Friday, February 24, 2017

Is Patient-Centricity at the Core of Clinical Trials?


Recruitment and retention of study subjects in clinical research is at an all-time low; the average retention rate in 2013 was 33% which is a 56% drop from 2003 levels. Patient centricity has to do with making the patient feel special, and therefore clinical trial participation attractive as well as more valuable to them. More importantly, an attitude of patient centricity helps with continuity of care, better diagnostic targeting and treatment outcomes, and thus retention.

We had the pleasure of sitting down with five leading clinical trial professionals to discuss how well clinical trials currently treat patients and to what extent patient-centricity is truly at the core of research. In this conversation, we look at the ways in which clinical research can be made more patient-friendly to enhance recruitment and retention, including wearable technology, social media, novel trial designs, data management, support groups and sensitivity to minorities.





Thursday, February 23, 2017

Clinical technology survey 2017 - complete for a chance to win a 2-day pass


Technology is changing the way clinical trials are run faster than ever before. There’s a huge amount of excitement and investment in mHealth, cloud-based tech, Big Data and Electronic Medical Records, yet there are also concerns over regulations, training and cost.

We are conducting one of the biggest surveys of its kind across our database of over 50,000 clinical trial professionals from within pharma, CROs, academia and patient groups. The final report will reveal unique insights into how companies view the challenges and benefits of different aspects of clinical technology, and to what extent they are implementing them.


Win a 2-day pass…

Completing the survey will take just 5 minutes and will give you exclusive early access to the final report. Plus everyone who completes the survey by 5th March 2017 will be entered into a prize draw for a free 2-day conference pass to T3: Trials, Tech and Transformation in Orlando, Florida on 11-12 May 2017 or to Partnerships in Clinical Trials Europe in Amsterdam on 28-29 November 2017. Full terms and conditions can be found here.

We’re excited to see the results of this unique study and we hope you are too.




Friday, February 17, 2017

'I'm a very big critic of the current approach towards research subject information sheets' - Dr Kieran Doran, Senior Healthcare Ethics lecturer

Patients as Partners Month


Dr Kieran Doran, Senior Healthcare Ethics lecturer at University College Cork, argues that one of the biggest failings of patient-centricity in clinical trials currently is patient consent. The information on consent forms is too often in very technical detail, whilst additionally there's often a 'telephone directory's worth of information'. For Dr Doran this is a major issue when 'the very basic concept of informed consent is that the patient can understand, retain and comprehend the information being given to them.'

Watch the full interview with Dr Doran above, where he also explores the benefits of a standardized approach to clinical trials across Europe, and the challenges of patient data confidentiality.

This post is part of Patients as Partners Month - explore more here

Patient-centricity is one of four streams at T3: Trials, Tech and Transformation on May 11-12 in Orlando, Florida. Register today and save up to $1,000 off standard rates and use the exclusive code T3BLOG17 to save an additional $200. Rates increase Friday, 1/27. Find out more here.




Tuesday, February 14, 2017

How is mobile health aiding patient-centricity?

Patients as Partners Month


As healthcare extends its ‘institutional’ role and becomes more personal and mobile, patient-centricity is becoming a significant strategic focus for healthcare stakeholders. The Institute of Medicine defines patient-centricity as a means of providing care that is transparent, respectful of and responsive to individual patient preferences, needs and values, ensuring that patient values guide all clinical decisions.  In other words, being truly patient-centric means that healthcare decisions are shared between patient and clinician.

More than any other aspect of drug development, patients are at the centre of clinical trials. Research has demonstrated that putting the patient at the heart of a clinical study by engaging them throughout the process, leads to greater compliance of patients' at-home medical care and results in more successful studies for all involved.

Driving greater patient engagement empowers the patient to take an active role in the decisions made about their own healthcare and the frequency of self-management behaviors increases. This not only drives improved patient participation in a clinical study, but also lowers the burden on the site. This is particularly critical in the clinical trial context because patient engagement is synonymous with compliance, which is vital to the progression of the trial.





Friday, February 10, 2017

Where can clinical trials most improve in their approach to patient-centricity?

Patients as Partners Month


As part of Patients as Partners Month, we spoke to six leading figures from pharma, CROs, academia and patient groups about the current state of patient-centricity in clinical trials. How can those running trials improve the treatment of patients and how big a difference does it truly make to research results?

