MMS Holdings (MMS) – an award-winning, data-focused CRO – announced today the launch of Automatiqc™ (pronounced: automatic). Automatiqc is a new cloud-based application that automatically performs quality control (QC) and style checks for medical writing, pharmacovigilance, clinical trial transparency, and other types of documents in the pharmaceutical, biotechnology, and medical device industries.
Automatiqc has proven that it can reduce QC time by up to 33 percent, drastically reducing the amount of time needed to perform quality checks and allowing teams to meet aggressive QC deadlines.
This new application is highly customizable, enabling users to tailor the software to specific client style guides including journal requirements and other established guides. Automatiqc does not require special training and can be easily incorporated into a medical writer’s standard workflow. Automatiqc can be used for any Microsoft Word-based document type including, but not limited to:
Clinical Study Reports (CSRs)
Protocols and Investigator’s Brochures (IB)
Module 2 IND and NDA submission documents (M2.5, M2.7.1, M2.7.2, M2.7.3, M2.7.4, M2.7.5, and M2.7.6)
Module 5 Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS)
Health Authority Responses and Response to Queries (RTQs)
Safety Narratives and Risk Management Plans (RMPs),
Publications for peer-reviewed journals and more!
“MMS is constantly searching for new, impactful ways to bring innovations, and efficiencies to the pharmaceutical industry, and I think we’ve proven that with the introduction of Automatiqc,” said Michelle Gayari, Executive Director, Global Operations, MMS. “The current focus for many is related to reducing budget and timelines – Automatiqc does both. We designed this perfectly programmed application to utilize our pharmaceutical industry intelligence to improve the QC process for everyone. QC is the final step before release of a document to regulators or the external environment and this efficiency allows us to be nimble to adapt to last-minute document changes.”
Using Automatiqc is easy, part of the workflow, and customizable.
“QC reviewers may need to check hundreds of style points per document; using Automatiqc ensures that every point in the style guide is checked, for every document, every time, consistently. Manual QC by different reviewers is prone to subjectivity and error – even with established guides,” said Kristin Chesney, Senior Operations & Quality Specialist, MMS. “Years from now, teams will wonder how deadlines were met without it.”
Now available!
This new application is currently available for use through a service relationship with MMS or licensing of the application as software-as-a-service (SaaS).
Syneos Health, the fully integrated biopharmaceutical solutions organization, introduced FSP 360, an evolved FSP model that provides access to the industry’s to a broad range of traditional and non-traditional FSP capabilities.
“As customers look to consolidate outsourced clinical solutions, traditional static FSP models no longer meet their unique scientific and operational demands,” said Paul Colvin, President, Syneos Health Clinical Solutions.
FSP 360 provides a range of capabilities through combining traditional service functions including monitoring, project management, safety/pharmacovigilance and data services, with non-traditional capabilities including investigator payments, eTMF, site contracts, feasibility and study start up. Engagements are scalable based on where a customer is in their outsourcing evolution.
With our evolved model, engagements can be scaled based on where a customer is in their outsourcing evolution. Ranging from accessing functional excellence to quickly meet specific project-based needs, to a multifunction FSP providing a combination of capabilities across an entire portfolio, FSP 360 achieves speed, quality and efficiencies.
This model is a hybrid solution that stands alone or in combination with full-service outsourcing. When combined with Syneos Health’s best-in-class Commercial Solutions, including consulting, regulatory and market access capabilities, we can further optimize customer outcomes.
An essential part of our Biopharmaceutical Acceleration Model™ (BAM), this comprehensive clinical continuum delivers what today’s customers need most — an end-to-end clinical partner committed to strategic solutions designed to accelerate performance.
Unrivaled scale and experience – wherever you need it
Syneos Health has more than two decades of FSP experience and expertise. This foundation fuels innovation to deliver new models while realizing efficiencies — leveraging thousands of lessons learned.
June 27, 2019 | A major step forward in making clinical trials less onerous to conduct has been recent sponsor focus on “reducing the amount of paperwork and bureaucracy” put on sites, says Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). Companies have started using shared data platforms, so they already have a lot of the information traditionally asked on site feasibility questionnaires.
Follow-up. Site Selection Visit. Feasibility Questionnaire. Confidentiality Agreement (CDA) First Contact. Site Selection Process.
