Tagged / clinical trials

COVID-19 affects research into other diseases

A systematic review published late last week assesses the impact of the COVID-19 pandemic on on-going and new clinical trials and research on a range of diseases [1]. The COVID-19 pandemic has resulted in a series of public health policies, including lock down, that have crippled the healthcare systems of many countries. These measures hugely impact on study participants, care providers, researchers, trial sponsors, and research organizations conducting clinical trials. This pandemic has a substantial impact on the trial sites as they experience difficulty in the continuation of trial activities which eventually hampers the progress of the trial and delays study timelines. Most sites are struggling due to delayed subject enrolment, shortfalls in monitoring, and risks of compromised data integrity, and this situation also has a negative impact on the start of future. Researchers are also concerned regarding the delay or cancellations of trials in the pandemic, which will have financial consequences for research organizations/human resources.

According to one survey, about two-thirds of the respondents have stopped or will soon halt subject enrolment in ongoing clinical trials, one-third halted randomization, and fifty percent of respondents are delaying or planning to delay the studies.  Adopting new approaches and understanding the key risk indicators will help managers support trial sites with flexibility and ingenuity. For instance, switching patient site visits to new-trial virtualization, and telemedicine to interact with patients will help manage current clinical trials also beneficial for the post-pandemic era.

 

Reference:

  1. Sathian B, Asim M,  Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, Borges do Nascimento IJ, Alhamad HK.  Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal J Epidemiol. 2020;10(3); 878-887

 

HRA Research Transparency Strategy Group minutes available

The Health Research Authority (HRA) has formed the Research Transparency Strategy Group in response to the House of Commons Science and Technology Committee Report on clinical trials transparency.

You can read more about the first meeting of the expert group, including the minutes by clicking here

In relation to this, the HRA’s Director of Policy, Juliet Tizzard has released a blog post entitled What’s the point of research transparency? You can read the post here.

BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. On ClinicalTrials.gov, it is free to do so.
Despite the name, the system may be used for other clinical research projects.

HRA Update – Travel insurance and participation in clinical trials

Please see below for a message from the NIHR Workforce Development team –

‘We are pleased to inform you that the Association of British Insurers (ABI) have confirmed to the Health Research Authority that participation in clinical trials does not affect eligibility criteria for travel insurance and have now withdrawn their guidance document “Clinical research trials and insurance”.

ABI agree that taking part in a clinical trial should not affect insurance cover if the medical condition itself doesn’t. Please share the following message with your teams, organisations etc.

‘When individuals apply for travel insurance, insurers will typically ask questions about an individual’s health in order to make an accurate risk assessment. This risk assessment takes into consideration the health of the individual and the insurer will often ask questions about any pre-existing health conditions and medical treatments for those conditions. Travel insurers do not typically ask about clinical research trials. Where an insurer does ask an individual about their participation in clinical research trials, the insurer must ensure the question is clear and the individual should answer it accurately and honestly”.

If you are aware of instances when participation in a trial is given as a reason for not providing insurance or insurance being an obstacle to participation in clinical trials, please contact hrapublicinvolvement@nhs.net