The speakers include:
  • - Dr Richard Thompson: Scientific Officer at Findacure
  • - Rob DiCicco: VP, Clinical Innovation and Digital Platforms at GSK & Transcelerate
  • - Mike Jagielski: CEO at KCR
  • - Anna Matranga: Managing Director at AMC Alliances & Consulting
  • - Dr Kieran Doran: Senior Healthcare Ethics Lecturer at University College Cork
  • - Virgil Simons: President at Prostate Net Europa




Wednesday, February 8, 2017

7 case studies of patient-centricity in clinical trials

Patients as Partners Month


Patient-centricity is one of those terms that connects to so many different aspects of clinical trials and yet is so often discussed in broad, theoretical terms. Over the last six months, we have spoken to dozens of drug development professionals leading the way in putting the patient at the centre of clinical research. Here we have gathered seven examples of how they're doing it and where they are succeeding.

1) Taking a patient centric approach to pediatric clinical trials: 'We have more than 20 years of experience with adult patients, but far more limited experience with children and young patients.' Patient Advocacy Manager at Sant Joan de Déu Children’s Hospital in Barcelona, Begonya Nafria Escalera, explores strategies that put the patient at the core of research.




Monday, February 6, 2017

Are patient-centric initiatives working in drug development?

Interview with Stella Stergiopoulos, Senior Project Manager at Tufts CSDD 


As Senior Project Manager at Tufts Center for the Study of Drug Development, Stella Stergiopoulos manages multi-sponsored and grant funded research projects. Having led a 2016 study on patient-centric initiatives, Stergiopoulos is uniquely placed to assess how well the drug development industry is currently working with patients and how successful new strategies are proving. As part of our Patients as Partners Month, we spoke to Stergiopoulos about the state of patient-centricity in clinical trials today.




Friday, February 3, 2017

INDUSTRY OVERVIEW: Patient-centricity in clinical trials today

Patients as Partners Month


For February, we will be shifting our topical focus from Niche Outsourcing to Patients as Partners. Over the course of the month we’ll be bringing you a range of interviews, videos and opinions on patient-centricity in clinical trial outsourcing, procurement, operations, and innovation. 

The clinical trials industry has come a long way from where is once was, but there is plenty of room for growth and improvement. Many industry professionals know nearly 80% of clinical trials fall short of their recruitment targets and that an estimated 30% of participants will drop out of a trial before its completion.

As an industry, there is a general understanding that an advanced commitment to patient-centricity will shape the future of this space. However, two questions first need to be asked: what does patient-centricity really mean? And is it truly at the core of clinical trials?




Friday, January 27, 2017

Conducting Clinical Research in Eastern Europe



With an over-saturation of the Western European market, there has recently been a shift towards conducting clinical trials in Eastern Europe - which now consists of roughly 20 countries. A majority of which are now part of the European Union, and this is big change compared to 10 or 15 years ago. The region has really become active in clinical trials and today, nearly 60% of the data for registering a product in Europe is coming out of Eastern Europe.

As a Clinical Operations Director at OptimaPharm, Nikola Strumberger has met many U.S. based companies in the recent years and always hears the same thing when discussing moving clinical operations to Eastern Europe: 'We are a conservative company with a conservative approach'. But looking at the data coming from this region; the quality of the data received and the increased number of sites should prove that there is no reason for companies to worry about conducting their clinical research in Eastern Europe.




Monday, January 23, 2017

‘For rare diseases, clinical trials are too expensive and take too long' - Fiona Lawrence, Director at Duchenne UK

Niche Outsourcing Month


This month we are focussing on niche parts of the clinical trials industry, including rare disease research.

As Director of Research and Clinical Development at Duchenne UK, Fiona Lawrence helps find and evaluate research projects that can contribute to fighting Duchenne Muscular Dystrophy. She has a particular focus on ‘projects that have the potential to accelerate the development of new treatments so making them available to patients as soon as possible’.

We spoke to Lawrence about the challenges and innovations impacting rare disease research today.

What are the biggest challenges of running clinical trials for a rare disease?

FL: ‘Duchenne Muscular Dystrophy is a relatively common rare disease, it is caused by a mutation in the gene located on the X chromosome that codes for the protein dystrophin and it occurs in approximately 1:3500 to 1:5000 live born boys and has the same incidence worldwide. The main challenge of running clinical trials for Duchenne is in the design of the trial. The inclusion criteria and endpoints need careful consideration in order not to be confounded by the natural history of the disease.’




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)


READ PART ONE OF THE REPORT HERE

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 2016...in 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.