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Speeding up [email protected]

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Clinical trials play a crucial part in ensuring that a drug comes to market and even more so towards affirming the safety and efficacy of the drug in question on the people it would impact the most – the patients. Even as the industry is going through its own set of trials and tribulations, the patient remains both the end user as well as at the core of the strategy. It then helps to understand how to enhance patient involvement in the process and utilise this towards making trials successful.

Tapping users, upping enrollment

It was perhaps with this in mind that a team of cardiologists, led by Dr Sharonne Hayes at Mayo Clinic turned to patient-run websites dedicated to heart conditions in order to recruit survivors of SCAD (spontaneous coronary artery dissection, a heart condition which affects fewer than 200,000 Americans annually). The novel recruitment method helped researchers assemble “large and demographically diverse patient groups more quickly and inexpensively than they could using traditional outreach methods,” the study noted. 18 participants lined up in less than one week, six more than those eligible to participate in the 12-person pilot.

The Internet might have brought the world closer, but challenges remain still. A 2011 Pew Internet report titled “The Social Life of Health Information” found that 62 per cent of Internet users and 46 per cent of adults use social media. While the number of users has increased to 85 per cent in 2013 with 72 per cent of those using social media to access health information, enrollment figures by Cutting Edge Information reveal that an estimated 80 per cent of trials fail to meet enrollment timelines, with half of them enrolling one or no patients.

“CROs and IT companies need to play a proactive role to make this happen. There is a need to make it patient centric, so that patients enrolled in a trial feel a sense of ownership.”
Ashish Dutt
Director, COO Bioquest Solutions

Ashish Dutt, Director and COO, Bioquest Solutions cites an instance of assisting a Europe based company for a trial of a drug which got stuck in Singapore, with one of the major reason being the non availability of patients. Social media then plays an undeniably important role in reaching to the patient and engaging them in the process. “This can be done either by seeking to acquire people to easily penetrate patient community or going one step further by engaging a patient enrolled in a trial,” he adds.

Sponsors and CROs have been traditionally using physician referrals and mass media advertising to reach and solicit patients, however, enrollment figures remain low. “With almost one third of clinical trial budgets spent for patient recruitment, cost is not the only prohibitive factor. There is a logistical challenge as well. Many clinical trials are delayed due to lack of enrollment, and increasingly pharmaceutical companies need to look beyond traditional methods of patient recruitment, exploring new avenues and potentially lowering cost while still increasing clinical trial participation,” pitches in Ruchi Dass, Founder and CEO, HealthCursor Consulting. Quintiles took a lead by launching Mediguard, which provides free medication safety monitoring to 2.6 million registered users worldwide as of today. The mediguard app launched earlier this year provides users information about potential adverse reactions from multiple medicines and a pill reminder which can be set for hourly, daily or weekly alerts. Clinical research.com, another initiative from the company provides social networking opportunities and information about clinical trials to 2,50,000 registered patients.

“The key to successfully leveraging your social media networks is identifying the studies’ core variables to help decrease the chance of running into problems, such as frustration or wasted recruitment budgets, because like any tool, social media is only as useful as the appropriateness of its application.”
Ruchi Dass
Founder, CEO, Healthcursor Consulting

Dass cites an example of Vancouver-based company Qu Biologics which recently harnessed social media to recruit patients and successfully get a lead for a phase I/II trial of its novel site specific immunomodulation treatment for Crohn’s disease- QBECO SSI. The company has a dedicated Twitter account @QuCrohnsTrial, along with a similarly focused Facebook page which share information about the trial as well as general information on Crohn’s disease. Launched in August 2012, the Twitter account has notched up more than 1,000 tweets, rising above the trend of new accounts starting well but quickly falling into disuse.

Strategising and crafting the blueprint

“There is a lot of information on clinical trials in the public domain with websites such as ctri.nic.in and clinicaltrials.gov which provide details on trials being conducted and can be accessed by anyone. Is that not social media?”
Sauren Das
Executive Director, Excell Life Sciences

The landscape in India is yet to warm up to the idea. “There is a lot of information on clinical trials in the public domain with websites such as ctri.nic.in and clinicaltrials.gov which provide details on trials being conducted and can be accessed by anyone. Is that not social media?” argues Sauren Das, Executive Director, Excell Life Sciences. He does accept that Twitter and Facebook are not being utilised as much in India as they are to this effect in the West. Perhaps this has to do with the fact that it is not difficult to find patients in India.

“Evidence-based informational websites like Centerwatch are doing really good in India as well. A leading source of clinical trials information for both clinical research professionals and patients, CenterWatch currently has one of the largest databases of clinical trials with listings in 20+ therapeutic areas representing more than 650 medical conditions in 58 countries,” chips in Dass.

However, just having a social media presence is not enough. The Mayo Clinic study helps us understand that certain key factors are necessary for a successful outcome. These include a positive brand association allaying any fears of the study not being genuine, a motivated patient population organised as a online forum coupled with a disease/condition that is unique(SCAD), favourable patient demographics relative to the study and no geographic constraints. Designing such a campaign thus is much more than placing an ad on social media, it requires a continous dialogue and strategy monitoring. Online forums are a great platform to recruit study patients. They allow potential patients and their loved ones to access information and connect with others in similar situations as well as keep the conversation going by creating a place where people who applied but didn’t qualify for a trial aren’t left feeling abandoned and may remain open for a different trial. In turn, this continues to build upon a targeted pool of potential participants that may be needed in the future.

Dass offers a few tips to help get the most out of social media. “The key to successfully leveraging your social media networks is identifying the studies’ core variables to help decrease the chance of running into problems, such as frustration or wasted recruitment budgets, because like any tool, social media is only as useful as the appropriateness of its application. Another important aspect is the quality of communication. To engage potential patients and their families or advocates, information about clinical trials must be translated in a way that is easy for the average, non-medical person to understand,” she says. For instance removing medical jargon (instead of using the term hypertension, just use high blood pressure), breaking down complex concepts and putting a human face to the study.

Dutt feels that safety might be a concern for patients who’d rather prefer to go to the doctor. “CROs and IT companies need to play a proactive role to make this happen. There is a need to make it patient centric, so that patients enrolled in a trial feel a sense of ownership,” he says. Das also echoes cautious optimism. “While it is a cost effective strategy to reach out to the masses and spread awareness across a wide geography, the flip side is that only the tech savvy ones who have access to the Internet or television can participate. Retention can be an issue since patients coming via this medium are from far off places which may in turn lead to a much larger enquiry coming in from all ends on hearing/seeing the news in the media,” he cautions. In the end, social media for patient recruitment remains a challenge, one that might be formidable but equally rewarding should it be tailored strategically.

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