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There are several significant issues coming together to blunt the impact of social media on the design and running of clinical trials. The concerns are essentially:

● Reporting of serious adverse events (SAEs)
● Confidentiality of patients
● Privacy and data protection
● Interacting with patients within social media
● Coercion and manipulation of patients

Coupled with a lack of detailed guidance from regulatory agencies on some of the key uses, these concerns are creating a barrier to full or rapid implementation of social media tools within the pharmaceutical industry. What is missing is a clear idea of the benefits of social media, which are hard to articulate and value. And, of course, if we do not even experiment, then a full exploration of the advantages is hard to achieve, further unbalancing the equation.

Despite few specialist organisations experimenting with the use of social media, there are many initial benefits, including:

● Patient empowerment – giving patients access to trials, even if their physicians are not participating
● Community-based trials – reducing the impact of trials on a patient’s life
● Improved protocol design
● Advanced protocol site planning
● Faster recruitment and better retention of patients

To enhance the cost-benefit assessment of these tools, we need to explore how to maximise the benefits and minimise the risks.

Risk Reduction


Reporting of SAEs

This is, in truth, a separate issue to using the tools for recruitment and retention which, on their own, have little or no impact on SAE reporting. The occurrence of a potential SAE arising in social media conversations is already with us – regardless of whether we use social media tools for recruitment or not. How to monitor and report them is a problem that needs urgent resolution across the trial world.

A lack of full guidance from regulatory agencies makes assessing this issue complex and risky for companies. But that should not stop us from using social media tools to enhance trials, as doing so will not make the situation any worse or more complex. Some companies are already testing out social media listening tools for SAE reporting, and the informal feedback is that the impact on workload is manageable.

Confidentiality

Social media tools have the potential to allow trial managers to find individual patients who might be appropriate to recruit into a study. Maintaining their confidentiality, however, is simply a matter of setting codes of practice and implementing external regulations; no different from the issues already addressed when using other large data systems to identify patients, such as prescription data. Typically, then, the terms of use of a tool should state that patients cannot be individually identified, and should be treated in aggregate, using regions such as postcodes as the smallest area to which patients can be identified.

Privacy and Data Protection
This is a related concern, but is particularly powerful as society in general grapples with the issues of privacy in social media. The UK courts recently dealt with a case concerning accusations of child abuse circulated widely on Twitter, naming a famous politician who turned out to be innocent. One of the main contributors to the rumour was successfully sued for libel, along with others responsible for propagating the remarks.

Although difficult to enforce, it laid a clear precedent that social media is no different from any other form of publication in the public domain. For our purposes, this means that what is published on Twitter – and other similar forms of social media – is public information and can be treated as such. There remains a concern that people who use these media may not realise this is the case, and do not wish their posts and public elements of their profiles to be used by third parties. This, however, is simply dealt with using the same rules that apply elsewhere: that the data used should only be from sources where the author has explicitly ‘ticked a box’ to make the data available.

Interacting with Patients
Thankfully, since June 2014, regulatory guidance – at least by the FDA – has been issued in the area of interacting with patients through social media, specifically how to promote products using media with limited characters (for example, through Twitter or SMS). The principle is that all such interactions need to include assessments of both the benefits and the risks, although it is acceptable to refer to sources of risk data in these formats rather than detail them each time.

Despite not being explicitly directed at trial recruitment information, the principles should hold. Coupled with previous statements from the FDA that it regards social media and similar in the same way as traditional media – and that the rules can be applied identically – we now have a workable environment for interacting with the public about the potential to recruit into trials through social media and the internet.

Coercion

Although coercion seems to be an issue in our discussions within the industry, when looked at in detail it is already dealt with adequately in other measures. The rules about the promotion of trials still apply, and to enter a trial the patient still has to undergo a detailed and highly-regulated process of informed consent. This should ensure that all potential patients are given the chance to make their own mind up about screening for a trial, with time to consider the decision and a clear opt-out clause that confirms that their medical treatment will not be affected if they do not eventually consent.

