08/20/2026  |   Michelle Andrews  |  MedicalXpress

https://medicalxpress.com/news/2026-08-clinical-trial-distance-hidden.html 

Connecting people with clinical trials is complicated—even if people identify a promising match, there's a slew of potentially thorny factors, including geographic incompatibility and financial and time considerations.

Simply finding an appropriate trial can present an enormous hurdle. In a recent online survey of more than 2,000 adults, 71% of patients with chronic conditions said they would be likely to participate in a clinical trial if given the chance. But two-thirds said that their health care provider had never discussed clinical trials with them.

In one study using data from 2020, just 9% of adults reported ever being invited to participate in a clinical trial.

Clinical trials are essential to the development of new and effective medical treatments. But gathering the real-world human data necessary to win U.S. Food and Drug Administration (FDA) approval for drugs, devices and other interventions can be an arduous task. By one estimate, up to 86% of clinical trials don't meet their recruitment targets during the trial time frame.

Getting people signed up isn't the only challenge.

"Recruitment is one thing—retention is another," said Alan Balch, executive board chair at the Patient Advocate Foundation, which has a clinical trial search tool and maintains extensive educational materials online. "Every touchpoint is an opportunity for access and affordability to become problems."

The need to improve patient participation in clinical trials is not a new concern, but it's attracting new interest.

In June, the U.S. Department of Health and Human Services (HHS) announced an effort to streamline and enhance clinical research…

08/21/2026  |  Rabbit IA  |  O Tempo

https://www.otempo.com.br/politica/2026/8/21/anvisa-veta-mudanca-em-pesquisa-de-farmaco-da-roche.amp 

The agency denied a request to amend the clinical protocol for the investigational drug Inavolisibe in a decision published in the Federal Official Gazette.

The Brazilian Health Regulatory Agency (Anvisa) rejected (formally denied) the request for a substantial amendment to the clinical protocol for the experimental drug Inavolisibe (GDC-0077, RO7113755), developed by Produtos Roche Químicos e Farmacêuticos S.A.

The decision is contained in Resolution RE No. 3,315, dated August 20, 2026, published in the Federal Official Gazette (DOU) on Wednesday (20). The resolution was signed by Claudiosvam Martins Alves de Sousa, the agency’s coordinator of clinical research on drugs and biological products.

In practice, the rejection means that the regulatory agency did not authorize the modifications suggested by the pharmaceutical company to the drug’s study plan. The denied request concerned a substantial amendment to the clinical protocol (a significant change that could impact the safety of participants or the validity of the data).

What the Decision Stipulates
According to the official publication, the rejected case is numbered 25351.465136/2022-26. The subject of the petition is classified under code 10824, which specifically addresses changes to ongoing clinical trials in Brazil.

For consumers and patients who may participate in the study, the resolution prevents the new guidelines proposed by Roche from being applied. The drug Inavolisibe remains in the experimental phase, which means it is not yet approved for sale in pharmacies.

Clinical trials (scientific studies conducted…

08/21/2026  |  Millie Hoe  |  BioXconomy

https://www.bioxconomy.com/modalities/silence-therapeutics-progresses-rare-blood-cancer-sirna-with-positive-trial-results 

Silence Therapeutics recently announced positive Phase II trial results for its siRNA drug.

Earlier this month, biotechnology company Silence Therapeutics, a specialist in small interfering RNA (siRNA ) therapies, announced positive initial results from its Phase II clinical trial, SANRECO (NCT05499013). The trial was evaluating the efficacy and safety of divesiran, a siRNA drug for the treatment of the rare blood cancer polycythemia vera (PV).

The trial met its primary endpoint and patients treated with divesiran showed an 88% response rate, versus 19% in placebo-controlled groups.

“[This] translates into far more consistent control of hematocrit without relying on frequent phlebotomies, which are burdensome, time consuming, and often poorly tolerated,” explained Silence’s chief medical officer Curtis Rambaran to BioXconomy. “Better hematocrit control is central to reducing the risk of thrombotic events, which are the major cause of morbidity and mortality in PV.”

“A nearly five-fold improvement in the primary endpoint potentially has very real and tangible implications for long term outcomes and quality of life.”

PV is a rare slow-growing form of blood cancer, which can increase the viscosity of the blood by producing too many red blood cells. patients with PV are at risk of life-threatening blood clots if blood is not routinely removed via phlebotomy.

“Data from large clinical studies have shown that keeping hematocrit [the percentage of red blood cells] under 45% significantly reduces the risk of major thrombotic events,”…

08/20/2026  |  Michelle Andrews/KFF Health News  |  Cancer Health

https://www.cancerhealth.com/article/want-join-clinical-trial-know-hurdles 

For people with serious illnesses, a clinical trial may offer the best hope for extending their life or improving their quality of life.

Connecting people with clinical trials is complicated — even if people identify a promising match, there’s a slew of potentially thorny factors, including geographic incompatibility, and financial and time considerations.

Simply finding an appropriate trial can present an enormous hurdle. In a recent online survey of more than 2,000 adults, 71% of patients with chronic conditions said they would be likely to participate in a clinical trial if given the chance. But two-thirds said that their healthcare provider had never discussed clinical trials with them. According to one study using data from 2020, just 9% of adults reported ever being invited to participate in a clinical trial.

Clinical trials are essential to the development of new and effective medical treatments. But gathering the real-world human data necessary to win Food and Drug Administration approval for drugs, devices, and other interventions can be an arduous task. By one estimate, up to 86% of clinical trials don’t meet their recruitment targets during the trial time frame.

Getting people signed up isn’t the only challenge.

“Recruitment is one thing — retention is another,” said Alan Balch, executive board chair at the Patient Advocate Foundation, which has a clinical trial search tool and maintains extensive educational materials online. “Every touchpoint is an opportunity for access and affordability to be a problem.”

The need to improve patient participation in clinical trials is not a…

08/20/2026  |  Abigail Beaney  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/news/reforms-to-uk-clinical-trial-sector-showing-signs-of-success/ 

The MHRA set out ambitious targets to have a 150-day set-up time, from application to recruitment, for clinical trials in the country.

Reforms to the UK clinical trial system seem to be working after 82% of studies were found to hit recruitment goals in July 2026.

In new targets for the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA), the UK Government hopes to reduce clinical trial set-up times to 150 days as part of its 10-year plan for the NHS.

MHRA and HRA reforms to clinical trials came into effect on 28 April, marking the first major change for the sector in20 years.

These developments, which were passed in parliament, include faster assessment of first-in-human trials and the introduction of notifiable trials, a fast-track route to allow lower-risk trials to start sooner, and modifications to be approved more quickly, while maintaining the highest safety standards.  

The data is already showing improvement in lots of metrics. The proportion of open studies is on track, and delivery of recruitment to time was 82% in July 2026, surpassing the 80% target from the MHRA. This figure has stayed relatively stable each month since August 2025.

Between April 2025 and September 2025, the median number of days from application to first participant recruited was 122.

Of the nine studies submitted to the MHRA in January 2026, 100% had a known set-up status within the 150-day target. This is compared to 62% in April 2025, showing significant improvement. The only other month between April 2025 and January 2026 to achieve a 100% set-up known rate…