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Disrupting the Status Quo: The Importance of Diversity in Clinical Trials

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Manage episode 356111856 series 2557441
コンテンツは Thermo Fisher によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、Thermo Fisher またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作権で保護された作品をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal

What are the ramifications from a clinical research perspective if diversity is not appropriately represented in a clinical study populations? Even as diversity becomes increasingly important across different sectors, minorities continue to be left out of clinical trials and medical research studies. So, why is diversity so critical in clinical trials? Nik explains, "I think in terms of the ramifications if diversity is not appropriately represented — I think we, unfortunately, saw this clearly playing out during the pandemic when we were seeing a lot of the data emerging that many underrepresented patients, particularly black and Hispanic patients, were having worse outcomes with COVID. Yet when we were looking at a lot of the trials for vaccines and therapeutics, those patients were not being included in the studies. And then as a result, from a scientific standpoint, when the results of the studies came out, people were understandably questioning, ‘Are these results that we're seeing generalizable to all the patients with the disease and especially the patients who're having the worst outcomes?’"

Recruiting and enrolling more representative populations does not mean delaying the study. Despite what many people think, enrolling diverse populations in clinical trials won't slow down the process. Nik shares his experience with including underrepresented minorities in peri- and post-approval studies through decentralized clinical trial models. He says, "The great thing was that not only did we complete that study and we had the data and that really gave us a lot more confidence in our medicine but also that trial recruited in record time, which was one of the myths that people had been saying, 'Oh, we could have a more diverse trial population, but it's going to slow the study, and we don't want to do that.' So, this study, we had 84% from underrepresented populations and actually was one of the fastest studies that Genentech ever enrolled and was published in the New England Journal of Medicine."

Clinical trials must strive to be more diverse. Enhancing diversity in clinical trials is a win-win for the entire public health system, not just for underrepresented populations. Nik explains, "We're thinking about this very carefully at Genentech, and we're trying to make sure that our efforts in terms of improving diversity in clinical trials is not just a one-off thing, that we really make this part of just the routine way that we do every clinical trial."

He adds, "I think our vision, as I mentioned, is that we really need to make enrolling a diverse and representative population a routine part of how we conduct all of our trials, which will not only increase the robustness of our research, but it will also help ensure broad patient access, and as we've seen from a few studies, not only will it not slow down studies but if done right can even accelerate trials. If we can do all of that, that can really represent a true win-win for patients, for us as a company, and for society as a whole."

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36 つのエピソード

Artwork
iconシェア
 
Manage episode 356111856 series 2557441
コンテンツは Thermo Fisher によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、Thermo Fisher またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作権で保護された作品をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal

What are the ramifications from a clinical research perspective if diversity is not appropriately represented in a clinical study populations? Even as diversity becomes increasingly important across different sectors, minorities continue to be left out of clinical trials and medical research studies. So, why is diversity so critical in clinical trials? Nik explains, "I think in terms of the ramifications if diversity is not appropriately represented — I think we, unfortunately, saw this clearly playing out during the pandemic when we were seeing a lot of the data emerging that many underrepresented patients, particularly black and Hispanic patients, were having worse outcomes with COVID. Yet when we were looking at a lot of the trials for vaccines and therapeutics, those patients were not being included in the studies. And then as a result, from a scientific standpoint, when the results of the studies came out, people were understandably questioning, ‘Are these results that we're seeing generalizable to all the patients with the disease and especially the patients who're having the worst outcomes?’"

Recruiting and enrolling more representative populations does not mean delaying the study. Despite what many people think, enrolling diverse populations in clinical trials won't slow down the process. Nik shares his experience with including underrepresented minorities in peri- and post-approval studies through decentralized clinical trial models. He says, "The great thing was that not only did we complete that study and we had the data and that really gave us a lot more confidence in our medicine but also that trial recruited in record time, which was one of the myths that people had been saying, 'Oh, we could have a more diverse trial population, but it's going to slow the study, and we don't want to do that.' So, this study, we had 84% from underrepresented populations and actually was one of the fastest studies that Genentech ever enrolled and was published in the New England Journal of Medicine."

Clinical trials must strive to be more diverse. Enhancing diversity in clinical trials is a win-win for the entire public health system, not just for underrepresented populations. Nik explains, "We're thinking about this very carefully at Genentech, and we're trying to make sure that our efforts in terms of improving diversity in clinical trials is not just a one-off thing, that we really make this part of just the routine way that we do every clinical trial."

He adds, "I think our vision, as I mentioned, is that we really need to make enrolling a diverse and representative population a routine part of how we conduct all of our trials, which will not only increase the robustness of our research, but it will also help ensure broad patient access, and as we've seen from a few studies, not only will it not slow down studies but if done right can even accelerate trials. If we can do all of that, that can really represent a true win-win for patients, for us as a company, and for society as a whole."

  continue reading

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