The official theme of the 50th annual meeting of the Drug Information Association (DIA), which took place mid-June in San Diego, was generic enough: ‘Celebrate the Past – Invent the Future’. But a look at the keynote speaker and several of the sessions indicates that the future of clinical trials is rapidly changing. Patients and clinical research sites will play a more prominent role in trial design and implementation. Pharma is destined to share control of the trial process with others.
For readers not familiar with DIA, the 18,000-strong group identifies itself as "the global connector in the life sciences product development process". Its annual meeting, like those held throughout Europe and Asia, is a marketplace of information and ideas.
And the San Diego Convention Center, a vast white steel and glass waterfront complex, was an ideal setting. Thousands of energetic DIA attendees from around the globe shuttled from presentation rooms to exhibition hall and back with levels of energy that could more than power the centre’s electrical needs. At the core of the structure stood a panel on which well-wishers could write congratulatory messages celebrating DIA’s 50th. It filled quickly.
Learn from experience
Jamie Heywood is co-founder and chairman of PatientsLikeMe, a for-profit that aligns patient and industry interests through data-sharing partnerships. He was also DIA’s keynoter. His message about his organisation, which has 250,000 patients in various PatientsLikeMe communities, was that "everyone learns from the experience of everyone else on every meaningful variable that can affect the outcome, in real time, across the whole medical system".
The organisation converts information from its registered patients to de-identified data and sells it to drug, device, insurance and other companies involved in product development and coverage. Among other benefits, this patient-to-company process helps speed the development of new and relevant solutions for patients.
‘Bringing the patient voice to clinical development’, ‘how patients will transform healthcare’, and ‘filling the gaps and speeding up results: what an educated, sophisticated patient population can do for you’ were among sessions exploring greater patient involvement in understanding, accessing, monitoring and sharing personal health data.
Asked about patient involvement in a ‘town hall’ meeting run by FDA’s Center for Drug Evaluation and Research (CDER), an FDA panellist said: "We welcome it. However, there is no average patient and the interests of the individual patient may not represent all patients in the disease category."
Research sites also are organising and taking other measures to have greater clout. A significant example comes from the Alliance for Clinical Research Excellence and Safety (ACRES).
ACRES describes itself as a non-profit global clinical research coalition committed to enhancing quality, safety, integrity and operational effectiveness in drug development and health research. During the DIA meeting, the group announced a programme that would establish a global accreditation system for clinical research sites worldwide. The fast-tracked effort plans to build and test a suite of standards that would be used with personnel, facilities, management, and information systems, as well as other areas of the clinical site enterprise.
In describing the effort, ACRES president and CEO, Greg Koski, PhD, MD, said that standardisation and accreditation for sites – there are over 80,000 worldwide – would result in more consistent quality and trial outcomes. "This will also provide sites with more field input in the trial process, which we believe will be helpful to sponsor and site alike."
Research engine
Patient input and site standardisation are two of many factors representing change in trial design and execution. Another on the minds of many DIA participants was facilitating secure use of the internet for the myriad aspects of the R&D process.
"We support external collaboration, and collaboration is what is happening across biopharmaceutical R&D," explains Vijay Takanti of Exostar. The company, which has roots in the aerospace and defence industries, is rapidly expanding into the life sciences, providing identity hub services to over 500 organisations including Merck, AstraZeneca, Charles River Laboratories, other large CROs and 50 research universities. "With the level of success we have experienced to date supporting the pharma industry, we are seeing significant interest from other life sciences consortiums that need to collaborate across multiple organisations."
Essentially, an identity hub is a way for organisations with many external collaborators to manage cyber-identities, regardless of which side of the firewall they occupy. "It adds security and it adds trust, and without either it’s impossible for effective collaboration to occur," says Takanti.
