MHRA Updates Guidance on Clinical Investigations of Devices | RAPS. Posted 27 January 2020 | By Zachary Brennan The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday published the fifth version of a guidance document meant to help manufacturers provide the necessary clinical data to CE mark a device. This latest update focuses on the practical decisions behind when a clinical investigation is required. This section offers four questions that a manufacturer needs to work through in order to decide if such an investigation is required, including: “What are the essential requirements relevant to the device in question with which compliance must be demonstrated?” And “Are clinical data required to demonstrate compliance?
If so, do the clinical data already exist on the device in question (published or unpublished) or by analogy with published data generated in respect of an equivalent device.” The updated guidance is part of a group of other documents related to notifying MHRA about a clinical investigation for a device. White males overrepresented in clinical trials. The researchers from Penn State Cancer institute suggested that there are two problems with this tendency: patients were not receiving treatments that were likely to increase life expectancy and also that treatments designed for the general public would not reach a diverse population.
These conclusions were drawn from data on more than 12 million patients between 2004 and 2015 in the National Cancer Database. Only 11,576 (0.1%) of these patients were enrolled in a clinical trial as a first course of therapy following cancer diagnosis. Research by the team found that those who received the clinical trial care were more likely to live longer than patients undergoing routine treatment. When quantified, this resulted in an extended median survival of seven and a half months. Diversity remains an issue A further problem arose from this analysis – it is difficult to determine the efficacy of a treatment used in clinical trial for the general population if the treatment group is homogenous. Traditional vs. Pragmatic: Changing the Trial Model with Real-World Evidence | 2020-01-24 | CenterWatch.
Studies based on real-world evidence (RWE) don’t have to be a replacement for randomized clinical trials but rather an integral part of an overall trial strategy. Both pragmatic and randomized trials have their pros and cons, but when combined they can produce more effective results. “I think using both of these to provide evidence to the regulators will be where we go in the future,” said Francis Kendall, senior director at Cytel. You could conduct one or two small phase 1 or 2 trials to show safety and efficacy, he suggested, then apply machine learning and analytics to data on the full targeted population to confirm results. “And if things are not going quite to plan, that’s when you bring in a controlled trial” as backup. The pragmatic approach is especially beneficial with hard-to-reach populations and studies of rare diseases with a limited number of patients. Registry data and electronic health records can provide evidence where a randomized clinical trial might not be possible.
Clinical Trial Root Cause Analysis Can’t We Do Better Than Five Whys. Many people in our industry have had root cause analysis (RCA) training. It is aimed at helping people understand an issue and the underlying reasons it happened. Once you have those reasons (the “root causes”), you can act on them. This is the most effective way of trying to stop the same issue from recurring.
And RCA is now a requirement for serious issues per ICH E6 (R2). If you’ve ever had training on root cause analysis, you are likely familiar with the most common RCA training approach — Five Whys. But something that should give you pause is how your physician responds when you tell her you have a pain in your arm. Where on your arm is the pain located? Your physician is gathering as much information as possible in order to diagnose — i.e., get to the root cause — and then treat you properly. Let’s continue with the Five Whys technique, however, and try it out in an example from a clinical trial. So that’s our root cause. It is not repeatable. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study - The Lancet. Background Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste.
The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance. Methods We downloaded data for all registered trials on ClinicalTrials.gov each month from March, 2018, to September, 2019.
All cross-sectional analyses in this manuscript were performed on data extracted from ClinicalTrials.gov on Sept 16, 2019; monthly trends analysis used archived data closest to the 15th day of each month from March, 2018, to September, 2019. Findings Interpretation Funding. Modernization. A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the intervention/treatment being studied.A type of eligibility criteria that indicates the age a person must be to participate in a clinical study.
This may be indicated by a specific age or the following age groups:The age groups are: Child (birth-17)Adult (18-64)Older Adult (65+)A measure of all deaths, due to any cause, that occur during a clinical study.A method used to assign participants to an arm of a clinical study. ACTA A Tool for Argumentative Clinical Trial Analysis | IJCAI. Juggling Recruitment Risks in Clinical Trials - Massachusetts Biotechnology Council. Successfully executing a clinical trial requires juggling the complexities associated with the clinical process along with developing sufficient incentives to promote enrollment. For many sponsors, removing barriers to participation is essential not only to improve the chances of reaching enrollment targets but to assure that both the science behind the protocol and patient safety are balanced to achieve the sponsor’s goals.
Often balancing science with a successful recruiting effort while ensuring the balance sheet is protected from exposures which might not be otherwise protected under traditional negligence-based clinical trials insurance policies factor into the success or failure of the recruiting effort. Regulators are trying to balance participant safety with the desire to avoid putting bureaucratic obstructions in the path of life-saving innovations. This is forcing many clinical trial sponsors to ask participants to travel across state or international lines.
A Broker’s Value. Complex Innovative Trials: New guideline adoption could get medicines to patients faster. Complex Innovative Design (CID) trials could be transformed for the better, following the publication of recommendations, published today in the British Journal of Cancer* (Monday). The authors believe, if implemented, the ten recommendations they've developed for CID trials could ultimately reduce the time it takes to get innovative treatments to patients with cancer. They are now calling on clinicians, funders, regulators and the pharmaceutical industry to get behind the recommendations and work together to rapidly implement them. CID trials are increasingly being used as an evaluation method by researchers, instead of traditional drug development pathways involving clinical trials from phases 1 to 4. The CID approach enables researchers to carry out more complex trials that address multiple clinical questions at once. However, they can be challenging to conduct and there are currently no practical guidelines for teams that fund, design and conduct these trials in Europe.
