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ACHIEVINGGREATER IMPACT

IN GLOBAL PATIENT RECRUITMENT AND RETENTION COMMUNICATIONS

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table of

INTRODUCTION

PATIENT RECRUITMENT IS AT THE CENTER OF TRIAL DELAYS

RECRUITMENT COMMUNICATION IS PAINFUL

DRIVING LOCAL RELEVANCE

CASE STUDY: THE IMPACT OF DELAYS

CONCLUSION

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6

12

20

26

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CONTENTS

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introductionDespite challenges surrounding increased regulations and evolving clinical standards, conducting clinical trials globally is an attractive option for life sciences organizations. Rising development costs along with the expanding volume and protocols of clinical trials have prompted sponsors to work with international investigators and global patient populations.

• Leading emerging countries will account for 28% of global spending on pharmaceuticals by 2015, as compared to 12% in 20051

• The number of active investigators in the US has declined 3.5% annually since 2001, whereas active investigators outside the US has increased 13.5% each year during that same period2

• Annual growth in non-US based investigators is decelerating due to a number of factors including diminishing economic advantages and global regulatory constraints2

• As rare diseases studies increase and chronic illnesses such as diabetes, heart disease, and cancer continue to grow, global trials open up new patient pools. Communication in clinical trials must evolve to meet the demands of the changing clinical landscape, with patient recruitment and retention communications at the forefront

In this eBook, we break down the challenges surrounding successful implementation of global patient recruitment and retention, and provide ways to ensure optimal results from a communications perspective.

GLOBAL CLINICAL TRIALS GROWTH:A VIEW FROM THE TOP

LET’S GET STARTED!

1The Pharmaceutical Industry and Global Health: Facts and Figures, 2011, IFPMA 2Getz, Zuckerman and Rochon, ‘Landscape changes highlight growing challenges for clinical research sponsors’ 2009

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The landscape of global clinical trials can be rough and rocky due to delays that cause a rippling effect. Delays can cause a trial sponsor to lose millions of dollars by having to extend study timelines — subsequently delaying the drug’s regulatory clearance and greatly impacting sales.

ROUGH AND ROCKY TERRAIN

NEARLY 80%

85% UP TO 50%

of clinical trials fail to finish

on time3

of clinical trials fail to retain

enough patients3

of sites enroll one or no patients

in their studies3

AND THE LIST GOES ON!

Examples of the kinds of delays that contribute to a challenging clinical trial landscape include:

• Patient recruitment delays

• Study start-up delays

• Study investigational product availability delays

• Translation delays

• Recruitment material creation and distribution delays

• Protocol amendment

PATIENT RECRUITMENT IS CHANGING

3Recruitment Roles Applied Clinical Trials, Sept. 2011

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A COSTLY EFFORT

The effort to recruit patients into clinical trials is often considered as challenging as drug discovery itself.

Changes in study designs are the greatest issue impacting the recruitment process. Studies today are twice as long as compared to studies completed a decade ago, and now require a larger number of patients.4 Protocols are more complex in both the amount and type of procedures required.

• The delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial5

• Each day a drug is delayed from market, sponsors lose up to $8 million5

• Eighty percent of total trials are delayed at least one month because of unfulfilled enrollment6

4Accelerate Time to Revenue with Less Risk and Cost Using the Medidata Clinical Cloud, Medidata Solutions, Inc. 2013 5Beasely, “Recruiting,” 2006. 6Lamberti, “State of Clinical Trials Industry”, 292

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CONSIDER COMMUNICATIONS FOR THE GLOBAL AGE

More and more, digital, mobile, and social media are becoming integrated elements of patient communications strategies. Social media, in particular, has been gaining ground in patient recruitment campaigns because of its immediacy, two-way dialogue, and customization capabilities.

