Rebuilding momentum on antibiotics research, giving innovators a chance to pull through

This article was first featured in a special Media Planet supplement on Antimicrobial Resistance, distributed in print with The Guardian. The full supplement can be accessed here

The pace of resistance to existing antibiotics is outpacing the rate at which new ones can reach the market and be used against difficult-to-treat infections.

According to the WHO, on average, resistance is reported to most new agents two to three years post-market entry.

Difficult environment to develop antibiotics

Research into new antibiotics is a long-haul journey: it takes 10–15 years to progress an antibiotic candidate from the preclinical to the clinical stages. For antibiotics in existing classes, on average, only one of every 15 drugs in preclinical development will reach patients. For new classes of antibiotics, only one in 30 candidates will reach patients. And even many that reached the market in the last decade continued to face existential challenges.

Sustaining research in this space requires patience, but more importantly, it requires financial resources and incentives. And that’s what most scientists and investors from big and small companies alike are calling for.

“There is a clear lack of funding for
antibiotic R&D, particularly in the later
and more resource-intensive stages”.

Sustained funding required

There is a clear lack of funding for antibiotic R&D, particularly in the later and more resource-intensive stages. Many have taken on a mission to tackle the scientific barriers, but few have managed to stay afloat despite having a successful product.

That’s the paradox with antibiotics: They need to be used appropriately to preserve their effectiveness and slow the development of resistance. Therefore, new antibiotics would be used only rarely, but we still need them to be available when nothing else works.

Need for policy reforms

The biopharmaceutical industry stepped in to provide relief through the creation of the AMR Action Fund — a USD 1 billion fund aiming to bring to market two to four new antibiotics by 2030.

But the Fund is a band-aid solution — we need an urgent, larger overhaul of how the antibiotic R&D ecosystem is stimulated. The most impactful solution lies in so-called ‘pull incentives,’ and it’s encouraging to see more political momentum build up. Several countries are piloting or considering different policy reforms and rethinking the value new antibiotics bring to society. Eyes are turned towards the US and the discussions on the PASTEUR Act. There is potential for a sea change at a global level. As attention turns towards the next UN high-level meeting on AMR in 2024, we need to set an expectation for all leading countries to implement impactful reforms of their own.

Renewing industry’s commitment to better access to diabetes care on World Diabetes Day

This article was originally published on LinkedIn on 14 November 2022.

This World Diabetes Day (WDD), IFPMA and its members are renewing our commitment to take proactive steps to improve access to diabetes care and make progress toward the achievement of SDG target 3.4.

We advocate for the integration of oral anti-diabetic medicines, insulin, glucose monitoring and insulin delivery devices, and consumables within Universal Health Coverage (UHC) schemes, leaving no one behind.

We also support the need for integrating essential support for people living with diabetes – such as education, mental health support, and nutritional information – to become a full part of publicly financed essential benefit packages at a national level. As the focus of this year’s WDD indicates, change starts with improved access to diabetes education and the work we do today impacts how we protect future generations.

Given the disproportionate burden of diabetes in low- and middle-income countries (LMICs), measures should be taken to improve access to affordable, high-quality diabetes care packages.

 “No one should have to choose between death and financial hardship. No one should have to choose between buying medicine and buying food.”

-Dr Tedros Adhanom Ghebreyesus, WHO Director General

IFPMA believes that innovative approaches such as digital health tools and the Diabetes CarePak are necessary to address this challenge, especially in low resource settings. IFPMA applauds the first WHO prequalification of human insulins and its aim of facilitating more equitable access to quality human insulin.

Thermostability issues need to be addressed to meet the needs of LMICs with low infrastructure and refrigeration capacities, and some of our member companies have taken significant steps to share data and evidence of insulin thermostability. They have taken measures to update storage conditions, which is helping to facilitate better use of insulin in specific settings, such as in humanitarian situations. Finally, companies are advancing on production and access solutions to make quality insulin affordable and more widely available in LMICs.

