Wednesday, November 30, 2016

REPORT: The 8 biggest challenges facing clinical trial professionals

As with any industry, the challenges facing those working in clinical trials at the moment are numerous; from patient recruitment, to adoption of technology, and regulatory requirements, to spiralling costs.

Over the last year we have asked dozens of clinical professionals about the biggest challenges they are facing and the graph above shows their most common responses. Here, in part one of our two-part report, we delve into the top replies to discover what it is about these issues that are most challenging trials today. 

Complexity of Trials (21% of respondents)

Clinical trials have been growing increasingly complex for years, and those running them are feeling the pressure to design trials ‘that give the right answers, in the most simple and unobtrusive way for patients, that are acceptable to regulators and payers’.

Respondents from study sites are particularly concerned with meeting the ‘challenge of focussing on the best study design’ for ‘very complex modern clinical trials’. Such concerns are borne out in the ‘high rate of failure to meet primary endpoints due to poor or complex design’.

Monday, November 28, 2016

The importance of networks in clinical trials

Interview with Aoife Regan, Head of Experimental Cancer Medicine team at Cancer Research UK

Networks are gaining increasing importance across various different aspects of clinical trials. The Experimental Cancer Medicine Centres Network is one such project made up of 21 locations across the UK, each a partnership of at least one NHS Trust and one university.

Aoife Regan heads up the team that supports the ECMC Network through training, sharing best practices, helping industry in accessing the network and providing opportunities for professional groups to network.

Following her presentation at Partnerships in Clinical Trials Europe, we spoke to Regan about the network, as well as the importance and challenges of such partnerships within clinical trials.

Friday, November 25, 2016

Taking a patient centric approach to pediatric clinical trials

An interview with Patient Advocacy Manager Begonya Nafria Escalera

Patient centricity is one of the key issues in clinical trials at the moment and one that was explored extensively at Partnerships in Clinical Trials Europe in Vienna last week. As a Patient Advocacy Manager at Sant Joan de Déu Children’s Hospital in Barcelona, Begonya Nafria Escalera spends more time than most exploring strategies that put the patient at the core of research.

We spoke to her about the state of patient centricity in the industry today, as well as the role technology can play in its future.

Wednesday, November 23, 2016

Hype or hope? Can mHealth accelerate completion in clinical trials?

by Sarah Iqbal

Clinical trials are the experimental foundation on which modern medicine is built.  However, the painstaking process is costly, takes a great deal of time, demands intensive effort, and can have a very high failure rate. Reports from the FDA show that around 30% clear Phase I trials, 14% clear Phase II trials and only 9% pass through Phase III trials. The entire process can take anywhere from 6 to 10 years, which excludes time spent on preclinical drug research.

Tuesday, November 22, 2016

Partnerships in Clinical Trials Europe pictures

Last week over 1000 of the leading figures in clinical trials gathered in Vienna for Partnerships in Clinical Trials Europe. As well as dozens of thought-provoking talks and hundreds of meetings, there was samba dancing, an Olympic gold medallist, fine dining and a lifetime acheivement award. But we're getting ahead of ourselves; let's start at the beginning...

Before the main conference started, workshops explored five of the hottest topics and biggest challenges in clinical trials today, before the Covance welcome casino kicked-off the social side of things.

Monday, November 14, 2016

Vienna Area Guide: Restaurants & Points of Interest

With Partnerships in Clinical Trials in Vienna this week, we have put together a handy guide to the restaurants, places of interest and taxis in the area. We hope you find these recommendations useful during your time spent in the city.

Casual Restaurants

Wohlmutstrasse 23, Vienna 1020
Phone Number: 676 35 95 174

This restaurant can be found just 500m from the conference venue, and can be walked in 6 minutes. The Wohlmutstueberl “combines traditional Viennese cuisine with delicacies for the health conscious” and has an extensive a la carte menu that can be viewed here.

Friday, November 11, 2016

‘Generally speaking, sponsor companies have really under-invested in some of the most critical aspects of their relationships with CROs’: Interview with Kenneth Getz, Director of Sponsored Programs at Tufts CSDD

With over 20 years’ experience in the industry, Professor Kenneth Getz, Director of Sponsored Programs and associate professor at the Tufts Center for the Study of Drug Development, is internationally known for his expertise on clinical trial management and outsourcing. We spoke to him about the trends and challenges in clinical research today.

