Partnerships have always been central to clinical trials, but with increased complexity and new opportunities created by technology, they are becoming more and more prevalent and vital to many pharma companies. Partnerships are no longer just between Sponsors and CROs, but also involve sites, academic centres, service providers, networks and patients.
We asked dozens of clinical professionals from all areas of research about the trends and innovations they are seeing in the clinical partnerships landscape. Here we’ve gathered eight of their responses.
Dr. William van't Hoff, Clinical Director at NIHR Clinical Research Network
'I think the opportunity for Sponsors is to have a new relationship with networks such as NIHR, but also networks that exist in other countries, and to use that partnership to change the way they work. Why should they do this? Because the older traditional model of clinical trials of Key Opinion Leaders and selected sites is not really delivering and it's at risk of delivering in the future of stratified medicine in vulnerable groups - in my own clinical field of pediatrics that's very relevant.
So what we're looking for is a different way of working. Partnerships offer the opportunity for early engagement with the whole national system, which gives much more accessibility to reach more patients and a key opportunity for patient engagement. I think part of the key change we need to see in a partnership is bringing the patient in early on; the concept of early engagement with a Sponsor in a network discussing what their development pathway is and where patients could contribute to get real life questions. This will help Sponsors deliver a protocol in collaboration with experts, Key Opinion Leaders and patients that should be more deliverable. It should reduce the time required to run the clinical trial, bringing the product closer to regulatory authorisation with a better market approach. So, for me it’s all about early engagement in partnership.'
Willie Muehlhausen, Head of Innovation at CRO ICON
‘I think that sites need more support, and we need to find out how to support them. We all talk about 'burden' on a regular basis - site burden, patient burden - and we at ICON have started a research program to find out what that really means. What constitutes burden for patients or for sites? And what can we do to either mitigate that or, the better option, remove it? I think it's important that we fix that.
We can also help sites to find the right patients. We would for example do pre-screening based on the patient records that they have to help them to find the right patients. On that same topic, protocols are getting more and more complex - in the last 10 years they've gone from 110 procedures per protocol to like 160 or 170 procedures.
The complexity has gone up, so it is more difficult for the sites to be compliant with the protocol, and more difficult with the inclusion and exclusion criteria to find the right patients. We have solutions and we think we need to develop solutions to make that easier for sites to enrol the right patients at the right time for the right study.’
Julianne Hull, CEO at consultancy WenStar Enterprises
‘A good start would be defining what a partnership actually is. It is more than preferred partnerships – whatever that means. A partnership should be two or more groups working together to ensure that all involved parties move their business forward. Is that really what happens? How often do groups actually get together looking for that win-win-win? In reality rarely. Does it matter? We persuade ourselves that partnerships matter, that partnerships will make it easier, better, more consistent.
If we actually look at the industry, yes there are lots of big players - both pharma and CRO. There are many, many more tactical relationships between tiny one-drug, several-trial biotech companies than there are relationships between the big guys. Why do we never seem to think of these and the value partnership can add to these clinical trials? Partnerships are really not just for the big guys or the medium guys, partnerships are really important for the small guys. In these instances, CROs can become Clinical Operations for the small biotech. This is really motivating for the staff at the CRO as well as at the biotech company.’
Dr MaryAnne Rizk, Global Vice President of Biopharma Partnerships at clinical data company Oracle
'I believe technology is going to be the hub for how Sponsors, whether they're global pharma, emerging biotech or in the MedTech space, are collaborating with CROs and defining these new ways of partnering. Data is by definition creating trust and transparency.'
Dr Steven Anderson, Chief Scientific Officer at Covance
‘The complexity of trials dictates additional considerations for interactions and relationships between all the key stakeholders - pharmaceutical/biotechnology companies, principle investigators and investigative sites, CROs and service providers, and the patients - for the trial execution and success. Flexibility, consultative interactions and new models for partnerships will help drive the way these relationships continue to evolve.’
Michael Mihut, Quality, Planning and Evaluation Management at the World Health Organization
‘Innovating sometimes only means taking what exists and using it differently. From the partnership point of view, advance or joint planning would help the CRO build sufficient pools of the required subjects so that recruitment is not delayed. Shared mobile apps could help track the various phases of the study from identifying PIs, to recruitment, to testing, analysis and reporting. Joint evaluation at the end of each project would help identify lessons learnt that will then more likely be applied by the partners in future projects.’
Matt Cooper, Business Development & Marketing Director at NIHR Clinical Research Network
‘Companies are starting to do more and more partnering. In the past some companies have been quite conservative in the way they've looked at their portfolios and pipelines and have kept most of the work in-house, but because of the expansion of the drug discovery side of things, these companies can't do everything themselves and they're looking for increased partnerships.
Networks such as ours are out there to make it easier for companies to partner with academic groups to look at the molecules they've got and get some really good data alongside the companies' main R&D thrusts.
In particular, consortia are now forming between different companies and academic groups, particularly in the pre-competitive space. In England we support 30 national specialty groups of key clinical experts and what we're trying to do is link those individuals with companies that are looking to partner to get some really good science behind some of their molecules.'
Vivienne Van de Walle, Director and Research Physician at the independent research site PT&R
‘You see now that a lot of pharma companies now outsource their clinical operations business. We see that as a sign that we’re not dealing directly with the Sponsor anymore, but more with CROs or CRAs, so there’s this new structure. Last year, for the first time, we broke the margin of over 50% were no longer working directly for the pharma company.’