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1.
Value in Health ; 26(6 Supplement):S310, 2023.
Article in English | EMBASE | ID: covidwho-20234761

ABSTRACT

Background: CROs play a major role in ensuring clinical trials (CTs) are executed in line with ethical and regulatory requirements, ultimately to support the development of new drugs that benefit patients worldwide. To meet the evolving needs of pharmaceutical and biotech companies, CROs have expanded their services they provide. Innovations in the areas of decentralized trials, artificial intelligence and patient recruitment strategies, among others, enhance efficiency and help bring new life-saving drugs, therapies and medical devices to the market faster. As a result of how they adapted during the pandemic, the value CROs deliver has increased significantly, thereby strengthening the role they play in the industry overall. Objective(s): To investigate how the COVID-19 pandemic has impacted CRO activities and the implementation and conduct of CTs. Method(s): An online survey of 52 EUCROF members was conducted between July and September 2022. Topics covered included the impact of COVID-19 on CTs and on in-field activities, and how CROs have come to terms with this reality. Result(s): The results evidenced that COVID-19 had significant impacts on CR activities. Key findings included: 77% of respondents adapted their internal organization, adopting home-based work, the most frequently reported negative outcomes were a slowdown in recruitment in CTs and the postponement of on-site monitoring visits. Approximately 61% set up remote visits and extended trial duration. 65% have been involved in COVID-19 CTs with, on average, at least two CTs fully dedicated to COVID-19. However, COVID-19 CTs represent less than 10% of respondents' activities. 69% implemented new digital tools and 77% implemented the "Guidelines on the Management of Trials during the Pandemic" released by the EMA. Conclusion(s): Investments in new technologies and processes have allowed CROs to adapt positively and quickly. This will enable them to deliver greater value to sponsors in a post-pandemic environment.Copyright © 2023

2.
Asian Development Review ; 40(1):1-12, 2023.
Article in English | Scopus | ID: covidwho-2298193
3.
Clinical Trials ; 20(Supplement 1):81-82, 2023.
Article in English | EMBASE | ID: covidwho-2253192

ABSTRACT

The average time between regulatory approval and labeling of an innovative medicine for adults and children is nearly a decade.1 Often this is the result of poorly integrated adult and pediatric studies within medicines development programs, which consequently leads to prolonged off-label pediatric use. Furthermore, the conduct of studies in children after adult market approval becomes difficult if not impossible. Experiences during the SARS-CoV-2 pandemic have heightened awareness of this disparity. The fact that most children have been less severely affected by COVID-19 combined with reluctance to include children in early phases of investigational research has contributed to delays in evaluation of potential treatments for those children who present with more severe forms of the disease.2 Our study sought to understand how adolescent inclusion in adult trials is positioned in regulatory guidance since such documents set critical expectations for trial design and regulatory decision-making for innovative medicines. The authors conducted multiple sequential PubMed searches in November 2019 (and repeated in August 2021) utilizing a variety of grouped search terms-including ''pediatric,'' ''paediatric,'' ''adolescent,'' ''adolescence,'' ''regulatory guidance,'' ''guidance,'' ''FDA guidance,'' ''regulatory guideline,'' ''guideline,'' ''EMA guideline,'' and/or ''meta-analysis.'' The searches failed to return any results showing that an analysis of regional regulatory guidance specific to age-inclusive research has been published. It is our understanding that this study represents the first comprehensive analysis of age-inclusive language within regulatory guidance for two globally important health agencies, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The study utilized a qualitative analysis approach to review FDA and EMA regulatory guidance documents assessing their recommendations about adolescent inclusion in clinical trials. The study found that regulatory guidance contained recommendations supporting adolescent inclusion in 32% of FDA and 15% of EMA documents, while 14% and 21%, respectively, were found to be exclusionary. In both regions, more than half of all guidance documents were silent regarding the applicability of adolescentinclusive trial methodologies. Analysis by therapeutic area revealed FDA guidance for infectious diseases and EMA guidance for conditions requiring blood products was the most permissive. A more inclusive approach was identified to disease guidance published by the FDA Oncology Center of Excellence. Our study has identified important opportunities for enhancement of regulatory guidance which, if addressed, can facilitate inclusion of adolescent patients in adult trials to accelerate adolescent access to life-changing medicines. Regulatory guidance plays a critical role in improving the type and the quality of data generated in clinical trials which inform medicines use in diverse patient populations. As pediatric policy reforms have led to significant experience with pediatric medicines development, this should be leveraged to update existing regulatory guidance, fostering scientifically justified inclusion of adolescents in adult clinical trials.

