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There are significant challenges facing the pharmaceutical and contract research organization (CRO) industries in relation to patient recruitment of clinical trials and the need to implement new strategies to finally overcome what has been called â€˜the most difficult and challenging aspect of clinical trials.â€™
This post was reposted with permission. It originally appeared on IVT Network.
There are significant challenges facing the pharmaceutical and contract research organization (CRO) industries in relation to patient recruitment of clinical trials and the need to implement new strategies to finally overcome what has been called ‘the most difficult and challenging aspect of clinical trials.’
The phenomenal growth and utilization of online social networks has created a range of new opportunities for recruiting patients into clinical trials. Social networking is a valuable modern patient recruitment tool, which if designed and executed properly, has the potential to be a very effective method for generating pre-qualified patient referrals, targeting specific patient groups, and reducing costs.
The aim of this paper was to determine if this new social media innovation has been widely accepted by the pharmaceutical and CRO industry as a potential patient recruitment tool for clinical trials. The research has concluded that although there are vast recognized benefits to the use of social media for patient recruitment in clinical trials, there remains a hesitation within the pharmaceutical and CRO industry to fully embrace this new platform. It appears that until the issue of guidance from US Food and Drug Administration and other regulatory authorities is received, the pharmaceutical and CRO industry will continue to follow the wait-and-see-approach, leaving a potentially significant patient recruitment method as an underused resource.
The contract research organization (CRO) and pharmaceutical sector has woken up to the power of social media and the benefits it can bring to the drug research process. Patient recruitment is one of the areas of clinical research where social media could have a real impact (1). A new survey has revealed that e-patients are a huge untapped population of potential clinical trial participants, with more than 80% of patients online interested in participating in clinical trials (2).
One of the biggest barriers that CRO and pharmaceutical companies face while conducting a clinical trial is recruiting patients to participate. “An estimated 85% of clinical trials experience delays in patient recruitment and some estimates suggest that one month of delays can account for $40 million in lost sales for a new approved prescription drug.” (2). Low rates of recruitment and retention during a clinical trial can have a number of negative implications:
However, social media could play an important role in reversing this trend. Social networking sites like Facebook and Twitter now have the ability to not only help companies spread the word about a specific trial, but they can also help reduce the cost per patient while targeting specific demographic populations (4).
A clinical trial is a study designed to determine if a new drug or treatment method is both safe and effective. Clinical trials involving new drugs are commonly classified into four phases (see Table I). Each phase of the drug approval process is treated as a separate clinical trial. The drug development process will normally proceed through all four phases over many years; for example, for some cancer clinical trials, it may be necessary to continue to monitor the subject even when in remission, and, therefore, the duration of each phase and each clinical trial is dependent on the subject drug. As for more severe medical conditions, it is a challenge to have enough volunteers in the later phases of the clinical trial.
Table I: Four Phases of Clinical Trials.
There are a number of traditional methods available for patient recruitment. The two most common methods of patient recruitment are (5):
There are many steps involved in the recruitment strategy. Potential volunteers may be recruited using a variety of methods. The general strategies that may be employed at each site subject to country/site requirements are shown in Figure 1.
Figure 1: Recruitment Strategies.
The ultimate success of a clinical trial is dependent on efficiently recruiting suitable participants from the medical community to conduct the clinical trial and also recruitment from the general public to participate in the trial (5). “If we are to expedite drug testing and widespread availability of approved drugs, we must increase patient recruitment into clinical trials. There are many opportunities to encourage patients to enrol in clinical trials so they feel confident about their decision to do so. One way is to improve the way we communicate with patients and with other healthcare professionals about the importance of clinical trials.” (5).
Patient recruitment plays a major role in establishing the objectives and the ultimate success of clinical trials (3, 6, 7). Until publication in 1992, there had been “no systematic guide to use for recruiting human subjects for clinical studies” (8), even though one of the greatest challenges currently facing the biopharmaceutical industry is targeting the right patients and retaining their participation in clinical trials (5-7).