Narrowing the scope of feasibility questionnaires by leveraging data that is available in tools like the TransCelerate Investigator Registry is an emerging industry trend. “As we invest more in technology we are going to be able to get a lot of that information on our own, and then hopefully get to the point—if we continue with site feasibilities at all—where we only send a four- to five-question survey narrowly focused on more unusual study-specific requirements,” says Lorena Gomez, director of global study startup and essential documents at Allergan. “The industry is absolutely heading in that direction… especially companies already using the Shared Investigator Platform [of TransCelerate], where sites are able to maintain facility and investigator profiles that contain much of the information that was historically gathered via feasibility questionnaires.”
Nurse and Patient Panels
Reliance on lengthy site surveys began to wane at AstraZeneca in 2017, coinciding with a new approach to gathering insights to inform protocol design and conduct and enhance the study experience for patients and sites, says Michele Teufel, the company’s patient and site engagement lead in development operations. The company began proactively seeking input from site nurse and patient panels, and study teams started reviewing draft study protocols and patient support materials with nurses. Many of the recommendations made by study teams were adopted—including simplifying the patient consent form, furnishing a patient study visit handbook and website, reimbursing patient travel costs and providing WiFi access at sites.
Building on existing internal and external data sources for feasibility and site identification, AstraZeneca last year piloted the use of real-world data (RWD) in a federated electronic health record (EHR) platform to identify potential patients and study sites, says Sandra Smyth, director of the company’s global feasibility and recruitment group. The RWD comprises more than 75 million live EHRs from more than 100 hospitals in 20 countries via licensing agreements with InSite and TriNetX. For some EHR-identified sites, feasibility surveys became “smarter and simpler,” focusing on areas where reliable information or data was unavailable, she adds.
The study team for a recent pediatric study used EHR platform to find five new suitable and interested sites with 250 potential eligible patients within two weeks, Teufel adds. “These sites are in progress for start-up.”
AstraZeneca is now developing a new digital data-driven feasibility and site identification tool, known internally as Merlin, to integrate multiple data sources onto one platform, says Smyth. Its introduction is part of a transformation program it calls “Our future reimagined” that aims to “optimize the use of data, speeding up the delivery of medicines to patients and freeing up scientists’ time for innovation.”
Merlin’s data sources currently include the company’s internal clinical trial management system, IxRS, Citeline, and ClinicalTrials.gov, says Smyth. The list will “continuously expand” to including RWD (e.g., claims and EHR) and data related to prevalence and incidence, publications and drugs. “There will be ongoing curation of data and the ability to apply predictive modelling,” she adds.
Smyth describes key features of the new platform as follows:
Single, global optimized site and investigator list that meets quality thresholds and study constraints
Optimal scenarios predicting activation, recruitment speed, and cost
Early indication and landscape feasibility to quickly pinpoint potential countries
Predicted randomization rates and reference studies
Automated workflow to incorporate local country intelligence to use in balance with data
In addition to reducing the manual effort in merging disparate data sources and data analysis, Smyth says, Merlin’s expected benefits also include greater focus on strategic feasibility planning at the program level less time spent coordinating feasibility surveys across high-volume sites at the study level. More informed, data driven decision-making will be balanced with real-time targeted site and patient survey, and local validation of sites, by final protocol—all of which translates into increased data integrity and speed in bringing potential new medicines to patients.
AstraZeneca is partnering with an external vendor for the initial build of the platform, Smyth says, and first features should be implemented by the end of 2019.
Certification Matters
As has been recently uncovered, how “professionalized” sites are matters a great deal when it comes to choosing investigators, says Kremidas. An analysis by WCG found that study coordinators who were ACRP-certified did significantly better at enrolling patients and had far fewer protocol deviations. Principal investigators who were ACRP-certified similarly perform better.
Study results were presented last June at DIA 2018, says Kremidas, and are starting to get the attention of sponsors and CROs. “The study coordinator in particular is absolutely critical to the success of a trial… sites with ACRP-certified coordinators, generally speaking, perform in the top quartile.”
Kremidas hypothesizes that where investigators are certified, study coordinators are as well because “the site supports that mindset of professionalizing the role.” A study a few years back found that sites with certified coordinators did better than those without them, as did sites with certified rather than non-certified investigators, but sites that had both saw a statistically significant difference in performance. “Consider the coordinators air traffic controllers,” he says. “You want those people to be professional and you want them to have qualifications.”