In summary, the concerns are actually quite manageable. SAEs guidance simply needs to be dealt with by regulators – but their continued delay actually makes no impact on the ability to use social media for other purposes. Confidentiality is adequately dealt with by other regulations on the use of personal data from long-standing major data sources, such as prescription data. Likewise, coercion is already fully dealt with. Privacy has also been addressed in the law courts and, clearly, the rules that apply to any publication apply in social media too. Overall, the uses of social media data are, in fact, quite clear and no different from those we are used to dealing with every day.

Maximising the Benefits

Protocol Design
Imagine this: you are writing a trial protocol and want to understand how attractive or otherwise it might be to potential patients. You have access to huge arrays of data on what people are saying about the trials that are already out there, what works well and what works poorly. You can also add information to that environment by asking people’s opinions about using certain types of comparative agent, durations of disease and previous therapies, for example, and then watch the conversations in the media discussing those questions and generating responses. These would come from doctors and nurses, as well as the general public. Your protocol design would be fully tested before it ever got to the sites for implementation.

Site Planning

Once you have finished designing the trial, you would be able to access the social media data to look at hundreds of billions of conversations and information elements that people are publishing about themselves. This would contain information on their conditions, the drugs they are taking and more, and enable you to pinpoint a large subset of high-quality screening candidates for your trial who are actively looking for studies to participate in.

You would know roughly where they lived, at least down to the postcode or city, what countries to go to with up-to-date global epidemiology data collected over the last 6 to 12 months, as well as exactly where to put your sites, and what patient access they had without ever having to ask them in cumbersome questionnaires. You would also be able to find the sites that are able to do the trial work.

Faster Recruitment

After the protocol is designed, the distribution of sites is planned and investigated, and actual sites are signed up, it is possible to reach out to potential patients with ethics committee-approved search engine campaigns. Companies are able to advertise, in a highly targeted way, on trusted internet and social media sites that patients use to access information, and launch Twitter campaigns to bring the trial to the attention of the right patient populations, by using hashtags proven to be those used by the target patient groups. At the end of that process, a screening website would be created, or contact information for a call centre would be issued, so that patients could put themselves forward for the trial.

Patient Empowerment

Today, only a small percentage of patients have access to trials; only 6% of physicians take part in studies at any given time, severely limiting patient access. Using social media and the internet will remove that barrier almost completely. If the patients themselves do not have access to the internet, then their spouse, children, friends, or even their doctor or nurse will, giving huge coverage of possible patient populations.

Community-Based Trials

These types of trials can reduce the impact on patients’ lives and, in these scenarios, sites become less critical. Access to patients is direct, so they can be referred to any chosen site, and those that produce the highest quality work. No sites will fail to recruit and far fewer sites will be needed. The patients will mostly be seen in their own homes by visiting nurse teams and physicians, and their local physicians will be fully informed of the trial, the patient’s data and their experience.

Giving patients access to trials directly and reducing the impact of the trial on their lives by running it in the community makes them much more likely to be aware of the study and consent to be screened. With this model, recruitment will accelerate dramatically.

Retention

Patients stay in trials in which they feel engaged. This is improved if they can communicate easily with their trial team. Sites and sponsors can provide data to patients, answer their questions and assess their health status, as well as reminding them to take their drugs, attend the clinic and complete their electronic patient-reported outcomes. This can be through tweets, research using Facebook pages, and so on. Retention leads to lower initial recruitment as drop-out rates reduce, there is greater duration of therapy, on average, and therapy compliance improves, along with many other benefits.

Just the Start

The advantages of using social media are huge – and we are only just beginning to understand them. It enables the testing of protocol designs, planning of country and site participation, and allows companies to reach out directly to patients to implement trials, improving the ability to run a study on time and on budget.

Of course, the concerns are real, but are entirely manageable and can be eliminated with a bit of thought and care. Using social media is inevitable, so companies may as well start now.

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Dr Graham Wylie is Chief Executive Officer at the Medical Research Network (MRN), and is responsible for both company strategy and making the MRN stand out from the competition. With a BSc in Pharmacology, an MBBS from St Bartholomew’s College London, and more than 21 years of experience in the pharma industry with names such as Pfizer, PAREXEL and Healthcare at Home, Graham has successfully grown MRN from a two-person start-up. As Managing Director of Healthcare at Home’s clinical trials division, he led the management buy-out to create the MRN in 2006.

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