It takes an average of 12 years for a medicine to make it to market and, regardless of the molecule’s Fast Track or Breakthrough Therapy status, the medicine must make it through the rigors of clinical trials before it can be marketed and sold.
Clinical trials rarely are completed on time; some sources suggest only 6% achieve their initial timeline. Patient recruitment delays average 4.6 months per study; for the average sponsor that can add up to a cumulative loss of 26 years.
In order to speed up the lethargic patient recruitment process, two things need to happen: People have to be aware of clinical trials and people must be willing to participate in them. Patient recruitment strategies have evolved to become more focused on how and where they target and message potential candidates. And while more patient recruitment is being conducted online to speed up the recruitment process, not everyone is on board.
How one learns about a clinical trial opportunity is scrutinized by lawyers, privacy officers and regulatory bodies, so the opportunity must be presented in a way that is neutral and free of coercion. Clinical trial sponsors traditionally tend to err on the side of caution and are extremely conservative in their interpretation of legal matters relating to the online recruitment of human subjects. According to a 2014 report from the Tufts Center for the Study of Drug Development, “Inhibiting faster adoption of social media in drug development has been a lack of regulatory guidance, particularly from the FDA, and concerns about the impact of social media on research integrity.” The report also found only one in five companies that use social media are directly interacting with potential study participants.
There is great innovation and technical advancement that can help speed up a trial, but people are proceeding with implementation very cautiously, due to concerns about patient confidentiality and unwarranted influence on potential study volunteers to participate in trials.
The basis for the concern relates back to the HIPAA (Health Insurance Portability and Accountability Act) privacy rule, a federal law that requires appropriate safeguards to protect the privacy of personal health information and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization. The privacy rule also gives patients rights over their health information, including the right to examine and obtain a copy of their health records. Having a patient sign a waiver authorizing an entity to use his or her information may take care of the majority of patient privacy concerns.
But there still is an elephant in the room. What if a patient willingly discloses personal health information in a social media outlet? How is that covered? How can you appropriately contact that person? With the advances in technology and little guidance on the appropriateness of the use of these advanced recruitment methods—such as social media listing or crowdsourcing—these methods are not being used to their full potential.
Once a patient learns about a trial opportunity and decides to consider participating, he or she still must agree to participate, which includes the legal contractual process known as informed consent. Informed consent includes an explanation of the patient’s rights, the purpose/use of the patient data and the risks and benefits of study participation. The purpose is to provide the patient enough information to enable a voluntary decision about participation.
Within this process, an Informed Consent Form (ICF) is executed and serves as a comprehensive legal and regulatory document that spells out the contractual rights of the study participant. The execution of the ICF is required to initiate screening or participation in any clinical trial. This process has traditionally been paper based, but advancements in the process have allowed information to be delivered via tablet with great success over the past few years. Besides creating a better user experience and enhancing the understanding of procedures with visuals, video and animation, tablet-based consent provides additional benefits including better data analysis and ease of re-consenting. So why aren’t sponsors using eConsenting for all of their studies? I suspect concerns stem mainly from small budgets and “we have never done it like that before” mindsets.
With the increased use of technology as a way to learn about study opportunities and to simplify the informed consent process, are legal and regulatory professionals staging comprehensive guidance to support a wider range of activities born from technology? In many cases, innovation is stifled by lack of regulatory guidance and a reluctance to not move forward without rules. In this environment, innovation can march forward, but its slow adoption and implementation will prevent its true efficiencies and limit its true potential.
Ashley Tointon directs patient engagement programs at ePharmaSolutions. She has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry.
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