The ACRP certification process is evolving to stay in step with changing roles in clinical research, Kremidas says, as reflected in the recent additions of a category for “certified professional” and a new subspecialty designation specific to project management. Soon to be added is a new certification for “medical device clinical development,” he adds.
Less than 10% of all investigators and coordinators are currently certified, “which is a shame,” Kremidas says. All other types of healthcare interaction—even a manicure and haircut—involve licensed professionals. “But there are literally no qualification requirements for clinical study coordinators, zero, nothing. It’s scary.”
Hopeful Signs
One important development, beyond improvements to the site feasibility process, is “clinical research as a care option”—a concept being formally explored by healthcare institutions around the country, says Kremidas. The idea is to expedite referrals from primary care physicians to specialists conducting studies appropriate to the condition and needs of patients. Several new-to-market organizations, including Javara and Elligo Health Research, are trying to help institutions expand access to trials in this way. “It could revolutionize the industry quite significantly.”
Many people don’t have access to adequate healthcare, notes Gomez, and as clinical research has become “demystified” over the years, more of those patients have been getting referred to a trial as a care option. Recruitment into studies should also improve if more sponsors identify trial sites based on where patients are already going for care.
“If a site has loads of patients but is not engaged in clinical research, there are now several vendors that can help to place a coordinator there,” Gomez says. Some companies have successfully used this tactic to build a rapport with research-naïve investigators and gain access to an untapped pool of patients.
IQVIA has a vast ecosystem of data streams to tap when looking for new sites, says Allen Kindman, IQVIA’s vice president of clinical planning and analytics. Sometimes it’s a registry that provides “an unusual insight about what’s going on at an institution or with a disease,” and in other cases consumer data that might “help mold how we do site selection,” including how sites and geographies get preferentially ranked.
While all sites like to think of themselves as high performers—the so-called “Lake Wobegon effect”—some investigators truly don’t need any help, says Kindman. They “enroll far more than anyone else and their quality is far higher. They’re just well set up and highly motivated.”
The data, algorithms and methodologies IQVIA is putting in place can “turbocharge” even the great performers, says Kindman. But he expects the greatest impact to be on the performance of investigators who “should be hitting their targets and just don’t.”
The view of Laura Galuchie, director of global clinical trial operations at Merck, is “no single approach is going to work for every company.” Feedback from multiple sources is required to find the best fit between protocol and site, she says, “which at the end of the day is a win-win-win for everyone involved—sponsor, sites and patients.”
Aside from chemotherapy, radiation, surgery and now immunotherapy to kill cancer cells, researchers have investigated using heat, or hyperthermia, to kill tumors. Naturally, it’s not as simple as applying a hot object to a tumor. New approaches include heating tumors by injecting nanoparticles that can heat up when a magnetic field is applied.
Researchers at Oregon State University recentlyimproved on a technique using magnetic nanoclusters. These nanoparticles are one-billionth of a meter in size, but once injected into a tumor, they are then exposed to an alternating magnetic field (AMF). This causes the nanoparticles to hit temperatures exceeding 100 degrees Fahrenheit, killing the cancer cells. Their research was published in May in thejournalACS Nano.
“There had been many attempts to develop nanoparticles that could be administered systemically in safe doses and still allow for hot enough temperatures inside the tumor,” stated Olena Taratula, associate professor of pharmaceutical sciences at OSU. “Our new nanoplatform is a milestone for treating difficult-to-access tumors with magnetic hyperthermia. This is proof of concept, and the nanoclusters could potentially be optimized for even greater heating efficiency.”
Nanoclusters are exactly that, clusters of nanoparticles. In this case, they are hexagon-shaped iron oxide nanoparticles treated with cobalt and manganese that are then transported via biodegradeable nanocarriers.
Other studies have shown that magnetic hyperthermia at moderate temperatures makes cancer cells more susceptible to chemotherapy, radiation and immunotherapy.
The researchers, Olena and Oleh Taratula, worked with mouse models of ovarian tumors that had been grafted beneath the skin of the mice. To move forward with the research, Olena Taratula indicates they will need to use animal models where the tumors will be inside the animals where they would actually be in the body.
