Friday, January 20, 2017

How the AKU Society recruited 50% of their patient population in 9 months

Niche Outsourcing Month

'All of our work is about focusing on patient-centricity...and this makes our trials run very, very smoothly. ' For Oliver Timmis, CEO of patient group AKU Society, treating patients as partners isn't simply a box ticking exercise - it is the key to successful research.

Setting out to find a cure for the rare genetic disorder Alkaptonuria, Timmis and his team gained funding from the European Commission and formed partnerships with a CRO and pharmaceutical company to launch their own clinical trials. Even before the trials began, they worked with patients to make sure the design was suitable; 'from the start patient-centricity was key'.

Monday, January 16, 2017

Are clinical trials ready for mHealth adoption in 2017?

by Sarah Iqbal

The mHealth industry has been making a strong case for its ability to optimize clinical trials and improve engagement with patients. This time last year the Mobile Health in Clinical Trials Survey Report showed that while 80% of respondents believe the industry’s use of mHealth technology is still in its infancy, 60% consider it to be very important. Let’s recap on where we are and the efforts needed to progress in the coming year.

Where are we in the mHealth industry now?

Innovative use of mobile health information and sensing technologies has been integrated in various clinical studies to reduce cost and improve research outcomes. These technologies can support continuous health monitoring at both the individual and population level, streamline clinical trial processes, engage patients to be more responsive in clinical research and provide on-demand interventions in ways previously unimaginable. In addition, mHealth is most useful when it comes to improving data quality and patient trial adherence through gamification.

Friday, January 13, 2017

'The rare disease research field is ahead of other areas in patient engagement' - Dr Richard Thompson, Head of Research at Findacure

Niche Outsourcing Month

Whilst the challenges facing clinical research today are numerous, running trials for rare diseases brings with it a whole different set of  problems. We interviewed Dr Richard Thompson, a man who, as Head of Research at Findacure, knows this better than most.

Recruitment is the obvious barrier to rare disease trials:
'Because there are so few patients and split around the world, it can be very hard to identify and recruit them for trials. Patient groups that form nationally or internationally can give you access to that network very quickly, making recruitment a much easier process.'

Away from recruitment, the lack of knowledge about many rare diseases means that 'it can be hard to know exactly how the disease should progress and that makes it difficult to understand the landmarks or endpoints you are looking for in a trial'.

Monday, January 9, 2017

VIDEO: The biggest challenges and changes expected in clinical trials in 2017

Clinical trials are going through a period of great challenges and change at the moment as the industry grapples with technology adoption, patient recruitment and innovative partnerships. We asked a number of leading professionals from pharma, CROs, academia and charities about the biggest challenges they are currently facing and the changes they expect to see in 2017.

Technology inevitably came up time and time again, with an emphasis on adopting new tech in faster, more efficient ways. Anna Matranga, MD at AMC Alliances & Consulting, insists 'there needs to be some investment in bringing technology on board and trying to make it compatible with the systems we have in place.' Similarly, Oliver Timmis, CEO at AKU Society, sees a 'much bigger reliance on real world data' replacing Phase III or IV trials.

Wednesday, January 4, 2017

The 10 most popular posts of 2016

Throughout 2016 we covered all the hottest topics that impacted clinical trials during the year, from patient-centricity to wearables, and strategic partnerships to regulatory changes. Here we have gathered together the ten most popular posts we published last year.

1) Whitepaper: Are strategic partnerships in clinical trials living up to what they promised?
The most popular post of the year was our in-depth whitepaper exploring how and why strategic partnerships are developing in the 21st century, as well as the reasons behind current trends, the pros and cons of partnerships, and the impact of partnerships on drug development.

2) The 8 biggest challenges facing clinical trial professionals
Based on interviews we did with dozens of clinical professionals, we gathered together a report on the biggest challenges you faced last year.

Wednesday, December 28, 2016

What is the typical partnership in the 21st century?

Traditionally clinical trials were conducted in-house by pharmaceutical companies. The pressure of market and economic forces combined with the dynamic changes in clinical trial demographics and the increasing complexity of conducting trials has lead sponsors (pharmaceutical, biotech and medical device manufacturers) to outsource clinical trials to Contract Research Organizations (CROs).

At the onset a partnership between a Sponsor and a CRO meant that the sponsor outsourced the drug development to the CRO and provided them with the experimental drug as well as medical oversight. The CRO carried out all the administrative work on a clinical trial, recruited and trained participating researchers, co-ordinated the study process, provided study material and the drug being studied, collected data from various study sites and ensured that the researchers complied with clinical protocols.