• Patients are going to social media to learn and communicate about their health

• Many countries have multiple popular social media outlets that can be utilized effectively to drive patient recruitment

• A report from Pew Research Center indicates that Egypt, Russia, the Philippines and 14 other countries outpace the U.S. in the proportion of internet users using social sites.7

DO’S AND DON’TS IN A GLOBAL CONTEXT:

• Do not alienate the target audience with an overly “English” centric tone in communication

• Do consider the cultural differences and challenges in order to recruit effectively globally

• Do execute differently based on each country’s communication method preferences

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With the goal to recruit more specific patient populations intensifying as the specificity of trial protocols increase, creative ways to recruit and retain the right patients for a trial’s target indication are important.

The traditional patient recruitment communication methods have been consistent for the last decade, and largely remain effective for certain types of studies.

The methods of recruitment communication have been:

• Phone

• E-mail

• Printed materials

• Traditional advertising (T.V., radio, newspaper)

• Websites

Retaining study participants is just as important as enrolling them into a study. In order to retain a study participant, frequent and meaningful communication is needed. Retention communications can be delivered in a variety of ways such as:

• Visit reminder cards

• Thank you cards

• SMS text messages

• Study appreciation items

Each communication method requires tailoring, and if executed incorrectly, could be detrimental to the success of patient recruitment and retention.

COMMUNICATIONS NEED TO BE CONTINUOUSLY EVALUATED

7Livescience: 17 Developing Countries that Love Social Media More Than US. Feb. 13, 2014

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RECRUITMENT COMMUNICATION IS PAINFUL

THE BIG MYTH:Everyone who works on a clinical trial speaks and/or reads U.S. English. This is the farthest from the truth, and is evident in in-country communication between Sponsors, CROs and Sites. Often, global patient recruitment and retention materials created in the U.S. overlook the impact of language and translation and its ultimate effect on the trial.

Something as simple as the word “you” — if not formalized correctly — can be interpreted as rude and offensive in some cultures. When considering global communication, remember that the official language is not the only language.

A LOT CAN GET LOST IN TRANSLATION IF THE APPROPRIATE RESOURCES AREN’T USED!

GLOBAL LANGUAGES: WHAT WORKS FOR ONE WON’T WORK FOR ALL

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It is common practice for Sites and CROs to have project teams based in different countries. If the Sponsor is based in Asia and the CRO is based in the U.S., for example, communication can be extremely difficult because as one country is completing their workday, the other country may not have started theirs yet.

• Is your team aware of time zone differences?

• Is your team sensitive to time zone differences?

• Does your plan and strategy work around the time zone challenge?

TIME ZONE CHALLENGE: COMMUNICATIONS ON A GLOBAL SCALE (AND CLOCK)

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EVERY CULTURE IS DIFFERENT AND REQUIRES DIFFERENT COMMUNICATIONS

The diversity of cultures participating in global clinical trials requires sensitivity as to how communications are developed. Words and images need to be carefully reviewed for relevance and understanding within each targeted patient recruitment population. From a patient retention perspective, culture and language differences may generate miscommunication of critical health care instructions, or encourage a lack of compliance with protocols, or could prompt other responses that may negatively influence patient safety and the trial’s success.

When communicating, it is important to consider your audience.

• This is true for spoken, written and visual communications

• Colors, imagery, slang and informal speech can be offensive

• Customs also play a role in global communication

LANGUAGE SELECTION

The number of languages selected to be translated in a patient recruitment program is often minimal, with only one or two languages utilized per country. This decision can limit the patient population significantly by reducing the number of potential patients who can access the study information. Global languages by region are multiple. In North America, for example, English and Spanish are predominant, yet French and Chinese are also very prominent. Potential patients could be excluded if a complete list of languages is not developed and agreed to in the initial recruitment planning stages.

• What options are available for patient populations that may want to participate but cannot, because the study does not include information in their language?

• How is the study message relayed to the community if the recruitment materials are not available in all languages spoken and read?

• When is language considered?

