It seems that there is almost a never ending stream of articles about how the clinical trial space is in crisis, and adaptation is required to avoid an impending catastrophe. However, whilst the stream of articles shows no sign of abating, the imminent collapse of drug development that they foretell is nowhere to be seen. In fact, the global pharmaceutical industry grows year on year and is anticipated to be worth $1.6 trillion by 2020; with R&D spend from major pharma also growing exponentially.
Yet one-man blogs and ‘big four’ consultancies alike continue to draw attention to harbingers of the death of clinical research. The DrugBaron blog points out that just 25% of novel agent drug trials succeed; a huge loss of investment on behalf of trial sponsors. Similarly, PwC point out that only 40% of companies have robust enough pipelines to fill revenue gaps when the current raft of drug patents expire over the next few years. However, over 194,000 trials have been registered worldwide at clinicaltrials.gov so far in 2015 – so the endeavour is there, if not the success.
It seems that clinical trial industry commentary should not be focused on this mythical impending collapse, but rather on what form future trials will take. Clinical research will certainly not fail, nor even reduce, but what will it look like? Certainly one area of growing discussion in recent years, in few places more so than at Arena International’s global conference series, is how the clinical landscape is changing due to the growth of increasingly smaller and smaller pharmaceutical and biotech companies, right down to virtual organisations. These tiny organisations, some with no office space, scientific facilities, and single figure employee rolls, now number in the ‘hundreds’, according to the Wall Street Journal.
However as the number of small companies increases, so does discussion of whether they can realistically gain a foothold alongside the major players. The growth in cost and complexity of clinical trials makes the process dangerous for small organisations – how can a company of two people, with one drug candidate, make an impact with service providers who can fight for a slice of the $7 billion+ plus R&D budget of Pfizer? Small, and virtual, biotechs lack both the clout and the volume of business to impress the global CROs; unsurprisingly as small companies represent little repeat business, especially when the failure of one trial could mean the insolvency of an entire firm.
So what is to change? Will small companies simply continue to fight for the attention of major CROs? (maybe) Will small companies simply disappear from the landscape? (almost certainly not) or will the vendor market adapt the same as the trial sponsor side has? (perhaps).
If the situation seems vague, it is because it very much is. A consensus doesn’t seem to exist one way or the other. One area of agreement is certainly that smaller companies can work with major providers: presentations from the likes of Dandrit and Mologen at recent OCT Series events have explained, in detail, the framework small organisations have in place in compete for attention with big pharma. However, would it be more beneficial for small trial sponsors to seek small, or even virtual providers, as their partners for clinical trials? Virtual CROs are currently very thin on the ground, a cursory Google search shows more articles discussing their potential as opposed to actual companies, but it is not at all unreasonable to suggest small or virtual trial sponsors may push for more providers who are also virtual. We have already mentioned the risk to a small company of starting a trial that will, ultimately, make or break them as a going concern, and perhaps working with a virtual CRO where clinical functions are spread around lots of different parties will limit the risk exposure and, of course, reduce costs. This is by no means a blueprint, but absolutely worth consideration.
Similarly, do virtual trials hold the answer for organisations with limited physical capital? It certainly seems like this would be the next logical step on the journey the industry is currently taking; a number of clinical trial aspects are now all but contact free – data collection perhaps the most prevalent where more and more advanced ePRO technologies are limiting contact time between patients and study staff, with many participants never having to visit a physical trial site. But this is not where the ‘hands-off’ approach ends. Even the relatively new areas of social media-driven patient recruitment now look ham-fisted compared with the accuracy provided by proposed wholesale access to electronic medical records. It could well be argued that the future of clinical research is one where patients never meet a single member of study staff; however, at time of writing, it is not the smaller companies in the market that have sought this ‘virtual trial’ approach, but rather those with, arguably, the smallest need to do so: Pfizer, Sanofi, and Shire have all tried out a virtual clinical trial model in recent years. However, it is worth pointing out, that these trials are very much a dip of the toe rather than a wholesale shift – perhaps smaller companies will chance their arm once the big guns have tried (and failed?).
In summary, if this article seems to raise more questions about clinical trials than it answers then that is by no means accidental. It seems the prevalence of commentary about the future of clinical trials, but no industry consensus or common path, speaks volumes. The industry must adapt, it will adapt, and it has been adapting for decades. Trials that are run more ‘virtually’ must become a bigger part of the clinical trial landscape – trial costs continue to rise, despite improving technology, and trials sponsors and solution providers alike will seeks ways to protect their bottom lines. I proffer the opinion that smaller companies, smaller providers, and increasingly virtual trials will be the direction the industry moves but, in what seems to be the only consensus in the stream of articles on this topic, it is really anyone’s guess.