According to a report in 2001 by CentreWatch, it has been estimated that 86% of all US clinical trials fail to meet subject recruitment goals, and dropout rates of 15% to 40% are common (3, 9). It is therefore easy to understand why patient recruitment has been called “the most difficult and challenging aspect of clinical trials,” with flaws in recruitment identified as one of the weakest links in the new drug development chain and therefore one of the main reasons for the failure of clinical studies (3, 7).
Low patient enrollment rates can have several negative implications:
To improve subject recruitment to clinical trials, the barriers to recruitment and retention must be identified in order for appropriate strategies to be developed to overcome this ever-increasing issue (3). These barriers are already well recognized in the literature and may be classified into four broad groups (see Figure 2):
These findings highlight that there are many issues challenging patient recruitment within the current procedures that lead the way forward for investigating other methods such as social media as a patient recruitment tool for clinical trials.
Figure 2: Previously reported barriers to recruitment and retention (3).
Firstly, what exactly is social media? Social media can be defined as:
“A communications channel that can be integrated into a larger social marketing campaign, and includes all of the various activities that combine technology and social interaction between people. This can take many different forms including Internet forums, message boards, texting via mobile devices, blogs, social networks such as Facebook and MySpace, wikis, podcasts, pictures, and video. Social media is less about the actual technology, and more about the way it enables individuals to interact online.” (10).
One of the most valuable uses for social media in the field of clinical trials research is its potential to increase patient recruitment. It can be a very effective method for generating pre-qualified patient referrals and lowering the overall cost per randomized patient (11, 12). In 2009, Acurian, a leading provider of clinical trial patient recruitment and retention solutions for the life sciences industry, generated 54% of their pre-qualified patient referrals through social networking channels and proprietary online health channels (4, 13).
“Because of their global reach, social media platforms like Facebook (with over 300 million registered users), Linkedln (with over 140 different countries), and Twitter, which is growing rapidly, would be ideal vehicles for recruiting clinical trial participants” (14). This highlights the potential gap available for patient recruitment by utilizing the facilities available through social media.
A study was carried out which outlined five advantages of using online tools to collect patient-reported data to monitor drug use. These were identified as follows 30:
It took only nine months from initiation of the tool (March 2008) to the first public sharing of preliminary results (December 2008).
There is a potential to rapidly recruit widely dispersed patients with rare conditions and to overcome selection bias favoring patients living near specialist centers.
Clinical outcome data were passively collected from thousands of patients who served as potential matched controls.
Online studies have lower marginal costs per patient as compared with thousands of dollars per patient in traditional trials.
Patients who submitted data using the PatientsLikeMe website were connected with other patients, which may have a range of benefits.
“For the moment, the Internet is not a panacea, nor has it replaced the more traditional forms of patient recruitment such as TV, radio, and magazine advertising. Rather, it is part of an integrated approach; one tool in an armory of different tools, albeit a useful one, with growing potential.” (16).
“Online communities in which patients monitor and submit data on the effects of novel drugs can accelerate pharmaceutical research by increasing the number of participants, and reducing the cost of conducting clinical trials.” (15). Companies are now starting to access online discussions for valuable information that has the ability to:
PatientsLikeMe is the leading online community for people with life-changing conditions. It provides an online data-sharing platform for patients and is opening up new ways of testing treatments and speeding patient recruitment into clinical trials (18). PatientsLikeMe uses an approach called clinical trial awareness. It provides companies with an aggregated and anonymized data from its patient profiles and discussion forums.
Clinical trial awareness was launched in 2008 and has since been partnered with numerous pharmaceutical companies, ultimately leading to the expedition of clinical trial recruitment by an average of six to eight weeks (19). “Novartis has used PatientsLikeMe services to recruit patients for clinical trials of a pill alternative, called Gilenya. Novartis received Food and Drug Administration approval for Gilenya in 2010.” (17).
