Phase I Recruitment Issues
Subject recruitment in all phases of clinical research can be costly and time consuming, but it can be especially problematic in Phase I studies. Phase I trials primarily test for safety, so they tend to pose greater risk than later phase studies. Furthermore, participants in Phase I trials do not experience any therapeutic benefit from treatment, unlike patients in Phase II through IV trials. The relatively high risk of experiencing an adverse reaction and the lack of health-related incentive makes recruiting subjects for Phase I trials particularly difficult.
A variety of approaches are typically used for patient recruitment, including print ads (newspapers, magazines, newsletters, medical journals, and phone books, among others), radio or TV ads, and clinician and patient referrals (word of mouth). The problem with most of these current options is that, along with being tedious and expensive, they simply do not reach enough people or a diverse or broad enough population. This leads to the next issue in the recruitment process: incentive to participate. Typically, Phase I studies offer monetary compensation as the only incentive to participate in the study. Offering a monetary incentive results in a high percentage of low-income study participants, which in turn produces a population sampling that may not be representative of the general population.
It is clear that the traditional – and outdated – methods of recruiting subjects do not target a diverse enough group of people, and a majority of the time these methods do not obtain enough participants. Phase I trials are delayed more often than not due to lack of suitable candidates. These delays could end up costing the sponsor millions, which is why researchers are eager to experiment with new recruitment tools such as social media. In 2013, the Tufts Center for the Study of Drug Development announced that 37% of all sites in a given trial fail to meet their enrollment targets, with more than 10% never enrolling a single patient. Given the poor success rates, it’s obvious that current recruitment strategies are inadequate, and need to be reviewed.
The Power of Social Media
Social media has the potential to be a powerful tool in the clinical trial recruitment process because of its low cost and ability to reach a diverse and broad audience. In 2014, Facebook boasted over 1.2 billion monthly active users, Twitter had 255 million, LinkedIn was at 187 million, and 77% of internet users read blogs (Bennett, S). These numbers outweigh the traditional recruiting numbers in every way. This capability is something that one-sided print/TV ads or even clinician/patient referrals cannot provide: access to diverse cultures, age groups, gender, and income levels.
People often connect over medical issues online, as can be seen on sites like WebMD, Mayo Clinic, and Medline Plus, and these are just the top three that come up on a Google search. MedlinePlus even provides a tool to find current clinical trials that are being conducted on a particular disease. MyHealthTeams, a website that hosts social networks for diseases such as epilepsy, Crohn’s, and COPD, provides an excellent example of using social media to recruit patients. In 2014, MyHealthTeams partnered with Biogen Idec, a pharmaceutical company, to screen and recruit patients for inclusion in Biogen clinical trials. After partnering with MyHealthTeams, Biogen was able to go from screening only 6 patients a week to screening about 400 per week. Biogen’s success in using social media in patient recruitment will hopefully help to incentivize other’s to follow their lead.
How to Use Social Media Effectively
Here are a few tips on how to effectively use social media in your trial:
- Find the correct forums and networks to effectively target the right audience for the trials;
- Learn about your target audience through analytics and insight;
- Utilize sites like Facebook and Twitter, which are both tools that can be used for instant communication with your target audience, and can trigger sharing throughout online communities;
- Create positive brand awareness online to encourage trust, as many people can be wary of what they see online;
- Make sure to target the correct geographic areas when creating a social media campaign (this is possible if using Facebook, Twitter, or LinkedIn campaigns).
There are very clearly defined benefits to utilizing social media when recruiting for clinical trials. A smart strategy would be to integrate social media into already existing print, radio, and TV ads, along with clinician referral. Utilizing the right combination of all available methods will be the key to the future of successful recruitment in Phase I clinical trials.
Sources and Further Reading:
Andrews, Christine. “Social Media Recruitment.” Applied Clinical Trials (2012).
Bennett, Shea. “Social Media Stats 2014.” Social Times (2014).
Elliott, C. “Guinea-Pigging.” The New Yorker (2008).
Gearhart, Jim. “Clinical Trial Recruitment Using Social Media is Growing.” Quorum Review IRB (2015).
Griesel, Dian. “Clinical Trial Recruitment in the Digital Era: Some Smart Ideas.” Applied Clinical Trials (2015).
“Patient Recruitment: is social media the cure for this headache?” Clinical Accelerator (2015).