WEBINAR: Optimizing Study Start-up in a Decentralized World

Thursday, September 24th @ 2:00pm EDT.

To register, please click here.

Our Founder & President is teaming up with the Director of Clinical Operations from one of the leading CROs – DZS Clinical Services – to talk through the challenges and opportunities of the shift towards decentralization and the new way of conducting trials. 

Anyone in the clinical trial space knows how difficult it can be to manage a team, make decisions, and drive progress to launch a trial, all while operating virtually. During this discussion, the speakers will show how sponsors can turn pitfalls and frustrations into opportunities and triumphs. 

Our speakers are:

  • Host: Kathleen Colatrella – Founder & President of LINEA System
  • Guest Speaker: Kari Brown, Director of Clinical Operations at DZS Clinical Services

LINEA System teams up with Trial By Fire in fully-integrated partnership

PARSIPPANY, NJ and OAKLAND, CA - LINEA System, LLC and Trial By Fire Solutions, LLC have begun a partnership to offer their clinical trial solutions, AcceleTrial™ and SimpleTrials, respectively, as a fully integrated solution. This partnership will allow sponsors to take advantage of AcceleTrial™’s study start-up benefits to select and activate the right sites, and of SimpleTrial’s robust clinical trial management system (CTMS) capabilities.

LINEA System’s Study Start-up Management System (SSMS) provides access to a built-in global database of over one hundred thousand objectively-ranked investigators and sites as well as an intuitive and automated workflow to ensure study start-up progresses efficiently. SimpleTrials provides end-to-end study management functionality, including eTMF, electronic visit reports, and site payments, fully validated and available as the industry’s first on-demand subscription based CTMS offering.

“Having LINEA System as a partner enables our clients to more effectively identify and qualify sites based on specific criteria” said Nancy Cecchettini, Co-founder and Chief Product Officer of Trial by Fire Solutions. “For more than a decade, we have provided comprehensive CTMS functionality to manage study start-up through closeout and this partnership will enable our clients to quickly move through the site selection and document completion aspects of their studies with one end-to-end service.”

The synthesis of LINEA Systems’ and SimpleTrials’ technologies will result in a more seamless execution of clinical trials from beginning to end. When a trial is optimized and proceeds efficiently, vital medicines reach patients who need them most.

“The current climate demands that clinical teams approach trials in an advanced way, considering all the hurdles to speed availability of critical treatments to patients” said Kathleen Colatrella, Founder and President of LINEA System. “I’m excited to begin the partnership with SimpleTrials and share the value of an SSMS with more clinical teams, and ultimately, make an impact on how trials are conducted.”

Colatrella and Cecchettini are excited to launch their partnership at such a time when efficiency and accuracy of clinical trials are more crucial than ever.


About LINEA System, LLC

LINEA System is a leader in helping accelerate clinical trials by leveraging data and automated technology in a completely new way. The company specializes in clinical site and investigator identification, feasibility, and site activation. LINEA System’s cloud-based Study Start-up Management System (SSMS), AcceleTrial™, enables sponsors to streamline and automate the study start-up process to drastically reduce the launch time of clinical trials and patient recruitment. For more information, visit http://www.lineasystem.com.

About Trial By Fire Solutions, LLC

Trial By Fire Solutions is a global leader in web-based clinical trial management solutions focused on innovative applications to improve planning, execution and tracking of clinical studies. With its SimpleTrials CTMS product, along with an experienced clinical technology team, Trial By Fire Solutions provides affordable eClinical solutions to teams of all sizes. For more information, visit http://www.simpletrials.com.

Press contact:

Sarah Hof
Marketing Associate, LINEA System

Why is a Study Start-up Management System the vital tool sponsors need?

By: LINEA System team

Countless industries are shifting to virtual and remote operations, and the realm of clinical trials is no exception. In fact, COVID-19 has only accelerated our industry’s dependence on technology to efficiently and successfully run trials. This shift has prompted the field to accept virtual or decentralized clinical trials as a trusted means to conduct research of such vital importance.

As teams become empowered to work from anywhere in the world, it is necessary for all stakeholders in a trial to have readily-available access to information on the clinical trial in real-time. The proper tools and technology to navigate a decentralized clinical trial ensures a successful outcome for the sponsor, and more importantly, an accelerated timeline for patients to gain access to life-changing medicines.

