Diversity in Clinical Trials

For Clinical Research Professionals

This video provides an overview of the importance of diversity in clinical trials. For clinical research professionals only.

Made possible by a sponsorship from WCG.

To read about the development process for this video, click here.

Best Practices in Design for Clinical Trial Communications: The Mysterious Art of Typography

Typography in Clinical Trial Communications

Written by: Paul Hurd


CISCRP produces a wide range of patient-friendly materials, such as informed consent forms, brochures, and trial summaries. These communications provide important information to clinical trial participants or potential participants.

These documents are written in plain language and are graphically designed to be easily read and understood by a wide variety of people. Plain language strives to be easy to read, understand, and use. It avoids complex language and jargon. To aid in readability, formatting and typography play a large part in the design process.

To learn more about these document types and to see examples, click below:

Typography is the arrangement of type to make written language legible, readable, and appealing when displayed. This blog will focus on what makes typography work to achieve these goals. But first, some definitions.

 

Typeface vs. Font

Simply put, a typeface is a collection of fonts. A typeface defines a type’s general shape and design. Typefaces have names such as Arial, Helvetica, or Times New Roman. The font is the type size in points, weight (regular, bold), style (italic, condensed), and so forth of the typeface when it is used. But don’t worry if you can’t remember when to use the terms font or typeface. These days, people use the terms interchangeably.

In typography, bigger is better for creating legible text. Here at CISCRP, font sizes for paragraph text are generally 12 to 14 points. The bold font style is used to emphasize important information. Though an italic font may catch your eye, it is not used for emphasis because the slanted and distorted letterforms tend to inhibit legibility. ALL CAPITAL LETTERS ARE ALSO AVOIDED because they are difficult to read with their lack of ascenders and descenders. AND IT MAY SEEM LIKE YOU ARE YELLING.

Legibility is a result of the chosen typeface and font, its size, its spacing, and the contrast between text and background. It can also be affected by the layout of the text, such as the text orientation and length of lines.

Serif and Sans-Serif type

Serif typefaces have flared ends and corners. An example of a serif typeface is Times New Roman. Serifs are as old as written language and have been traced back to the Latin alphabet. Typefaces with no serifs are called sans-serifs. Arial is a sans-serif typeface. The earliest use of sans-serif type appears in printed media as early as 1805. In general, it is best to use a sans-serif typeface, especially in paragraph text. Studies have shown that sans-serif type aids legibility among people who are dyslexic.1,2

 

Is it pronounced leading, or leading?

Leading (“Leh-ding”) is the space between lines of text in a paragraph. The term comes from the early days when type was made of little blocks of metal. Leading (actual slivers of lead) was used to space the lines of words and letters from each other on the page before it was printed.

Normally, leading is set at 1.2 times the type size. So, a paragraph of 12-point type size would have each line spaced 14.4 points from each other, depending on the size of the type and letterform characteristics. Confusing? Yes, but you don’t have to remember that, either. Document and page layout programs already do that calculation for you.

What you should know is that for increased legibility, leading should be set higher than 1.2 times the type size. There is a “sweet spot” where the leading size increases readability and comprehension. This is especially important for people with dyslexia. Paragraphs with a leading size too small may look like a solid block. Too large a leading size and the readers’ eyes jump from one line to another and have trouble finding the next line. Again, this amount of leading varies by type size and what the letterform looks like. How much leading is just right? That is part of the “mysterious art of graphic design.” Not really. Experts recommend a leading of 1.5 times (150%) of the type size. For instance, a 12-point type size would have a leading space of 18 points. See the figure below for how this would look using the Avenir typeface.

Spacing between paragraphs is another important design consideration. Space between paragraphs is just as it sounds. It is white space, sometimes called a “carriage return,” between paragraphs. How do you know what size space should be used between paragraphs? A good rule to follow is that the space between paragraphs should be a little less than 2 times the leading. For instance, in the figure above, paragraphs of Avenir 12-point type would be spaced an additional 9 points from each other. Think of the measurement as 27 points of leading between paragraphs.

Here are some other considerations for readability in lines of text:

  • Do not break words from one line of text to another (hyphenating)
  • Keep numbers on the same line as the thing they describe (i.e., 13 participants, 3 weeks)
  • Whenever possible, keep the character count per line to 50–60, including spaces.