These are examples of practical, multi-stakeholder solutions on which IFPMA and its members are already working on, and want to continue partnering to speed up progress on our shared 2030 goals. The presence of our insulin manufacturers at the recently held WHO Private Sector Dialogue on Diabetes reaffirmed how they remain committed to improving access to quality diabetes care.

Is an extension of the TRIPS waiver needed for COVID-19 tools?

Evidence shows that progress made in sharing IP through voluntary agreements, combined with tiered-pricing and not-for-profit arrangements for low- and middle-income countries has led to production of COVID-19 therapeutics exceeding demand for all disease severity levels and in all patient settings. Efforts must now focus on ensuring these products reach those in need.

Last week, we saw yet another powerful example of the spirit of collaboration and partnership that has supported the global response against the COVID-19 pandemic. The Medicines Patent Pool (MPP) signed another voluntary license agreement with Japanese pharmaceutical company, Shionogi, to enable generic companies to produce its COVID-19 antiviral treatment pill candidate, provided it gets regulatory approval.

This voluntary license agreement adds to the over 140 collaborations already established by innovative pharmaceutical companies with partners across the world.  In the first year of the pandemic alone, companies developing COVID-19 treatments entered into over 40 collaborations to expand manufacturing capacity. Many – like Shionogi, but also Gilead – did so even before regulatory authorities granted full regulatory approval, reflecting commitments to broad patient access and allowing for time to establish a robust framework with partners that would allow them the time and knowledge necessary to produce safe, quality and effective treatments.

The number of collaborations has more than tripled since then. Today, 92% of these collaborations involve technology transfer, which proves that the voluntary approach has been widely embraced as a solution scaling up manufacturing of COVID-19 treatments. Voluntary licenses are not just a matter of simply licensing intellectual property and walking away. To make the collaboration really work, and ultimately result in the treatments reaching the people who need them, companies work hand in hand sharing technology and know-how, building internal capacity, solving problems as they emerge and celebrating successes.



Voluntary licenses on therapeutics are already in place to support manufacturing scale up without needing a TRIPS waiver

Biopharmaceutical companies have acted decisively early on by putting equitable access to therapeutics at the top of their priorities. Far from being a hindrance to ramping up global supply, IP rights have provided companies with legal certainty for their discoveries, as well as created trust to engage with other partners for such deals. In addition to voluntary licensing, pharmaceutical companies have also implemented multiple strategies to enhance access, including tiered pricing.

The number of existing voluntary license agreements (bilaterally and through Medicines Patent Pool) is a testament to this. For example, MSD, which makes molnupiravir (Lagevrio), and Pfizer, which makes nirmatrelvir/ritonavir (Paxlovid), have struck voluntary licensing agreements with 70 generic manufacturers in Asia, Africa, and Latin America. Gilead, which makes remdesivir (Veklury), has issued voluntary licenses to nine generic manufacturers, covering 127 countries.


Supply for treatments exceed demand and a WTO TRIPS waiver would not result in more access to therapeutics

Developing countries have faced unjust scarcity and hardship in obtaining COVID-19 tools, which the biopharmaceutical industry has been vocal about as well. But extending the TRIPS waiver would do nothing to address the real barriers to access.

Even though it takes time to set the agreements up, already, data indicates that currently, production exceeds demand for treatments for all disease severity and patient setting.

Partnerships with multilateral organizations and over 140 voluntary licensing partnerships made it possible to ramp up production of therapeutics and, combined with tiered pricing and not-for-profit arrangements for low- and middle-income countries, mean that even in resources-limited settings, governments have effective tools to give their population access to the key therapeutics.



What’s more, in recent months, Airfinity has revised demand forecasts downward and there is no evidence to suggest that supply is constrained relative to actual demand.


Unintended consequences of a WTO TRIPS waiver will undermine generic manufacturers who have signed agreements, overburden regulatory systems without any upside for patients

The TRIPS waiver extension that is being discussed will have unintended consequences and will undermine the business of the generic manufacturers who have signed voluntary agreements. It may also, even more worryingly, impact the very people that need help.

