Innovative Drug European Associates


It’s hard to consider a bright side to the current coronavirus pandemic the world finds itself in, but the delays and temporary suspension of many clinical trials do present an opportunity to step back and address gaps in many trial processes.

The question, then, is how can you use this time efficiently and effectively to improve clinical outcomes?

One of the problems companies often run into is that their trials lack a patient impact assessment. Companies need to show that the product has an appreciable impact on patient-centred outcomes – in other words, does it improve the patient’s quality of life? And can that be demonstrated? This is important, since payers are unlikely to agree to reimbursement without this data.

Let’s consider a diabetes drug. The value of a new diabetes medicine is not measured by reducing blood glucose but by appreciable patient benefits, such as avoiding amputations, ulcers, and even untimely death. It’s about understanding what parameters are going to be beneficial and providing the statistical data to the payers in a way that demonstrates a product’s value to patients and the healthcare system.

Demonstrating value starts with having a good understanding of the patient’s story, how their lives could be improved, and where their priorities lie, and then building those tests into clinical studies. That might be a walk test or a detailed patient diary that takes daily measures of mood or stomach upsets or whatever disease signals the patient is dealing with daily. Ask yourself whether these parameters have been accounted for in the trial design and if not, take the opportunity to design a new patient reported outcomes (PRO) checklist and ensure it has been properly qualified and tested.

Building relationships

Use this time when many trials are suspended to talk to the patients. Do you have a solid relationship with the relevant patient advocacy group and have you included that group’s input into the study design? If not, now would be a good time to ask how you can involve them in any amendments you will have to make when the study restarts.

Above all, ascertain whether you have a clear understanding about the patient’s struggles, that you can clearly articulate how the disease affects that patient’s day-to-day life, and that you have ways to measure those effects. There may be simple changes that can be made to the trial going forward, such as adding some information to the case report forms or patient diaries, or perhaps including a new questionnaire for patients to fill out. There are potentially activities that patients could be doing now, depending on how the study is being held, such as using a patient diary as a control diary in preparation for restarting the trial, and providing input to get a new PRO validated for use

Rather than dwell on the potential setbacks to suspending trials during the pandemic, it’s worth remembering that time is only lost if it isn’t used productively now. Use this time to carry out a review of your regulatory and clinical trial strategy so that when trials resume you can demonstrate, with statistical data, the value your product brings to patients.

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Despite having talented teams, small companies are forced to work with limited resources and access to specific expertise. They often lack the resources and experience in navigating specific regulations, the nuances of working in different countries and have limited time to spend on regulatory intelligence.

Working with a regulatory expert who is familiar with your product development and can provide on-call services or advice can make all the difference. Through our Regulatory-on-Call service, IDEA Regulatory offers a team of experts at the end of the phone or email, ready to answer any questions or carry out regulatory tasks.

Our Regulatory-on-Call service can supplement your existing team, allowing them to focus on managing and delivering your overall regulatory strategy. IDEA Regulatory’s experts know the relevant guidelines across all EU markets and stay on top of local developments. We can quickly answer questions about a process, regulation, guideline, or submission in the EU, or you can simply call our experts, who can point you in the right direction. With clinical trial uncertainty due to the coronavirus, if you need to make an urgent protocol amendment or a submission to temporarily halt a study, having an expert partner lined up at IDEA Regulatory means there’s always someone to guide you.

How does Regulatory-on-Call work?

You pre-purchase agreed hours of consultancy advice per month and IDEA Regulatory will have a team of qualified regulatory consultants who are familiar with your product and development plans available ‘on-call’ to answer your questions. The service includes:

  • A kick-off call to determine the potential types of advice and assistance needed
  • Familiarisation of our team of experts with your product and development plans
  • Assessment of the complexity of each query/task to determine the service needed
  • A flexible rolling balance of hours in credit allows you to roll-over unused time in to following months, or in more busy months, spend in advance from your future balance.
  • Regular reviews to ensure you are on the right plan

Whether it is supplementing your team or providing quick pieces of advice on-demand, IDEA Regulatory can support small businesses with stretched resources and small teams.

Contact IDEA Regulatory to learn more.

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