Clinical Leader

23/12/2022

Enrollment has been the sponsor’s classic mantra for achieving success in a clinical trial. We should replace this notion with four equally essential building blocks: the selection of the right CRO, the identification of study sites, the engagement of sites, and the enrollment of patients.

By Oscar Segurado, ASC Therapeutics



https://www.clinicalleader.com/doc/essential-drivers-in-clinical-development-for-emerging-biotechs-0001?utm_source=editorpost&utm_medium=link&utm_campaign=socialmedia

Enrollment, enrollment, enrollment has been the sponsor’s classic mantra for achieving success in a clinical trial. Rather, we should replace this notion with four equally essential building blocks: 1) the selection of the right CRO, 2) the identification of study sites, 3) the engagement o...

22/12/2022

The increased demand for hybrid and decentralized approaches to clinical trials has increased the use of digital devices and other tools that will make studies more patient centric. Sanofi is one of the companies leading the way in getting devices into the hands of patients.

Featuring Terttu Haring

The increased demand for hybrid and decentralized approaches to clinical trials has increased the use of digital devices and other tools that will make studies more patient centric. Sanofi is one of the companies leading the way in getting devices into the hands of patients.

21/12/2022

Data scientists from Merck's Real-World Data Analytics and Innovation team share how they applied the Use-case specific Relevance and Quality Assessment (UReQA), a fit-for-purpose RWD quality framework, to assess and select high-quality and relevant data for RWE studies.

Data scientists from Merck's Real-World Data Analytics and Innovation team share how they applied the Use-case specific Relevance and Quality Assessment (UReQA), a fit-for-purpose RWD quality framework, to assess and select high-quality and relevant data for RWE studies.

20/12/2022

Industry and academia alike are experiencing a greater urgency for awareness, education, understanding, and application of diversity, equity, and inclusion ( ). This begs the question of whether people are willing to move from the comfort of “recommended” training to the potential discomfort and discord inherent in “required” training.

By Gelise Littlejohn Thomas, JD, MS, Case Western Reserve University

Industry and academia alike are experiencing a greater urgency for awareness, education, understanding, and application of diversity, equity, and inclusion (DEI). This begs the question of whether people are willing to move from the comfort of “recommended” training to the potential d...

20/12/2022

There is increased emphasis on evaluating treatment benefits using patient-centric concepts & input from the patient community. Regulators urge sponsors & researchers to engage patients & caregivers to define the disease burden & unmet needs.

https://www.clinicalleader.com/doc/how-to-educate-regulators-on-what-matters-to-patients-0001?utm_source=editorpost&utm_medium=link&utm_campaign=socialmedia

With the greater emphasis on patient-centricity, patients are valued as an active participant in their own care. There is an increased emphasis on evaluating treatment benefit using patient-centric concepts and input from the patient community. Regulators now urge sponsors and researchers to syst...

19/12/2022

In January 2023, Janice Chang will take over as the head of industry consortia non-profit organization TransCelerate BioPharma Inc.

Chang has been involved with TransCelerate since it was just a concept and notes the time spent in the group since its launch has been an amazing journey.



https://www.clinicalleader.com/doc/the-future-of-transcelerate-clinical-trial-modernization-0001?utm_source=editorpost&utm_medium=link&utm_campaign=socialmedia

In January 2023, Janice Chang will take over as the head of industry consortia non-profit organization TransCelerate. Chang has been involved with TransCelerate since it was just a concept, and notes the time spent in the group since its launch has been an amazing journey.

16/12/2022

Patient recruitment for clinical trials is complex and can cause many studies to be delayed or canceled. Two groups that are particularly difficult to recruit are patients of color and those living in remote and rural areas of the country. In those two instances, overcoming recruitment barriers can be challenging.

Patient recruitment for clinical trials is difficult and can cause many studies to be delayed or cancelled. Two groups that are particularly difficult to recruit are patients of color and those living in remote and rural areas of the country. In those two instances, overcoming recruitment barrier...

16/12/2022

Bert Hartog, Jennifer Lee, and Stephen Kemler joined Clinical Leader’s Ed Miseta to share what new technology implementations have and haven’t worked for them. is now available on-demand. Supported by Medrio, Inc.

16/12/2022

Most life sciences execs agree that their companies — even early adopters of AI — still need to make significant changes to leverage AI properly. Here's how to get started (or keep forging ahead).

By Will Bryant and Jason Hirschhorn, Point B

Most life sciences execs agree that their companies — even early adopters of AI — still need to make significant changes to leverage AI properly. Here's how to get started (or keep forging ahead).

14/12/2022

With a greater emphasis on patient-centricity, patients are valued as active participants in their own care. There is an increased emphasis on evaluating treatment benefits using patient-centric concepts and input from the patient community. Regulators now urge sponsors and researchers to systematically engage patients and caregivers to define the disease burden and unmet needs.