In the first instance, a waiver may create a counterproductive proliferation of manufacturers, who would operate outside of voluntary agreements that foster trust and knowledge-sharing.  Basically, it would put the legal basis for these existing collaborations at a disadvantage and potentially jeopardize them, including those under the MPP agreements.

Beyond COVID-19, if the waiver is approved, it could potentially impact innovation to treat other diseases.  Currently of the 2% of treatments that have made it through the pipeline and are approved for COVID-19, more than half are either approved or could have other uses.  As hopefully more innovations get approved, the waiver could potentially undermine the legal certainly industry needs to continue innovating, ultimately hurting patients worldwide.


Rather than a TRIPS waiver, we need more focus on test and treat

While innovator pharmaceutical companies and their hundreds plus licensees continue to increase manufacturing output to supply the world, there is a concern that local systems do not have the absorption capacity for the new therapeutics to be most impactful in curbing the effect of the COVID-19 pandemic. More efforts are needed to ensure that eligible patients can access the COVID-19 therapeutics that are being produced, at the right time. Low levels of testing, as well as insufficient capacity to distribute and administer treatments, has left uptake of therapeutics low, and put millions of doses at risk of going unused and being destroyed.  After peaking during the Omicron wave, the frequency of testing for COVID-19 has fallen globally.


… And we need more innovation, unhampered by uncertainty of an unnecessary TRIPS waiver

Our conclusion is that, rather than a TRIPS waiver and the uncertainty that comes with it for no apparent improvement in equity, the innovation pipeline needs to be encouraged. The IP framework has been a key enabler for an unprecedented pace of R&D and manufacturing scale-up. It’s what’s given confidence to public and private researchers to investigate thousands of molecules that could work against COVID-19, supporting breakthroughs in our pandemic response. As the virus evolves, so must further research, supported by strong IP protections.

As WTO Member States engage in discussions around an extension of a TRIPS waiver to COVID-19 therapeutics and diagnostics, the innovative pharmaceutical industry calls on researchers from their labs join us in urging policymakers to consider the data and evidence-base that highlights not only that such an extension is not needed, but how it would in fact have a consequential impact on modern health innovation and patients.

Innovative partnership model to improve access to cancer care in LMICs

This blog was originally published on Health Awareness on 3 October 2022.

Through public and private sector partnerships, a global initiative innovates for better access to cancer care worldwide.

The global prevalence of cancer is increasing rapidly, presenting an especially heavy burden for people in low and middle-income countries (LMICs). Collaborative and innovative thinking is now needed to expand access to quality cancer care.

In this spirit, the Access to Oncology Medicines (ATOM) Coalition, launched in May 2022 by the Union for International Cancer Control (UICC) and other partners, aims to bring together a wide range of actors around the common goal of improving access to cancer medicines, quality diagnostics and care for people in lower-resource settings.

Increasing availability and affordability

Comprised of approximately 20 global health-focused civil society organisations, medical societies, global oncology centres, as well as 10 biopharmaceutical and generic manufacturers and associations, the coalition can help countries deliver their national cancer control strategies by providing support on capacity building, training and increased availability of essential cancer medicines.

Access to medicine worldwide

The goal is to ultimately improve timely access to essential cancer medicines as well as increase countries’ capacities to provide quality cancer diagnosis, treatments and care. To this end, priority will be given to essential cancer medicines on the World Health Organization’s Model List of Essential Medicines, which outlines the minimum medicine needs for any health system.

The ATOM Coalition partners will work collectively to increase access to generic and patented cancer medicines in 46 LMICs, selected by the coalition based on a number of criteria, including existing health system readiness. In parallel, partners will work together to implement coordinated capacity building, starting with a handful of countries in the first phase of operations.

Solutions-based model

Innovation in oncology should include leading-edge research and development for the next line of treatments that will continue to improve outcomes for patients. Innovation also means developing new access solutions to ensure greater availability of quality cancer diagnostics and care. We are confident that the unique model will spur new types of collaborations, provide tangible solutions to people living with cancer in LMICs and help address the pressing global cancer burden.

