Sverre Bengtsson – co-founder and senior vice president of the Swedish company Viedoc Technologies AB , which provides Viedoc, a clinical trial software – gives an update on the situation and tips for those running an ongoing or planning a new clinical trial.
What is the current status of clinical trials?
– We see that study activities have clearly decreased but have not eliminated all studies. The pandemic and its effects on our life as we knew it, is forecast to continue with estimates ranging from a couple of months to well over a year from now. Both ongoing and future studies are affected.
It is estimated that new patient recruitment has decreased by around 60 to 80% in comparable studies and the same clinics compared to 12 months ago in a sample of 6 countries*. Global pharmaceutical company Eli Lilly is delaying the start of most planned studies and pausing recruitment in ongoing studies**. It will almost certainly become even more challenging in the near future.
– At the same time, your clinical trial is ongoing and you need to stay on top of the study and make sure it finishes with as few disruptions as possible, and hopefully on time and on budget. Or if you are currently planning an upcoming study and realize that you need new methods or a new design to carry it out. The challenges vary from study to study, depending on, for example, the area of indication and where in the world the study is conducted.
Many authorities (e.g. FDA and EMA) have issued advice for ongoing/upcoming studies and what in the study may need to be changed. (These are listed at the bottom of the article).
– The most important aspect of clinical trials is patient safety. Focus on what might affect the patient and modify the study accordingly. Inform all stakeholders (patients, clinicians, etc.) of changes.
Sverre points to several challenges that companies can face. Can the study continue in the current way or at all? Are there cases where some patients have to be excluded from the ongoing study? What is the recruitment and retention of patients in the study?
Patient visits to clinics and what is measured may need to change. How do you see studies being adapted to the new situation?
– The studies can use telemedicine and different types of apps, wearables and other connected methods to measure patient response and adherence to treatment.
The studies borrow processes and possibly technology from so-called Remote Trials, Virtual Trials, Decentralized Trials or Hybrid Trials i.e.. conducting the study remotely, either entirely (there are a few examples of this) or where parts of the study are conducted remotely.
How do you do it?
– Imagine a patient visit to one of the digital patient platforms such as Doktor24, Kry or similar – but in a clinical trial – and data coming in from the patients and apps or devices directly into your electronic study database.
The methods can be used at all stages of a clinical trial from patient recruitment, informed consent (eConsent) and data collection in the ongoing study.
– In an ongoing study, you can use one of the established video call platforms such as Skype or WhatsApp. Study materials and equipment can be sent directly to patients for use in the study. The monitoring of the study is also done remotely via the corresponding platforms.
Remember to inform.
– No matter how the studies are conducted, it is very important that patients and other study participants are well informed and trained in the procedures used. Ask yourself “how is this ensured with backup techniques or processes?”.
Below are links, advice and questions you should ask about your study.
Many authorities (e.g. FDA and EMA) have issued advice for ongoing/upcoming studies and what in the study may need to be changed.
- The most important aspect of clinical trials is patient safety. Focus on what might affect the patient and modify the study accordingly. Inform all stakeholders (patients, clinicians, etc.) of changes.
- Consult authorities and ethics committees about changes to the study.
- Alternative approaches to the patient may need to be evaluated.
- COVID-19 screening may need to be added to the study, either because the new procedures of the study clinics require it and/or because there may be new endpoints in the study.
- Normally, changes should not be made before ethics committees or authorities approve them, but in some cases it may be allowed if patient safety is at risk – but must be reported and approved as soon as possible thereafter.
- Patient visits to clinics and what is measured may need to change.
- Use central and remote monitoring instead of traditional monitoring.
Some challenges – think about this!
- Can the study continue in the current way or at all? Are there cases where some patients have to be excluded from the ongoing study?
- What is the recruitment and retention of patients in the study?
- Extend the study or should it be temporarily stopped?
- Monitoring visits: Clinics want to minimize the number of visits that are not directly necessary here and now. Do they have time to take care of your study or do they have other priorities?
- Patients: There are all sorts of different reasons such as travel restrictions, quarantine, canceled bus lines or not wanting to expose themselves to the risks of travel itself.
- Study materials: Are the transports working, will temperature-sensitive materials arrive on time and can they be handled properly?
- How do we ensure that all participants are adequately informed about changes in ongoing studies?
- If study design changes, it may affect the number of patients needed or how we measure endpoints.
- Project management and monitoring: Do you have the right tools and processes to monitor the study or do you need to adapt them?
- Risk-based approaches such as central and remote monitoring of the studies should be considered. Not all data are monitored in the clinic but mainly safety and primary efficacy variables for a relevant number of patients.
Links:
EMA: Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
FDA: Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
MHRA: Advice for Management of Clinical trials in relation to Coronavirus
https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/
Overview of European authorities’ recommendations:
https://www.linkedin.com/pulse/europe-covid-19-overview-european-regulatory-john-hutchinson/
ACRO (American CRO Association), concrete tips:
https://www.acrohealth.org/wp-content/uploads2/2020/03/ACRO-Statement-on-Monitoring-Oversight-FINAL-3.13.20.pdf
Citation of sources in the text:
* https://www.medidata.com/wp-content/uploads2/2020/03/COVID19-Clinical-Trials_20200323-1.pdf
* * https://www.outsourcing-pharma.com/Article/2020/03/23/Eli-Lilly-disrupts-trial-activity-for-COVID-19
Here you will find SwedenBIO’s information page related to Covid-19:
https://swedenbio.se/om-life-science/covid-19/
