January 22, 2018 – The US Food and Drug Administration (FDA) is launching a new pilot program this month aimed at increasing clinical trial transparency – though many opportunities remain to improve the scope, clarity, and usability of data, says TrialScope CSO.
January 22, 2018 – A new FDA pilot program will publish information from sponsor-produced clinical study reports (CSR) — starting with documents volunteered by companies following a drug’s approval — as part of broader agency efforts to boost transparency in clinical trials and streamline the review process.
January 9, 2018 – The FDAAA (Food and Drug Administration Amendments Act) Title VIII, which required clinical trial results to be disclosed on ClinicalTrials.gov, went into effect in September 2007. The industry has now reached the 10-year anniversary of the act, which is a good time to reflect on progress that has been made and whether the requirement has actually improved transparency in clinical trials.
December 18, 2017 – Some of the world’s largest pharmaceutical companies have improved the transparency of their clinical trial data disclosures, according to new analysis from Bioethics International, yet many studies for approved drugs still go unreported.
November 1, 2017 – How do you thank someone for taking part in a clinical trial? Evidence is mounting that an effective way to thank study volunteers is to provide them with a plain-language summary of the trial results. Plain, or lay-language summaries, distill the findings of the clinical trial into a brief summary that is understandable to the general public.
October 26, 2017 – Clinical trial sponsors plan to release more trial results summaries over the next year as part of patient engagement efforts, according to a recent survey.
TrialScope Tackles Issue of “Sharing Clinical Trial Results with Patients” at CBI Conference; Presents Sponsor Survey Findings
October 3, 2017 – TrialScope, the global leader in clinical trial transparency and compliance solutions, announced new findings from its sponsor survey on clinical trial results sharing practices, at CBI’s second annual Plain Language Summit in Philadelphia.
October 3, 2017 – Sponsors, especially larger ones, understand TRS is an important foundation to a strong patient engagement program, says Thomas Wicks, chief strategy officer for TrialScope, who conducted the survey. Of the 86 respondents, 71 self-identified as pharmaceutical drug sponsors, while 15 said they were biotech sponsors.
September 29, 2017 – TrialScope, a global leader in clinical trial transparency and compliance solutions, announced new findings from its sponsor survey on clinical trial results sharing practices.
September 28, 2017 – TrialScope announced findings from its sponsor survey on clinical trial results sharing practices at CBI’s conference this year. The survey focused on obtaining feedback from sponsors about their current approach to trial results summaries. It was centered around receiving information on what the sponsors plans are for sharing the summaries in the future. The hope for the future is to make sure patients are acquiring the clinical trial results for which they participated in.
September 1, 2017 – Researchers, physicians, pharma, and biotech developers all want to do the right thing for patients. Everyone in the industry understands the need to develop transformative therapies for those with disease. But historically, patients have often been invisible.Although patients are the ultimate customers, companies would only deal with prescribers and payers. Within drug development,companies would work with patients through intermediaries such as principal investigators and patient groups. Because of this, companies didn’t always think reflexively about patients’ needs.
August 14, 2017 – Citing the need to meet requirements in 90 countries and across 30 trial registration websites, TrialScope has launched a “one entry” trial data disclosure platform. Its Core Disclosure solution is designed to allow research teams to approve disclosure once for worldwide dissemination. “Core Disclosure moves toward the ever-elusive “standard” for disclosing clinical trial data,” Thomas Wicks, chief strategy officer at TrialScope told CenterWatch. “This model greatly reduces the risk of data entry errors and inconsistent data becoming available to the public.”
August 8, 2017 – The process of disclosing clinical trial data can be quite arduous because many trial sponsors use spreadsheets and databases to track and manage clinical trial disclosure content. Mark Heinold, the CEO of TrialScope and his team of experts, are working to simplify the entire clinical trial transparency and data sharing process to make it easier for sponsors to manage compliance and disclosure content.
August 7, 2017 – TrialScope, the global leader in clinical trial transparency and compliance solutions announced the launch of its newest solution, Core Disclosure. Promoting a new level of data efficiency accuracy and alignment, Core Disclosure enables teams to approve disclosure content once and then reuse the disclosure data around the globe.
August 4, 2017 – TrialScope yesterday launched Core Disclosure, enabling teams to approve disclosure content once and then reuse the disclosure data around the globe. The product is intended to promote a new level of data efficiency accuracy and alignment.
August 3, 2017 – TrialScope, a global clinical trial transparency and compliance solutions company, launched its newest solution, Core Disclosure. The solution works with teams to approve disclosure content one time and then reuse the disclosure data globally.
August 1, 2017 – New regulations cause a scramble to understand them, their impacts, and the timelines required to move from words in a document to compliance with daily activities. Many face this daunting task with a healthy dose of anxiety and uncertainty surrounding the interpretation of the new requirements and questions that naturally arise whenever current processes need an adjustment.