What is a Study Start-up Management System?

A Study Start-up Management System (SSMS) is an essential tool to efficiently accelerate clinical trial start-up. From all steps throughout the start-up process beginning with targeting the right sites, assessing site interest, conducting feasibility, collecting essential regulatory documents, obtaining approvals and contracts, and finally, enrolling patients, an SSMS ensures that a trial launches on-time and with the optimal sites.

There are three hallmark features of an SSMS:

  1. A built-in database of investigators. To deliver the optimal sites, every SSMS includes a built-in database of investigators.
  2. An automated workflow. By design, the system’s automated workflow enables a sponsor to quickly move from task to task and ensure that the start-up is progressing with no hold-ups.
  3. A cloud-based structure. The cloud-based nature of the system provides readily available access to data, metrics, and reporting anytime and anywhere.

Differing from other trial management software, an SSMS assists in the launch of a trial, while others such as a CTMS manage separate aspects of a trial after it has been launched and patients are being enrolled.

How can an SSMS help sponsors?

It is well-known that the most common source of delays to a trial is patient recruitment. This stems back to sponsors selecting initial sites that either prove unreliable once patients have been enrolled, or fail to enroll patients at all. In fact, according to the Tufts Center for the Study of Drug Development, 37 percent of sites selected under-enroll, and 11 percent fail to enroll a single patient. These routinely poor start-up metrics can lead to delayed trial timelines, and a 20 percent or higher increase in the originally projected trial budget.

When a sponsor selects the optimal sites first, patient recruitment is realized, the trial can proceed on-time, and the sponsor gains approval of vital medicines for patients in need. This efficient sequence of the events is possible using a Study Start-up Management System, with the built-in database of ranked investigators and an automated workflow to effectively launch the trial.

How does AcceleTrialdrive clinical trials forward?

AcceleTrial™ was created with the founding principle that nearly all clinical trials can avoid delays by selecting the right sites initially. Not only does AcceleTrial™ have a database of over 100,000 global expert investigators, those investigators are all ranked objectively. Its proprietary algorithm pulls hundreds of data points from multiple sources based on clinical expertise, access to patients, and former clinical trial experience, among other metrics. This powerful ranking system ensures that ultimately, the most effective and optimal investigators and sites are selected for the trial, thereby mitigating any chance of delay.

The “push and pull” workflow ensures a steady momentum, tracking each step and keeping the process seamless. To add transparency, both the sponsor and the sites and investigators are able to access the platform and complete their respective tasks while monitoring the full scope of the process. AcceleTrial™ is designed to be intuitive and make a significant and immediate impact on a trial’s launch time and operational costs.

When a trial progresses smoothly, the greatest value is the potential to make available life-changing medicines for patients who need them most.

LINEA System: Advanced Technology for Accelerating Clinical Trial Launch


LINEA System is proud to have been recognized by MD Tech Review as a Top eClinical Trial Management Solution Provider for our work to accelerate clinical trials! To read the full story and see the spread, please visit their website, or click the PDF below.

 AcceleTrial™ identifies sites based on objective data validating therapeutic expertise, clinical trial experience, and access to patients that provides transparency for sponsors in choosing the right site. This model takes the guesswork out of clinical trial site identification and combined with an automated workflow, accelerates clinical trial start-up.”

-Kathleen Colatrella, Founder and President





COVID-19 & Clinical Trials: Understanding The Long-Term Impact

Like companies in all industry sectors, many biotechnology and pharmaceutical companies are struggling to understand and find strategies to address the challenges presented by the COVID-19 outbreak. For many, the impact of the pandemic on the conduct of clinical trials has forced both smaller biotechs and Big Pharma to make tough decisions to pause ongoing trials and reconsider timelines for data readouts, regulatory reviews, and product launches. Factors including impaired access to the healthcare system, travel restrictions, patient willingness to participate in trials, new guidance from regulatory agencies, and a shift in resources to fighting the pandemic are influencing the ability to advance many clinical research programs around the world. As companies focus on the immediate impact of COVID-19 on their development efforts, industry insiders are now starting to consider what the longer-term implications will be and how to address them.

