Clinical trials and evidence
Clinical trials and real-world evidence support evidence-based medicine in healthcare, playing a pivotal role in validating and advancing medical treatments and interventions. Clinical trials assess the efficacy and safety of new drugs and therapies, with real-world evidence providing data to inform clinical and regulatory decisions based on empirical data.
Top Stories
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Podcast
18 Sep 2024
Exploring chronic disease management trends, strategies
Chronic disease management and prevention strategies are of increasing importance as chronic conditions increase in prevalence. Continue Reading
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News
26 Aug 2024
Long COVID effects in adolescents, young children vary
NIH-funded research through the RECOVER initiative revealed that long COVID symptoms among pediatric patients varied from sleepiness to headaches, underscoring vaccine importance. Continue Reading
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News
03 Apr 2020
Key Prescription Drugs Being Used to Treat COVID-19 Patients
The pharmaceutical industry is focused on developing COVID-19 treatments as the pandemic worsens. Here are the leading prescription drugs being tested as potential cures. Continue Reading
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News
01 Apr 2020
FDA Issues Guidance on Conducting Clinical Trials During COVID-19
The guidance will help industry and investigators navigate clinical trials during the COVID-19 pandemic, including how to focus on patient safety and how to move forward. Continue Reading
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News
31 Mar 2020
Johnson & Johnson Announces a Lead COVID-19 Vaccine Candidate
The pharmaceutical company expects to initiate human testing of the lead COVID-19 vaccine candidate by Sept. 2020, with the first batches available in 2021. Continue Reading
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News
31 Mar 2020
FDA Accelerates Review of COVID-19 Diagnostic Tests
FDA provided an update on the review process for COVID-19 diagnostic tests, recognizing the urgent need for even faster testing availability during this pandemic. Continue Reading
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News
27 Mar 2020
How the Pharmaceutical Industry Is Approaching a COVID-19 Vaccine
With the coronavirus pandemic showing few signs of slowing, pharmaceutical companies are collaborating to accelerate the development of a COVID-19 vaccine. Continue Reading
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News
27 Mar 2020
Gilead Requests FDA to Rescind Orphan Drug Status for Remdesivir
The biopharmaceutical company asked FDA to revoke orphan drug status for investigational antiviral treatment, remdesivir, a potential COVID-19 treatment. Continue Reading
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News
25 Mar 2020
Vivli Launches COVID-19 Portal to Share Clinical Trial Data
The portal will make clinical trial data sharing quick and easy to support patient decisions and enhance potential COVID-19 treatments. Continue Reading
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News
24 Mar 2020
HHS Funds Clinical Trial for Potential COVID-19 Treatment
The clinical trial will evaluate whether the FDA-approved rheumatoid arthritis drug Kevzara is effective against COVID-19. Continue Reading
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News
23 Mar 2020
Gilead Halts Access to Potential COVID-19 Drug Remdesivir
Gilead has temporarily stopped granting patient access to a potential COVID-19 treatment, remdesivir, focusing on current requests and speeding up future requests. Continue Reading
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News
23 Mar 2020
COVID-19 Concerns at US Clinical Trial Sites Jump 88% Over 4 Days
While US clinical trial sites are concerned about COVID-19 impact on trial enrollment, Europe reported a higher level of concern overall. Continue Reading
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News
20 Mar 2020
Lopinavir- Ritonavir Not Effective in Adults with Severe COVID-19
A randomized clinical trial uncovered that adult patients with confirmed COVID-19 saw no significant advantages from lopinavir-ritonavir beyond standard care. Continue Reading
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News
20 Mar 2020
Court Tells Mallinckrodt to Pay $650M in Back Medicaid Rebates
The US District Court supported HHS and CMS in Mallinckrodt’s lawsuit surrounding the company’s calculation of Medicaid drug rebates for Acthar Gel. Continue Reading
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News
18 Mar 2020
GSK, Chapel-Hill Renew $20M Partnership to Discover HIV Treatment
The partnership brings together experts in academia and the pharma industry to develop a new understanding of how HIV works and launch a possible HIV treatment. Continue Reading
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News
17 Mar 2020
FDA Proposes Broad Approach to Clinical Trials for Diabetes Drugs
A revision of the 2008 draft, the proposal does not include that manufacturers conduct clinical trials for diabetes drugs to rule out unacceptable cardiovascular safety risks. Continue Reading
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News
16 Mar 2020
Patients Benefiting from Immune Checkpoint Inhibitor Drugs Limited
Immune checkpoint inhibitor drugs are gaining popularity due to their ability to boost immunity against cancer cells, but a new study shows that only about 11% of cancer patients benefit. Continue Reading
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News
16 Mar 2020
Major NY Opioid Trial in Delayed Due to COVID-19 Concerns
Amid the COVID-19 outbreak in the US, the nation’s most “comprehensive lawsuit” against opioid manufacturers and distributors has been delayed by nearly a month. Continue Reading
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News
13 Mar 2020
Cell and Gene Therapy Development Increased 20%, PhRMA Finds
As cell and gene therapy development continues to rapidly increase in the US, patients can expect more personalized treatment on the horizon for more diseases. Continue Reading
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News
