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COVID-19 not only advanced scientific boundaries, but also transformed research methodologies and accelerated adaptive clinical trial design.

COVID-19 Five Years Later: The Impact on Drug Discovery 

Addressing systemic barriers and biases faced by women in research to foster a more diverse talent pool.

It’s Time for the Life Sciences Industry to Accelerate Action for Gender Equality

Investigators find that most exclusion criteria in critical care randomized clinical trials are justifiable, but 60% include at least one poorly justified exclusion, most commonly affecting pregnant or lactating individuals.

Study Finds Many Randomized Clinical Trials Have Poorly Justified Exclusion Criteria

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, talks collaboration and maximizing resources among the various stakeholders in rare disease research.

The Role of Collaboration in Advancing Rare Disease Research

, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, discussed the unique challenges in rare disease R&D, including competing priorities among researchers, difficulty in diagnosing and treating patients, and defining endpoints due to varying symptoms. Ansel also touched on the potential of technology and artificial intelligence to address some of these challenges and improve rare disease research.

ACT: Is there anything you would recommend to help advance rare disease research from a policy or strategic perspective?

Another great question. I think it's really about collaboration. Now more than ever, I think the rare disease community and its various stakeholders need to really join forces to support and maximize really every resource available to the community. As I mentioned earlier, if you think about finances, there’s only so much money to go around. For example, if rare disease advocacy organizations could join arms, link together, and share additional funding to support research initiatives or research projects or clinical trials or registries that overlap with other groups might warrant financial benefit to those groups. I think coming together also supports conversations with regulatory authorities. By having a unified front, by working together, there's greater strength in greater numbers, and I think that's particularly true for regulatory authorities. From data sharing infrastructures, I think it's important that even our biotech partners and pharmaceutical companies, who spend a lot of money, time and energy developing programs in are disease, have some sort of exit strategy, whether, if the drug is not as safe and efficacious as we thought it was, using that data and other venues, are there patient advocacy organizations who would ingest that data and can use it to support subsequent clinical trials, so that another biotech company who's looking to research in the same disease doesn't have to start from square one at the very beginning. I think the lens of true collaboration, at least in industry, could really benefit all communities, I think, for drug development, at least for the time being.

Videos

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, highlights where regulatory agencies currently stand on sustainability in clinical trials and how pharma companies are looking to reduce their carbon footprint.

Being Prepared for Regulatory Sustainability Requirements in Clinical Research

, Theirry Escudier, Portfolio Lead, Pistoia Alliance, discussed the alliance’s newest initiative to assess the carbon footprint of clinical trials. The initiative aims to answer whether decentralized clinical trials positively or negatively impact carbon footprints. Escudier also discussed how clinical research stakeholders are slowly beginning to adopt more sustainability practices, focusing on reducing waste and costs.

ACT: How will this initiative aid in regulators’ increased demand for sustainability and transparency?

In a way, it's beyond, I would say, the regulatory requirement, because, as such, regulatory agencies, that is to say those health regulatory agencies looking for new drug submissions are not yet asking for any data on sustainability itself. This is more of a high-level request from in particular Europe, we have some very ambitious goals to reduce the carbon footprint in order to have less impact on the climate change. Some of the goals have been set up by the European Commission, the European Parliament, the National Parliament, and the national government, so there is, I would say, an overall trend within the industry, not specifically in the pharmaceutical world. Therefore, currently, I don't think there is any requirement from specific regulatory agencies such as the EMA, MHRA, or the FDA. It may come one day or the other, so that's why we have to be prepared, but it's more the voluntary approach from the pharmaceutical industry to consider that they want to also behave even beyond the fact that, as you know, the pharmaceutical industry is working to provide new drugs for saving lives, I would say, reducing the pain, maintaining people in good health, and at the same time, we know that our processes, whatever they are coming from R&D or from the industry, are producing carbon footprint, therefore may have an impact on the climate change, so therefore it's even more important that as an industry as a whole, the pharmaceutical companies are looking to how to reduce the production of carbon in order that in fact, not to offset the benefit of the new drugs, or the drugs we are currently, I would say offering to the to the patient.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, discusses the alliance’s latest step in evaluating the sustainability of digital versus traditional clinical trial approaches.