The Life Sciences Practice at CRA recently reached out to a number of industry stakeholders, including regulatory and policy experts, venture capitalists, and contract research organizations (CROs), to better understand concerns about the impact of COVID-19 on clinical trials and how new challenges are likely to reverberate through the industry. Findings indicate that the impact on clinical development programs is already severe and will be broad and long-lasting, while the magnitude and nature of the impact will vary from trial to trial and company to company.

Addressing Short-Term Implications

In response to the pandemic, the FDA, EMA, and several national-level European governments have acted quickly to assess the impact and issued new recommendations related to clinical trials, including strategies for how companies can adapt to the current situation while reinforcing the essential need for any change to meet acceptable standards in patient safety and trial integrity. The agencies have also communicated their intention to remain flexible in evaluating protocol changes, deviations, and clinical efficacy and safety data. Industry insiders generally agree that the new guidelines provide a sufficient framework for trial sponsors to adapt their trial designs and protocols as needed at this stage.

As companies learn to adapt and consider implementing new strategies to keep clinical trials on track, in many cases the only option is to temporarily pause or delay development programs. For example, Provention Bio recently paused a Phase 3 trial in type 1 diabetes and Iveric Bio temporarily stopped a pivotal trial in geographic atrophy. But these decisions are not limited to smaller companies. Eli Lilly, Bristol-Myers Squibb, and Pfizer have announced pauses or delays in multiple development programs.

While consensus is that the impact of COVID-19 on clinical trials will be far-reaching, our analysis suggests that the level and duration of this impact will be especially severe in studies that have the following characteristics:

  • Enrolled vulnerable populations, including the elderly, the immunocompromised, and patients with pulmonary conditions (e.g., COPD)
  • Have primary or secondary endpoints that require in-person visits or hospital infrastructure and equipment (e.g., CT and PET scans) for assessment
  • Involve indications with minor safety or quality of life implications for patients (e.g., “lifestyle drugs”) and indications where a patient’s environment has a significant impact on therapeutic success (e.g., psychiatric and neurological indications)
  • Are currently in the patient recruitment stage or are in Phase 1 with healthy volunteers
  • Have trial sites located within hospitals or tertiary academic centers and in areas with high COVID-19 case density, potentially reducing the availability of staff to perform required activities and increasing the risk of adverse events and patient loss
  • Are evaluating immunosuppressive therapies or therapies that require complex and prolonged hospital visits (e.g., CAR-T cell and gene therapies)
  • Involve smaller patient populations where there are minimal margins of statistical power or people living with rare diseases (because patient accrual is already difficult, and the pandemic increases the risk for patient loss)

In the earliest stages of the pandemic, trial sponsors were primarily focused on essential decisions to pause or delay trials that were in the recruitment or pre-recruitment stages. Attention then shifted to trials in progress, where decisions related to protocols or timetables could have an impact on data integrity and statistical power.

The Longer-Term Impact

Looking ahead, organizations involved in clinical research are working to identify and assess financial, regulatory, and policy considerations that will affect their clinical programs in the longer term. Many are recognizing the need to plan for implementation of new and previously untried strategies to advance drug development programs.

In working to address the challenges of COVID-19, small biotechs could face potentially severe cash flow and financing issues as a result of trial delays. Companies with a single asset could be especially vulnerable. Delays in clinical trials may lead smaller companies to need additional funding at a time when their stock values have likely dropped and market conditions are not optimal. Many companies may be forced to make difficult cuts or prioritize development opportunities. Companies with potentially high-value products and platforms may be at risk of acquisition based on unfavorable terms.

Delays in clinical trials are likely to cause delays in projected launch timelines. This may in turn lead to shorter periods of patent exclusivity (barring patent term restoration) and lower near-term revenue forecasts. Changes in launch timelines also may shift the competitive landscape in many therapeutic areas, possibly presenting new opportunities for competitors that are able to adapt and act quickly in response.

From a regulatory standpoint, many stakeholders, including regulatory experts, trial site investigators, and CROs, anticipate that global agencies will require additional documentation and new protocols and procedures when considering new drug applications. The need for additional documentation can present significant challenges to trial sites and staffs. Processing this information also could cause delays in regulatory reviews and the ability of trial sponsors to quickly reply to follow-up inquiries from agencies.

