Where possibilities begin

We’re a leading marketplace platform for learning and teaching online. Explore some of our most popular content and learn something new.
Blogs category
Clinical Research
1
Clinical Trials
3
Search
Popular categories
Clinical Trials
3
Clinical Research
1
All categories
Latest blogs
The Importance of Clinical Trial Feedback
The Importance of Clinical Trial Feedback
Clinical trial participants should expect to learn about the outcomes and impact of the research they are part of, but communicating with them has never been straightforward. We explore the best ways to engage and inform clinical trial participants.Clinical research is a clear form of social good; testing the efficacy of new forms of treatments that can change and save lives. The impact of new treatments and drugs can be seen in improving health outcomes, but for those who take part in trials “there remains no consensus on the best method of disseminating study findings” or informing them of outcomes. [i]The 2008 declaration of Helsinki states that making clinical trials results available to the public is an ethical duty. It proposes that: “All medical research subjects should be given the option of being informed about the general outcome and results of the study.”[ii]Writing in the BMJ, clinical research participant Cynthia Chauhan describes the importance of engaging and informing participants: “Including patients’ voices from inception through to the completion of trials, as well as focusing on the emotional, social, and financial aspects of trial participation for patients, can make participation easier for more of us.”[iii]The majority of those involved in clinical trials appear to agree, with 75% of clinical trial participants surveyed in one study agreeing that ‘patients should be informed of trial results’. [iv]So, the question is: what’s the best way to engage and inform those who take part in clinical trials?Effective communicationsFor the inquisitive participant, the results of the majority of clinical trials conducted in Europe and the USA are published and freely available on international databases. But with an estimated 25% of the European and US populations considered ‘scientifically illiterate’ unpicking the meaning of clinical trials can be challenging and potentially frustrating. [v]It’s for this reason that the new EU Clinical Trials Regulation, due to come into force in 2019, includes a requirement upon all researchers to provide summary results of all clinical trials in a format and a style that can be understood by ‘laypeople’.[vi]While not explicitly aimed at participants, these short and simple summaries could provide a useful mechanism to share more widely the impact, outcomes and benefits of trial participation – among those who have taken part, and the wider general public.Feedback Best PracticeIn 2014, the European Commission produced outline Summary of Clinical Trial Results for Laypersons guidance for those creating summaries for the general public. They include common sense advice like:[vii]Develop the summary for a general public audience and do not assume any prior knowledge of the trial.Develop the layout and content for each section in terms of style, language and literacy level to meet the needs of the general public.Keep the document as short as possible, and focus on unambiguous, factual information.Ensure that no promotional content is included.Follow health literacy and numeracy principles. The Commission advises that these summaries are written for a reader with an International Adult Literacy Survey (IALS) reading proficiency of 2 -3, roughly that of someone who had completed secondary or high school.The European Medical Writers Association favours brevity, suggesting that: “anything beyond two pages seems inappropriate.” [viii]  Best practice suggests communications are short, snappy and written in plain English.Define patients as a stakeholder and an audienceThose conducting trials are required to post results and summaries no later than a year after trial completion. The EU expects that those running trials will do more than simply post a summary, encouraging them to provide: “direct feedback to patients who have taken part in their trials including an acknowledgement of their contribution and an expression of thanks for their time.” Simply publishing a summary online isn’t enough.[ix]Every clinical trial should be accompanied with a communications plan that identifies your key audiences, stakeholders and communications methods. The Communications Handbook for Clinical Trials proposes that communication with participants should be considered a key priority, and one of the first – and most important – actions in this plan.[x]Within the accompanying plan, those running trials should use various methods to engage participants, including newsletters, websites, social media and direct communication. The UK’s 100,000 Genomes Project demonstrates a progressive approach to communication, with the programme supported by solid clinical information and professionally produced marketing collateral.The Centre for Disease Control and Prevention in the USA has produced some guidelines on creating simple communications the public, including information on how to incorporate images and pictures into text, as well as guidance on best practice.Whatever communications methods you choose, research into effective trial feedback concludes that feedback and results should be shared quickly with participants. The authors caution that “interest in a study quickly wanes for both patients and centres”, and that “dissemination of results is needed if it is to have any impact at all.”