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Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. rubin_head_shot_2015.jpgViews represented here may not be those of PhRMA, though they are no less key to a healthy dialogue on issues in health care today.

In celebration of Clinical Trials Awareness Week, we are pleased to share a blog post
that was written by Eric Rubin, M.D., medical oncologist and vice president, Global Clinical Oncology, Merck Research Laboratories. The post was
originally featured on a forum featuring Merck’s scientists.

Few innovations have helped as many as the advent of the modern clinical trial, especially in cancer research. Without these important studies, doctors, regulators, patients and caregivers would not be able to determine what kinds of medicines may help patients, or the potential risks.

While the idea that we can carefully evaluate new medicines is taken for granted today, the clinical trial as it is understood today dates back only to the 1940s. Prior to that time, hucksters could – and did – push useless or harmless “cures” on anyone. It's no coincidence that the great leaps forward in medicine, such as antibiotics, are closely linked with the adoption of clinical trials as the gold standard for understanding a medicine’s effects.

The basic foundations of the randomized, blinded clinical trial – comparing different groups of otherwise-similar patients and ensuring that neither doctor nor patient is aware of who receives what treatment – have proven their value. But our recent work at Merck is focused on ensuring that the clinical trials system advances and works more effectively. Quicker, smarter ways of conducting clinical trials means that we can answer scientific questions more quickly and more confidently, allowing more patients access to medicines that may potentially help them.

In some cases, we have worked closely with regulators to modify ongoing trials to enroll more patients and gather more data. New FDA rules around “breakthrough” products have allowed more collaboration with the FDA, and this kind of collaboration has helped Merck and others in the pharmaceutical industry to quickly gather the data needed to demonstrate the potential benefit of new treatment options.

Our immuno-oncology research program has been one area where we’ve been able to use these new tools. We have had the opportunity–when the early trials show promise–to expand studies to gather additional high-quality data, helping advance the potential for bringing medicines to cancer patients.

The design of Merck's oncology trials, too, is becoming more innovative. We have made important strides in developing new trial designs that allow us to evaluate multiple types of cancers in one study. This, in turn, makes it more likely that we can identify potential new medicines in a more efficient manner. The years to come are likely to see more such trials helping us to better answer questions on the best way to treat cancer.

But clinical trials can only advance cancer research if patients volunteer to participate. Merck is committed to helping educate patients, doctors and caregivers about oncology clinical trials. For more on our approach on clinical trials and ongoing clinical trials, please visit Merck Clinical Trials.

Guest Contributor

The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view on issues facing our industry and the health care system.

Guest Contributor

ICYMI: PhRMA submits comments to White House on artificial intelligence

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March 6, 2025

ICYMI: More evidence of the IRA’s harmful consequences on post-approval research and development

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Decentralized clinical trials and the future of drug development

August 9, 2023

ICYMI: PhRMA CMO Dr. Michael Ybarra speaks with Dr. Fabian Sandoval about clinical trial diversity

May 16, 2023

PhRMA submits comments to OSTP on enhancing clinical trial diversity

March 21, 2023

Watch: Building trust and enhancing clinical trial diversity

June 24, 2021

PhRMA hosts first stakeholder workshop on clinical trial diversity

June 11, 2021

Increasing diversity at investigator sites could increase minority participation in clinical trials

December 17, 2020

Strengthening a culture dedicated to patients and equity: A conversation with Percival Barretto-Ko, President of Astellas US

December 16, 2020

Committing to diversity, equity and inclusion: A call to action for clinical trials

November 19, 2020

Just released: PhRMA members’ new clinical trial diversity principles

November 18, 2020

How biopharmaceutical researchers are ensuring COVID-19 vaccines will be safe and effective­

June 29, 2020

Clinical Trials Awareness Week: Recognizing unsung heroes in medical research

May 18, 2020

Guest Post: Preserving clinical research sites during the coronavirus pandemic

April 29, 2020

The biopharmaceutical industry’s unique role in responding to COVID-19

April 2, 2020

COVID-19 Response: Supporting the frontline

March 30, 2020

America’s biopharmaceutical companies are working around the clock to beat coronavirus

March 20, 2020

ICYMI: America’s biopharmaceutical companies are taking on COVID-19

March 16, 2020

Clinical Trials Awareness Week: Celebrating innovation in clinical research

May 15, 2019

Clinical trials impact state economies

May 3, 2019

Examining the truth behind clinical trial costs

October 2, 2018

New report details the setbacks and challenges to Alzheimer’s research

September 12, 2018

Guest post: Ensuring communities have a seat at the table: The importance of diversity in clinical trials

May 25, 2018

Bringing innovation to clinical trial design

April 23, 2018

EFPIA-PhRMA Principles successfully enable responsible clinical trial data sharing

November 29, 2017

Guest Post: Film chronicles clinical trials ‘paying it forward’

November 28, 2017

Biopharmaceutical industry policies aim to increase access to clinical trial data

July 27, 2017

Guest Post: The Clinical trial experience from a patient & researcher perspective

May 5, 2017

Guest Post: Patients as research partners - Rethinking patient access to clinical trial data

May 4, 2017

Guest Post: Spotlighting the heroes in clinical trials

May 3, 2017

Clinical Trials Awareness Week: Celebrating the impact of clinical research

May 1, 2017

Driving innovation through collaboration

April 17, 2017

Watch: Biomarkers in drug development with Dr. Bernie Zeiher

February 14, 2017

Guest Post: Advancing oncology research through clinical trials

Clinical Trials

Guest Post: Advancing oncology research through clinical trials

May 2, 2017

Guest Post: Advancing oncology research through clinical trials

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