Travel restrictions and social distancing measures will make protocol updates and deviations inevitable. Fortunately, per recent guidance from the FDA and EMA, trial sponsors will not be required to report protocol deviations prior to annual reports as long as the changes do not significantly impact the validity or safety of the trial. But sponsors and trial sites should meet with the appropriate institutional review boards (IRBs) to seek approval for protocol updates to reduce the risk that any changes could ultimately be rejected by the FDA or EMA.

The fact that trial participants cannot or will not attend in-person visits with investigators is a critical issue affecting many trials, but companies also should recognize the potential consequences if patients introduce COVID-19 to the trial itself. If patients contract the disease, it may impact clinical data by introducing elevated rates of related symptoms with a corresponding impact on endpoints. Any COVID-19-related fatalities would require these patients to be removed from data sets, potentially impacting the ability of trials to reach statistical significance. These consequences could be especially devastating for trials in rare diseases, where available patient populations are very small.

Based on our analysis, the impact of the pandemic on clinical trials will be felt on a policy level, including in drug pricing negotiations. The Pan-Canadian Pharmaceutical Alliance has already announced their intention to delay price negotiations for non-COVID-19 therapies. Pricing negotiations in Europe also could be impacted by the pandemic, especially for some non-COVID-19 therapies (e.g., the third or later drug to market in a class) where historically there has been a perception of low unmet need.

The Future

While most regulatory agencies have stated an intention to be flexible during these unprecedented times, it is critical that drug developers continue to monitor their risk diligently and develop contingency plans to adapt and respond to factors that affect their clinical development programs. Sponsors will need to balance patient safety, trial integrity, and statistical power considerations against funding and revenue issues on a trial-by-trial basis. In addition to reevaluating clinical development plans, companies may need to reassess their assumptions around pricing and revenue as well as the competitive landscape for both their pipeline and in-line products. There will not be a one-size-fits-all solution for the many short- and long-term challenges caused by COVID-19, but companies that are willing and able to rapidly adapt are likely to have the strongest chances for success.

Source: Clinical Leader

Clinical Trial Practitioners Begin Cautious Return to Work Sites

Leigh Burgess, MHA, MEd, MA, vice president of research operations for Dartmouth-Hitchcock Health, couldn’t wait to get back to her office after COVID-19 safety precautions forced her and most of her team to work remotely back in March.

Burgess has been able to work full-time onsite since mid-May, and says her facility has done a tremendous job of making everyone feel safe. Employees are screened before entering the office with a temperature check, there are sanitizing stations in place, all common areas are wiped down every two hours, and meetings are limited to 10 people with adequate social distancing.

“I feel safer here than I do at the grocery store,” Burgess says. That’s key, because “you want folks to feel comfortable,” she adds.

However, as a leader and manager, Burgess realizes her enthusiasm about returning to the office might not be universal. “Be a good listener and be open to adjusting” to each team member’s unique perspective, she advises.

For example, older personnel may understandably feel more vulnerable to getting COVID-19, or other personnel may have daycare issues or any number of challenging, extenuating circumstances to juggle if they can’t work from home. Don’t forget, some employees may be performing even better by working remotely.

Join Burgess Tuesday, June 23 at 12:00pm ET for a live Webinar exploring the considerations, processes, and procedures for research recovery and ramp-up related to COVID-19 and the impact it has had on research operation and administration. All Webinars are free for ACRP Members.

While she was already a fan of telecommuting, Burgess sees “a new openness” to the concept. She’s also been encouraged by how her team members and others have leveraged technology during this upheaval.

For those still mulling when and how to return to the office, Burgess stresses it’s never a one-size-fits-all solution, in part because of regional differences in the coronavirus’s impact. She also advises developing a three-month plan to reopen the office, rather than trying to focus efforts on a month-by-month basis.

Source: The Association of Clinical Research Professionals

Sites Struggle to Remain Solvent Amidst Trial Slowdown

Alarming economic news continues to pummel the clinical trial industry as more and more trials are stalled or even scrapped while industry tries to navigate its way through the COVID-19 pandemic.

Earlier this month, an ongoing quantitative survey conducted by Continuum Clinical in partnership with the Association of Clinical Research Professionals (ACRP) found 31% of clinical research study sites fear total closure as COVID-19-related stay-at-home orders and patient concerns over interacting with healthcare professionals continue to increase. Nearly 80% of sites indicated at least one of their current clinical trials had been put on hold or cancelled in recent weeks.