During DIA, Exostar announced a collaboration with SAFE-BioPharma. The arrangement will enable Exostar to issue a form of digital identity credential compliant with the SAFE-BioPharma standard. This will allow participating companies to leverage a single, standardised, and globally trusted identity credential providing business partners, outside researchers, government agencies, and others with secure access to cloud-based information assets such as proprietary toolsets, analytics, and other internal and external applications.
"Whether it is a patient, a site, a CRO or a business partner, effective internet-based collaboration is all about the ability to trust the people on the other side of the screen and to exchange documents and data securely," explains Mollie Shields-Uehling, president and CEO, SAFE-BioPharma.
The SAFE-BioPharma digital standard was developed to make secure and trusted internet communications possible within the biopharmaceutical and healthcare sectors. It was conceived by IT experts on loan from their Big Pharma employers and developed with significant input from FDA and EMA.
In short form, the standard sets ground rules for issuance and use of digital identity credentials that are uniquely bound to the proven identity of the person to whom the credential is assigned. Once issued, the credential can be used for many purposes, including the application of legally binding digital signatures to electronic documents. Digital identity credentials compliant with the SAFE-BioPharma standard are interoperable, meaning they will be recognised, trusted and accepted by any company or other entity participating in the standard, by all US Government agencies, even within other industries supported by similar standards.
Sign, seal, send
Not long ago, EMA announced that it now requires digital signatures on certain submissions and uses them on all outgoing correspondence requiring a legal signature. Among the agency’s requirements for a digital signature are that it must be applied with an identity credential that is closely bound to the user’s proven identity and that the identity must be provisioned by a member-state certification body. Digital signatures made with identity credentials compliant with the SAFE-BioPhama standard meet those criteria.
"In many ways, we are the behind-the-scenes lubrication that helps the gears and pulleys of the pharmaceutical industry run smoothly," explained Shields-Uehling, as she visited exhibitors and met with other industry leaders at DIA.
One of those exhibitors, Verified Clinical Trials, is using de-identified credentials to track all participants in clinical trials. A specific area of need is in trials using controlled substances, where patients are known to double or triple-enrol in order to gain access to opioids and other addictive medicines. "Multiple enrolment at different sites can compromise study outcomes," says company president, Mitchell Efros. "Helping manage participation is one of the many roles our technology plays in the trial process."
Another exhibitor, InnovoCommerce, a leading source of eClinical collaboration products and solutions, is using standardised identity management to improve effective trial collaboration. According to Daniel O’Connor, company president and chief business officer, standardising identity management under a single global standard allows sponsor companies to manage collaborative exchanges with sites in ways that lead to far greater productivity, quality, and compliance.
And Verizon, the telecoms behemoth, showcased a unique application that physicians can use to sign e-prescriptions for controlled substances, a function in the US requiring a digital identity credential that is closely bound to a user’s proven identity.
Network detected
Like other large meetings, DIA’s annual event feels longer than its three core days. It’s an all-consuming experience with a wide range of satellite meetings and events. For some organisations it’s a time of celebration, as shown by a number of large-scale receptions and parties. MediData hosted its dinner in the USS Midway Museum, a decommissioned aircraft carrier. One pier away, ERT and TransPerfect held their ‘castaway’ party, the likes of which may have caused a serious spike in next morning’s Starbucks sales.
The meeting was a time to learn, to sell and to network. It’s the networking that sticks with this observer. Collaboration is a form of networking, but it’s only effective when all parties can trust the identities of the others. DIA may have gathered for a few days in San Diego where people who work with each other may have met face-to-face for the first time. When they return to their respective roles in their many locations, connections will be over the phone and online, where they are represented by their cyber-identities.
Whether they are patients and their representatives playing an expanded role in designing trials, sites aspiring to higher levels of professional standards, CROs engaged in managing increased outsourced responsibilities, or the multitude of companies helping streamline processes and improve outcomes, they are all internet-dependent. Being internet-dependent increases our need to know – and trust – the identities of people on the other side of the screen. Without a system of standardised internet trust, the gears simply stop working.