[xi]Large amounts of research has focused on the removing the barriers to clinical research participation, but little has focused on engaging existing participants. There is no agreed best-practice, with trial managers encouraged to identify the best methods for communicating their own cohorts.Engaging and informing participants in the outcomes of research isn’t just a demonstration of respect; as the testimony of Cynthia Chauhan attests, it can prove a valuable and effective tool in encouraging them and their wider communities to take part in further research too. --------------[i] Darbyshire JL, Prce HC. Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population. BMJ Open 2012;2:e001252. doi: 10.1136/bmjopen-2012-001252 http://bmjopen.bmj.com/content/2/5/e001252#ref-11[ii] World Medical Association, WMA declaration of Helsinki – ethical principles for medical research involving human subjects, Online. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ [Last accessed: 18.12.2017][iii] Chauhan, C. Patients’ views can improve clinical trials for participants. BMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i1922 http://www.bmj.com/content/353/bmj.i1922[iv]Moorcraft, S., Marriott, C., Peckitt, C., Cunningham, D., Chau, I., Starling, N., Watkins, D. and Rao, S. (2016). Patients’ willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials, 17(1). https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-1105-3[vi] Official Journal of the European Union, Regulation. Online. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf [Last accessed:18.12.2017][vii] European Commission, Summary of Clinical Trial Results for Laypersons. Online. Available from: https://ec.europa.eu/health/sites/health/files/files/clinicaltrials/2016_06_pc_guidelines/gl_3_consult.pdf [Last accessed: 18.12.2017][viii] Sroka-Saidi, K. Boggetti, B. Schindler, T M. Transferring regulation into practice: The challenges of the new layperson summary. The European Medical Writers Association 2015 DOI: 10.1179/2047480614Z.000000000274http://journal.emwa.org/media/1903/2047480614z2e000000000274.pdf[ix] European Commission, Summary of Clinical Trial Results for Laypersons. Online. Available from: https://ec.europa.eu/health/sites/health/files/files/clinicaltrials/2016_06_pc_guidelines/gl_3_consult.pdf [Last accessed: 18.12.2017][x] Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage Controversy, Convey Your Message, and Disseminate Results. Online. Available from: https://www.fhi360.org/resource/communications-handbook-clinical-trials-strategies-tips-and-tools-manage-controversy-convey [Last accessed: 18.12.2017][xi] http://bmjopen.bmj.com/content/2/5/e001252

Tue, 24 Jan 2023
AI, big data and clinical trials
AI, big data and clinical trials
The MIT Technology Review reported on a new research collaboration between Google’s DeepMind – their machine learning division – and Moorfields Eye Hospital in London; a renowned specialist in eye diseases and injuries.According to the article by Jamie Condliffe, DeepMind’s artificial intelligence software will work its way through over a million eye scans; analysing the common patterns in visual degeneration cases. The software can detect precise detail that humans can’t see, and of course it works much faster too. Eventually, DeepMind’s software will learn how to spot early signs of sight loss and catch at-risk patients while there is still time to help protect their vision.This isn’t Google’s first foray into healthcare research and clinical trials. Their Connectivity Bridge and wearable health sensor are just a couple of other examples.The emerging realm where technology, big data and clinical research meet is starting to produce some of the most exciting and innovative shifts in how we’ll conduct medical research in future. But it’s also raising new issues around data privacy and informed consent that are catching researchers and the wider biosciences industry off guard.We’ve already seen examples where our enthusiasm for the potential of new technology has led researchers to overlook data privacy risks and concerns. DeepMind’s work with the Royal Free Hospital London, on an app called Streams that helps HCPs detect acute kidney injury, led to criticism that users were not properly informed about how and what data would be shared with Google. Similarly, NHS England’s care.data programme was delayed several times over concerns around data protection and opt-out options.Tech giants like Google and Apple move fast – much faster than the heavily regulated world of clinical research is used to. The opportunity presented by new technology and big data could revolutionise healthcare and how we do research; so how do clinical researchers and regulatory authorities avoid standing in the way of progress, while ensuring patient welfare and informed consent are not compromised?Some of the key questions that need to be answered are:- How do we guarantee permanent anonymisation of data in a world where we can’t predict how future innovations might change the nature of the protections we put in place now?- As we get better at detecting early signs of health risks among people who have let researchers use their data, do we have a responsibility to feed that information back to patients? If yes, how do we reconcile that with the need for anonymisation and data privacy?The answers to these questions are not simple. We may need to re-evaluate how we work with research participants, to ensure they can benefit from and have some ownership over research findings that are increasingly detailed and personalised.As we journey towards realising the full benefits of artificial intelligence and big data for healthcare research, some things are for sure:More than ever before, we need to maintain and build on the trust relationships between researchers and their participants.The capacity for clinical trial regulatory authorities to evolve in a timely way will truly be tested. 