Even before the coronavirus hit, the clinical trial infrastructure was straining under a shorthanded workforce and tight financial margins. For example, 59% of sites in 2019 told the Society for Clinical Research Sites (SCRS) that they have only three months or less of operating cash.

Unfortunately, the dire news continues to pour in for beleaguered sites, according to an April 20 analysis of a global dataset covering more than 300,000 recruiting sites around the world by Phesi that found an “alarming” 10% spike in site suspensions in the past two months. “The timing aligns perfectly with the COVID-19” pandemic upending life in the U.S. and around the globe, says Phesi President Gen Li.

Sites are struggling and some are mulling or have gone ahead and furloughed some staff. The short- and long-term consequences will be negative and significant, says ACRP Executive Director Jim Kremidas. “In addition to putting highly qualified and valuable professionals on the shelf during a healthcare crisis, site cutbacks will make it very difficult for the industry to get back up and running as the impact of COVID-19 recedes,” Kremidas says.

The financial costs to a sponsor to replace a lost site is at least $30,000, Li estimates. In addition to the financial hit, time will be lost, typically three months or more, and possibly patient data and other trial results during the interim, he adds. “The situation is alarming and frankly has me concerned” for the clinical trial infrastructure, Li says.

And it’s not as simple as flipping an “on” switch to get a stalled trial back on track, Kremidas notes. “Learning a new trial protocol is akin to learning a new type of software,” he says. “It takes time to become familiar with both, and it’s easy to become rusty on both if you stop using them for any length of time,” he adds.

“Sponsors need to think about the financial stability of their clinical development supply chain, and sites are the most crucial link in it,” Kremidas says. “We urge sponsors, contract research organizations, and other interested parties to help us deliver educational resources now to help everyone operate more effectively throughout this difficult time, and to speed up restarting of trials once we’re past this crisis.”

In addition, ACRP joins SCRS’s call for sponsors to release site payment hold back funds during the crisis.

“There’s going to be a level of permanent damage,” Li says. “It’s up to us now to make it as small as possible.”

Source: The Association of Clinical Research Professionals

US clinical trial sites are most affected due to the Covid-19 pandemic

With the recent development of the current Covid-19 pandemic, there has been an increased urgency for both industry and non-industry sponsors to focus on finding a suitable therapeutic or vaccine for this highly contagious viral disease. In an effort to find a suitable treatment and prevention options for Covid-19 infection, more Covid-19 clinical trials are being planned and initiated, while a large number of clinical trials for non-Covid-19 indications are suffering delays.

With many regulatory agencies such as the FDA and EMA offering accelerated approval for Covid-19 therapeutics and vaccines, it could be in part that sponsors have shifted focus and research onto the current pandemic. But the majority of trial disruption could be attributed to patient safety, strict lockdown, social distancing, and the high demand for medical professionals to treat Covid-19 patients. High profile pharmaceutical companies have announced disruptions to planned and ongoing trials, postponing trial start dates and halting subject enrolment.

The Covid-19 Dashboard on the Pharma Intelligence Center dynamically tracks these disrupted trials from the Clinical Trials Database, along with the list of companies that are the sponsor, collaborator, or contract research organisation (CRO).

With over 1,000 trials being disrupted and more trials being added to this category daily, there is a direct impact on trial site activation and patient enrollment. Many of these sites are either being used for other purposes or are temporarily closed. With many countries enforcing strict lockdown measures, sponsors are unable to activate these sites, making it harder for existing trials to continue. According to GlobalData’s Clinical Trials Database, 56.1 % of disrupted trials are currently suspended while 20.7% are ongoing, but not recruiting any additional participants. When looking at site locations, the US had the highest number of disrupted trial sites at 66.1% followed by the UK at 12.8%, France at 9.3%, Spain at 6.5%, and Germany at 5.2%, as shown in Figure 1. According to the guidance of FDA and EMA procedures, many of these disrupted trial sites are now being repurposed for Covid-19 trials. Activation of new trial sites is usually not recommended for non-Covid-19-related trials unless no other solution exists for the ongoing trials. According to the EMA, “If there is an urgent need to open a new trial site for critical trial visits, for example outside the hospital, this may be implemented as an urgent safety measure (USM) first, followed later by a substantial amendment (SA) application for the approval and initiation of this additional site.” With the possibility of reallocating trial sites, there is also the need to move subject data such as medical records. In such cases, it is highly recommended from the EMA that this is done virtually and that any eCRFs can be adjusted accordingly to allow the receiving site to enter new data.