Type size, leading, and spacing between paragraphs is calculated to make use of white space or “negative space”. Why white space is important and how it aids in legibility will be explored in a future post.

In conclusion, when it comes to readability, the care you take with typography in a document can be just as important to plain language as the actual words.

Along with our plain language expertise, the legibility and accessibility of our printed and online educational and patient-facing materials are designed with the goal of improving participants’ experience in all stages of clinical research.

References

  1. https://dyslexiahelp.umich.edu/sites/default/files/good_fonts_for_dyslexia_study.pdf
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977080/

Building Bridges Between Health Care Providers and Clinical Research

Health Care Professionals (HCPs) have direct access to thousands of patients who they see on a regular basis. Patients often report having a high level of trust in their HCPs and a recent CISCRP study found 64% of the public believes people should learn about clinical research through discussions with their doctor and nurse…

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CISCRP, ACRP Collaborate on 5K Run & Walk Event To Recognize All Clinical Trial Volunteers

Research Professionals and the Public to Honor Study Volunteers Who Give the Gift of Participation in Clinical Research

Boston, MA and Alexandria, VA– The Center for Information and Study on Clinical Research Participation (CISCRP) and The Association of Clinical Research Professionals (ACRP), two independent non-profit organizations, are excited to announce the upcoming Medical Heroes Appreciation 5K Run & Walk in Atlanta to celebrate the volunteers who give the gift of participation in clinical research and to raise awareness about the importance of clinical research in advancing public health.

MedicalHeroes-4399CISCRP will hold the Medical Heroes Appreciation 5K Run & Walk in conjunction with the ACRP 2016 Meeting & Expo. The event will take place on Saturday, April 16, 2016 near the Georgia World Congress Convention Center from 6:30-8:30am. Participants are encouraged to register early as space is limited. To register, visit medhero5k-atlanta.eventbrite.com. On behalf of every 5K registrant, the Greater Gift Initiative will donate a vaccine to a child in need.

“Medical Heroes are the millions of people who help advance public health and medical knowledge by taking part in clinical trials each year,” said CISCRP’s founder, Ken Getz. “With the support of ACRP, we continue to recognize their gift, raise public awareness, and express our gratitude and admiration through this special event.”

Running and walking enthusiasts, and CISCRP and ACRP supporters, are invited to participate and attend the event. Proceeds from the 5K will support education and outreach programs to patients and families interested in learning more about the clinical research process.

“We’re proud to partner with CISCRP and host another 5k at our meeting this year. We expect many of our distinguished members and other clinical research professionals to run again in appreciation of the clinical trial participants who make new medical treatments and discoveries possible,” says Jim Kremidas, Executive Director, ACRP.

CenterWatch, a leading provider of clinical trials information for both professionals and patients, is the event’s official media partner providing additional support in raising awareness about the 5K. “Clinical research volunteers truly are the medical heroes of our industry,” said CenterWatch COO, Joan Chambers. “Part of CenterWatch’s mission has always been to educate patients on the importance of clinical research so it was without hesitation that we offered our support to promote this exciting event.”

Check-in the day of the event begins at 6am; and the 5K Run & Walk will begin at 6:30am. For more information about the event, to volunteer, register or become a sponsor, visit ciscrp.org/medhero5k-atlanta. Questions about event registration should go to Maya Wise (617) 725-2753, e-mail medhero5k@ciscrp.org, or call toll free 1-877-MED-HERO.

**About CISCRP**

CISCRP is a 501(c)(3) non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. CISCRP provides free education and outreach to the general public and patient communities. Visit www.CISCRP.org for more information or to support CISCRP.

**About ACRP**

Based in Alexandria, Va., and founded in 1976, the nonprofit ACRP has a worldwide membership of research professionals dedicated to the safe and ethical conduct of clinical trials across the globe for new drugs, medical devices, and therapies in human subjects. Our mission is to provide global leadership to promote integrity and excellence for the clinical research profession. For more information, visit www.acrpnet.org.

**About CenterWatch**

Since 1994, CenterWatch, has been the recognized global leader in providing clinical trials information to a broad and influential spectrum of clinical research professionals ranging from sponsors and CROs to research sites and niche providers. For more information, visit www.centerwatch.com.

