1 http://www.makrocare.com/development/pace-patient-recruitment

W H I T E P A P E R

eEnrollment: Making Patient Recruitment a Cost-Efficient Approach with Digital & Social Media Options

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W H I T E P A P E R

eEnrollment: Making Patient Recruitment a Cost-Efficient Approach with Digital & Social Media Options

http://www.makrocare.com/development/pace-patient-recruitment

Patient Recruitment is one of the most important aspects of clinical trials and a key determinant of the success of a drug development program. Despite of more than two decades of focus attention and continuous improvement in the recruitment methodologies, patient recruitment has been the largest challenges and the greatest contributor for the delay in clinical trials. It is becoming more challenging with the increased complexity of study protocol design, difficult new study procedures, stringent eligibility criteria and the requirement for targeted patient populations. The complex, “difficult to recruit” kinds of studies require specialized support from a patient recruitment company to ensure timely and successful completion of a clinical trial or program.

As per the statistics (1) goes-

Also, as shown in the figure 1 below, the overall recruitment success rate has been decreasing over last few years which is adding tremendous cost burden on the sponsors.

Figure 1: Aggregate Patient Recruitment Success Rate

Source: Tufts CSDD, N=3,534 Phase II-IV protocols

Rising protocol complexity adds extra burden to patient recruitment success rate. The data below shows that percentage increase in study complexities in last few years in terms of number of protocol procedures, number of eligibility criteria, number CRF pages etc. That adds additional burden to investigational sites to divert their focus from patient recruitment. As shown in the table below there is 58% increase in eligibility criteria from period 00-03 to 04-07 which obviously makes patient recruitment more difficult for investigational sites.

73% 67%

49%

59%

49%

29%

57%

43%

25%

Screen to Randomized Randomized to Completion Screen to Completion

1999-2003 2004-2008 2009-2013e

Around 80% trials fail to meet their initial enrolment timelines

Up to 50% investigational sites recruit 1 or zero patient on clinical trials

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W H I T E P A P E R

eEnrollment: Making Patient Recruitment a Cost-Efficient Approach with Digital & Social Media Options

http://www.makrocare.com/development/pace-patient-recruitment

Figure 2: Changes in the protocol complexities (2, 3)

00 – 03 04-07 Difference

Unique procedures per protocol (median) 20.5 28.2 38%

Total procedures per protocol (median) 105.9 158.1 49%

Total investigative site work burden (median units) 28.9 44.6 54%

Total eligibility criteria 31 49 58%

Number of case report form pages per protocol (median) 55 180 227%

Overall protocol complexity has increased steadily in last five years. This increase in protocol complexity is accompanied by a downward trend in the ratio of enrolled-to-screened patients, going from roughly 71 percent in 2007 to about 62 percent in 2011. This lower ratio translates to a higher ratio of screen failures, indicating that fewer subjects are continuing into study enrollment (4).

In the last two decades, investigational sites used to provide their total patient enrolment by reaching into their own database of patients. However, due to complexity of the current protocols, rigorous eligibility criteria and the rarity of some disease conditions, sites need to go beyond their practice to achieve their recruitment targets on time. The longer it takes to complete the recruitment, the more money and resources sponsors have to spend to complete the trial. The sponsors have to shell out additional budget on change orders for extended enrolment timelines, as well as additional spending for adding more sites and countries to the study when the existing sites’ in-practice patient pool fails to reach the recruitment goal. Moreover, due to delays in patient recruitment, sponsors fail to achieve their critical, planned milestones of “time to reach market” and lose vital time from the exclusive marketing phase of the patent period. Each day delay in patient recruitment cost a million dollar or more loss in sales revenue for life science companies.

This makes sponsors, CROs to look into other cost-effective approach to optimize patient pool at the sites by reaching out the potential patients who are otherwise “out-of-reach” patients for investigational sites.