The biopharmaceutical industry continues to innovate and push science forward to manage the COVID-19 pandemic and be better prepared for future global health threats

Viruses don’t stand still. And neither do we. It’s been almost two years since the administration of the first COVID-19 vaccine in December 2020 and as of September 2022, more than two thirds of people worldwide had received at least one COVID-19 vaccine dose.

The biopharmaceutical industry is proud to continue to play a key role in helping to manage the worst global health pandemic in our lifetime. We are constantly innovating, pushing science forward to help us stay ahead of this pandemic and be better prepared for future ones.


We continue to develop new COVID-19 vaccines and adapting existing ones to offer longer, broader and more durable protection. This includes multi-valent and next generation universal vaccines that can offer protection against more than one variant of COVID-19 and variants that have not yet emerged.


We’re also developing ways to make COVID-19 vaccines easier to transport, store and administer. This includes vaccines that don’t need to be kept constantly cold and vaccines that can be taken as a nasal spray. Plus COVID-19 vaccines that can be given in one dose with other vaccines for flu or pneumonia.

In parallel with vaccine innovation, we also continue to develop new medicines to treat the symptoms of COVID-19 at every stage of infection, which helps relieve pressure on health systems, for example by reducing the risk of hospitalization.


After decades of research, mRNA vaccines were used for the first time in response to COVID-19. Now we’re using that breakthrough to explore how it could offer new hope for other diseases like flu, cancer, TB and malaria.

New vaccine technology like mRNA can also make it easier to scale up production or quickly pivot production to tackle new variants and other viruses with pandemic potential.


Pandemics are global – vaccines supply chains must be too. We are investing in new manufacturing facilities and partnerships to help enhance long-term local production of innovative vaccines and treatments in places that lack local production capacity.

We’ve also entered into over 500 voluntary manufacturing partnerships, sharing our technology, processes and know-how to expand vaccine production and treatments without compromising on safety and effectiveness. Now we’re working to strengthen this innovation ecosystem.


The COVID-19 pandemic was a huge learning moment for us all. We’re applying these lessons today to make sure we’re ready to respond when the next outbreak happens. Threats will continue to emerge – like monkeypox or Ebola outbreaks.

Employees from across our industry – from scientists in the labs to engineers in production facilities and medical experts on the ground – are applying their scientific expertise, passion and creativity to find new and better solutions. To make sure everyone has the opportunity to be protected, wherever they live.

A collective approach can improve access to quality cancer care

This article was originally published by Re:solve Global Health on 14 July 2022.

The task of taking quality care to those living with cancer grows more difficult with the exploding number of new cases. A new initiative pools together expertise to widen access to timely and effective treatment.

The global cancer population is significant and expanding. From over 19 million a year in 2020, the number of new cases is expected to reach 30 million by 2040, including over 16 million premature deaths due to cancer, with massive human and economic costs.

In 2020, more than 3.5 million new cancer cases were diagnosed in low- and lower middle-income countries (LLMICs) and an estimated 2.3 million deaths were caused by cancer. People living with cancer were disproportionately impacted by the covid-19 pandemic, as their access to screening, diagnosis, treatment, and care was severely disrupted.

Most LLMICs do not have sufficient resources to respond to the needs of people living with cancer. They have a limited availability of essential medicines, diagnostics, and human and material resources required for quality cancer prevention, diagnosis, treatment, and care services.

According to Dr Anil D’Cruz, president of the Union for International Cancer Control (UICC) and director of oncology at Apollo Hospitals in India, “Simply making medicines available does not guarantee that people living with cancer will receive the medicines they need at the right time.”

Working towards a common goal

It is in response to this urgent threat that the Access to Oncology Medicines (ATOM) Coalition brings together close to 30 partners, including the biopharmaceutical industry, with a common goal to improve access to medicines as well as quality diagnostic and care pathways for people living with cancer.