 

From the Editor, November 2015

The CISCRP team is finally winding down after a very active fall season! The team held three AWARE for All events in three major cities: St. John’s University in New York CityLoyola University Medical Center in Chicago, IL and the William and Ida Friday Center in the Triangle, NC. The results of the 2015 Perceptions & Insights study were unveiled with a webinar to discuss findings, and staff members have been busy presenting at conferences across the country.

I’m pleased to share that our staff is growing rapidly to support many exciting initiatives. This fall, we welcome four new members and two familiar faces to the CISCRP team. Audrey Birkett, Cynthia Korisky and Jennifer Clemens join Communicating Trial Results as Project Managers. Annick Anderson, Associate Director, Research Services, joins us full time, and Susannah Buzard, Special Programs Manager, returns to CISCRP after working in education. David Getz joins as the Finance and Operations Manager, and Bella Osmanov, UMASS Boston, joins CISCRP as our newest intern.

The 2nd Annual SCRS Run for the Heroes 5K in October marked our fifth Medical Heroes Appreciation 5K to be held in conjunction with a professional conference. Thank you to SCRS and DAC Patient Recruitment Services for their support. We are very excited for the two upcoming 5K events this spring at the ACRP 2016 Global Conference & Exhibition in Atlanta, GA and the DIA 2016 52nd Annual Meeting in Philadelphia, PA. In addition, there will be a 5K Run/Walk at the ISPE Conference on November 9 to benefit CISCRP. Bring your colleagues and register for a fun, active way to kick off the conference!

Finally, I’d like to extend a warm thank you to all of our supporters. Without your dedication and enthusiasm, our many programs and events would not be possible. As we move toward the holiday season, I wish you all the best and hope you will keep CISCRP in your thoughts.

 

Warmly,

Maya Wise

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Medical Hero Spotlight: Kyle Bryant

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Credit: Rick Guidotti

Getting the Wheels Turning for a Cure

When Kyle Bryant was diagnosed with Friedreich’s Ataxia (FA), a rare, progressive neuromuscular disorder, at age 17, he knew he had to do something, so he did the thing he knew best: he got on his bike.

He spent the first few years after his diagnosis challenging himself to achieve new personal records in cycling, both as a way of coping and proving to himself that he could still do what he put his mind to.

By the time he was 26, after riding from San Diego, CA to Memphis, TN, Kyle’s passion became so much more. That’s when the idea for rideATAXIA, a program of the Friedreich’s Ataxia Research Alliance (FARA), got wheels of its own. Kyle began organizing rides to fund FA research for his organization that now has locations in five states and plans rides across the country.

Catrike_700
Blake Andrews, SLOtography.com

“Hearing there’s no treatment or cure was a huge blow, so cycling and fundraising became our therapy— how we dealt with the disease and continue to deal with it,” Kyle says. And even though Kyle had to trade in his standard bike for a more handicap-accessible Catrike 700 model, it hasn’t slowed him down.

The same gumption with which Kyle started rideATAXIA also led him to begin participating in clinical trials. In his early twenties, Kyle volunteered for his first trial; and while the inpatient study required him to stay in a hospital bed and get his blood drawn up to four times a day, he didn’t mind.

He references a saying in the FA community that the cure to the disorder is a “puzzle” – all of the pieces are out in the world but it’s up to the community of researchers, patients, families, and supporters to put them together. Sitting in that hospital bed giving blood, Kyle says, was his piece of the puzzle.

Kyle continues participating in trials, trying out new drug and therapy treatments. And although his personal health doesn’t always improve, he always considers his participation valuable.

“There’s a chance that these drugs could be therapeutic for me, but that’s not why I participate. I participate because I want to push the science forward. There is no way to get these trials done without participants. Even if these drugs aren’t helpful for me now, it will help find something in the future,” he says.

Credit: Karen O’Brien

Participating in research gives Kyle hope, not only for himself but for future treatments and a potential cure for the disease that he’s built his life around fighting.

And he’s fighting alright— saying moderation “keeps us from reaching the extreme points of our potential.” And for someone who uses a wheel chair but still bikes cross-country and works out in a gym, he means it.

