Increased access to clinical studies: Yes, but not at all costs.
Tackling trusts issues and ethical concerns.
Sustainable healthcare of high-quality will be transparent, collaborative and technology-enabled.
The political paper “Action Plan for Clinical Studies (2021–2025)” was released in Norway by the Ministry of Health and Care Services. The Norwegian Minister of Health and Care Services promised that more patients will now have the opportunity to participate in clinical studies as part of the treatment. I am looking forward to contributing to the Norwegian government’s vision.
Over the past years, I worked with PubGene to build a groundbreaking Digital Health solution for Personalised Medicine, intending to help patients and their healthcare team find the right treatment. As such, we are responsible for defining what a best-in-class evidence-based, personalised, shared decision-making experience can be.
In this post, I explain solutions to address an important consideration when a country works towards doubling the number of clinical studies: Tackling trusts issues and ethical concerns.
This relates to the action plan’s Focus Area 3: Norwegian healthcare service and the industry in partnership.
Tackling the trust issues
The Norwegian action plan for clinical studies aims to double the number of clinical studies in Norway by increasing the number of industry-funded studies, which has declined over the past ten years. However, to reach that objective, Norway will need to tackle some trust issues:
The scepticism and concerns of healthcare professionals in studies financed by the industry are prevalent in Norway and many other European countries.
The public’s perception of the pharmaceutical industry, and commercial vendors in general regarding well-being and healthcare, has been primarily negative for a long time. Only a few citizens believe that those actors will put their well-being over profits. Ipsos research finds that, across 29 countries, a global country average of 31% rate pharmaceutical companies trustworthy.
Finally, the pandemic highlighted the countries’ shortcomings with populations with low trust in their government. Fortunately, this is not the case in Norway today. Citizens’ confidence and satisfaction in the national government and public health care remains very high compared to the average range, according to Gallup World Poll from 2014 and 2018.
Norway needs to work to stay that way when trust in government is declining in surrounding countries. According to a recent IPSOS study: it’s a fact, scientists are the most trusted people in world. Healthcare Systems need solutions that facilicate the transparent collaboration between patients, their healthcare team and scientists — regardless if the study is financed by the industry or by public funding.
People are not guinea pigs. Experimental treatments call for ethical safeguards.
When experimental treatments are considered the last hope, some people might be willing to try anything when all other options have been exhausted. Even if there are uncertainties about the efficacy or safety of the treatment. Instead of spending the time they have left at home with their friends and family, they may embark on a stressful process that might lower their quality of life and be harmful. So, there are ethical issues associated with experimental treatments.
Healthcare providers and citizens need solutions to see through “evidence” that may be cherry-picked, led by sales and marketing teams, or by the career and reputation of individuals, rather than clinical teams.
Solution 1: Transparency — A solid regulatory framework and the continuous monitoring of Quality Indicators by an independent body
A solid regulatory framework and continuous monitoring of Quality Indicators by an independent body are necessary to tackle the trust issues in studies financed by the industry, commercial vendors and ensure continuing trust in the government.
Coremine Vitae analysts or subject matter experts, powered by Vitae Evidence software, will find relevant clinical studies and experimental treatments for patients with cancer, autoimmune and neurodegenerative diseases. Building this solution, we focus on quality and transparent impact by design. Financed mainly by research grants and angel investors with a personal attachment to the cause, the solution is developed independently from the pharmaceutical industry or specific healthcare service providers.
The clinical studies and experimental treatments that Coremine Vitae suggests for a patient are selected after considering all studies available worldwide. They are evaluated according to quality criteria tailored to the individual patient: it considers the complete medical history, the genetic and molecular profile, and patient preferences. The selection also considers the quality of the study design and results from earlier phases. Preliminary results for similar intervention / patient profile are searched in a wide range of information sources encompassing medical news feeds, including conferences, pre-prints and scientific publications repositories, and medicine agencies. Vitae Evidence indicates how the search for studies was planned and performed, why a study was picked for a particular patient, and why others were excluded.
The match between the clinical studies and the individual patient is quality controlled. A feedback loop is designed to collect information at point-of-care.
The software solution is certified as a Medical Device Class I, and the AI and Human process is formalised by Standard Procedures (SOPs). We defined processes for our independent Quality team to perform regular audits of both the software design, it output and its usage, according to ISO 13485.
Solution 2: Collaborative — provide more than one option.
Citizens need to choose freely among multiple options.
Coremine Vitae provides treatments and clinical trials options independently reviewed and presented using Share Decision-Making best practices.
We create choice awareness by giving tailored information in plain language encompassing the relevant standard of care and options in research — reassuring the patient that all appropriate options have beeen explored. Case Managers at Coremine Vitae deliver insights with human empathy, keeping the need of the patient in the center, and considering the real hurdles of healthcare provider with little time at hand.
Solution 3: Technology-Enabled — continuous monitoring to give patients a quick way out of the study if necessary.
Our grandbreaking Digital Health solution for Personalised Medicine uses a patient remote monitoring portal and specialised algorithms to find the next best course of action for a patient with cancer, autoimmune disease, or neurodegenerative disease. Such a solution enables recurring clinical assessment forms to measure patient-reported outcomes and experiences from the convenience of his home (smartphone) between the scheduled doctor visits. That way, it is possible to detect when it is no longer safe for the patient to continue the experimental treatment or when the medical team should be alerted.
It is less scary to embark on a clinical study (or enrol your patient in a clinical study) when you know there will be a safe, continuous follow-up.
Such a level of transparency, personalisation and follow-up will not be feasible at scale without using the digital health technology that our times deserve. Vitae Evidence is building a world where the collaboration of patient, clincians, researchers and bioinformaticians makes personalised medicine available to all. It empowers patients and clinicians with the knowledge to find the right treatment, whether it is standard of care or as part of a clinical study.
Would you like to learn more about our quality process, and how we can help the patient-healthcare team-scientists transparent collaboration? Contact me or Vitae Evidence
In case you’ve missed the previous articles in this “Norwegian Action Plan for Clinical Studies” series:
- Norwegian Action Plan for Clinical Studies — The opportunities that lie in Translational Bioinformatics and Digital Health
- Clinical trials will be an integrated part of patient care. Here is how Coremine Vitae is going to contribute to the Norwegian government’s vision
- How Translational Bioinformatics and Digital Health will contribute to increased opportunities for patients to participate in clinical trials
- Better use of health data in clinical trials. Explainable AI and Digital Health to unlock the potential of clinical registries
References
- New political paper: Action Plan for Clinical Studies https://oslocancercluster.no/2021/01/15/new-political-paper-action-plan-for-clinical-studies/
- Trust: What next for the Pharmaceutical industry? https://www.ipsos.com/en-uk/trust-what-next-pharmaceutical-industry
- It’s a fact, scientists are the most trusted people in world https://www.ipsos.com/en/its-fact-scientists-are-most-trusted-people-world
- Ethics of Experimental Treatments for patients https://www.hcplive.com/view/ethics-of-experimental-treatments
- ISO ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes https://www.iso.org/standard/59752.html
- BMJ Best Practice - Shared Decision Making https://bestpractice.bmj.com/info/us/toolkit/practise-ebm/shared-decision-making/
- Redesigning phase 3 and 4 trials to adopt shared decision making https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(21)00385-0/fulltext