The National Cancer Institute (NCI) has developed a mobile application, [email protected], that is available for certain mobile handheld devices (20) (see Figure 3). It allows users to:
Acurian is one of the leading companies in the patient recruitment and retention industry. Incredibly, on average, Acurian reduces enrollment timelines by four months (21). Patient Recruitment and Retention is one of the services provided by Acurian, which includes:
An increasing number of patient referrals that Acurian generates come from online sources, including large health networks and social media platforms like Facebook and MySpace.
Figure 3: Examples of Two iPhone Screen Shots of [email protected]
Once deployed, they have a data-driven process to monitor, track, and report on every part of the program to ensure the chosen tactics successfully meet the patient recruitment objectives (21).
MediGuard.org was set up by Quintiles in 2007 and is an example of how social media is actively helping US patients manage their health through a free online service. With direct access to over 2.5 million clinically profiled, engaged patients, Quintiles directly invites the patients required by the protocol to participate in the observational study, completing enrollment in days rather than months.
A number of online social networking sites are gathering groups around particular disease types as a way of creating interest in clinical trials and the data they are collecting on members (21). With the right approach, experience, and tools, social networking channels have the potential to be cost effective and efficient patient recruitment tools that allow sponsors’ messages to be directly in front of selected, active and engaged audiences (11).
Social media is a powerful source for reaching patients engaged in their health. It offers unique access to patients actively participating in healthcare discussions online. However, implementing a successful social media campaign is not simply a matter of posting messages, adding links, and developing a fan page. The ability to communicate so easily makes social media communications reliably unpredictable and illusive, which in turn is causing unique challenges for the regulatory authorities as well as the companies they regulate, in particular with regards to advertising (22).
In December 2011, US Food and Drug Administration released a new draft guidance entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites (23). According to the guidance, many firms encounter requests for off-label information about their products through websites, discussion boards, chat rooms, or other electronic forums (23). The guidance states that “as these firms are regulated by the FDA and have their own robust and current information about their products, FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date information about the firm’s products.” (24). While this may not be the social media guidance many people were expecting, it is a step in the right direction.
While social media can be complex and challenging to implement, especially in support of clinical trials, it also holds tremendous, untapped promise (25). As the popularity of social media rapidly spreads throughout the field of healthcare, it will be essential for FDA and other regulatory authorities to issue guidance on how to navigate the complex and powerful tools of using social media for patient recruitment in clinical trials (26).
Emerging platforms for online collaboration are fundamentally changing the way pharmaceutical and CRO industries can work, offering new ways to engage with customers, colleagues, and the world at large. Social media is a powerful communication tool that has a significant impact on organizational and professional reputations. Therefore, an understanding of how best to use this ever-growing source of technology is essential for the correct application and utilization, particularly within the pharmaceutical and CRO industry where there is a web of regulations and guidelines to be followed and maintained at all stages.
A short online questionnaire was designed with the objective to establish the views of the CRO and pharmaceutical industry on the use of social media as a patient recruitment tool for clinical trials. The questionnaire was used to gain the views and opinions within the pharmaceutical and CRO industry with regards to their knowledge of social media and how they feel it could be used and applied within their company. A total of 200 questionnaires were sent out via email to a variety of both European and global pharmaceutical companies and CROs.
On review of the results obtained from the questionnaire, it became clear that there is a low level of awareness in regards to the use of social media as a tool for patient recruitment in clinical trials. This is evident from Figure 4, below, where 40% of respondents indicated a low level of awareness and only 15% indicated a high level of awareness. This was further confirmed with 65% of respondents believing that there is not a good knowledge or understanding of the potential uses of social media tools within the pharmaceutical industry.
