Lisa Howe is a biomedical scientist at ICON plc. She received her Masters in Pharmaceutical Quality Assurance and Regulation from Dublin Institute for Technology.

Lisa Howe, MsC

This post was reposted with permission. It originally appeared on

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:

Inadequate accrual of subjects may result in the termination of the trial (3).

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. 

Current Patient Recruitment and Enrollment Procedures

There are a number of traditional methods available for patient recruitment. The two most common methods of patient recruitment are (5):

Through direct advertising campaigns by the sponsor or advertising agent to the potential participant

Directly through the investigators practice. 

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.

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). 

Current Difficulties that Challenge Patient Recruitment

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:

More expensive clinical trial in which extra resources may be dedicated to the recruitment effort

Longer duration of clinical trial, which lowers morale of staff and participants

Less statistical power for the study and validity of the results (7).

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).

Where Does Social Media Fit into Current Practices?

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 

 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).

Examples of Current Companies using Social Media as a Patient Recruitment Tool for Clinical Trials

“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:

Identify trends in patient symptoms and outcomes

Spot complications with drugs and drug interactions

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, 

, that is available for certain mobile handheld devices (20) (see Figure 3). It allows users to:

Find and identify relevance and share information about cancer clinical trials

Link directly to the NCI’s Centre for Cancer Research (CCR) clinical trial database

Access detailed information about studies being conducted at the NIH Clinical Centre

Articles

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€™

Lisa Howe, MsC

Articles

Clinical Trials and Social Networking