Digital & Social Media:

The rising cost of patient recruitment has prompted many sponsors, CROs, and patient recruitment firms to explore new avenues and strategies to improve recruitment outcomes. As digital and social media offers powerful, cost-effective tool for patient recruitment in clinical trials, many of these organizations have turned to digital and social media to augment patient enrolment. With around 80% of those on web are seeking healthcare information and approximately 62% of the global population is now engaged in social media , the use of digital and social media has been growing drastically allowing patient recruitment efforts to better target the pool of potential clinical trial participants.

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W H I T E P A P E R

eEnrollment: Making Patient Recruitment a Cost-Efficient Approach with Digital & Social Media Options

http://www.makrocare.com/development/pace-patient-recruitment

Figure 3: Patients top sources for clinical trial information

As per data published by CISRP 2013 in the figure 3 shows that internet is the top source that patients use across the globe to get clinical trial information.

Source: CISCRP 2013; N = 5,701 respondents.

Digital Profile

Websites & Search Engines

Mobile Apps

Banner Ads /Click Throughs

Behavioral Targeting /

Gamification

Viral Sharing

3rd Party Email &

Newsletter Ads

Social Media

22%

20%

50%

40%

41%

46%

13%

7%

13%

23%

30%

35%

13%

24%

13%

10%

8%

31%

11%

14%

43%

6%

32%

5%

5%

7%

15%

21%

24%

35%

11%

3%

12%

7%

12%

27%

Primary Care Physician

Speciality care Physician

Internet

Email

Media

Mail

Advocacy Groups

Pharmacists

Family North America

South America

Europe

Asia Pacific

Social Media - use of web-based and mobile technologies to turn communication into interactive dialogue such as collaborative projects, blogs and micro blogs, content communities, social networking , sites, virtual game worlds, virtual communities

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W H I T E P A P E R

eEnrollment: Making Patient Recruitment a Cost-Efficient Approach with Digital & Social Media Options

http://www.makrocare.com/development/pace-patient-recruitment

Figure 4: Public use of Social Media (SM)

Source: IMS Institute of Healthcare Informatics. CISCRP. 2013 Public Poll Results.

Also, digital and social media offer patient centric approach and allow patients to access the information and respond at their convenience, at their own pace, as per their needs and interest with maintaining adequate privacy.

Based on data gathered by IMS & CISCRP public poll results 2013, around 89% US population between age 18-29 years use social media to find general heath information whereas 36% population between age 18-29 years use social media to explore clinical trial information.

Figure 5: How patients use social media

Source: Tufts CSDD 2013. Total Respondents 27 patients who have participated in a clinical trial

42%

89%

US All Adults US Aged 18-29 Years

Percent of Total

4%

36%

US All Adults US Aged 18-29 Years

Percent of Total

18% 15%

19%

13% 8%

7% 10%

6%

12% 17%

Gather information about the medical

condition

Join a support group for patients with the

medical condition

Gather information about clinical trial

opportunities

Connect with other individuals with the

same condition

Check for other patients within the

same trial

Use SM to Find General Health Information Use SM to Find Clinical Trial Information

# Patients Do Use it for this Reason # Patients do NOT Use it for this Reason

NU

MB

ER O

F R

ESP

ON

DEN

TS

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W H I T E P A P E R

eEnrollment: Making Patient Recruitment a Cost-Efficient Approach with Digital & Social Media Options

http://www.makrocare.com/development/pace-patient-recruitment

One has to use tactical and strategic approach while using digital and social media like these channels bring greater results if we want to target younger population on clinical trials. As in elderly population, the use of social media is not that wide spread, it is not possible to target most of these elderly patients directly but one has to rely on the responses from their care givers. It is important to create a compelling message or advertisement for digital and social media to get better responses. As these messages/advertisements need to be approved by IRB/EC, it would be advisable to have flexible plan with IRB approved multiple visuals and written variations which could be used with proper timing and staggering approach. It is necessary to carry out test campaigns for a few days to find out which ones work better based on the responses and then refine accordingly to increase potential responses. In order to make social media as result-oriented strategy, it is necessary to direct all responses to one source for screening purposes and also to maintain the metrics and plan for alternative campaign in advance. Some of the metrics are important to follow like-