Figure 4: Level of Social Media Awareness
Of the companies surveyed, there appears to be a certain hesitation towards the use of social media for patient recruitment. This is evident in the results where only 15% of companies that participated in the questionnaire use social media as a means for patient recruitment, with 45% indicating that their company does not use social media as a patient recruitment tool. However, 35% of respondents stated that they do not use social media currently but would consider it in future studies. This figure is expected to grow as the current concerns within the pharmaceutical and CRO industry are assisted by regulatory guidelines and uniformity and more companies branch out into the world of social media.
There are a number of patient recruitment methods currently available. Figure 5 clearly indicates that the current patient recruitment method of choice is using physicians/consultant/direct contact. This highlights the importance of incorporating a physician into a social media strategy, particularly as doctors are reported in surveys as the most trusted source by patients for clinical trial information. Blue Chip Patient Recruitment carried out a survey on “Engaging E-Patients in Clinical Trials through Social Media.” In this survey, e-patients were asked where they would turn to first to learn more about a clinical trial; 46% responded that they would consult a doctor as a first source (18).
Figure 5: Methods of Patient Recruitment
A total of 42.9% of respondents believe that social media has the potential to be used for specific disease areas. The following were described:
As previously highlighted, “an estimated 85% of clinical trials experience delays in patient recruitment and some estimates suggest that one month of delays can account for $40 million in lost sales for a new approved prescription drug.” (2). Therefore it was no surprise to see that reduction in cost (65% of respondents) and the ability to target specific patient groups (60% of respondents) were the key advantages recognized for using social media as a recruitment tool for clinical trials (see Figure 6), particularly when success stories can already be seen. For example, in 2009 Acurian generated 54% of their pre-qualified patient referrals through social networking channels and proprietary online health channels (3, 13). On average, Acurian significantly reduces enrollment timelines by four months (27). These results demonstrate that social media has the potential to be a valid and effective patient recruitment method.
Figure 6: Advantages of Social Media
An additional comment added as an advantage in the ‘other’ section included the ability to reach audiences who may not be using traditional methods. This comment highlights the changing times and how the internet has grown in both accessibility and demand. A recent study indicated that “24 of the 25 largest newspapers are experiencing record declines in circulation, yet over 1.5 million pieces of content (web link, news stories, blog posts, notes, photos, etc.) are shared on Facebook daily” (5). This, in turn, indicates the opportunity available to the pharmaceutical and CRO industries to utilize the ability to target such a large population through social media and the possibility overcome one of the greatest challenges for clinical trials that numerous studies have highlighted to be patient recruitment.
Figure 7 highlights the main concerns/disadvantages that are currently within the pharmaceutical and CRO industry. These results suggest that there are still a lot of concerns within the pharmaceutical and CRO fields that need to be addressed, particularly from a regulatory perspective. The main concerns highlighted were:
A number of interesting comments were added in the ‘other’ section including:
There are many concerns surrounding the topic of social media that, in turn, are causing companies to shy away from using social media to recruit patients for clinical trials. Addressing these concerns and establishing regulations and guidelines will allow companies access to the full array of benefits related to the use of social media with the knowledge that they are compliant with current regulations. This can be seen in the results whereupon 25% of respondents do not use social media as an option for patient recruitment due to a lack of understanding or expertise in this area and also 15% of respondents believe there is a lack of regulatory guidance available to them in order to use social media effectively.
Figure 7: Disadvantages of Social Media.
These concerns will hopefully be addressed once the FDA Draft Guidance on the Internet and Social Media is released. The guidance is expected to contain information on “how sponsors/investigators should incorporate links, respond to unsolicited requests, follow regulatory requirements when using tools associated with space limitations, fulfil post-marketing submission requirements, utilize online communications for manufacturers, packers, or distributors, and correct misinformation on the internet.” (10). This is particularly important considering that 55% of respondents indicated that they would consider the use of social media tools for patient recruitment if FDA and other regulatory bodies issued guidance. This suggests that companies are very much open to the use of social media and its benefits as a patient recruitment tool provided that there are quality and compliance guidelines in place.