Featuring Ebony Dashiell-Aje, PhD, BioMarin Pharmaceutical Inc.

U.S. Food and Drug Administration

With the greater emphasis on patient-centricity, patients are valued as an active participant in their own care. There is an increased emphasis on evaluating treatment benefit using patient-centric concepts and input from the patient community. Regulators now urge sponsors and researchers to syst...

13/12/2022

Cultural and psychological safety is essential to achieving diversity in clinical trials. As sponsors enable their diverse teams to unleash their creativity in a psychologically and culturally safe environment, they will design protocols, consent forms, and reimbursements adapted to the needs of real-world patient populations.

By Valerie Schaeffer, PhD, NREMT-P, The DOT Connector, LLC

Cultural and psychological safety is essential to achieving diversity in clinical trials. As sponsors enable their diverse teams to unleash their creativity in a psychologically and culturally safe environment, they will design protocols, consent forms, and reimbursements adapted to the needs of....

09/12/2022

The shifting landscape of industry innovation and unconventional partnerships has created a need for an increased number of pharmacovigilance agreements (PVAs) with higher levels of complexity. As a result, many stakeholders face new challenges in drafting, negotiating, and finalizing PVAs.

By Jennifer Whittaker, Roche

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The shifting landscape of industry innovation and unconventional partnerships has created a need for an increased number of pharmacovigilance agreements (PVAs) with higher levels of complexity. As a result, many stakeholders face new challenges in drafting, negotiating, and finalizing PVAs.

09/12/2022

For years, Boehringer Ingelheim operated with a system comprised of best-of-breed solutions from different vendor companies. After carefully evaluating the technology environment, the company decided to move from best-of-breed solutions to an end-to-end product development platform.

Featuring Uli Broedl

For years, Boehringer Ingelheim operated with a system comprised of best-of-breed solutions from different vendor companies. After carefully evaluating the technology environment, the company decided to move from best-of-breed solutions to an end-to-end product development platform.

07/12/2022

AstraZeneca is an emerging leader in the chronic lymphocytic leukemia space. It now hopes to develop treatments so patients can avoid chemotherapy, hoping those therapies will prolong survival in patients while also producing a better quality of life.

Featuring Carlos Doti and Kelly Page

AstraZeneca is an emerging leader in the chronic lymphocytic leukemia space. It now hopes to develop treatments so patients can avoid chemotherapy, with the hope those therapies will prolong survival in patients while also producing a better quality of life.

07/12/2022

In “Better Than Expected — A Firsthand Experience In Africa,” Kamila Novak shared her positive impressions from visiting medical research centers in sub-Saharan Africa. However, the picture would not be complete without discussing the continent’s safety and professional security, regulatory landscape, and ongoing socioeconomic challenges.

By Kamila A. Novak, KAN Consulting MON. I.K.E.

In “Better Than Expected — A Firsthand Experience In Africa,” Kamila Novak shared her positive impressions from visiting medical research centers in sub-Saharan Africa. However, the picture would not be complete without talking about the continent’s personal safety and pro...

05/12/2022

The projected growth of the clinical research industry demands that the workforce keep pace with the workload — and it must be diverse and research-ready. What’s at stake? Nothing more than the risk of delaying approvals of new treatments for patients who need them.

By Susan P. Landis, ACRP - Association of Clinical Research Professionals

The projected growth of the clinical research industry demands that the workforce keep pace with the workload — and it must be diverse and research-ready. What’s at stake? Nothing more than the risk of delaying approvals of new treatments for patients who need them.

02/12/2022

Whether in the world of employment or clinical trials recruitment, if recruits can’t find what they’re looking for from you, they will find it from someone else or fail to engage entirely. Explore five trends crucial to successful employee and trial participant recruitment.

By Howard Johnson, RBW Consulting

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Whether in the world of employment or clinical trials recruitment, if recruits can’t find what they’re looking for from you, they will find it from someone else or fail to engage entirely. Explore five trends crucial to successful employee and trial participant recruitment.

30/11/2022

A new development could potentially change the patient recruitment challenge. In 2022, CVS Health Walgreens and Walmart officially entered the clinical trials space. The patient access capabilities of all three organizations may change the way drug developers access patients while also solving the patient diversity problem.

A new development could potentially change the patient recruitment challenge. In 2022, CVS, Walgreens, and Walmart officially entered the clinical trials space. The patient access capabilities of all three organizations may change the way drug developers access patients while also solving the pat...

30/11/2022

Except for South Africa, sub-Saharan African countries are still largely underrepresented in the global clinical study map. Hesitation to conduct clinical studies in Africa may be partly a result of assumed poor infrastructure, missing regulations, and inexperienced researchers. But is it truly so? Or is our thinking stuck somewhere in the past?