Due to site closures and lockdown measures, many companies involved in trial site management and coordination are feeling an economic hit. The top three countries with affected companies are the US, UK, and France. Contract research organisations are experiencing a hit too, with many organisations having to disrupt trials. According to GlobalData’s Clinical Trials Database, the top three CROs that are affected are IQVIA, Covance, and Sarah Cannon Research Institute. Among CROs, a statement from ICON highlights that 65% of their global sites are impacted in some way, which poses a period of financial uncertainty. Many companies are reviewing alternative approaches by using remote measures and virtual clinical trials, which aim to bring the study directly to the patient via online data collection and video call progress checks. It is important to note that with many countries easing lockdown, some trial sites may begin to reopen slowly to focus on other studies. With many companies shifting to alternative ways to conduct trials, it is possible that even after the Covid-19 pandemic the use of virtual trials will remain prominent.

Source: Clinical Trials Arena

Commonly used steroid reduces risk of death in sickest coronavirus patients, preliminary study results suggest

(CNN) – The widely available steroid drug dexamethasone may be key in helping to treat the sickest Covid-19 patients who require ventilation or oxygen, according to researchers in the United Kingdom.Their findings are preliminary, still being compiled and have not been published in a peer-reviewed journal — but some not involved with the study called the results a breakthrough.

The two lead investigators of the Recovery Trial, a large UK-based trial investigating potential Covid-19 treatments, announced to reporters in a virtual press conference on Tuesday that a low-dose regimen of dexamethasone for 10 days was found to reduce the risk of death by a third among hospitalized patients requiring ventilation in the trial.

“That’s a highly statistically significant result,” Martin Landray, deputy chief investigator of the trial and a professor at the University of Oxford, said on Tuesday.

“This is a completely compelling result. If one looks at the patients who did not require ventilators but were on oxygen, there was also a significant risk reduction of about one-fifth,” Landray said. “However, we didn’t see any benefit in those patients who were in hospital, had Covid, but whose lungs were working sufficiently well — they were not taking either oxygen or on ventilators.”

Landray added that “there are outstanding questions” and people treating Covid-19 at home should not be taking dexamethasone on the back of these results.

“We have not studied patients in the community,” Landray said. “We show no effect in the patients who are not on oxygen and we did not study the patients who are not in hospital.

“The dexamethasone arm of the Recovery Trial closed last week and researchers are now compiling its data. It included about 2,100 hospitalized Covid-19 patients who were randomized to receive dexamethasone, and about 4,300 hospitalized Covid-19 patients who were randomized to receive the usual standard of care at their hospitals.

In the trial, dexamethasone was provided at a dose of 6mg once a day for up to 10 days, administered either as an injection or taken orally. The researchers reported no serious adverse events among the patients taking dexamethasone, but the results are preliminary.

“At this stage, we found no clear adverse effects of doing this. Let’s recognize that there are sort of two messages here. In the people who required oxygen or ventilation, it clearly works, and the benefits are biggest for those on ventilators. In the people in hospital with Covid who do not require oxygen — so, their lungs are working moderately well — then actually there’s no benefit,” Landray said on Tuesday.”

In the trial, our focus was on mortality, which obviously a drug can affect in either direction, but the overall results in the patients on oxygen and ventilation was a clear, clear benefit,” Landray said, adding that deaths in the study were examined over a 28-day period. “We’ve looked, for example, were there deaths due to other forms of infection, which are sometimes considered a risk? And the answer is no, there was no excess of any other particular cause of death.”

Dexamethasone is typically used to treat certain forms of arthritis, severe allergies and asthma, among other conditions, including certain types of cancer. Side effects can include upset stomach, headache, dizziness, insomnia and depression. GoodRx estimates the drug can cost as low as about $8.

In the United States, dexamethasone already has been used to treat some Covid-19 patients during the pandemic.

When told about the preliminary Recovery Trial results, Dr. Mangala Narasimhan, the regional director for critical care at Northwell Health, which owns 23 hospitals in New York, said to CNN, “We’ve used it for Covid from the beginning.”