An interview was also carried out to gain the views, knowledge, and opinions within the pharmaceutical and CRO industry with regards to the use of social media for patient recruitment. The volunteer recruitment manager of one of the leading global CROs who is currently using social media for patient recruitment assisted the research in gathering further information by participating in an interview. The company is a global provider of outsourced development services to the pharmaceutical, biotechnology, and medical device industries and specialize in the strategic development, management, and analysis of programs that support clinical development from compound selection to phase I-IV clinical studies.
The company in question has been using social media as a patient recruitment tool since February 2011. Their main reasons for not using social media to recruit patients for certain studies is “mainly that they don’t have a large enough audience yet in social media, although they recognize that if they can just get some growth in their Facebook fans and on Twitter they would be able to recruit for many studies.”
The main issues/concerns within their company in using social media for patient recruitmentare that “restrictions on study-specific postings don’t necessarily sound appealing as a Facebook or Twitter post; finding enough material to engage their fans/followers and keep them watching us; time for postings and limitations on who can post. Also, responding to open requests/questions can be tricky—they have to be sure they are responding with the proper verbiage and don’t deviate from it.”
They are beginning to find social media a big benefit and have seen growth, particularly on Facebook, with more fans liking their page and recommending them to their friends. They feel that social media will be a tremendous asset to them in recruiting previously unreached new participants, particularly younger people (under 30) for their healthy studies.
To date, this company has had no restrictions or issues with the regulators in relation to their use of social media to recruit patients for their clinical trials and have stated that they feel that social media will be a tremendous asset in recruiting previously unreached new participants. They believe that social media can be effectively applied to any disease recruitment, stating “they don’t see any reason why they wouldn’t try it—they already post every study on Facebook as soon as it is available, no matter what type of study it is.”
This interview highlights the benefits, confirms the concerns and issues reported in the literature survey, and confirms the results generated from the questionnaire regarding the use of social media as a patient recruitment tool. However, from this interview, it is also clear that social media can be successfully integrated into a company with benefits being observed after only a short period of time as an active recruitment method. Although like all new approaches, the pharmaceutical and CRO industry are being conservative in their approach to implementing social media as a patient recruitment tool.
A number of conclusions have been reached as a result of this study. The study has demonstrated that social media as a patient recruitment tool has not been fully embraced by the pharmaceutical and CRO industry to date. This study highlights the benefits and also confirms the concerns and issues regarding the use of social media as a patient recruitment tool. The opinion within the pharmaceutical and CRO industry appears to be that these concerns would be greatly reduced if FDA followed up on their promise to issue guidance in relation to the Internet and social media.
Unfortunately, it appears that until further guidance from FDA is issued, the majority of companies will continue with the “wait and see” approach and continue using traditional recruitment methods thus failing to improve the current clinical trial process and reduce the estimated 85% of clinical trials that experience unnecessary delays in patient recruitment.
However, it is also evident from this study that the industry recognizes the future significant role that social media will play regarding patient recruitment. The Mayo Clinic has demonstrated this by making record-breaking progress when they recruited all patients for a study of SCAD in just one week using a rare disease-specific social networking site (28). Liz Moench, president and CEO of MediciGlobal, believes that “patient recruitment is becoming patient engagement, and that companies must be comfortable with social media.” (28).
Companies such as Acurian that are currently using social media as a patient recruitment tool are encouraging others to take their first steps towards engaging in “one of the most promising and mutually beneficial online marketing activities: leveraging social media networks to drive clinical trial patient recruitment.” (12). Social networking sites have the ability to provide unlimited potential for companies looking to reach their core market, especially if they are small demographics that traditional methods failed to reach. “If they can help remove the large burden that companies have carried regarding patient recruitment, imagine what they can do in other areas of marketing and public relations. The sky is limit and this is only the beginning.” (5).
|CRO||Contract Research Organization|
|FDA||US Food and Drug Administration|
|NIH||National Institutes of Health|
The author would like to acknowledge the Dublin Institute of Technology for their assistance.