to wait for some therapeutic inflection point.”

Resource: http://www.mmm-online.com/ms-patients-hungry-for-info-on-orals-says-survey/article/284423/

The Federal Trade Commission (FTC) is setting a precedent for future drug regulations. As if developing and testing a drug for its efficacy isn’t hard enough, marketing the drug on social media is now a bigger hurdle. The FTC has issued the following new rules for social media and mobile ads:

• Full-disclosure rules must appear in Twitter and on Facebook, somehow working its way into further limited boundaries.
• Advertisements have to be clearly identified as such with comprehensive, easy-to-read disclaimers. In some cases, these disclosure descriptions could be included at the ad’s destination zone, such as website landing pages.

The FTC is mindful that the disclosure policy might be inadequate and customers may choose alternative methods of obtaining their product. These online stores may be Amazon, Cabela’s or Net-a-Porter. However, if the product is sold directly from the advertiser, then disclosures could bypass social media outlets like Twitter; these disclosures would already appear in the advertiser’s landing page to be reviewed prior to a purchase.

As of now, it is anyone’s guess what the FDA might do, but we won’t be surprised if they follow the FTC’s lead.

Reference:

http://www.fiercepharma.com/story/ftc-issues-social-media-ad-rules-will-fda-finally-be-next/2013-03-13

We are proud to announce that our graphic design made the cut in Unbounce.com’s best landing page design criteria.

See our Landing Page here: IMMUNOeResearch

How to make the most out of a website’s landing page, to yield the most leads, is certainly a question web and graphic designers contemplate over and over again. In addition to this objective, we at ClinEdge try to exceed clients’ expectations and focus our designs on their missions and research, so that they can focus on providing the best care for their patients. By expediting the patient enrollment process, ClinEdge can greatly increase the pace of clinical trials and reduce the time to market novel therapeutics.

According to Unbounced.com, here are some of their tips on what makes a landing page design effective:

The principle reasons are an adherence to the fundamental rules of conversion centered design:

• Use a clear and concise value statement so visitors understand the purpose of the page immediately
• Focus the whole page on a single message, with a single primary call to action (CTA)
• Use conversion design rules to make your CTA stand out (whitespace, color, contrast, directional cues)
• When using a form to collect data, balance the amount of information requested with the perceived value of the item being given in return (report, eBook etc.)
• Use modal dialogs for supplementary information (terms & conditions, privacy policy, product details) as opposed to sending them to your website (which removes them from your intended conversion path)
• And many more that I’ll get into in the examples below…

Keep reading to find out the highlighted features Unbounced.com found in our landing page design for one of our clients:

• Clear headline and sub-header
• Directional cue: There is an arrow pointing from the sub-header to the form, helping to guide the visitor to the conversion goal
• Encapsulation: This is a great example of how to use encapsulation to highlight a form, which is exactly what I was talking about for #8
• Details: All of the main details needed are covered in simple terms – study criteria, length of trial and the cost. This is a great example of layman’s terms based writing
• Questioned based CTA: Having a question for the CTA encourages engagement by making it more personal (and yay, no “Submit” copy)

Contact us at ClinEdge if you are a clinical site and would like us to create a design for you. We work on any size project, and design our services to fit any budget or time constraint.

Learn more about our services:

http://clin-edge.com/patient-engage.html

Do you know of someone who suffers from breast cancer and now you are interested in investigating all that you can on the topic? Or are you impacted by the idea that breast cancer continues to be the most common form of cancer in women worldwide; and the second leading cause of death in females with cancer. Recently, a research article was released that shed light upon this bleak area.

Researchers used transgenic mice that produced omega-3 fatty acids were also developing aggressive mammary tumors. These test subjects were then compared to mice that were genetically engineered to develop the same tumors only.

“This model provides a purely genetic approach to investigate the effects of lifelong omega-3s exposure on breast cancer development,” said David Ma, a professor in Guelph’s Department of Human Health and Nutritional Sciences.

This groundbreaking study appeared in the Journal of Nutritional Biochemistry and provides significant evidence that omega-3s reduce the risk of cancer.

As novel research approaches are developed, new research results are coming in, and greater therapeutic options are in the pipeline leading to an increased immediate need for individuals to participate in the growing diversity of clinical trials. Visit our site regularly to find out more about the clinical research studies we are working on filling as well as all the questions you might have regarding this critical field.

Reference:

http://www.medicalnewstoday.com/releases/256754.php

Marketing and Patient Recruitment Associate

ClinEdge is seeking an organized, energetic marketing and patient recruitment associate. We are a small, dynamic, rapidly growing company offering business development and marketing services in the clinical research industry.
Ideal candidates will be detail oriented, deadline driven with willingness to take ownership for meeting deadlines with little supervision, take an analytical approach to solving complex, multifaceted problems and will work well in a team environment as well as autonomously.

Roles and Responsibilities for this Position include:

• Establishing and maintaining long-term relationships with new and existing customers
• Assisting the marketing department, clients and Physicians with consultations, marketing project campaigns and social media management
• Generating new sales leads through strategic phone, email and follow-up methods.
• Project support for all recruitment initiatives, including centralized advertising campaigns for patient recruitment

We’re seeking candidates with:

• Bachelor’s Degree in Communications, Advertising, Marketing, English or related Research field
• A minimum of 1 year working experience in research/patient recruitment, marketing, public relations, advertising or communications field. Familiarity with clinical research industry is strongly desired.
• Very strong writing skills, excellent communication skills and proofreading abilities
• Strong knowledge of social media platforms (Facebook, Twitter, LinkedIn & YouTube)
• Medical industry experience is a plus; clinical trials experience is even better.
• Understanding or experience with patient recruitment campaigns in a clinical research setting is ideal.

Key Skills and Competencies:

• Excellent communication skills, both written and verbal, with the ability to understand and effectively deliver information on clients.
• Highly organized
• Must have high initiative and superior work ethic
• Ability to independently manage simultaneous projects
• Proficiency in MS Word, Excel, PowerPoint, and Outlook.
• Experience in Web/internet marketing strategies, online advertising best practices
• Experience with patient recruitment campaigns, either site specific or centralized