Dexamethasone has been a controversial drug when it comes to treating respiratory viral infections, Peter Horby, chief investigator for the Recovery Trial and a professor at the University of Oxford, said on Tuesday.

“This was included in the Recovery Trial because it’s a readily available, cheap and well understood drug, and because there have been reports in the past of benefit in viral respiratory infections, but it’s been an area of huge controversy,” Horby said.

“Even at the time of SARS1 in 2003, steroids were used, but at very different doses. Some of the studies showed a harm from steroids in SARS, some said there’s possible benefits. A meta-analysis in 29 different studies in SARS was inconclusive. There’s also been inconclusive results on MERS coronavirus and also influenza,” Horby said. “So really it’s been a huge ongoing debate as to whether you should use steroids in patients with viral respiratory diseases.

“The researchers said on Tuesday that they think this now should become a standard of care in the United Kingdom for Covid-19 patients requiring either oxygen or ventilation — but in the meantime, the Recovery Trial continues to investigate other treatment approaches.

“This is tremendous news today from the Recovery trial showing that dexamethasone is the first drug to reduce mortality from COVID-19. It is particularly exciting as this is an inexpensive widely available medicine,” Sir Patrick Vallance, the UK Government’s chief scientific adviser, said in a news release from the Recovery Trial team on Tuesday.

“This is a ground-breaking development in our fight against the disease, and the speed at which researchers have progressed finding an effective treatment is truly remarkable,” Vallance said. “It shows the importance of doing high quality clinical trials and basing decisions on the results of those trials.”

Nick Cammack, the Covid-19 Therapeutics Accelerator lead at Wellcome Trust in the UK, said in a written statement on Tuesday that the dexamethasone findings are a “major breakthrough.”

“This is a major breakthrough: dexamethasone is the first and only drug that has made a significant difference to patient mortality for COVID-19. Potentially preventing 1 death in every 8 ventilated patients would be remarkable,” Cammack said in the statement.

“Finding effective treatments like this will transform the impact of the COVID-19 pandemic on lives and economies across the world. While this study suggests dexamethasone only benefits severe cases, countless lives will be saved globally,” Cammack said in part. “Dexamethasone must now be rolled out and accessed by thousands of critically ill patients around the world. It is highly affordable, easy to make, can be scaled up quickly and only needs a small dosage.”

Now researchers and physicians around the world are calling for the Recovery Trial team to release its data on dexamethasone as a potential treatment for severe Covid-19.

“The Oxford group’s important results, based on a scientific trial in over 6000 NHS patients, show that dexamethasone — a common, widely used, inexpensive medicine — can save lives in seriously ill patients with COVID-19,” Robin Ferner, honorary professor of clinical pharmacology at the University of Birmingham and honorary consultant physician at the City Hospital Birmingham in England, said in a statement released by the UK-based Science Media Centre on Tuesday.

“It is not a treatment for mild disease,” he said. “We hope the data on which these results are based will be published as soon as possible so that doctors can confidently put the treatment into practice.”

Source: CNN

Johnson & Johnson is moving its coronavirus vaccine into human trials by July, 2 months ahead of schedule

Johnson & Johnson said Wednesday it plans to start human testing of its coronavirus vaccine candidate in July. 

Previously, J&J had said the goal was to enter human trials in September. J&J is the world’s largest healthcare company with a market value of $390 billion. The company has previously pledged to distribute its vaccine on a not-for-profit basis for emergency pandemic use. 

Paul Stoffels, the company’s chief scientific officer, said in a news release Wednesday that the accelerated pace stemmed from “the strength” of preclinical data and conversations with regulators.

The study will start in the second half of July and enroll 1,045 healthy volunteers in the US and Belgium. The initial study will have a placebo arm to compare results against. Researchers will look to see how safe and tolerable the vaccine is when injected in humans, and if it causes an immune response.

It won’t be the only trial for J&J’s vaccine. The company said it is talking with the US National Institutes of Health to start a larger, late-stage study “ahead of its original schedule.” J&J executives have previously said they expect the vaccine to be ready by early 2021 for emergency use.

J&J’s program is one of more than 125 ongoing vaccine research programs. Ten are now in human testing, and more than 25 are expected to enter the clinic by year’s end.

Source: Business Insider