What is the single greatest development that will help improve clinical trials? (Part Two)

In our second installment to celebrate International Clinical Trials Day 2015, we hear from a European pharmaceutical company and patients involved in research in USA and Australia, in what they think the single greatest development that will help improve clinical trials will be.

Monday’s launch blog to celebrate International Clinical Trials Day 2015 revealed insights from a funder in the United Kingdom and an Ethiopian trialist, on what they think the single greatest development will be that will help improve clinical trials.

We’re continuing today with perspectives from a European pharmaceutical company and patients involved in research from the USA and Australia.

What do you think is the single greatest development that will help improve clinical trials in the next 5–10 years?

Peter Kristensen, Senior Vice President and Head of Global Development at Novo Nordisk
Peter Kristensen, Senior Vice President and Head of Global Development at Novo Nordisk

From the pharmaceutical company perspective, Peter Kristensen, Senior Vice President and Head of Global Development at Novo Nordisk, affirms how patient knowledge and experience can enhance clinical research:

“Reflecting global trends, patients – and their related advocacy groups and patient organizations – are taking an increasing interest in becoming involved in all aspects of their disease management. This includes becoming involved in development of new products and may well be the key to unlocking an unprecedented win-win potential.

“Historically, patients have only had a role as research subjects in the clinical development process, while companies have turned to healthcare providers for advice on aspects such as trial design.

“However, patients and patient leaders are able to offer unique insights and perspectives based on their own or collective experiential knowledge, i.e. knowledge acquired through living with and managing their disease.

…Partnering with patient organizations is beginning to prove its ability to increase the quality of trial materials, as well as to expedite recruitment…


Peter Kristensen
Senior Vice President and Head of Global Development at Novo Nordisk

“Along with this, the PatientPartner project has designed a framework and guidance for how sponsors of clinical trials – industry included – and patient organizations may engage to drive value enhancement in clinical research. Partnering with patient organizations is beginning to prove its ability to increase the quality of trial materials, as well as to expedite recruitment.

“The majority of clinical trials done by companies target the generation of data for inclusion in product labels, or generates other forms of information on product risk-benefit. The extent to which regulators and payers will be willing to listen to the feedback from patients and their organizations will determine how fast a pharmaceutical company with patient partnerships could become a game-changer in clinical development, at both process and product level.

“Such interactions are the new reality, and something that I believe is here to stay, to the benefit of everyone.”

For the full list of clinical trials Novo Nordisk is currently conducting, see their website.

Deborah Collyar, President of PAIR
Deborah Collyar, President of PAIR

From the patients’ perspective, Janet Wale, Chair of HTAi Patient and Citizen Involvement in HTA Interest Sub-Group in Australia, and Deborah Collyar, President of Patient Advocates In Research (PAIR) in the USA, assert that listening to the patient voice leads to patient-centered, informed clinical trials:

“The biggest enhancement to clinical trials is already improving designs, accrual of participants, and outcomes. Patient and patient advocate voices are helping to create clinical trials that adequately cross into real world clinical decision-making – with more realistic trade-offs for patients.

“Well-resourced projects, such as the United States PCORI and EUPATI in the European Union, strive to provide patient representatives with the necessary training and expertise to be part of the discussions across a range of disease areas, rather than only those that are the most lucrative or highly rated by the medical profession.

Janet Wale, Chair of HTAi Patient and Citizen Involvement in HTA Interest Sub-Group
Janet Wale, Chair of HTAi Patient and Citizen Involvement in HTA Interest Sub-Group

“The patient voice is important for randomized controlled trials directed at regulators and payers, as well as studies that address uncertainties and knowledge gaps regarding side-effects and adverse events. The patient voice is also vital in disease management, longer-term outcomes, and whether surrogate endpoints translate into clinical outcomes that are important to healthcare systems, patients and their caregivers.

“Patient advocates and their support groups, if provided with the same information on new therapies as the medical profession, can ensure that patients and their families understand the implications of clinical trials with regard to their immediate health needs and the promise of knowledge gained for future patients.

“Quality of Life and Patient-Reported Outcomes (PROs) are not just nice to have; they are ESSENTIAL to the physical and mental wellbeing of each person and their ability to function in daily life, and to adhere to trial protocols and treatments.

“Patients led the way through ACOR.org, over a decade ago, in documenting the side effects of treatments for serious illnesses that were not recognized by others, causing a ripple effect that is still visible.

… The patient voice is important for randomized controlled trials… Patients are, after all, the reason why clinical trials exist…


Janet Wale and Deborah Collyar
Respectively, Chair of HTAi Patient and Citizen Involvement in HTA Interest Sub-Group, and President of PAIR

“Today, electronic clinical outcome assessments create large databases. Well-researched PROs are supported by e-learning packages and research on overcoming difficulties in adequately explaining disease processes, collecting information, and adhering to treatment regimens for different age groups and populations.

“Much of this work is done by organizations and consultancies working for industry, outside the academic world, which has traditionally dominated the scientific literature.

“Not-for-profits, including patient groups, now run their own online trials involving large numbers of participants. Journals and regulatory agencies are also changing to provide clinical trial results in more searchable and understandable ways.

“Patient advocates are experts in patient experiences, documenting and presenting these to assist in trial design, implementation, and presentation of results in plain language. Patients are, after all, the reason why clinical trials exist.”

So what is the single greatest development that will help improve clinical trials?

The four perspectives we have seen from those involved in clinical trials, and from across different continents, give us insight into what this might be.

Patient and public involvement in clinical trials (and medical research generally) is a key factor, echoed across multiple sectors. Indeed, this is why we recently launched our new patient and the wider public involvement journal, Research Involvement and Engagement. However, as highlighted in Part One, fundamentally there needs to be strong clinical trial leadership, particularly in developing countries who have a vital role to play in the clinical research.

Clinical trials have come a long way since James Lind and his oranges and lemons on board the Salisbury; this is an exciting point in time for clinical trial development and these perspectives give insights into what key factors may shape them over the years to come.

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