By Kamila A. Novak, KANConsulting MON. I.K.E.

Except for South Africa, sub-Saharan African countries are still largely underrepresented in the global clinical study map. Hesitation to conduct clinical studies in Africa may be partly a result of assumed poor infrastructure, missing regulations, and inexperienced researchers. But is it truly s...

29/11/2022

When the COVID pandemic hit in the spring of 2020, many companies were unprepared for the changes that were about to impact their studies. Astellas is one company that was better prepared than most. The company had initiated a formalized, internal project on decentralized clinical trial (DCT) technologies and their use in clinical trials about nine months prior to the pandemic.

Featuring Marie Rosenfeld, Astellas Pharma US

When the COVID pandemic hit in the spring of 2020, many companies were unprepared for the changes that were about to impact their studies. Astellas is one company that was better prepared than most. The company had initiated a formalized, internal project on decentralized clinical trial (DCT) tec...

23/11/2022

The industry is compelled to embrace digital transformation in its approach to patient recruitment and engagement, study design protocols, and overall trial management. But what's the crucial component to ensuring its success? Global standards that help cultivate trust.

By Maria Palombini, IEEE Standards Association

The clinical trials industry is compelled to embrace digital transformation in its approach to patient recruitment and engagement, study design protocols, and overall trial management. But what's the crucial component to ensure its success? Global standards that help cultivate trust.

22/11/2022

While working for BMS, Ian Walters noticed a disturbing trend in the industry. Big Pharma companies would often lament that small biotech firms do not develop drugs the same way it is done at large companies. He is now working to change the biotech model.

Featuring Ian Walters, Portage Biotech

While working for BMS, Ian Walters noticed a disturbing trend in the industry. Big Pharma companies would often lament that small biotech firms do not develop drugs the same way it is done at large companies. He is now working to change the biotech model.

18/11/2022

Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.

By Penelope Przekop, PDC Pharma Strategy

Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to pa...

16/11/2022

Sponsors are increasingly choosing independent medical monitors to work on their behalf to provide oversight across multiple study sites or multiple separate clinical trials. This article explains the role of medical monitors and how to effectively integrate them into your clinical study team.

By Harriet Gray Stephens, Boyds

Sponsors are increasingly choosing independent medical monitors to work on their behalf to provide oversight across multiple study sites or multiple separate clinical trials. This article explains the role of medical monitors and how to effectively integrate them into your clinical study team.

16/11/2022

Medtech companies are increasingly searching for a destination where they can recruit patients faster, easier, and cheaper for their early feasibility studies. Companies want to avoid the uncertainty of the FDA Investigational Device Exemption (IDE) review process. Due to the new European Medical Device Directive (MDR) 's difficulties since May 2021, the medtech clinical trial pendulum is shifting from Eastern Europe to Latin America. Many more medtech companies are now looking at Latin America (especially Colombia) as their destination for their early feasibility research instead of Eastern Europe.

By Julio G. Martinez-Clark, Bioaccess: CRO. Regulatory. Commercialization

Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America. 

14/11/2022

Quris has developed a treatment for Fragile-X Syndrome, the most common inherited cause of autism and intellectual disabilities worldwide. Isaac Bentwich, founder and CEO of Quris, believes the rare disease space, in general, is a difficult one to navigate.

Quris has developed a treatment for Fragile-X Syndrome, the most common inherited cause of autism and intellectual disabilities worldwide. Isaac Bentwich M.D., the founder and CEO of Quris, believes the rare disease space, in general, is a difficult one to navigate.

11/11/2022

As companies look for ways to increase diversity in their patient populations, I am reminded of a presentation I attended at the 2016 SCRS Global Solutions Summit. Ola Akinboboye, a cardiologist, gave one of the best presentations I have heard on how to increase the participation of African Americans and other minorities in clinical research.

As companies look for ways to increase diversity in their patient populations, I am reminded of a presentation I attended at the 2016 SCRS Global Solutions Summit. Ola Akinboboye, a cardiologist, gave one of the best presentations I have heard on how to increase the participation of African Ameri...

11/11/2022

Intersectionality is the framework for how a person’s relationships, identities, interactions, and interdependencies can create different advantages and disadvantages. In order to fully embrace intersectionality and make meaningful impacts in clinical trial recruitment of diverse populations, the entire journey of the patient must be realized — every step of the way.

By Inez Ruiz-White, PhD, Otsuka Pharmaceutical Companies

Intersectionality is the framework for how a person’s relationships, identities, interactions, and interdependencies can create different advantages and disadvantages. In order to fully embrace intersectionality and make meaningful impacts in clinical trial recruitment of diverse population...

09/11/2022

Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.

By Kieran O'Donnell and Nicola Kidman, Arriello

Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been...