What do you see as the biggest trends in drug development and clinical research today?

KG: ‘There are a number of key trends that are redefining the drug development landscape. The first is the ongoing movement towards precision medicine and the targeting of patient sub-populations. The other area is patient centricity, where the clinical research enterprise has expressed a very keen interest in engaging patients as well as healthcare provider and payer communities as partners in the clinical research process.

Additionally, there are a number of challenges that have been around for a very, very long time and continue to plague the industry. There is the ongoing trend towards rising drug development costs, declining success rate of our programmes in development, and the difficulties we've had in accelerating drug development timelines.’

Thursday, November 10, 2016

‘Data integrity & patient safety underpins everything we do in managing clinical trials’, Dr Stephen Nabarro, CRUK

Dr Stephen Nabarro is Head of Clinical Operations and Data Management at the Cancer Research UK Centre for Drug Development. We spoke to him about how data is used in clinical trials today, as well as his work with the Experimental Cancer Medicine Centre Network.

Firstly, please could you explain a little about your role at the Cancer Research UK Centre for Drug Development?

SN: ‘I have worked at Cancer Research UK for fast approaching 10 years now and I am the Head of Clinical Operations and Data Management in our Centre for Drug Development (CDD). CDD plays a unique role in our industry as our remit is to do the highly complex, cutting edge early phase oncology trials that would not happen without our involvement. We sponsor numerous first in class trials, and it is incredibly exciting to see how patients tolerate being treated with a new class of drug and to see the emerging evidence of efficacy in expansion cohorts.’

Tuesday, November 8, 2016

Technology platforms shaping the way we run clinical trials

Four industry leaders reveal the technology that they think is most shaping the way trials are run and how beneficial it will actually be.

Technology is rapidly changing clinical trials in ways that few can predict, shaping the way they are being run on a monthly basis. It can be easy to blanket ‘technology’ as one single disruptive innovation, but there are countless platforms with countless uses. Any discussion on technology has nuanced benefits and challenges, and everyone working in the industry has a different view of how best to use it.

We asked four leading figures in clinical research which platforms they think are most shaping the way trials are run and how beneficial they will actually be.

Dr David Fajgenbaum - Assistant Professor of Medicine, University of Pennsylvania; Executive Director, Castleman Disease Collaborative Network

‘Social media and patient discussion boards have enabled patient advocacy groups and industry to identify large numbers of patients for clinical trials that were impossible to find beforehand.’

Thursday, November 3, 2016

The ethics of patient consent in clinical research

Interview with Dr Kieran Doran Senior Healthcare Ethics Lecturer, University College Cork

As Senior Healthcare Ethics Lecturer at University College Cork, a legal advisor to the Clinical Research Ethics Committee and a consulting solicitor specialising in health law, Dr Kieran Doran is well placed to discuss ethics in clinical research. For him the biggest issue at the moment is around patient consent; ‘making sure patients have all the relevant information to participate in trials’.

Participation in any form of clinical research is considered to be a voluntary decision, which means legally trial leaders must ‘give the patient every piece of information; outline to them every hazard and every level of risk of it occurring no matter how statistically negligible it is’.

Tuesday, November 1, 2016

Clinical trials: is commercial research worth it for the sites?

Much of the conversation around partnerships and collaborations in clinical trials revolves around improving the relationship between sponsors, CROs and external vendors, but it is also claimed that the way all of these groups work with study sites could need an urgent, industry-wide rethink.

Increasingly complex studies, slow payment and a lack of recognition and loyalty towards experienced sites are among a number of issues that are leading many good sites to turn their backs on commercial research entirely.

Kate O’Brien, senior research nurse at Albany House Medical Centre in the United Kingdom, conducts commercial primary care Phase 2-4 studies since 1999, and she believes that when studies are being designed, there is room for sponsors to collaborate more with experienced sites.

“I think because we are on the ground, we have a good perspective on the way studies work,” says O’Brien.

Thursday, October 27, 2016

Exciting Innovation at the Heart of Clinical Trials

On the heels of an exciting Partnerships in Clinical Trials US earlier this month, Lisa Henderson, Editorial Director of Applied Clinical Trials sat down to discuss the current state of the clinical trials industry, the role that innovation will play in the coming years, patient centricity, and strategic partnerships. Take a look at this exclusive interview below.  