In the 21st century partnerships have evolved from transactional, tactical, ‘fee-for-service’ arrangements with price as a dominating factor, to strategic partnerships where both profits and risks are shared, and core competence is the dominant factor. Strategic partnerships entail larger amount of work commitment, longer timelines, broader scopes and building infrastructure to support the entire product development cycle.

The above excerpt is from our recent whitepaper "Are Strategic Partnerships in Clinical Trials Living Up to What They Promised?". This paper describes how and why strategic partnerships are developing in the 21st century, elaborates on the reasons behind current trends, the pros and cons of the partnerships, impact of partnerships on drug development, ensuring the success of partnerships and future trends. Access the complete whitepaper here.

Wednesday, December 21, 2016

Managing trials and patient recruitment in emerging markets

With the current high cost of research conducted in the US and EU, researchers have turned to developing countries for research participants for a number of reasons.  First, costs are 30-50% lower. Second, there are large populations of prospects who have not participated in research trials previously.  Third, these countries have poor medical care and as a result, have a higher incidence of advanced diseases. For all the benefits of off-shore recruitment, there are significant hurdles to overcome: Adapting the universal paradigms of research to local cultural norms, language, ideas, and literacy levels can be demanding without local support.

Prospective subjects in developing countries are also vulnerable to patient abuse and exploitation. Poverty, limited health-care services, illiteracy, cultural and linguistic differences, and limited understanding of the nature of scientific research may increase the possibility of such exploitation. Examples of abuse and exploitation are all too common providing enough examples to support this contention, causing concern for more appropriate design and development of future models.

The growth in the lucrative Indian research subject market has all but dried up due to series of discoveries involving the unethical recruitment, inadequate regulatory systems, validity of the data, injury to subjects, and allegations of fraud. Between 2007 and 2010, at least 1,730 people died during or after trials.  These deaths were never investigated.

Monday, December 12, 2016

EXCLUSIVE INTERVIEW | Sir Steve Redgrave: Winning Olympic gold with diabetes

Sir Steve Redgrave is one of Britain's greatest ever Olympians, winning five Olympic gold medals in rowing. What is less well known is that he was diagnosed with diabetes three years before the Sydney 2000 Olympics where he won his final gold. At Partnerships in Clinical Trials Europe in Vienna, we interviewed him about his experience of living and competing with the condition.

'I was thinking my GP was going to say: "your rowing career is over, you can't compete again internationally"...but he said to me: "I see don't see why you can't compete in three years' time". That was the point that I thought that hasn't given me an excuse to give up, we'll give it a go. I came up with a slogan at that point - "diabetes has to live with me, not me live with diabetes".'

Watch the full interview above.

Wednesday, December 7, 2016

REPORT: The 8 biggest challenges facing clinical trial professionals (pt. 2)


Over the last year, we interviewed dozens of clinical trial professionals representing pharma, CROs, sites and vendors. We asked them all about the biggest challenges they are facing and eight answers came up time and time again. Here we reveal the most common after the top four (which we explored here).

Staff Roles & Responsibilities (9%)

As the complexity and rate of change in trials both continue to increase, hiring and training the right staff is getting equally tricky. Respondents commented that ‘working in a constantly dynamic environment both in and out of the company’ means that ‘roles and responsibilities are evolving’.
Another aspect is the ‘increasingly remote nature of teams’ which has ‘an impact on how we manage and retain staff’. Similarly, with trials becoming more and more geographically diverse, another new challenge is ‘obtaining experienced clinical research professionals in developing countries’.

Monday, December 5, 2016

Ataxia UK: Taking a patient-centric approach to curing rare disorders

The ataxias are a group of rare neurological disorders that affect speech and movement. The Specialist Ataxia Clinic in London - accredited by the charity Ataxia UK - combines cutting-edge research with a patient-centric approach to care for those affected by the disorder.

We visited the clinic and spoke to five of the people working with Ataxia UK, including the Head of the Specialist Ataxia Clinic Dr Paola Giunti, as well as a patient and volunteers.

Ataxia UK spoke at Partnerships in Clinical Trials Europe 2016 - find out more here.

Wednesday, November 30, 2016

REPORT: The 8 biggest challenges facing clinical trial professionals (pt.1)

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”.