Sustainability in Clinical Trials: The Pistoia Alliance’s Initiative to Assess Carbon Footprint

ACT: Could you tell our audience a bit about the Pistoia Alliance’s newest initiative to assess the sustainability of different clinical trial models?

In fact, to be very clear, we have started with this already three years ago, to dig into the issue of how can we assess the carbon footprint of clinical trials? Our aim with this three years ago was to try to assess the impact of DCT (decentralized clinical trials), but it was so tough to be able to evaluate or propose a standard framework to be able to do that that in fact, with the partner company we have been working with called Sustainable Healthcare Coalition (SHC), we have decided, in fact, along the journey in the last three years, first to focus, can we build a proper tool and framework to assess the carbon footprint of any type of trial? Let's start to do that. To do that, we had to collect data from both company members, the one from the Pistoia Alliance and the one from the Sustainable Healthcare Coalition. We have been collecting, let's say, operational data from in a way, protocol start until clinical summary report finalization, and we have identified what we call an activity based model, that is to say, looking at the clinical trial flow chart and looking for preparation, implementation, regulatory, IRB, monitoring, data collection, and among those bricks we have went to lower bricks, and we have been able to ask our members, we want to collect your operational data, such as monitoring visits, your monitors are going to visit one site, by car, by train, by foot, or whatever, for the patient, the same type of story for the investigator also at the site, we have tried to collect those data, not easy, because most of the people have never done that before, but so at least, we have been able to put in place the standard framework that is now available. In the next step of the journey, we are going really to come back to the early days of our question: do DCTs have a good or bad impact on the carbon footprint of clinical trials? We will be able to answer, hopefully in one year time, when we will have collected a lot of data, hopefully from our members.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, highlight the results and how patients are interested in learning more about clinical trials relevant to their condition. 

Findings from StuffThatWorks’ Barriers in Clinical Trials Survey

, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discussed results from the Barriers in Clinical Trials survey conducted by StuffThatWorks. Key challenges identified by the survey include lack of physician communication, patient education, and the complex recruitment process. Elish and Ross highlighted how the findings can be used to streamline processes and leverage patient data to improve clinical trial recruitment.

ACT: Could you tell our audience a bit about the Barriers in Clinical Trials 

 and highlight some of its most noteworthy findings?

I would just love to take just a few minutes to give context on the platform on which this was done and why we got into doing that. The survey was conducted by StuffThatWorks and StuffThatWorks is the company that I founded and I'm the CEO of and StuffThatWorks is a crowd sourcing platform that allows collection of crowd sourced data from patients with chronic conditions at scale and in organized numbers. The reason I started this company was from personal experience, where I was taking care of my daughter and my dad, and I realized that there is not enough information about what happens in the real world with patients. While you have a lot of clinical trial information about treatment outcomes, or generally medical information about conditions, it's very different from what actually happens in the real world. It's very different in terms of how treatments really work and impact people and different people and all that. Because I came from Waze, prior to that, I was in the founding team of Waze, I thought that crowdsourcing is really ideal for collecting data at scale, and the point being not discussion data, like in groups and discussion boards, but transforming that into real, organized, structured data that you can analyze and do stuff with. In essence, it's almost like transforming survey data at the base of it into structured data consistent across all conditions. We now have about 3 million patients across 1,250 conditions, chronic conditions. At some point, since pharma is our target market as a business model, we decided to dive into this issue of, why is it that clinical trials are constantly facing a major problem with recruiting patients by asking patients what are the barriers for participation? We conducted this survey where we have basically questioned patients across all 1,250 conditions with about 35 questions, and received a really, really amazing, interesting data that I think highlights a lot of what on what needs to be done in the industry.

Just to build on what Yael is saying, as the data came in on the survey, some of the most noteworthy things that come out are that the majority of patients, their individual doctors do not discuss clinical trials with them. The survey had 6,000 respondents, and 97% of them said their doctor is not discussing clinical trials with them. The majority of those individuals knew what clinical trials are all about, and they're extremely interested, like 93% of them are very interested in hearing about clinical trials, and yet it's not happening. I think we have to start to ask ourselves, why not?

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