How would you rate and/or describe the state of innovation, generally, in clinical today? Where has the industry made progress and where have we fallen short?

Overall, innovation is good. If you keep in mind that the pharma industry in general is viewed as very conservative and risk-averse, then major strides have been made on the clinical trials/clinical operations side. Just in the past four years, the progresses include:

• - Including patients in the paradigm
• - Changing actual clinical trial processes (RBM)
• - Colleagues sharing more at conferences and in articles/blogs on what works and what doesn’t.
• - TransCelerate, pre-competitive alliances

Most change is slow and incremental, and in many cases, is a people issue…a change management issue. And that requires educating employees, engaging them in the change, getting them comfortable with the change and leading them to another vision.

Tuesday, October 25, 2016

Ask the Experts: 5 of the most exciting developments in clinical trials

With new technologies, partnerships and strategies developing in clinical trials all the time, the industry is changing at a rapid rate. Over the last six months we have spoken with dozens of clinical trial professionals and asked them what they think the most exciting developments are. Here we have gathered six of the most common answers we got.

1) Real-time data management

“The use of Apps and tablets for collection of data, to improve timing and quality of trials.” Isabella Salerio, Clinical Operation, Zambon

“Improved system interfaces leading to real-time reporting of clinical trial operational status at your fingertips – really supporting management and oversight of trials.” Julianne Hull, CEO, WenStar Enterprises

Friday, October 21, 2016

"Multi-million pound deals are being struck by sponsors and CROs with a little bit of hope and naivety"

Meeting the challenges of the sponsor/CRO partnership with John Faulkes, CEO of PPMLD

“Sponsors want now what they always have; they want the CRO to deliver what they say they will. But despite many years of experience and loads of money in the system, the intense conversation that goes on tells us that this doesn’t always happen.”

For John Faulkes, consultant and CEO of PPMLD, it is clear there are issues with most of the partnerships between sponsors and CROs at the moment. Despite the fact pharma companies have “tried all sorts of ways to make this work”, targets aren’t being met and budgets are being stretched.

One of the big debates over how to combat these issues is around long term strategic partnerships versus tactical outsourcing. However, for Faulkes, “that’s the wrong question; there are other things that are more fundamental that would make more of an impact”.

One such example is for sponsors and CROs to agree on more realistic propositions at the start of the partnership: “They need to learn from their experience…Even in this day and age, multi-million pound deals are being struck by sponsors and CROs with a little bit of hope and naivety sometimes.”

In this fascinating interview, Faulkes explains why there are issues all over the world and describes some of the ways he thinks partnerships could be improved - watch the full interview above.

John Faulkes is joining over 120 other industry leaders speaking at the Partnerships in Clinical Trials Europe conference in Vienna on 16-17 November 2016. Join 1000+ others with 10% off ticket prices by entering the code CQ3011BLOG at the checkout (T&Cs apply).

Thursday, October 20, 2016

If you had the power to change one thing about the clinical trial industry, what would it be?

We spoke to dozens of the leading experts working in clinical trials and asked them what the one thing they would change about the industry would be if they had the power. Here are some of their answers.

Simplification of regulations

An unsurprising one to start with, the complexity of regulations is a complaint bound to be heard at every conference. As Julianne Hull, CEO of WenStar Enterprises, explains, she would like the “Streamlining, simplification and clarity of new and ongoing regulations.” Wenke Schult, MD emovis home care visits GmbH, puts it even more simply: “Reduction of red tape”.

Tuesday, October 18, 2016

The past, present & future of wearable technology in clinical research

by Sarah Iqbal

The intersection of technology and healthcare covers a range of solutions in various sectors of the digital health industry. One particular solution is wearable technology. While healthcare organizations such as pharmaceuticals in clinical trials have not yet embraced wearables in large numbers, they are certainly intrigued. Wearables are emerging as a solution for creating more efficient clinical trial processes, from recruiting patients to collecting real-time patient data.

Mobile health (mHealth) tools that enable clinicians and researchers to monitor the type, quantity, and quality of everyday activities of trial participants have long been needed to improve daily care, design more clinically meaningful randomized trials, and establish cost-effective, evidence-based practices. Wearables (or activity trackers), also seen as a mobile health tool, have begun to fulfil this need.