Tue, 24 Jan 2023
The Rise of Home Diagnostics in Clinical Trials
The Rise of Home Diagnostics in Clinical Trials
The field of home diagnostics has seen significant innovation and advancement in the past few decades – and in the wake of the COVID-19 pandemic, the growing use of home testing has allowed important clinical research to continue remotely.The advantages of embracing remote trial protocols are substantial, suggesting that the adaptations made in response to COVID-19 are part of a broader move towards decentralizing trials and clinical research. As clinicians increasingly embrace virtual tools and remote testing, home diagnostics will play an important role in how clinical research progresses. In this article, we discuss the advantages and disadvantages of home diagnostics, and the implications of its rise for the future of clinical trials. The growth of home diagnosticsHome diagnostics has a varied history; initially developed to offer patients sensitive testing in the privacy of their own homes, the field has expanded greatly since the first at-home pregnancy tests became available in the 1970s (1). From intimate procedures such as testing for sexually transmitted diseases – at-home HIV tests have been available since 1996 (2) – commercial home diagnostics has expanded to include DNA and genealogical testing, as well as starting to cover the wellness market by offering consumers proactive testing for fertility, organ function, and more. In fact, by the late 2010s the home diagnostics market was fast-growing, with one 2017 report showing the market expected to reach USD 6.53 billion by 2025 (3). But at-home testing is not limited to commercial products – the applications for clinical research are many. Home diagnostic tools provide clinicians with the ability to gather important data points remotely. Health data that can be collected via home testing includes blood pressure, pulmonary testing, dermatological diagnosis (4), and neurological testing. In addition, highly customized home collection kits allow patients to collect and submit their own biological samples directly for laboratory testing, removing the need for clinicians to manage the preparation, packaging, and shipping of samples. As clinical research adopts remote testing and patient monitoring as standard protocol, the clinical trial landscape will need to adjust to help see trials and research to successful outcomes. The advantages of home diagnosticsFor clinicians and health care practitioners (HCPs) alike, home diagnostics offers a host of benefits:Easing strain on healthcare systems – as at-home testing and monitoring becomes more affordable, faster, and more accurate, this can ease pressure on HCPs managing heavy workloads – particularly when it comes to routine testing and patient monitoring.Improving and increasing telemedicine – many medical appointments are now conducted over phone or video chat, and home diagnostics lets HCPs request tests remotely, reducing the need for patients to visit clinics and hospitals.Personalizing patient care – home diagnostics improves clinicians’ ability to offer faster and better-targeted medical care and gives patients a more accessible and personalized approach to managing their own individual healthcare.Improved patient experience in clinical trials – home testing can eliminate the need for time-consuming site visits, reducing the burden on patients who may be either too busy to miss work for appointments, or too unwell to leave home for travel.Better patient enrollment and retention in clinical trials – making the trial process easier on participants increases patient enrollment and retention, reducing the commercial impact associated with patients dropping out of trials.Cost reduction in clinical trials – with fewer and smaller clinical sites required, it becomes easier and less costly for trials to scale up studies for larger regions and bigger patient pools. Logistical challenges for clinical researchersThe logistics of implementing at-home testing involve a number of key considerations for clinicians and trial service providers alike, including:Getting the right kits to the right patients at the right time – at-home testing necessitates careful logistics management, particularly for large-scale studies, that clinicians may lack the expertise to undertake. Working with