The authors stated in the article, “Despite its promising therapeutic potential, nano-particle-mediated magnetic hyperthermia is currently limited to the treatment of localized and relatively accessible cancer tumors because the required therapeutic temperatures above 40° C can only be achieved by direct intratumoral injection of conventional iron oxide nanoparticles. To realize the true potential of magnetic hyperthermia for cancer treatment, there is an unmet need for nanoparticles with high heating capacity that can efficiently accumulate at tumor sites following systemic administration and generate desirable intratumoral temperatures upon exposure to an alternating magnetic field (AMF).”
This is similar work to what was being conducted by Angl Apostolova and colleagues from the University of Architecture, Civil Engineering and Godesy in Sofia, Bulgaria. They studied magnetic hyperthermia using several nanoparticles of iron oxide (ferrite) which included tiny amounts of copper, nickel, manganese or cobalt atoms, which is called doping. They published their work in the journal, The European Physical Journal B.
They studied their approach in both mice and cell cultures, evaluating two different heat-generating methods, direct and indirect. One of their surprising findings was the absorption rate increased as the diameter of the material increases—which does sound completely nonintuitive. They found that as long as the doping level was high enough and the diameter of the nanoparticles didn’t exceed 14 nanometers for cobalt and 15 nanometers for copper, the absorption rate increased as the particle diameter increased.
Hyperthemia therapy appears to work if the nanoparticles are absorbed well enough by the cancer cells but not by healthy tissue. The two different methods studied were related to how the heat is actually generated.
This morning, Illinois-based AbbVie announced it will acquire Ireland-based Allergan for $63 billion in a cash and stock deal. The acquisition is expected to be “transformational” for both companies, AbbVie said.
Richard Gonzales, chairman and chief executive officer of AbbVie, said the acquisition of Allergan achieves “unique and complementary strategic objectives” for both companies. In a statement outlining AbbVie’s proposal, Gonzales said combining the two companies will allow AbbVie to diversify is business, while “sustaining our focus” on scientific research and the company’s pipeline, which includes the top-selling drug, Humira.
In its announcement, AbbVie noted that a deal this size, in comparison to smaller “bolt-on” deals, is designed to deliver immediate scale to the company’s growth platform and also meets its strategic goal to reduce reliance on Humira, which has been the primary cash cow of the company.
“Smaller bolt-on acquisitions provide opportunities for future growth, but also require significant R&D investment amid scientific and clinical uncertainty. This transaction offers immediate compelling financial and strategic value to our shareholders with a much lower risk profile,” AbbVie said.
For Allergan, which includes the tent-pole of Botox and a strong migraine treatment pipeline, an acquisition has been years in the making. At one time, Allergan was a target for acquisition by Pfizer. However, that deal was called off due to the implementation of new regulations from the U.S. Department of Treasury regarding tax inversions. Since the 2016 termination of that deal, Allergan has repeatedly been rumored to be the target for acquisition, particularly as its stock slipped for several quarters in 2018, in large part due to generic competition in the U.S. As a result, some shareholders have called for changes to its board of directors.
Brent Saunders, chairman and CEO of Allergan, said the acquisition will lead to a company with combined revenue of approximately $48 billion this year. The combined companies generated $19 billion in operating cash flow in 2018. The two companies will have a strong pipeline in multiple therapeutic areas and “robust cash flows.” Saunders also said the combined companies will be able to make larger contributions to global health than either company could on their own.
“Our fast-growing therapeutic areas, including our world-class medical aesthetics, eye care, CNS and gastrointestinal businesses, will enhance AbbVie’s strong growth platform and create substantial value for shareholders of both companies,” Saunders said in a statement.
AbbVie said the combined companies will have several strong franchises across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care and virology. Allergan’s product portfolio will be enhanced by AbbVie’s commercial strength, expertise and international infrastructure, the company said.
AbbVie also noted that the acquisition of Allergan will benefit shareholders through significant cash flow generation and said the deal is expected to be 10% accretive to adjusted earnings per share over the first full year following the close of the transaction, At peak, Allergan said accretion could be greater than 20%. AbbVie’s enhanced growth platform is expected to grow at a high-single-digit annual growth rate well into the next decade, from more than $30 billion in 2020, the company added.
Unlike the proposed Pfizer deal that would have seen that company move its headquarters to the U.K. for tax benefits, the combined AbbVie and Allergan will maintain principal executive offices in North Chicago, Ill. Gonzales will continue to helm AbbVie as chairman and CEO. Two members of Allergan’s Board, including Saunders, will join AbbVie’s Board upon completion of the transaction.
