Last week, the Drug Information Association held its 51st Annual Meeting. As one of the largest conferences in our industry, DIA covers a wide range of topics over the entire spectrum of drug development, and it would be nearly impossible to provide a comprehensive accounting of the meeting. However, I will try to share the most notable trends and themes from the meeting.
Clearly, one of the biggest take-aways from DIA was patient-centricity. While for many of us patients have long been the motivation for the work we do, patients now are playing a central role throughout the drug development process. In addition to their roles as patients in clinical trials and eventual consumers, patients increasingly are participating in all aspects of development, from study design to advisory committee meetings. As we make this transition, patient advocacy groups can be powerful allies in reaching out to patients.
Some keys to patient outreach and involvement are relevance, logistics, and psycho-social components. For patients to be on-board with trials, they need to understand why a study is relevant. Patients need to see the link between how their participation now can lead to improvements in treatment in the future. Often, patients are interested in the outcomes past their own participation. Keep them updated as trials complete and results are available.
Patients can also provide useful insights on logistics. What may seem like minor considerations to scientists and others involved in study design, could be significant when it comes to patient participation. Logistics around scheduling, childcare, and uncomfortable procedures can be a study’s downfall if patients aren’t willing to sign-up or eventually drop-out because of inconveniences.
There are psycho-social issues that should be considered for certain patient populations and conditions. For example, it is likely that diabetics would have little concern over using an injectable treatment. Many have already used injectable products or have at least considered the need to use them in the future. On the other hand, patients used to oral dosing may have objections.
Finally, one suggestion made by a patient advocacy group at the meeting was to have all members of the clinical study team spend a day with a patient from the population being study. Understanding their daily routines and struggles can provide important insights.
Social Media is Big—And Getting Bigger
Nearly every track featured at least one presentation on social media. We are now moving past theoretical uses to real world applications in patient recruitment, medical information, safety monitoring, and even regulatory agencies.
Use of social media is becoming commonplace in patient recruitment. In addition to being a more cost effective option when compared to traditional media like broadcast, radio, and newspaper ads, it also allows for better targeting and reporting. For example, social media allows you to show ads only to those within appropriate demographic groups. Even demographic groups previously considered poor targets for social media, like the elderly or lower income populations, are increasingly online in one way or another. Additionally, Sponsors and CROs have largely found ways to address regulatory and privacy concerns.
Medical Information is another area where social media use is increasingly common. With several FDA guidance documents now in place, Medical Information professionals’ perspectives on social media are changing. Patients making contact with pharmaceutical companies are being seen less as a risk to respond to and more as an opportunity to engage proactively. While companies should still be careful to present scientifically-based balanced information, social media can provide an opportunity to correct faulty information and even respond to questions about off-label use in a non-promotional way.
Safety monitoring is another area primed for growth in social media use. With the question of how to deal with adverse event reporting through social media largely handled—be prepared for it and treat it the same way you would treat reports coming in through traditional channels—product safety professionals are turning their attention to ways they can use social media to improve patient safety. Dr. Ran Balicer of the Clalit Research Institute is pioneering a system to identify safety signals in social media and compare it to information being reported by clinicians and to regulators.
Regulatory agencies are embracing social media as well. FDASIA Section 1138 instructs the FDA to create a communication plan to better inform and educate consumers with a focus on communicating with underserved sub-groups. The working group at FDA is relying on social and digital media to build the core of this program.
Despite incredible growth in outsourcing over the past 20 years, Sponsors still struggle with the right balance of outsourcing models. Both Sponsors and CROs report dissatisfaction with outsourcing relationships. Strategic relationships aren’t delivering the promised cost and time savings. The number of companies entering into strategic alliances and functional service provider relationships has been steadily growing over the past few years, yet virtually all Sponsors admit that they are still making outsourcing decisions (full service, FSP, or niche providers) on a study by study basis.
One major challenge identified by several speakers is the ability to select key performance indicators (KPIs) that both accurately measure the CROs performance and those for which CROs are prepared to provide the data necessary to produce the metric. Existing KPIs have largely been selected because they are easy to measure and report on regularly, but they are often a better measure of the study design and the Sponsor’s ability to manage the relationship than they are a measure of the CROs performance. However, ability to produce metrics and willingness to be transparent continue to be make-or-break for Sponsors when it comes to selecting preferred providers, entering into strategic alliances, and picking functional service providers.
eSource, eTMF, and Risk-Based Monitoring
Perennial favorites, there was no shortage of presentations on the topics of electronic trial master file (eTMF) solutions, eSource and electronic data capture (EDC), and risk-based monitoring. Although eTMF has been a hot topic for a number of years, adoption is still slow. Many companies are considering implementing an eTMF, but most are still using paper systems, network file systems, content management systems, or a combination. However, growing Sponsor expectations for remote access to TMF documents combined with improved audit readiness will continue to push CROs in this direction.
On the other hand, risk-based monitoring has become a reality for many studies. Companies have been investing in tools and processes and regulators continue to show support. As a result, more studies are taking advantage of the benefits of risk-based monitoring.
Although it has seen widespread (and in some instances near complete) adoption, EDC has left many feeling it hasn’t lived up to expectations. It hasn’t reduced significantly the cost or time of trials. Because much of the information clinicians need to record during study visits isn’t recorded in the CRF, information is still being recorded in one place and then transcribed into EDC. eSource—a combination of ePRO tools, EHR/EMR integration with EDC, and other electronic sources—offers new hope to deliver on the original promise of EDC.
Were you there? If so, use the comments to let me know what you thought were the most important take-aways from DIA this year.