4.
Oxford Review of Economic Policy ; 38(4):742-770, 2022.
Article in English | Web of Science | ID: covidwho-2190129

ABSTRACT

We review economic arguments for using public policy to accelerate vaccine supply during a pandemic. Rapidly vaccinating a large share of the global population helps avoid economic, mortality, and social losses, which in the case of Covid-19 mounted into trillions of dollars. However, pharmaceutical firms are unlikely to have private incentives to invest in vaccine capacity at the socially optimal scale and speed. The socially optimal level of public spending may cause some sticker shock but-as epitomized by the tagline 'spending billions to save trillions'-is eclipsed by the benefits and can be restrained with the help of careful policy design and advance preparations. Capacity is so valuable during a pandemic that fractional dosing and other measures to stretch available capacity should be explored.

5.
Working Paper Series National Bureau of Economic Research ; 90, 2020.
Article in English | GIM | ID: covidwho-1789339

ABSTRACT

Vaccines exert a positive externality, reducing spread of disease from the consumer to others, providing a rationale for subsidies. We study how optimal subsidies vary with disease characteristics by integrating a standard epidemiological model into a vaccine market with rational economic agents. In the steady-state equilibrium for an endemic disease, across market structures ranging from competition to monopoly, the marginal externality and optimal subsidy are non-monotonic in disease infectiousness, peaking for diseases that spread quickly but not so quickly as to drive all consumers to become vaccinated. Motivated by the Covid-19 pandemic, we adapt the analysis to study a vaccine campaign introduced at a point in time against an emerging epidemic. While the nonmonotonic pattern of the optimal subsidy persists, new findings emerge. Universal vaccination with a perfectly effective vaccine becomes a viable firm strategy: the marginal consumer is still willing to pay since those infected before vaccine rollout remain a source of transmission. We derive a simple condition under which vaccination exhibits increasing social returns, providing an argument for concentrating a capacity-constrained campaign in few regions. We discuss a variety of extensions and calibrations of the results to vaccines and other mitigation measures targeting existing diseases.

6.
Working Paper Series National Bureau of Economic Research ; 67, 2021.
Article in English | GIM | ID: covidwho-1745151

ABSTRACT

We argue that alternative COVID-19 vaccine dosing regimens could potentially dramatically accelerate global COVID-19 vaccination and reduce mortality, and that the costs of testing these regimens are dwarfed by their potential benefits. We first use the high correlation between neutralizing antibody response and efficacy against disease (Khoury et. al. 2021) to show that half or even quarter doses of some vaccines generate immune responses associated with high vaccine efficacy. We then use an SEIR model to estimate that under these efficacy levels, doubling or quadrupling the rate of vaccination by using fractional doses would dramatically reduce infections and mortality. Since the correlation between immune response and efficacy may not be fully predictive of efficacy with fractional doses, we then use the SEIR model to show that fractional dosing would substantially reduce infections and mortality over a wide range of plausible efficacy levels. Further immunogenicity studies for a range of vaccine and dose combinations could deliver outcomes in weeks and could be conducted with a few hundred healthy volunteers. National regulatory authorities could also decide to test efficacy of fractional dosing in the context of vaccination campaigns based on existing immune response data, as some did for delayed second doses. If efficacy turned out to be high, the approach could be implemented broadly, while if it turned out to be low, downside risk could be limited by administering full doses to those who had received fractional doses. The SEIR model also suggests that delaying second vaccine doses will likely have substantial mortality benefits for multiple, but not all, vaccine-variant combinations, underscoring the importance of ongoing surveillance. Finally, we find that for countries choosing between approved but lower efficacy vaccines available immediately and waiting for mRNA vaccines, using immediately available vaccines typically reduces mortality.

7.
Working Paper Series National Bureau of Economic Research ; 61(30), 2020.
Article in English | GIM | ID: covidwho-1408101

ABSTRACT

Advance market commitments (AMCs) provide a mechanism to stimulate investment by suppliers of products to low-income countries. In an AMC, donors commit to a fund from which a specified subsidy is paid per unit purchased by low-income countries until the fund is exhausted, strengthening suppliers' incentives to invest in research, development, and capacity. Last decade saw the launch of a $1.5 billion pilot AMC to distribute pneumococcal vaccine to the developing world;in the current pandemic, variations on AMCs are being used to fund Covid-19 vaccines. This paper undertakes the first formal analysis of AMCs. We construct a model in which an altruistic donor negotiates on behalf of a low-income country with a vaccine supplier after the supplier has sunk investments. We use this model to explain the logic of an AMC-as a solution to a hold-up problem-and to analyze alternative design features under various economic conditions (cost uncertainty, supplier competition). A key finding is that optimal AMC design differs markedly depending on where the product is in its development cycle.

8.
Brookings Papers on Economic Activity ; : 212-235, 2020.
Article in English | Web of Science | ID: covidwho-1226880
9.
Lancet ; 397(10271):277-278, 2021.
Article in English | Web of Science | ID: covidwho-1126076
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