Already this year, he has biked up Mt. Evans, the highest paved road in the U.S., and says a European cycle tour could be next. As for clinical research, he will continue placing his piece in the puzzle, one rideATAXIA fundraiser and clinical trial at a time.

For more information about Friedreich’s Ataxia and rideATAXIA, please visit www.curefa.org.

To learn more about Kyle’s story, visit his website at www.kyleabryant.com.

UPDATE, January 2016: Kyle is honored and excited to be speaking at the third annual 2016 Patients As Partners conference in Philadelphia, PA this March. He will be speaking on a panel about patient networks and support programs. To hear from Kyle, along with other patients and clinical research professionals, register for the 2-day conference by visiting the Conference Forum webpage for more information.

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

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Second Annual SCRS Run for the Heroes Supports CISCRP’s Educational Initiatives

Clinical Research professionals laced up their sneakers and hit the road to recognize Medical Heroes at the 2nd Annual SCRS Run for the Heroes 5K.  The event was hosted in collaboration with the Global Site Solutions Summit on October 11.  All event proceeds support CISCRP’s Medical Heroes campaign to raise awareness of the important contribution made by study volunteers. CISCRP thanks both SCRS and DAC Patient Recruitment Services for their generous support.

“This is our second time sponsoring the walk and we’re pleased to do so based on the overwhelmingly positSCRS 5K Runnersive feedback and response we received last year,” said Steve Swanson, DAC president, Imperial CEO, and member of the SCRS Global Impact Partner board. “DAC is a strong advocate for the patient’s perspective in studies. Events that showcase and acknowledge the positive impact of study participation are important opportunities for us to support,” he said.

“It’s so very important that all of us recognize the millions of people who give the gift of their participation in clinical research each year to advance knowledge about disease and how to treat it,” said CISCRP’s founder and board chair Ken Getz.  “We’re grateful to SCRS and DAC for their support of the Walk/Run for the Heroes event .”

MedicalHeroes5K-logoThis is the fifth Medical Heroes Appreciation 5K to be held in conjunction with a professional conference. These events are a unique opportunity for professionals and members of the public to show their appreciation for clinical research study volunteers.  During the past 18 months, a growing number of patients and members of the public have been participating in the Medical Heroes events.

Check out the upcoming Medical Heroes Appreciation 5K events below:

If you are interested in sponsoring or participating in a Medical Heroes Appreciation 5K/Walk in the future, please visit our website and contact ellyngetz@ciscrp.org for more information.

 

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CISCRP Unveils the Results of the 2015 Perceptions & Insights Study

This Fall CISCRP will unveil the results of the 2015 global Public and Patient Perceptions & Insights study beginning with a webinar in late October followed by conference presentations and onsite company meetings.

The webinar on October 28 posed a unique opportunity for professionals from all over to tune in and hear directly from CISCRP Founder and Board Chair, Ken Getz and key leadership staff. CISCRP shared the recent study findings around public and patient perceptions, attitudes, and experiences in regards to clinical research, as well as the meanings and implications associated with these results.

With more than 12,000 respondents, the 2015 CISCRP Perceptions & Insights study is the largest global survey of its kind. The large response base allows CISCRP to conduct in-depth subgroup analyses by a variety of demographic and attitudinal variables including age, race & ethnicity, socio-economic status, disease condition, and global region.

In late 2015 and into 2016, CISCRP will be publishing the results of the study in special reports, peer-review journals and trade-press articles.

The 2015 Perceptions & Insights study offers invaluable insights for clinical research professionals — sponsor Perceptions & Insights_2.19.15 018_2companies, CROs, investigative sites, and other stakeholders – looking to more effectively engage their study participants as partners in the clinical research process.

Later this year and throughout 2016, based on a generous educational grant from Acurian, CISCRP will be holding onsite company ‘Roundtables’ to present and discuss the results of the 2015 Perceptions & Insights study.  As part of these programs, CISCRP will facilitate a discussion to generate concrete action steps.  Roundtable meetings are already scheduled at AbbVie, Boehringer-Ingelheim, Astellas and Takeda.

If you’re interested in learning more about the opportunity to host an exclusive roundtable discussion of the study results and their implication at your company, please contact Ellyn Getz at ellyngetz@ciscrp.org.

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