Under the financial nuts and bolts of the deal, Allergan shareholders will receive 0.8660 AbbVie shares and $120.30 in cash for each Allergan share they hold. That will provide a total value of $188.24 per share of Allergan. When the deal is finalized, AbbVie shareholders are expected to have an 83% stake in the combined companies and Allergan shareholders will have a 17% ownership. AbbVie is expected to generate significant annual operating cash flow, which will support a debt reduction target of $15 to $18 billion before the end of 2021.
Sponsors recognize the advantages of using a single system to handle all trial operations, but progress from theory to practice has been slow, a new survey shows.
Software company Veeva Systems’ recent survey of clinical trial professionals about the benefits of unified clinical operations — single centralized technology systems that handle all operations tasks — points out the major problems created by using disconnected systems for individual functions.
The top two challenges the 461 respondents identified are the direct result of keeping data siloed in disparate systems, Veeva’s report says. Integrating multiple applications was the top problem, cited by 68 percent of respondents, followed by difficulty reporting across multiple applications, chosen by 57 percent.
Respondents reported experiencing problems with tracking and reporting data (71 percent), misfiled or missing documents (57 percent) and manual document exchange (47 percent).
CROs responding to the survey reported more challenges with misfiled documents than sponsors (59 percent and 54 percent respectively) and with redundant data transcription (43 percent and 33 percent respectively). Veeva suggests the difference could be due to CROs’ greater use of paper and email to exchange trial documents with sites.
The adoption of unified systems would break down silos and make information exchange and collaboration easier, says Veeva vice president of clinical marketing strategy Jim Reilly.
“What the idea of unified clinical technology is saying is, let’s change the dynamic where pharma, CROs, sites alike end up looking at individual technology solutions that solve individual business needs in clinical,” Reilly says, “and instead move to a more unified model where they can leverage more modern technologies that bring together what has historically been disparate full sets.”
The survey shows widespread agreement among respondents that implementation of more integrated technology can address the primary problems that slow down the clinical trial process — reliance on manual processes, ineffective collaboration with sites and lack of visibility into and oversight of clinical trials.
Unified clinical operations help improve oversight and visibility according to 70 percent of survey respondents. Speeding up trials was cited by 63 percent as a benefit of unified systems and smoother collaboration with stakeholders was named by 61 percent.
Outdated methods also are bogging down trials, the survey shows. The problem is notable particularly in the study start-up process; 81 percent of respondents said they still use spreadsheets to manage study start-up tasks. In the current climate, sites often have to manually respond to sponsor and CRO surveys and frequently end up sending redundant information to the sponsors and CROs they work with on multiple trials.
But some progress is being made. Nearly one-quarter (23 percent) of survey respondents say they are using newer, purpose-built study start-up applications.
Among function-specific electronic systems that have replaced manual work, the most prevalent are electronic data capture (EDC), which 88 percent of respondents reported using, followed by electronic trial master files (eTMF) at 69 percent and clinical trial management systems (CTMS) at 61 percent.
Almost all respondents (95 percent) cited the need for better use of CTMS. Improved reporting topped the list of reasons to modernize CTMS use at 68 percent. Increased trial visibility was on 60 percent of respondents’ wish lists and enabling proactive risk mitigation came in at 58 percent.
The environment is ripe for change, according to Reilly. “There is a significant industrywide opportunity to improve study visibility and partner collaboration to speed trial execution. As more sponsors, CROs and sites focus on streamlining clinical processes and systems, drug development will become more efficient and stakeholders will be better aligned throughout the trial lifecycle.”
Health Canada released new guidance that the agency hopes will make it easier to study the off-label benefits of drugs in clinical trials.
Canadian regulations currently require any treatments purchased for clinical trials for their off-label properties to be designated “investigational drugs.” But Canadian officials worry that’s adding unnecessary hurdles that slow life-saving or life-changing research.
Under the new guidelines, Canadian officials will ask a series of questions about a given treatment before deciding whether it has to be designated an investigational drug, including:
Does the drug have “an established safety profile when used off-label in the study population;”
Is it being used as part of a comparator arm in a clinical trial, as supportive or rescue therapy, or whether it’s part of a standard therapy “that another investigation drug is being used to supplement in the investigational arm of the trial;”
Is there any uncertainty about the risks and benefits of the off-label use;
Is the drug already authorized in Canada and will trial doses will be bought in Canada;
Does the off-label use increase the risks for patients beyond the normal risks of taking the medicine; and
Is it “otherwise clear that the drug to be used off-label is not being tested in the clinical trial.”