IMPORTANCE OF TRANSLATION QUANTITY AND QUALITY

1918

most common languagesGLOBALLY

English

Spanish

French

Chinese

Other

70%

9%

3%

1%

17%

NORTH AMERICA

Spanish

Portuguese

Creole

English

Other

58%

33%

2%

1%

6%

LATIN AMERICA

Arabic

Swahili

French

English

Kwa

Hausa

Other

17%

8%

6%

4%

4%

3%

58%

AFRICA

Russian

German

Turkish

English

Italian

French

Polish

Spanish

Ukrainian

Other

22%

12%

9%

8%

8%

8%

6%

6%

4%

17%

EUROPE

Chinese

Hindustani

Bengali

Indonesian

Japanese

Punjabi

Other

34%

12%

8%

6%

3%

3%

34%

ASIA & PACIFIC

Babla.com

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DRIVING LOCAL RELEVANCE

IMPORTANCE OF QUALITY TRANSLATIONS

SINGLE SOURCE PROVIDER

Communications created with a Western bias cannot succeed in different cultures when recruiting and retaining patients in global clinical trials. Initiatives undertaken with insufficient knowledge of local cultures and languages create recruitment delays and trigger losses in revenue. Poorly or inaccurately translated materials could lead to severe clinical consequences, putting patients at risk.

A way to ensure that quality translations are provided on a consistent global basis is to source a single translation resource with a comprehensive understanding of the life science marketplace and a global footprint to provide on-the-ground support. This minimizes the chances of error, eliminates learning curves, and speeds the process. Quality is paramount! Centralizing translation and localization with one provider improves consistency and quality.

More often than not, language translation is the smallest line item in any global clinical trial or regulatory effort, but improper translations have a profound effect on the success of a clinical trial.

Partrnering with an LSP with a wide global footprint and east-to-integrate technologies that safely and convenientyly enable the sharing and re-use of translated content from prior studies helps assure trials with favorable outcomes.

Face to Face Interpretation

In person interpretation for hospitals, small meetings, cultural diversity training, court hearings.

CLINICAL SITE COMMUNICATIONS

When vital information has to cross language barriers in real time, there’s no room for error. Assisting clinical sites with interpretation services allows for more accurate communication to patients, caregivers, administrators and trial sponsors for an enhanced communications continuum.

Interpreters can be available to assist with site visits, site recruitment plan calls, or any other time assistance is needed with interpretation. Two forms of interpretation are used:

• It is important to be able to seek a resource that has expertise in a multitude of languages to ensure that language is not an impediment.

• Be certain interpreters are carefully screened and selected to deliver the highest quality language interpretation services.

• Make sure they are thoroughly trained and tested on their knowledge of protocol and ethics before they enter the site.

• Work with a provider that can source onsite interpretation services quickly, and as close to your site as possible in order to reduce travel costs and time delays.

Over the Phone Interpretation

24/7 on-demand and scheduled calls for hospitals, federal clients, call centers, and customer support.

TRANSCREATION

With so much at stake, sponsors are moving past current standards of culturally inflected translation to a higher level of quality in which the meaning, emotion and intent of a given sentence is rendered. By transcreating materials, the new standard is creative marketing that bridges the gap between translation and comprehension in regions with different attitudes toward diseases and therapies.

Examples of content ideal for Transcreation include:

• Tag Lines

• Multimedia Campaigns (Digital, Print, Online TV, Radio)

• Brand messaging

• Overview brochures and instructional guides

• Web copy

A good rule of thumb to follow is that transcreation should be used when the success of the communication relies on an essential voice and style that must be maintained in another language or culture.

TRANSCREATION IS THE KEY TO GLOBALLY CONSISTENT, LOCALLY IMPACTFUL BRAND EXPERIENCES

With some trials taking place in as many as 30 different markets, it is critical for translated instruments to be conceptually equivalent to the original content and to all of the other language versions.

