It’s a tough time to conduct clinical trials, thanks in no small part to heavy travel restrictions, site visitation restrictions, and potential subjects being stuck in quarantine. According to medical data-management company Castor, the COVID-19 pandemic is affecting recruitment for 262, 366 clinical trials worldwide.
In short, it’s a challenging time for biotech companies working with CROs. Particularly in the realms of oversight and governance. Sponsors and CROs need to work together more smoothly than ever, just as the waters are getting far more choppy and tough to navigate.
How can sponsors manage CRO governance and oversight in the face of all these changes and restrictions?
Be proactive, rather than reactive
If your trial hasn’t made it out of the recruitment and treatment phases, there is a good chance you will face delays, or at least deviations from the usual protocols, as more and more (even healthy) patients forgo the necessary site visits out of fear of contracting the virus. Recognizing this, and putting patient safety first (as they should), many sponsors are deciding to delay patient enrollment for new clinical trials.
Sponsors and CROs alike are being put under immense pressure, forced to come up with creative ways to salvage data from ongoing trials while protecting their patients through remote monitoring.
Unfortunately, all the changes and uncertainty have put many biotech companies in reaction mode. However, to pull these trials off in the face of the COVID-19 crisis, the exact opposite is needed: biotech companies need to be more proactive than ever.
Sure, in this new and novel situation, it’s important to adapt processes and implement new technologies to help you, for example, monitor better from a distance. But there’s a human factor that’s even more important, more key to trial success: strong outsourcing partnerships. Sponsors and CROs need to work even more closely together to move their clinical research forward in these trying times.
Here are 5 ways our clients have been doing just that.
1. Update Your Risk-Management Plan
With COVID-19 changing everything, it’s time to take a step back and reevaluate your risk-management plan.
You need to ask yourself the following questions:
- How will the pandemic impact the participants, as well as the staff running the trial?
- How will it impact your processes
- How will it impact your product?
Though it’s natural to want to jump in head first and plough forward in the face of uncertainty, figuring it out as you go, taking the time to step back and really evaluate the situation first will likely save you a lot of headache and heartache down the road. It will leave you better prepared for more of the unexpected situations sure to come, with mitigations and interventions ready to go when needed.
Creating a robust risk-management plan gives you the framework to manage unexpected situations, and forge a better working relationship with CROs as part of the process. A relationship where risks and responsibilities are clear, and both parties are aligned to tackle them together.
This video from the European Centre for Clinical Research Training has some tips on how to address the new concerns raised by the COVID pandemic.
2. Transition to Remote Monitoring
The new EMA guidelines recommend “conversion of physical visits into phone or video visits, postponement or complete cancellation of visits to ensure that only strictly necessary visits are performed at sites” to lower your and your patients’ risks.
Sponsors are strongly encouraged to consider these measures in their planning, and how they could be most seamlessly and painlessly implemented.
However, remote monitoring requires its own preparation and planning. Sites need to be given the time, equipment, and budget to pull it off.
The good news, though, is that sponsors who work with and support their CRO partners through this process are also working toward improving their long-term relationships with CROs, who are then more inclined to see the sponsor as an organization to be trusted. This makes partnering in this tough time and beyond easier, helping you both achieve your common goals now and later.
3. Simplify Procedures
It is the sponsor’s responsibility to define expectations, but striving for alignment with their CRO partners is essential. This might mean working together to cut through some of the red tape.
The International Council for Harmonisation’s guideline for good clinical practice E6 (R2) recommends that you “avoid unnecessary complexity, procedures and data collection” – now or any other time.
Meaning: it might be time for a total redesign of the trial and protocols, revising and simplifying your plans to achieve more reliable results in the current world of uncertainty.
4. Focus on Your KPIs
You might also need to rethink the way you measure trial success.
Reevaluating and adjusting your Key Performance Indicators (KPIs) will allow you to measure the quality of deliverables and operational performance in an objective way. Furthermore, establishing clear KPIs could help you identify and resolve potential problems in advance, minimizing their impact.
5. Make Your Communication Transparent
Encouraging open communication and transparency has never been more important.
While striving to maintain timelines is the concern of every sponsor at the moment, sponsors also need to understand the difficulties that CROs are currently facing, and give them the tools to communicate effectively.
Luckily, in our internet-driven world, we do have the tools to do this: simply make use of technology and online platforms that enable immediate data sharing.
How to Pull This Off?
This is a lot to take in – we get that. The current crisis is forcing you to rethink basically everything about running clinical trials. It’s normal not to know where to even begin.
Luckily, there are experts who can lead you through this process step by step. At Suess+, we have been doing just that for clients who are trying to navigate these stormy waters. We can offer you expert vendor-management advice as we help you identify your shifting risks, build effective remote governance and oversight policies, create a common culture and set common goals in your sponsor-CRO-supplier partnerships, escalate issues, and make the right decisions for your ongoing and upcoming clinical trials.
Get in touch for a free consultation to find out how we can help.