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expert reaction to new legislation being laid in Parliament today on new regulatory framework for clinical trials

Scientists comment on new legislation on regulatory frameworks for clinical trials, as laid out by UK Parliament. 

**Dr Catriona Manville, Director of Research Policy at the Association of Medical Research Charities (AMRC), said:**

“The new clinical trial regulations will help to embed transparency at all stages of the research process – from trial registrations right through to reporting to participants. Making research and its results publicly available is fundamental to building trust and encouraging participation.

“As a member of the Make it Public campaign group, we’ve been calling for change alongside others from across the sector. The next step is ensuring there is clear guidance to accompany the legislation and deliver on the ambition.”

**Dr Janet Valentine, Executive Director of Innovation and Research Policy at the Association of the British Pharmaceutical Industry (ABPI), said:**

“Passing this much-anticipated legislation is an essential step toward providing the certainty commercial trial sponsors need to invest in and plan more clinical trials in the UK.

“The addition of diversity and inclusion guidance will help to broaden patients’ opportunities to participate in trials of the latest treatments and will bring the UK in line with clinical trials diversity and inclusion expectations already in place in other parts of the world.”

**Professor Sir Martin Landray,  Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford, Co-lead, RECOVERY trial of treatments for COVID-19, Chief Executive, Protas, said:**

“I am delighted that new clinical trials legislation is being tabled in parliament. 

Clinical trials are the foundation of evidence-based medicines. They are the way we get to understand whether the hopes of a promising new treatment turn into real benefits for patients.

We live in a time when there are huge innovations in medical treatments – from vaccines for COVID and influenza through ultra-personalised treatments for cancer and novel ways to prevent heart disease.

If we are to see those innovations have a real impact on patients and public health, we need an efficient way to thoroughly test their efficacy and safety through clinical trials.

New legislation that shortens the timelines for clinical trials, reduces the burden for patients, and increases the quality of the evidence they generate are key to putting the UK at the forefront of advances in medical care.

The announcement is timely. In September, the World Health Organization issued new Best Practices for Clinical Trials which set out the key principles that all clinical trials should meet. I trust that the new legislation will enable the UK to deliver clinical trials of the highest quality effectively and efficiently, mindful of the needs of clinicians, patients and the public. 

I look forward to reading the details of the legislation.”

[https://www.gov.uk/government/news/patients-the-nhs-and-the-life-sciences-sector-set-to-benefit-from-new-clinical-trials-framework-being-laid-in-parliament-today](https://www.gov.uk/government/news/patients-the-nhs-and-the-life-sciences-sector-set-to-benefit-from-new-clinical-trials-framework-being-laid-in-parliament-today)

**Declared interests**

**Prof Martin Landray:**

CEO or Protas – a not-for-profit organisation focused on smarter trials for better health; see [www.protas.co.uk](http://www.protas.co.uk)) 

I design and conduct clinical trials in common conditions.

My work is supported by grants to the organisations I work for from government (NIHR, MRC), charity (Wellcome, Bill & Melinda Gates Foundation), philanthropic organisations and the biopharmaceutical industry.

I do not have personal financial interests (such as shares) in or receive personal funding, honoraria or speaker fees from the biopharmaceutical, tobacco or alcohol industries.

Protas is a not-for-profit company registered in the UK.

**Dr Janet Valentine:** “None” 

For all other experts, no reply to our request for DOIs was received.

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