Sponsors will have to provide the proposed off-label drug’s Notice of Compliance or Drug Identification Number and explain what the original indication was for. They also will have to explain the proposed off-label use in the trial, how the proposed use is “consistent with current or recognized medical practice,” why the off-label use shouldn’t be considered as a separate clinical trial, and the risks of off-label use, the agency says.
An experienced CRA may follow all the rules and requirements for writing a site monitoring visit report (SMVR), but there are nuances that can make the difference between a report that simply follows that formula and one that really paints a picture its audience can understand.
Roslyn Hennessey, senior project manager at Westat describes the ideal SMVR as “a snapshot in time of what’s happening at the site.” To develop that snapshot, start by asking who will read the report, she advises. There are several types of audiences for SMVRs, all of which have slightly different interests:
The sponsor wants to know about the performance of the site — is it in compliance with the protocol, are improvements needed, are there any major concerns;
The PI and site staff want to know if additional training or procedural changes are needed;
Regulatory authorities and auditors want to know if the site is in compliance and, if not, what corrective action was taken;
Future monitors need enough information to ensure a smooth hand-off from one CRA to another.
It’s important to give all of the key stakeholders the “heart or the core of the information that they are most interested in,” she says.
And although an SMVR should be comprehensive, it also needs to be concise to avoid burying important information or tiring the reader. Writing an SMVR is an exercise in deciding what information needs to go in and what needs to stay out.
“We really need to get more efficient in terms of going just from point A to B,” she says, “but in that A to B, we need to include some important things.”
Hennessey recommends starting at the end. A monitor usually will have an overall message to convey in the report and should choose the information that supports that message. “Know what you want to say ahead of time and write to your conclusion,” she says. “What do I need to say to get me to that conclusion?”
Be analytical in what you write, she advises. A good SMVR is more than an “information dump.” When writing the report, provide the reader with some context instead of just transcribing notes. Explain what those notes indicate, Hennessey urges. Look for common denominators in the findings and identify root causes of problems. Pay attention to trends, from a single visit and across several visits.
In addition to being analytical, an SMVR should be objective. Elizabeth Weeks-Rowe, a clinical research training consultant, advises SMVR authors to keep the human factor in mind. A monitor may encounter many different personalities in a trial, but they should not be reflected in the site report.
“Taking the emotion out of verbiage is critical,” says Weeks-Rowe. “Be factual, not emotional.” If, for example, a principal investigator is less than professional, this impression should not be included in the report. Instead, address any outcome of that behavior. Making sure that all findings are actionable helps avoid an emotional narrative, she says.
Hennessey notes that an attentive monitor can enhance communication between the site and the sponsor. “Sometimes the investigators feel like the sponsor is too far removed,” she says, and wonder “where is my voice heard?” The investigator may feel more comfortable communicating with the CRA, who then passes the information on to the sponsor via the SMVR.
The last step in writing an effective SMVR is recommending corrective actions, Hennessey says. All issues/findings noted in the report should have an associated action and/or resolution. Have a “no finding left behind” policy, she advises. But, she cautions, don’t be overly prescriptive. It’s important that the PI and site staff take responsibility for problems and solutions.
Both Hennessey and Weeks-Rowe stress taking care of the basics, carefully reviewing the SMVR for misspellings and grammatical errors. Flaws in the presentation, Hennessey says, distract from the content and message and ultimately hurt the credibility of the monitor and the company.
Ultimately, the SMVR must be able to stand the test of time, Hennessey says. Trials can last for years and go through several CRAs along the way. “It’s not often that a CRA gets to work with a site from initiation to closeout,” she notes. And a regulatory request for further information or an audit can come at any time. In one case, she says, the FDA came back to question the SMVR 10 years after the fact.
June 17, 2019 | TrialAssure, a Canton, Michigan-based global software company, recently launched a web portal for clinical trial sponsors to publicly share plain language, or lay, summaries with clinical trial participants. The portal, called TrialResults.com, allows trial participants to access the plain language summaries in any region of the world and in their native language with ease, simultaneously reducing the burden for sponsors who do not have their own public portal.