Monday, October 17, 2016

Clinical research: Part art, part science, all communication

by Michael A. Martorelli, Fairmount Partners

I’ve followed contract research for twenty years as an investment analyst and banker. I’ve seen the industry fragment and consolidate, shrink and expand and I’ve used these observations to advise CROs and other service providers of the opportunities and pitfalls.

The most important lesson I’ve learned is that having a clear aim from the outset is the key to success in any drug development project.

The goal of clinical research is to provide regulators with the information they need to make informed decisions about the marketability of new therapeutic products as quickly and efficiently as possible.

Friday, October 14, 2016

What is a project leader’s real source of authority? Interview with consultant John Faulkes

As CEO of PPMLD, John Faulkes spends his days helping life science projects work more efficiently through collaboration. We sat down with him to ask what good project management looks like in a sponsor/CRO partnership.

For John, the key to building the perfect team is all about developing the members of that team; ‘Great teams have lots of features, but two in particular are: every player works towards a common goal, and there is a level of trust in the team.’

He explains that ‘Team members need to be developed so they can give quality input into the system and the project manager can trust it and not bore down into the details. The project manager can then stick to the leadership issues.’

If this can be achieved, ‘the long term aim should be to generate in the extended team a “one team atmosphere”. It may be possible, it may not be possible and if it is, it does take a long time.’

John Faulkes is joining over 120 other industry leaders speaking at the Partnerships in Clinical Trials Europe conference in Vienna on 16-17 November 2016. Join 1000+ others with 10% off ticket prices by entering the code CQ3011BLOG at the checkout (T&Cs apply).

3 Key Takeaways from 2016 Partnerships in Clinical Trials US

By, April Schultz, Content Marketing Writer, Forte Research Systems

Steve Wozniak is the keynote at the Biotech Week Boston
Photo credit: @TogoRun
The 2016 Partnerships in Clinical Trials (PCT) conference, held as part of Biotech Week Boston (BWB) on October 4-7, proved a valuable opportunity to both network with industry peers and learn more about the state of clinical research. I appreciated hearing expert proposals and updates from leaders in the research industry on topics such as data, collaboration and technology. I came away from PCT brimming with ideas and a better understanding of what’s needed for future improvement in the industry. Here are a few of my takeaways from a week filled with actionable insights:

1. The ‘deluge of data’ needs to be refined.

During his presentation on technology’s influence in clinical research, Kailash Swarna of IBM Watson Health Group discussed the potential for Big Data to improve drug development. Swarna began by celebrating the industry’s ability to collect patient data that could lead to more informed clinical trials. He affirmed the potential of Big Data to be used for predictive modeling, remote monitoring, personalized medicine and more. However, Swarna noted that many clinical trials collect far too much study data and aren’t able to use it for these purposes. He proposed the solution is to identify meaningful patterns in the “deluge of data.”

Read more

Thursday, October 13, 2016

3 keys to patient centricity in clinical trials

There was a lot of talk on patient centricity and sustainable patient recruitment for clinical trials at the Partnerships in Clinical Trials US conference this October in Boston. We've gathered some of the key takeaways from industry leaders.

While speaking on utilizing technology solutions to talk to patients, Melanie Goodman, Patient Recruitment Planning at ICON, emphasized two big ideas. Firstly, it’s important to have an understanding of where our audience is, so we can provide them with the information in a timely manner and via the platform they are using. And secondly, we have to understand who the patients are as consumers, and Patient Profiling helps with that.

1) What is a Patient Profile?

In order to answer this question, we first need to address some of the following questions:

    - What are the people looking for?
    - How are they looking for it?
    - Who are we looking for?
    - How can the new technology help patients?
    - How do we understand our patients?

Social listening comes in handy when tapping into the conversations taking place on various social media platforms. Social listening helps identifying the influencers – those who influence patients’ decisions; it helps to monitor spikes of stories and engagement; it helps to learn the language patients use to describe their symptoms, but also it provides a way to watch the conversations as they unfold.

Wednesday, October 12, 2016

Words of wisdom from Woz the Wizard

Steve Wozniak, the co-founder of Apple and the man who developed the first personal computer, came to Biotech Week Boston and Partnerships in Clinical Trials to talk about innovation and patient centricity.