The ATOM Coalition can help the world achieve the 2030 UN Sustainable Development Goal (SDG) 3.4, which aims to reduce by one-third premature mortality from non-communicable diseases (NCDs) like cancer, heart disease, and diabetes.

Launched in May 2022 by UICC and a broad array of partners, the Coalition aims to improve timely access to essential cancer medicines in LLMICs, as well as increase the capacity for high-quality diagnosis and treatment.

Priority will be given to medicines currently on, or likely to be included in the World Health Organization (WHO) Essential Medicines List (EML) for the treatment of cancers with the heaviest mortality burden in LLMICs, including lung, colorectal, breast, cervical, prostate, and childhood cancers.

Forging a unique collaborative model

The Coalition brings together numerous partners with expertise in implementing cancer-focused access programmes. As of June 2022, the partnership consists of 19 global health-focused civil society organisations, medical societies, and global oncology centres, and nine biopharmaceutical and generic manufacturers and associations, along with informal expressions of support from various organisations.

The ATOM Coalition has always exemplified a collaborative partnership model, integrating civil society and private sector perspectives from the beginning through a series of co-creation workshops and meetings to find ways for all stakeholders to work together for improved cancer care in LLMICs.

It is also working to generate synergies across a wide range of existing global and country-level initiatives that are implementing access to cancer care projects in LLMICs. By building on the networks, health expertise, and experience of all partners, the intention is to create links between different health initiatives to complement, enhance and amplify impact across projects.

To achieve the Coalition’s ambitions, partners will collectively increase access to select generic and patented cancer medicines in 46 LLMIC countries, which were selected based on existing health system readiness. In parallel, the ATOM partners will implement intense, coordinated capacity building in five to 10 LLMICs within this group for the first phase of operations.

The initial selection of countries for capacity building will be based on a range of criteria—including the presence of ATOM partners, health system readiness, diagnostic capability, the status of the national EMLs, and the existence of access programmes in the country.

We are encouraged by the new way of working illustrated by the ATOM Coalition. As noted by Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), “Building on ‘same old’ ways of working will not achieve this goal [of improving health outcomes for people living with cancer in LLMICs]. We need to push ourselves to share ideas and expertise, inspire new thinking, and co-create new types of solutions for LLMICs.”

This first-of-its-kind model will spur collaborations and provide solutions to communities and, if the model proves successful, we could devise many more collaborative approaches to address other priority global health issues.


The opinions expressed are those of the author and do not necessarily reflect the position of Re:solve Global Health.

Vanessa Peberdy is deputy director for Global Health at IFPMA. She joined in 2015 and covers a wide range of global health affairs relating to the access to medicines agenda, including non-communicable diseases, universal health coverage and multilateral engagement.

Melissa Rendler-Garcia is senior advisor to UICC and project lead on ATOM. She has worked with the CEO and the team for over 15 years designing and implementing global cancer control initiatives including the World Cancer Leaders’ Summit and the City Cancer Challenge.

Caring for chronic diseases in lower-resource settings

This blog was originally published on Business & Industry on 29 June 2022.

In the wake of COVID-19, lower-resourced settings need sustainable healthcare more than ever to build back better. Promising solutions are at hand.

Each year, 41 million people die from heart disease, cancer, diabetes and chronic respiratory diseases[1]. This group of chronic diseases, called non-communicable diseases (NCDs), burden health systems and put people at increased risk of other illnesses such as COVID-19.

Sadly, NCDs disproportionately affect people in parts of the world with limited access to health services[2]. Tried and tested solutions should be leveraged to strengthen health systems to prevent, diagnose and treat them in a timely way. [3]

Tailored health packages

Cost-effective packages of health interventions[4] could help support low- and middle-income countries reduce by one third premature mortality from NCDs by 2030, one of the global goals to which countries have committed.

