Emerging disruptive innovations for clinical trials have immense potential to benefit entrepreneurs and established companies alike. By adopting disruptive innovation, interventions can be made at each stage of the clinical development process to radically change and improve the way trials are designed and conducted, to the benefit of the industry and, most importantly, patient lives. Earlier this year, ICON hosted a panel session chaired by Nuala Murphy. During the session, three senior executives from leading pharma companies shared their views on ‘Disruptive Innovation,’ and provided insight into the challenges and barriers to innovation, the likely shape of clinical trials in the future and the important success factors to drive innovation in organizations.
Improving patient recruitment through destigmatization of clinical trials
From profiling patients to finding patients in novel ways, significant changes are occurring in how clinical trials are conducted. Historically, only about 3% of patients have participated in trials, however, many more would be interested in taking part if they had a mechanism to find information about the clinical trials for which they could potentially be eligible. Democratizing and destigmatizing clinical trials by putting patients at the forefront of the process has huge potential. Approaching patients directly via online channels, using decentralized clinical trial design and partnering with online companies are just some of the ways that we can change our traditional approaches. By doing so, the time taken for patient recruitment can be significantly reduced along with the cost to conduct the trials.
Direct-to-patient strategies
‘Disintermediation’, where a company goes directly to patients for clinical trials rather than going through intermediaries such as CROs or pharma companies, is an important development in innovation. For example, the genetic testing company 23andMe® is conducting clinical trials. Genetic profiling, which is now available at a cost of less than $100 per test, will significantly change how clinical trials are conducted because the cost enables every patient participating in a trial to be profiled.
Another area of growth is the use of decentralized or ‘site-less’ trials, a disruptive approach in which a trial is conducted connecting directly with the patient rather than a centralized trial site. Digital developments, such as the availability of a database of patients who are ready to take part in a trial, are set to have a significant impact in clinical trials and are another means by which the time required for patient recruitment can be substantially reduced.
Patient privacy and data protection
With the vast amount of data available, an important question is who owns it. According to a panelist, the pharma industry is very burdened with data privacy, but studies of patients’ attitudes indicate that they don’t care as much about their data privacy as one might expect. If patients think that sharing their data can improve their clinical condition or that of others, approximately 50–70% of people will be willing to allow their data to be part of a broader data consortium.
In terms of technology, blockchain is an important development for data privacy and protection and increasingly pharmaceutical companies have a position or initiative in this area. Blockchain is an excellent example of how patients can have control over their own data, a phenomenon which another panelist believes, “could completely transform adverse event reporting and pharmacovigilance so regulatory authorities around the globe will have more information on the drugs than they have ever had before.”
Choosing the right innovation and the right partner
When partnering with technology companies, two aspects are important: First, it has to be a true partnership, not just an investment in the company and second, an ecosystem has to be created within the pharma company that fosters innovation and ensures the partnership is successful. In large organizations, it can be difficult for people or departments to adapt to change, to take risks or to adopt innovation. It is important, therefore, it is part of the culture of the organization and is driven from the top.
Harnessing disruptive innovations to facilitate change
Disruptive innovations have potential to lower development costs, reduce time to market, and mitigate risk – yet they challenge companies to rethink the way they approach the entire spectrum of drug development. Pharma companies and CROs must embrace disruptive change and be open to learning about emerging technologies to optimize drug development and remain competitive as the field evolves.