Woz the Wizard was just as joyful, playful, curious and enthusiastic as ever. His advice for this generation of entrepreneurs: 
“You know in your heart what you like doing. Do that.”
"Engineers like solving complicated problems, so get them on board in a new company as quickly as possible," he told the audience. "Hire people who have built stuff – started programs and finished them. Engineers don’t necessarily have to have lots of degrees – what they do need is a history of invention."

Tuesday, October 11, 2016

Whitepaper: Is patient centricity truly at the core of clinical trials?

The complexity of clinical research trials, their exorbitant cost, and poor patient recruitment has reached a critical junction where novel methods of data design and recruitment are essential.  Fortunately, the offspring of technology and the internet has provided options that promote patient recruitment and retention, cut costs and avoid much of the paperwork and angst involved in clinical trials.

The ubiquitous smartphone can be used in a variety of ways. It is a way for researchers to remind patients to take their medications, be available for appointments, and give encouragement and transmit news. Innovative giants like Google and Apple have developed novel wearable devices and app development software so that the patient’s status can be monitored continuously and remotely.  Patients are not inconvenienced by having to travel to the research site which allows researchers access to the elderly, infirm, and rural patients. In addition, study nurses can go to the patients for follow up.

What will the US presidential race mean for healthcare?

Biotech Week Boston. Panel: What our next President mean for Biotech and Pharma

by Julie Walters, Founder Raremark

We’ve heard a lot about the presidential candidates’ tone, style and experience in the presidential debate, but what about their actual policies - particularly in healthcare? Delegates at Biotech Week Boston heard from industry leaders and commentators on what to expect, depending on who wins.

Kathleen Weldon Tregoning, Senior VP, Corporate Affairs at Biogen thought a Democratic win would mean no real surprises as Hillary Clinton has a lot of well-documented policies in health and a long history in the space. The Democratic nominee knows full well that any change in healthcare will be hard. Dylan Scott, Washington correspondent with thought one of Hillary’s first priorities, if she won, would be to decide on where to spend her energies. If the Affordable Care Act (ACA) faces further challenges, he predicted that, in defense of her predecessor’s legacy, ACA would become her first priority.

Less predictable were the policies of the Republican candidate. 

Friday, October 7, 2016

Applying Wozniak’s Take on Innovation to Clinical Research


By, April Schultz, Content Marketing Writer, Forte Research Systems

Admittedly, my inner technology nerd squealed with excitement at the chance to hear Steve Wozniak, Co-Founder/Chief Scientist at Apple Computer, speak at Biotech Week Boston (BWB) today. Wozniak's presence at BWB and Partnerships in Clinical Trials US proved very appropriate, reasserting some of the overarching themes that have maintained a consistent presence over the past three days. Wozniak’s talk served as a reminder of the power of innovation to produce real results and ultimately influence the way individuals function on a daily basis. In the clinical research industry, similar innovation and forward thinking can lead to life-changing therapies, as well as improvements to the drug development process overall.

Aligning the industry 

During his interview, Wozniak touched on the need for companies to remain open to change. He noted, “When something simpler comes along, you often don’t see it.” Wozniak applied this to the unfortunate tendency for corporate culture to adopt an attitude of stagnation, holding to age old values rather than adjusting to meet changes in society. In clinical research, this is all too familiar. While the research industry is full of brilliant minds and innovative ideas, the clinical trial process and its associated bodies are notoriously slow to adopt change. This slow adoption may be attributed to stakeholder silos, largely between sponsors, sites and patients.

Deciphering a Deluge of Data: Patient Support


By, April Schultz, Content Marketing Writer, Forte Research Systems 

The shear amount of data generated by each person is truly mind-blowing. Be it online shopping, locating the nearest coffee shop, or tracking what you ate for lunch, your devices have become inseparable parts of your daily life. The actions you perform when using your phone or laptop become tiny droplets in the enormous ocean of consumer data produced on a daily basis. 

Albeit a bit unsettling, it’s hard to ignore the immense potential of this data pool, if only it could be deciphered. During day two of Partnerships in Clinical Trials US, data-deciphering became a theme throughout the course of many presentations. Several presenters discussed the potential to target patterns in the ‘deluge of data’ for use in clinical research, including finding novel therapies for infectious diseases, aiding in the search for an Alzheimer’s cure, and creating predictive models of clinical research. All of these ideas are incredible and could lead to greater efficiencies in clinical trial conduct. However, one idea stood out to me as a concept so universally applicable: using data to enhance the patient experience.