For example, the upfront costs of diabetes management – such as glycaemic control, footcare, and screening and treatment of kidney disease – are high. However, these are associated with considerable health and socioeconomic benefits when combined with cardiovascular disease prevention throughout the life-course[5].

Streamlining patient care by supporting a ‘one stop shop’ for daily disease management is another approach. Launched in 2020, the PATH-led CarePak initiative, which bundles diabetes treatment, consumables and educational material, has positively impacted health outcomes in Kenya, Mali, Mozambique and Tanzania.

Integrated care

Integrated care at primary healthcare level, such as screening and treatment of multiple diseases at the same point of care, is a powerful model for leveraging scarce healthcare resources. One initiative looking to optimise limited resources is Sanofi’s Diabetes and Hypertension clinics[6], which detect, treat and manage the two conditions.

So far, this initiative has trained over 1,200 healthcare professionals and treated more than 50,000 patients in Cameroon, Côte d’Ivoire and Senegal. More integrated care models tailored to local needs should be developed.


[2] Ibid


[4] NCD Countdown 2030: efficient pathways and strategic investments to accelerate progress towards the Sustainable Development Goal target 3.4 in low-income and middle-income countries. Dr David Watkins et al. Lancet 2022; 399: 1266–78. DOI:

[5] Ibid


Collaboration can help find a vaccine within first 100 days

This blog was originally published on Health Awareness on 21 June 2022.

We must take pandemic preparedness farther, faster by ensuring a joint response to future outbreaks.

Our efforts against COVID-19 have surfaced critical learnings, including the need to establish a global foundational capability, fit for purpose ahead of the next health emergency.

Key learnings for a better vaccine ecosystem

We have witnessed the importance of solid multistakeholder collaborations to develop pandemic countermeasures. We have also seen the need to build a robust, functional and decentralised vaccine ecosystem to ensure the world is better protected against infectious diseases today and can respond faster to future pandemic outbreaks.

The first COVID-19 vaccine was approved for emergency use only 326 days after the genetic sequence of SARS-CoV-2 was released. This was the fastest vaccine development ever, slashing by a fifth the previous record.

This speed of response has been key to change the impact of COVID. Now, we can prepare to react even quicker to the next pandemic and ensure equitable access to new innovations sooner. With sustained political and industry leadership and collaboration, we could cut this time to a third.

Success ingredients for the 100 Days Mission  

Spearheaded by the Coalition for Epidemic Preparedness Innovations (CEPI) and supported by the G7 UK Presidency, the 100 Days Mission aims to develop and deploy high-quality diagnostics, therapeutics and vaccines in just 100 days after a new pandemic threat is identified.

This programme is our best shot at preventing the next emerging pathogen from reaching pandemic proportions, because the faster an effective vaccine is developed, approved and deployed, the faster the next Disease X can be contained and controlled.

For this, the biopharmaceutical industry will build a portfolio of promising candidate vaccines, treatments and technologies against pathogens with epidemic and pandemic potential. These efforts will work best if paired with improved surveillance infrastructure and regulations for the immediate sharing of pathogen data, so that threats are quickly detected and candidate tools swiftly tested.

Equally important, we need to standardise regulatory processes to speed up market access and expand manufacturing capacity so that these tools are deployed faster, fairly and equitably in future health emergencies.

Our collective ability to foster and maintain a sustainable innovation ecosystem will determine the success of this ambitious initiative. Academia, national governments, international organisations, private companies, regulatory officials and manufacturing sectors have roles to play. United for a common goal, rather than working alone, we can go farther and faster.

Vaccines are making an impact through vaccinations

This blog was originally published on Health Awareness on 21 June 2022.

The challenge is not getting hold of COVID-19 vaccines, it is getting vaccines into arms. The healthcare community is continuing to showcase the value of vaccines throughout one’s life course.

Over the last two years, the global healthcare community’s efforts in mounting a response to COVID-19 have materialised. This pandemic has brought home the power of vaccines to save lives and protect the vulnerable. Breakthrough new vaccines and a historic scale up of production and deployment have resulted in the largest mass vaccination campaign the world has ever seen.

