Innovation in clinical trials – What’s the future of patient recruitment?
Clinical trials sit at the core for answering important scientific questions, advancing medical research and improving outcomes against diseases. Patients are at the heart of clinical trials. They are the real “end users” of the drug that is being investigated and whose well-being matters the most. Needless to say, patient recruitment and retention is fundamental for the conduct, completion and the eventual success of a clinical trial. No patients – no clinical trials, no new drugs, surgical procedures or devices and thus no advancement in science to combat diseases. Despite such paramount need, recruitment in clinical trials remain as one of the biggest issues plaguing the industry. The data is there and the numbers are astonishing. According to the National Institutes of Health (NIH), more than 80% of clinical trials in the US fail to meet their enrollment timelines. Retention of study subjects is at an all-time low with average drop-out rates being 30% across all clinical trials1. For each day a pharmaceutical or biotech company goes beyond the planned deadline for a clinical trial it stands to lose millions of dollars in expected sales. Such implications go even beyond the financials; delays significantly hamper innovation and medical progress.
“No patients – no clinical trials, no new drugs…”
Judging by the numbers, it comes as no surprise that drug companies and CROs are spending significant amount of time and money towards increasing patient enrollment and retention. Relying on the investigators to find suitable patients is simply not enough. Pharma companies must adopt digital health tools and go directly to the consumer. Powerful social media networks and smartphones can be used to increase company relevance and help drive patient acquisition and retention.
Healthcare organizations and pharmaceutical companies must take digital health seriously as a tool to attract, engage and retain patients. Smartphones are slowly becoming the no.1 device for consumer attention replacing television, radio etc. By 2020, 67% of 65+ seniors who use the internet will also have smartphones. Consequently, the adoption of mhealth – wearables, mobile apps, etc. is also increasing amongst seniors. Among the 65+ population, wearables adoption has grown by 264%, more than 5 times faster than general population8. A recent research showed patients are getting more and more comfortable communicating with providers via digital channels: 83 percent of patients are comfortable communicating via mobile apps, 77 percent are comfortable with texts, 75 percent are comfortable with online chat, and 69 percent of patients are comfortable with video chat7. These numbers will only continue to increase as technology advances and as millennials and future generations’ age. In the next decade or so, wearables will advance by not only acting as data providers for an individuals health at a single time point but also as consultants/coaches providing 24/7 real world, real-time analysis of your health and suggestions to be the healthiest version of yourself. Patients are relying more and more on digital health tools to understand their health.
This recognition of the advantages of digital health has kick started collaborations between pharmaceutical companies and digital health tools which has led to increased patient recruitment and engagement in clinical trials.
PatientsLikeMe is a health network for patients to connect with others, find new options for treatments and contribute data for research. One of the aims of PatientsLikeMe is to provide its commercial partners a platform to increase clinical trial awareness by allowing targeted messaging about trials for which patients might be eligible for based on the data they have submitted through their profiles. Last year, Biogen and PatientsLikeMe collaborated on a study to investigate whether patients with multiple sclerosis found it useful to track their activity using FitBits. Within a day of launching the study, 248 patients had been enrolled and 77% completed the study and follow-up survey. Collaborations like these benefit both the patients, who get accelerated access to clinical trials, and pharmaceutical companies who get a boost in patient recruitment, improved clinical trial timelines and thus save millions of dollars.
There have also been instances where digital health devices have been used by research sites to recruit a large number of people who might be willing to participate in future trials. Using Apple’s ResearchKit framework, a group at the Icahn School of Medicine at Mount Sinai in New York, developed a free Asthma Health app. The app was downloaded by 50000 people and it enabled users with asthma to participate in a large-scale medical research study entirely through their iPhones. The study enrolled more than 8,600 participants within six months without any direct, in-person contact with researchers2. The app also helped widen the geographic reach of the study; 87% of the participants enrolled did not live near the study site in New York. This highlights the potential digital health has in significantly improving the efficiency of clinical trials saving time, money and resources. Participating in a clinical trial where patient has to travel long distances often acts as a deterrent for the patient especially if it requires multiple visits. “Virtual trials” through mobile health allow all patients to participate regardless of geographic location. This not only ensures geographic diversity in patient populations but also results in a clinical trial requiring less sites, investigators and other operational costs.
The phenomenal growth of social media in spreading information and creating communities is undeniable. It has created a wide range of opportunities for recruiting patients into clinical trials. From Facebook, Twitter to Snapchat, Instagram and YouTube, social media is where the patients are and that offers sponsors an avenue to engage directly with them. 72% of internet users look online for health information, however, only 3% of pharmaceutical promotional spending goes to digital channels4. According to Accenture report, 63% of 65+ seniors use the internet and 47% of them use social media in 20158. A recent report shows that millennials, who are also the world’s largest generation, are present across all social media platforms such as Facebook, Instagram, Twitter, Snapchat etc6. Another report shows YouTube can be a strong resource for patient recruitment and engagement. It has a billion active users and it reaches more 18-49 year olds than any cable networks in the US. 35% of Gen X, 49% of Gen Y & 70% of Gen Z watch videos on YouTube on a daily basis and only 4% of Gen X, 2% of Gen Y & 1% of Gen Z doesn’t use the platform at all5. As Gen Y & Z ages, they will rely more and more on social media for health related information than ever before.
A group at The Hospital for Sick Children in Toronto, Canada analyzed the impact of social media on the recruitment of pregnant women in an ongoing randomized, open-label clinical trial. This study assessed the effectiveness of social media as a recruitment tool by comparing it to traditional recruiting methods. In Phase 1 of the study, only traditional healthcare-based sources such as posters, ads and brochures were used for recruitment. In Phase 2 of the study, the traditional methods were used and social media was added as a supplementary source. In the first phase of the study, with over 56 months of recruitment using traditional sources, 35 women were enrolled in the study. However, in the 6 months implementing recruitment through social media, 45 women were recruited representing a 12-fold higher rate of mean recruitment per month3.
This shows how far the pharmaceutical industry lags behind towards understanding consumer behavior and using it to drive patient recruitment. Following that, the question becomes how do sponsors leverage these platforms to drive patient recruitment? The answer is: by driving consumer engagement and wielding influence. Social media can be used to share research and get the word out about a clinical trial device or treatment that patients may not know about. For example, Twitter can be used by sponsors by tweeting out a headline (containing the hashtag of the drug and the disease) and linking the tweet to an article regarding the particular trial. Facebook being the no.1 social media platform can be used as an effective tool to get important information out to the audience by using Facebook Ads or using various Facebook disease groups to get the word out for a particular trial that may benefit that patient population. Creating effective videos about a certain trial and sharing it on YouTube as well as Instagram and Snapchat stories will allow pharma companies to reach a wide range of audience. The idea isn’t to use all these platforms to coerce patients but rather to drive engagement and discussion thus creating more awareness about a trial for which a particular patient or even a physician might not have been aware of before.
As technology advances and users, healthcare providers and pharmaceutical sponsors work together, we will see a seamless integration of all digital health tools in clinical trials. This will lead to faster, better and extremely efficient clinical trials resulting in faster breakthroughs and thus faster drug discovery and development.
- Lee SM. How an iPhone Medical Research App Is Helping People with Asthma. BuzzFeedNews. September 29, 2015.
- Shere, Mahvash, Xiu Yan Zhao, and Gideon Koren. “The role of social media in recruiting for clinical trials in pregnancy.”PloS one9.3 (2014): e92744.
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