12 Mar 2020
$125M Initiative to Boost Drug Discovery for COVID-19 Treatment
The $125 million initiative will enhance patient access to therapies, remove potential barriers for drug discovery, and scale-up treatment to address COVID-19. Continue Reading
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News
11 Mar 2020
First Gene Therapy Clinical Trial to Address Genetic Blindness
The gene-editing tool CRISPR is being used in the first-ever gene therapy clinical trial to address a blindness-causing gene mutation. Continue Reading
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News
06 Mar 2020
New Ruling to Expand Public Access to Clinical Trial Data
The new ruling last week will require the government to post a decade’s worth of clinical trial data results that should have been public back in 2007. Continue Reading
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News
05 Mar 2020
Former SARS, MERS Drug Could Treat COVID-19 Patients
Antiviral Remdesivir, used previously as a treatment for MERS and SARS, showed results that it may be an effective and safe vaccine for patients with COVID-19, the coronavirus. Continue Reading
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News
28 Feb 2020
ICER, Aetion to Boost Real-World Evidence for Clinical Trials
ICER adopts Aetion’s platform to advance standards for how real-world evidence can inform decision making for clinical trials and enhance overall patient care. Continue Reading
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News
26 Feb 2020
NIH Launches Clinical Trial for Potential Coronavirus Vaccine
The first US clinical trial will enroll adults affected with COVID-19 in Nebraska to uncover if antiviral remdesivir is a safe and effective coronavirus vaccine. Continue Reading
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News
25 Feb 2020
Organizations Demand Clinical Trial Coverage for Medicaid Patients
Over 100 healthcare organizations are calling on Congress to ensure Medicaid patients with a life-threatening condition receive coverage for clinical trials. Continue Reading
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News
25 Feb 2020
Members of Congress Demand Fair Drug Pricing for COVID-19 Vaccines
In an official letter, members of Congress demand accessible and affordable drug pricing for coronavirus vaccines to ensure access to care for all Americans. Continue Reading
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News
21 Feb 2020
IBM Watson Unveils Cloud-Based Clinical Trial Efficiency Tech
IBM Study Advance will provide access to patient population data and templates which will enable greater clinical trial efficiency and reduce unplanned costs. Continue Reading
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News
21 Feb 2020
Former Pharma Executive Pleads Guilty to Antitrust Conspiracy
The former generic pharmaceutical executive is the third executive to plead guilty for his role in an antitrust conspiracy, targeting elderly consumers. Continue Reading
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News
20 Feb 2020
HHS, J&J Partner to Boost Vaccination Discovery for Coronavirus
The partnership will boost the vaccination discovery for the coronavirus and will identify compounds with promising antiviral activity against SARS-CoV-2. Continue Reading
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News
18 Feb 2020
CMS Launches New Billing Code for Coronavirus Testing
CMS took further action to ensure healthcare facilities are prepared to respond to the coronavirus by developing a new billing code for coronavirus testing. Continue Reading
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News
17 Feb 2020
Children’s Hospitals Team Up to Link Patients to Clinical Trials
Michigan Medicine recently joined other top children’s hospitals around the world to help children with high-risk brain tumors receive promising clinical trials. Continue Reading
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News
11 Feb 2020
Chronic Disease Management Drug Shows Real-World Efficacy
Real-world efficacy was also even higher in patients ineligible for randomized clinical trials for the chronic disease management drug used to treat type 2 diabetes. Continue Reading
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News
05 Feb 2020
Many Antibiotics Prescribed Without ‘Clear Rationale,’ Study Says
A new study published in Health Affairs highlights the need for monitoring prescribing behaviors, citing 45% of antibiotic prescriptions lacking a clear rationale. Continue Reading
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News
05 Feb 2020
WHO Touts Vaccines in Global Principles Against Cancer
WHO warns on the potential for a 60 percent spike in new cancer cases worldwide over the next two decades, creating urgency around the need to step up cancer services. Continue Reading
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News
29 Jan 2020
CEPI Pushes for Vaccine as Coronavirus Spreads
Inovio Pharmaceuticals, the University of Queensland and Moderna, Inc. and the National Institutes of Health will participate in CEPI’s programs for a coronavirus vaccine. Continue Reading
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News
23 Jan 2020
GlaxoSmithKline Leads Group Combatting Antimicrobial Resistance
A new benchmark report look at efforts made by 30 pharma companies to limit antimicrobial resistance. Continue Reading
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News
09 Dec 2019
Guidelines Call for Patient-Reported Outcomes in Clinical Trials
Advocates say patient-reported outcomes are essential to effective sickle cell disease clinical trials. Continue Reading
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News
02 Dec 2019
3 Principles for Patient-Centered Research Design, Clinical Trials
Patient-centered clinical trial design can improve participant recruitment, study questions, and results dissemination. Continue Reading
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News
15 Nov 2019
How Is Real-World Evidence Impacting Drug Discovery, Development
The pharmaceutical industry is turning to real-world evidence to improve drug discovery and development, and new FDA guidance should see that trend continue. Continue Reading