Site traffic – what content causes spikes in traffic Social conversations - who & how many are talking about it Social sharing – who is sharing your content to how many new people Referral data – how many are referred to your trial Conversions – how many are enrolled

One can take systemic approach with the following 3- steps to maximize benefits, while using social media for patient recruitment, -

1. Listening (Assessment): This is the key step in assessing suitable social media that needs to be used based on the patient population required for a clinical trial and geographical area of the investigational sites. The pattern and type of use of social media vary country to country. This step will give idea which social media are used more by the patient population one wants to target and what information is being shared on the social media. i.e. what language they use, what are their concerns, how they share the information etc. This is very important step to plan strategies to use social media for patient recruitment. There are tools available in the market to make this process more efficient. The tools provide customized analytical reports to see different patient profiling based on “Listening”

2. Educating (Awareness): Educating and creating awareness of a clinical trial is the important step once the social media sites are selected for advertisements. One can create compelling, targeted message to individual patient or page advertisement to attract potential patients. One has to assess time to time the effectiveness of message/advertisement reach based on the responses received or by using relevant metrics.

3. Engaging (Partnering): Right strategies need to be in place to build further confidence of interested patients and build trust by addressing their concerns appropriately with support from investigational sites or qualified recruitment expert. There should be patient friendly pre-screening methodology to ensure no single patient will be missed out. The multilingual support is advisable. This is the key step to maximize the patient recruitment once interested patient is identified. One needs to have right strategy and screening methodology in place to respond patients, create more interest and provide more confidence about study participation.

Social Media Explained: The type and message of advertisements need to be planned also depend on the kind of social media one wants to use. The following is a classic example how social media can be explained.

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W H I T E P A P E R

eEnrollment: Making Patient Recruitment a Cost-Efficient Approach with Digital & Social Media Options

http://www.makrocare.com/development/pace-patient-recruitment

Though, there are no clearly defined regulations to guide use of social media in patient recruitment, many believe that the existing clinical guidelines for patient recruitment can easily be applied to use social media. However, still life science companies see few challenges in use of social media for patient recruitment. Some of the concerns are like compliance with country specific regulations, patient privacy and protection of personal data, and inappropriate targeting patients etc. Another concern of many sponsors is inability to manage messaging and conversations related to a clinical trial on social networking sites. Many believe that this lack of control may seriously compromise the integrity of some clinical protocols and jeopardize accurate reporting of trial results. Some fear that any trial participants may falsely report adverse events or call attention to safety concerns that may jeopardise further recruitment on a clinical trial or hinder approval of experimental drug. However, Considering the challenges in patient recruitment, digital & social media offers patient centric, cost efficient approach to optimize patient pool at the sites.

Conclusion:

Patient recruitment has been the largest challenges and the greatest contributor for the delay in clinical trials. Delay in patient recruitment not only brings additional burden to sponsors but also delays their critical, planned milestones of “time to reach market”. As 80% of those on web are seeking healthcare information and approximately 62% of the global population is now engaged in social media, the digital and social media offers cost-efficient, patient centric approach to identify potential patients if used strategically and tactfully. Proper planning and systemic approach in using digital and social media can bring great results in supporting patient recruitment efforts.

References:

1. http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=738753) 2. Getz et al. Assessing the Impact of Protocol Design Change on Clinical Trial Performance. American Journal of

Therapeutics. 2008 15(5); 450 - 457 3. Tufts CSDD analysis of 10, 038 phase I-IV protocols 4. ( Ref: http://blog.mdsol.com/are-more-complex-protocols-hurting-enrollment/)

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