experienced providers capable of managing quick turnarounds and accelerated timelines will help clinicians deal with these emerging logistical challenges.Participant coaching – patients need to be guided in how to administer tests and study drugs at home. Clinicians may need to provide in-person or video training, and clear at-home kit and testing design is needed to make the process as simple as possible for trial participants.Tracking and tracing of clinical samples – to preserve the integrity of clinical materials, trial sample kits must be properly labeled and assembled, with clear instructions for use and automated tracking to mitigate the risk of human error.Inventory tracking – in order to manage the supply and distribution of testing and drug administration kits, inventory must be carefully monitored. Use of an external system, such as PASSPORT™ from Avantor Clinical Services, can greatly reduce the logistical burden that at-home testing places on clinicians.Preservation of sample integrity through the shipping process – kits must be properly assembled to make sure samples are securely packaged for their return, including the option of refrigerated shipping to keep samples at optimal temperature during the journey from home to lab.Data and privacy concerns – to guarantee patient privacy and data security, labeling and indexing must be carefully managed throughout the shipment, collection, and storage of all patient samples and data, to accurately record the source of such samples, where appropriate, or to anonymize or blind samples in other cases. What home diagnostics means for clinical trialsThe field of home diagnostics has the potential to ease the transition from traditional on-site clinical research models into a remote approach that takes advantage of improved health technologies. Combined with the increased use of mHealth tools such as wearables and smartphone apps, and the adoption of telemedicine, home diagnostics will play a vital role in enabling trial protocols to shift towards a decentralized approach. With significant clinical advantages to be gained by using home diagnostics – particularly as COVID-19 necessitates a remote approach to clinical research – it’s important that clinical trial managers and clinical service providers work together to manage the fast-changing needs of the trial landscape. At Avantor Clinical Services, we have been able to move quickly to help identify the resources needed for at-home testing and expedite the provision of kits for collecting at-home patient samples in a COVID-19-related study. These kinds of interventions will be crucial in adapting home testing to the meet the changing needs of clinical trials in future. SummaryAs the field of clinical research responds to changing circumstances in light of global health concerns, home diagnostics is one tool among many that will facilitate remote clinical research, but it is an essential one. Decreasing or eliminating the need for on-site visits will improve patient enrollment and retention and reduce the cost of research studies – enabling trials to progress quickly and efficiently, and ultimately get important treatments to market faster.  This article has been produced by Avantor Clinical Services as part of our ongoing commitment to creating a better world through the delivery of mission-critical products and services. To learn more, contact us today ReferencesErin Blakemore. This Is What the First Home Pregnancy Test Looked Like. June 2015. https://www.smithsonianmag.com/smart-news/what-first-home-pregnancy-test-looked-180955478/. Accessed May 2020.Mobolaji Ibitoye, Timothy Frasca, Rebecca Giguere, and Alex Carballo-Diéguez. Home Testing Past, Present and Future: Lessons Learned and Implications for HIV Home Tests (A Review). May 2014. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3988264/. Accessed June 2020.Global Home Diagnostics Market is Expected to Reach USD 6.53 Billion by 2025: Fior Markets. August 2019. https://www.globenewswire.com/news-release/2019/08/28/1907833/0/en/Global-Home-Diagnostics-Market-is-Expected-To-Reach-USD-6-53-Billion-by-2025-Fior-Markets.html. Accessed May 2020.The Medical Futurist. Digital Skin Care: Top 8 Dermatology Apps. June 2019. https://medicalfuturist.com/digital-skin-care-top-8-dermatology-apps/. Accessed June 2020.

Tue, 24 Jan 2023

 All blogs