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WHAT TO LOOK FOR WHEN TAPPING AN EXPERT GLOBAL RESOURCEA resource that has a proven track record in providing quality translation services, capabilities in cultural adaptation for both online and offline communications, and access to worldwide markets will create efficiencies for your organization, and will support your success across global patient recruitment and retention communications.

THE EFFECT OF POOR TRANSLATIONS

LOCAL MARKET KNOWLEDGE

REGULATORY PARAMETERS

CULTURAL ACUMEN

MARKET ACCESS

PATIENT RETENTION

preferred delivery methods, profile

of country’s healthcare

infrastructure.

permissible/not permissible tactics, patient timing for

study entry.

socially-accepted tactics, best way to convey images and

messages

measuring country feasibility,

sourcing a translation

specialist, study scale-up.

strong rates, comprehensive

project management.

POOR TRANSLATION

SPONSOR LEVEL

CRO LEVEL SITE LEVEL

Loss in revenue,

inaccurate study data, longer time to market.

Missed timelines,

budget issues, loss of trust

from Sponsor and Sites.

Difficulty communicating study message,

potential harm to study participants.

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case study:THE IMPACT OF A DELAY

• Global infertility study recruiting in Canada, US, Argentina, Chile, Brazil, Belgium, Netherlands, Spain, United Kingdom, and Hungary.

• Enrollment was one year with standard recruitment materials as the main form of recruitment tools.

• Participants only had to agree to allow sites to collect unused study samples, no investigational product was given and no study visits were required.

• Enrollment was behind and the sponsor was dissatisfied with the CRO’s recruitment assistance.

• The CRO reexamined why enrollment was behind and implemented site-specific recruitment plans which involved asking each site why enrollment was behind and what needed to change.

• All sites agreed that the recruitment materials needed to be revised, as the participants could not relate to the study message.

BACKGROUND:

ISSUE:

TIMELY PATIENT RECRUITMENT HINGES ON EFFECTIVE COMMUNICATIONS

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• Infertility, a difficult and stressful medical condition, did not evoke images of women walking on the beach and through the park.

• The established study identity was inappropriate and not representative of the medical condition or patient population.

• A new identity and message set was developed to identify with those in the emotional state of not being able to achieve pregnancy.

RESOLUTION:

RESULT:

• Communication between the CRO, Sponsor and Sites and enrollment rapidly improved.

• Enrollment increased so dramatically that the enrollment targets were exceeded and enrollment ended six months early.

THE TAKEAWAY

Communication matters through all levels in patient recruitment and retention. Talking to the Study Coordinators and hearing feedback from the study participants ensured relevant and relatable patient communications.

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HOW CAN LIONBRIDGE LIFE SCIENCES HELP?

Recognized by Forbes as one of the most trustworthy companies in America, Lionbridge Life Sciences works with some of the largest pharmaceutical and clinical research organizations supporting their global clinical trial activities, many with thousands of patient participants in numerous countries per trial.

With Lionbridge, you have access to a highly-specialized network of linguists and translators who have extensive medical and scientific training and experience. Our centralized approach to translation coupled with our global project management methodology ensures consistency and quality across languages, while reducing the total time it takes to adapt and translate patient recruitment and retention support materials.

Lionbridge Life Sciences is a specialized business unit within Lionbridge, providing medically trained linguists in more than 40 full-service solution centers in 26 countries. We work exclusively with Pharmaceutical, Medical Device and Clinical Research Organizations to maximize global communication effectiveness within the boundaries of a highly regulated, complex and always-challenging life science environment.

http://lifesciences.lionbridge.com/

conclusion

This e-book was adapted from the Lionbridge Life Sciences Webinar, Achieving Greater Impact in Global Patient Recruitment and Retention Communications.

Special acknowledgment to the Author, Nicole Vives, Clinical Resourcing Manager, Lionbridge Life Sciences, and Moderator, David Palmer, Business Development Director, Lionbridge Life Sciences.

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