July 26, 2017 – Recent developments such as the Food and Drug Administration’s Amendments Act and the European Medicines Agency’s mandatory data sharing policies have made it difficult for clinical trial sponsors to ensure they are disclosing information and complying appropriately. TrialScope sees this as especially problematic for small and mid-sized trial sponsors.
July 24, 2017 – Patient-centric clinical trial transparency and compliance solutions company, TrialScope, announced that the Trial Results Summaries Portal now supports trial summaries in English and seven additional languages—Chinese, French, German, Japanese, Polish, Russian, and Spanish.
July 20, 2017 – The Clinical Trial Disclosure Maturity Assessment aims to collect information on how different organizations manage the clinical trial disclosure process, recognizing that publication of trial data through peer reviewed journal articles is one of several ways that clinical trial data becomes available in the public domain.
June 1, 2017 – Earlier this year, TrialScope launched its Trial Results Summaries Portal, www.trialsummaries.com, with information from its first partner, AstraZeneca. The portal is a publicly accessible, sponsor-agnostic, unbiased website for people looking to read clinical trial result summaries in layperson, easy-to-understand language.
June 1, 2017 – TrialScope has launched Atlas Global Compliance, a software-as-a-service (SaaS) solution that ensures clinical trial sponsors are tracking and managing global clinical trial disclosure compliance appropriately.
May 17, 2017 – Clinical trials are inherently high risk and any errors can result in major disruptions or completely collapse the trail. It is extremely telling that only 12% of medicines in clinical trials make it to patients and, whilst there are many reasons that a trail could be unsuccessful, there is potential to mitigate some areas of risk and error.
May 17, 2017 – Regulatory affairs as an internal-company function encompasses a range of areas, but largely concerns the maintenance of already-approved drugs. Because filings vary slightly internationally and need to be harmonized at a global level to remain compliant, just keeping a license to sell, keeping it consistent and maintaining transparency is a huge task.
April 13, 2017 – ATLAS Global Compliance is a Software-as-a-Service (SaaS) solution that helps clinical trial sponsors to “disclose locally and comply globally,” says TrialScope CEO. According to the clinical trial transparency and compliance solutions provider, ATLAS Global Compliance enables sponsors to ensure trials are compliant by consolidating information from all trial sites into one view.
April 10, 2017 – The pharmaceutical industry is witnessing a deep shift in the traditional approach to patient disclosure in clinical trials. While most companies are struggling to meet basic compliance requirements, a longer-term objective has emerged that is shifting the transparency goal post.
March 22, 2017 – In February 2017, trial transparency provider TrialScope announced the launch of its Trial Results Summaries Portal that was developed in partnership with AstraZeneca. The Portal is a publicly accessible website where clinical trial sponsors can inform and educate trial participants and the general public about trial results in a non-promotional and non-biased venue.
March 13, 2017 – AstraZeneca partnered with TrialScope to launch the Trial Results Summaries Portal, a website that allows sponsors to pay to input their trial results, and trial participants can check to see what became of the trial in which they participated.
March 10, 2017 – In the world of clinical trials, many life science companies will love you and leave you. They take the data and the clinical notes, with no effective feedback loop or post-study engagement.
January 19, 2017 – In 2007, the Food and Drug Administration Amendments Act (FDAAA) was passed. Title VIII of this act requires sponsors to register and provide results for Applicable Clinical Trials (ACTs) on a public database.
January 5, 2017 – 2017 will be a challenging year marked by public scrutiny of disclosure practices by regulators, stakeholders, and watchdog organizations. Expanded regulations require a significantly broader range of data to be disclosed within ever tighter timelines.
April 7, 2016 – The technology advancements in the pharmaceutical and life sciences industry is driving a paradigm shift across the business—from powerful new drug chemistries to innovative R&D partnerships and marketing plans.
January 6, 2016 – I recently had the opportunity to host TrialScope’s Leadership Forum on Clinical Trial Transparency. The attendees, representing organizations that conduct global clinical trials, had come together to discuss pending changes to global transparency requirements, which will increase the scope of disclosure and shorten timelines.
August 31, 2015
Thomas Wicks, TrialScope’s Chief Strategy Officer, participates in a video interview with Taren Grom from PharmaVOICE at the DIA Annual Meeting in Washington, D.C. Thomas shares his thoughts on his leadership role within TrialScope and within the industry.
August 25, 2015
There are over 40 countries or regions with mandatory trial disclosure regulations and over 30 trial registries for posting clinical data. Few sponsors have evolved systems for continuous monitoring of trial disclosure and registry requirements. Thomas Wicks describes four practices that rise to the surface as major risks for trial sponsors regarding current and ongoing compliance.
June 1, 2015 – Clinical Trial Disclosure is a complex compliance challenge that clinical trial sponsors around the world face every day. The complexity of managing dynamic clinical trial data and working with evolving health authority requirements on a global basis can be significant, and the sheer quantity of trials being conducted today only increases the complexity of this task.