Tools for doctors key to increasing clinical trial diversity. Jasmine Benger, senior project manager, research services at The Center for Information and Study on Clinical Research Participation (CISCRP), made that point during an Outsourcing-Pharma webinar titled Clinical Trials in Special Patient Populations. The webinar is available on-demand.
On the webinar, Benger presented data from the 2019 CISCRP Perceptions and Insights Study, which surveyed more than 12,000 people about their attitudes to clinical trials. The survey identified some differences between women, older people and the wider population. Notably, women and older people expressed less confidence in their ability to find the trial right for themselves and felt it was important for their doctor to know about local clinical trial opportunities. Among the over 65s, 72% of people said it is very important for their doctor to know about clinical trials in the local area, as compared to 57% of the surveyed individuals aged 34 years and under. Physicians weigh risks, rewards of social media for clinical trial recruitment.
Mina Sedrak Less than 5% of eligible adults participate in cancer clinical trials, even in the information age when more opportunities exist than ever before to raise awareness of these trials and facilitate patient recruitment. Research suggests physicians who design and conduct clinical trials play a critical role in recruitment simply by bringing up the topic with patients, whereas mounting evidence indicates physicians who promote available trials via social media have a positive impact on trial enrollment.
Nevertheless, many physicians who participate in clinical trials harbor concerns about the use of social media channels to increase trial participation, according to results of a study published in JAMA Open Network. Mina S. The physicians identified several positive impacts that social media could have on clinical trial recruitment, including by increasing visibility and awareness of trials and boosting patient engagement, as well as improving communication. William Dale References: Practical Considerations For Adaptive Designs In Clinical Trials. By Julia Ogier, consultant, and Matthew Cardinal, associate principal consultant, Halloran Consulting The life sciences industry and academic world seem to produce incredible scientific breakthroughs on a daily, if not hourly, basis these days.
The pace of scientific breakthrough is mesmerizing, as a dazzling variety of technologies and studies have helped humans understand the underlying causes of disease. Whether those causes are genetic, environmental, or behavioral, it seems that we have an arsenal of tools to understand much more than ever how we can meet unmet human health needs. From the ambitious (at the time) Human Genome Project to the current application of machine learning and artificial intelligence to vast integrated data sets, it would seem that humans could be on the cusp of fundamentally altering the quality and longevity of human life. However, a curious thing has happened. References: About The Authors: 4 Questions AbbVie Asked To Create More Diverse Clinical Trials.
By Charlotte Owens, M.D., AbbVie The U.S. Census continues to affirm what we see in healthcare every day — that our country is becoming more diverse. As an OBGYN and medical director at AbbVie working to develop medicines that help people live healthier lives, I believe we must ensure our trials include diverse groups of patients. Inclusivity in our clinical trials means better outcomes for all patients today and even 10 years from now. Accepting diverse perspectives is a key component of the process.
I’m an African American woman whose parents worked extremely hard and yet had limited material resources. Over the five years I have been at AbbVie, the idea of diversity and inclusivity in healthcare was especially relevant to our clinical trials in uterine fibroids. 1. Patients are at the core of the work we do. In our study, each woman had to visit monthly for more than a year and collect and carry one month’s worth of sanitary products from their home to the study site. 2. 3. 4. Meeting Clinical Trial Data Requirements In Asian Markets. By Caitlin Bancroft, Regulatory Affairs, Pharmatech Associates Drug sponsors looking to enter the pharmaceutical markets of China, Japan, and India will be faced with regulatory requirements specific to the design, collection, and management of clinical information that are unique for each marketplace.
We’ll discuss potential strategies for dealing with these requirements, from planning to clinical studies, to successfully launch a product that’s ready for Asia. Pharmacokinetics And Ethnicity The primary reason that countries oppose the use of foreign clinical data to justify a marketing authorization for new drugs is the potential influence of ethnicity on drug pharmacokinetics.
Pharmacokinetics is the branch of pharmacology having to do with how a drug moves through the body. Clinical Data Requirements In Asia Japan Japan has issued two major notifications regarding the acceptance of foreign clinical data to support a marketing authorization application. China India Going International. RAO Alert 23 January 2020 | NHMRC. NHMRC is pleased to release the Toolkit for Consumer and Community Involvement in Health and Medical Research (the Toolkit), providing practical advice on engaging with consumers and the community to undertake high quality and relevant research. The Toolkit, comprising five individual resources, complements the 2016 Statement on Consumer and Community Involvement in Health and Medical Research by providing further detailed guidance on the expectations, effectiveness and impact of research involving consumers. NHMRC thanks members of the Community and Consumer Advisory Group from the 2015-2018 and 2018-2020 triennia for their leadership and contributions in developing the Toolkit.
To access the Toolkit and to find more information, visit the NHMRC website. UK cell and gene clinical trials up 45% from 2018. The Cell and Gene Therapy Catapult (CGT Catapult) has revealed that there are currently 127 ongoing cell and gene trials in the UK, representing a ~45% increase compared to 2018, and accounting for 12% of the total global cell and gene therapy clinical studies. Last year a report from the CGT Catapult also documented the rise of employment in the sector, showing that the industry currently supports over 3,000 jobs, with 1,700 roles in manufacturing and bioprocessing. Further, the report showed that the UK is set to more than double its cell and gene employment by 2024, as more therapies are moving towards commercialisation.
This means that in the last seven years, the industry has expanded from 500 jobs in 2012 to over 3,000, and is predicted to reach over 6,000 jobs by 2024. The promising figures show that the NHS and UK ecosystem are providing the right platforms to allow innovative therapies to progress through to the clinic in ever increasing numbers. Speed Study Start-Up: People, Process, and Technology Pillars | Veeva.
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