Using a unique identifier provided by their trial sponsor, patients can search for their specific trial and review the results in a lay language trial results summary.
The summaries, written either by the trial sponsors or by medical writers through a partnership with clinical research organization MMS, provide details including the purpose of a given clinical trial, results from that trial, the treatment participants received, and the medical problems a patient might have had.
TrialAssure believes the timely posting of these results in a way that is understandable to all participants will lead to a more positive clinical trial experience and strengthen support for future participation and public perception of health sciences research overall.
TrialAssure’s Product Solutions Manager, Zach Weingarden, told Clinical Research News that the new portal is an electronic makeover to an antiquated system.
“As [plain language summaries] become more common, and regulations start to come out ensuring how trials come out with information, one of the challenges is how to distribute this information to patients,” Weingarden said. Traditionally, trial sponsors will mail these documents out to trial participants, but this process often becomes difficult and clunky, especially in a large trial with multiple sites.
The obvious solution is to digitize the process, but rather than simply sending out PDFs through email, which presents its own set of problems, Weingarden says TrialAssure’s portal simplifies the interaction between clinical trial sponsors and the trial participants in a secure, centralized way.
TrialResults.com also offers a degree of transparency that, unfortunately, is often lacking in the clinical trial industry.
“The distribution of this information is overly cumbersome, and it’s been a reason why a lot of sponsors haven’t been able to do as much outreach to patients—especially the ones who are in their trials—as they’d like. It’s a major logistics problem,” he said.
In a press release, TrialAssure pointed to a report by Applied Clinical Trials, saying that only 2% of clinical trial sponsors have issued plain language summaries to participants in the past few years. For many trial participants, trying to understand the clinical trial results as posted to government clinical trial registries can be difficult, given the highly technical scientific jargon.
Weingarden sees trial sponsors leveraging the new system, offering trial participants the ability to see the impact their making in process of finding new drugs and therapies.
“Making it easier for patients to access the results from trials they’ve participated in is our goal, ultimately, because that’s how it should be,” said Weingarden. “The participants are really the ones making the trials possible, they’re the ones that are putting their health and lives on the line for science, so as a general practice it’s an obligation of trial sponsors, researchers, and the research community at large to show patients what the results of a trial were and what they learned from it.”
RAHWAY, N.J., June 14, 2019 /PRNewswire/ — Today, LifePod Solutions Inc. announces a strategic collaboration with SDI Technologies Inc., and their iHome division, to bring to market a first-of-its-kind proactive- voice service designed to improve the quality of life for family and professional caregivers as they monitor and support their aging relatives or healthcare clients coping with social isolation, various medical conditions or special needs in their homes.
The collaboration with LifePod builds on iHome’s history of innovation in home audio and areas of connected consumer electronics with LifePod’s innovative voice-first, proactive platform which provides an easy-to-use, voice-activated service for older adults and others in need of care and their caregivers. Unlike traditional voice assistants, LifePod’s Virtual Caregiver service can be set up and controlled by a remote caregiver using an intuitive online portal that delivers personalized voice check-ins, reminders, and virtual companionship.
“Voice is the most transformative technology of our lifetime, and focusing our caregiver-controlled, proactive-voice service on serving the needs of older adults and chronic care patients is a perfect fit,” said Stuart R. Patterson, CEO of LifePod Solutions. “SDI Technologies is an ideal partner to support our launch because of their award-winning, smart device and AI Voice experience and their impressive history of innovation and tailored solutions for the home.”
Addressing the vast home-healthcare market and the growing digital-health movement catering to out-of-hospital settings, LifePod is the first AI-powered, Virtual Caregiver platform and portal that will simultaneously monitor and proactively engage family members and healthcare clients, via customized voice prompts, while providing real-time alerts, daily reports and peace of mind to the caregiving teams.
“The visionary leadership team at LifePod is driving the voice industry forward,” said Gary Schultz, Director of Product and Business Development at iHome. “Our strategic collaboration with the LifePod team is perfectly aligned to build on iHome’s product leadership in AI Voice. We look forward to extending our platform offerings with LifePod’s state-of-the-art, proactive-voice service that will transform the caregiver industry to better support families, senior living communities and healthcare service providers.”
LifePod’s proactive Virtual Caregiver service on an iHome device will be available this fall.