We now have to redouble efforts to accelerate countries’ mobilisation and remove barriers to efficient distribution and administration of COVID-19 doses, as the risk perception with Omicron has changed.

Global pandemic response

The biopharmaceutical industry took up the challenge to develop, manufacture and deliver safe and effective tools to combat COVID-19, including vaccines. The strength of a robust innovation ecosystem – decades of partnerships, scientific exploration and investment – enabled the development of technologies such as mRNA and viral vector COVID-19 vaccines, a process that would have taken years if started from scratch.

All companies were asked to ramp up manufacturing capacity to meet the global need, with 14 billion doses produced today. It is now publicly recognised that there is more supply than demand globally. The demand is going down, so much so that the Indian company, Serum Institute, halted its production last December, as Aspen in South Africa might have to do this month.

Getting vaccines into arms

But despite collective efforts, equitable access to COVID-19 vaccines remain a challenge. Countries face implementation bottlenecks, including funding gaps, weak health systems and infrastructure, competing health priorities and COVID-19 fatigue. Vaccine hesitancy has also had a serious impact and this may affect other vaccination programmes.

Healthcare systems and infrastructure need to be stronger, financing for in-country delivery must be prioritised and the biopharmaceutical industry will continue to work with all stakeholders on three overarching priorities so that COVID-19 vaccines reach those who need them the most.

Vaccines for life

The COVID-19 pandemic has shown that when we work together, we can achieve more than we ever thought possible. But there is more to be done. Vaccines can help protect you and your family from over 30 different infectious diseases – not just in childhood, but at every age and stage of life. Together, we can give vaccines the greatest chance to make an even greater impact on our health, our communities and our world.

How do we improve clinical trials post-pandemic?

This article featured in the Media Planet Clinical Trials campaign, available online and disseminated in print with the New Scientist.

The COVID-19 pandemic has taught us a lot and yet we can still keep learning. While the pandemic has impacted everyone globally in ways that could never have been imagined, it has provided a spark for further exploration into how clinical trials should be improved, strengthened and better coordinated globally.

To ensure this happens, we must first acknowledge the critical role of well-designed clinical trials. During the pandemic, there were many examples of small, under-powered clinical trials that lacked coordination and did not deliver scientifically meaningful results.

Governments recognised this early on and helped lead the development of the G7 Therapeutics and Vaccines Clinical Trials Charter to avoid proliferation of such trials in the future. When you are looking for hope in the form of prevention, treatment or cure, such outcomes can be tragic and/or disheartening at best.

Implementation of regulatory guidance

Broader implementation of ICH Good Clinical Practice (GCP), specifically E6 R3, is key here. This regulatory guidance is critical to future-proofing clinical trials and seeks to support their modernisation by installing a ‘quality by design’ mindset.

For those of us involved in clinical research (e.g., national regulatory authorities, academia, biopharmaceutical industry), ICH GCP may be the best way to promote greater capacity and capability building around the world.

Role of digitalisation

Secondly, we must look more extensively into the benefits of digitalisation and the use of virtual tools and methodologies within the context of clinical trials. Digitalisation can help clinical research to be more efficient and coordinated, principally via telemedicine, use of innovative health technologies, virtual healthcare visits, e-documents, etc.

Digitalisation can also support clinical researchers with the conduct of decentralised (or hybrid) clinical trials by increasing recruitment, reducing screening failures and allowing for remote monitoring of patients. Thus, offering the best guardianship of patients’ time and resources.

Benefitting those in greatest need

Finally, we need to ensure that the clinical trials we design benefit those who need it most. With a spotlight on patient centricity, best practices for greater diversity and inclusivity of under-served populations must underpin the development of all future clinical trials. The pandemic highlighted the ongoing disparity within clinical research and in the end, we must strive to make sure that these good principles become routine.

Bettering clinical research, in a more innovative and sustained fashion, has the potential to accomplish far greater results for global health that will be felt well beyond the present pandemic.