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27-Oct-2020

Panthera clinical trial sites continue to operate throughout Covid

Panthera clinical trial sites continue to operate throughout Covid

Panthera has put in place a raft of measures to ensure that clinical trials can continue to operate safely for patients, staff and sponsors as the impact of Covid-19 continues to affect so many other areas of healthcare and society.

Stuart Young CEO of Panthera commented “Covid is not going to go away anytime soon. We are committed to staying open throughout, our view is that protecting patients means more than just shutting the doors. It is vital that we continue to help bring forward treatments which will help millions of patients. We have therefore implemented a number of measures that will ensure that the safety of patients and staff is looked after while the studies continue to recruit and sites remain open. We also risk assess every study and individual patient to make sure the study is run safely and efficiently. We are also in the fortunate position that our dedicated clinical trial sites are stand alone and patients don’t mix with any other patients.”

Panthera has found that many patients are keen to become involved in a clinical trial so that they can visit a clinic and have the opportunity to discuss their health as many have not been able to go to their local health care provider.

The comprehensive measures that have been put in place by Panthera cover the oncology trials that are carried out in partnership with Rutherford Cancer Centres at their four centres and Panthera’s three dedicated research clinics in Preston, North Manchester and North London where conditions treated in primary care including cardiac disease, osteoarthritis, osteoporosis, diabetes, allergies and migraine are undertaken.

The safety measures include:

Prior to each appointment

·         Each patient is risk assessed based on their condition and access to the site. The appointment, transport and safety provisions are then made in line with the risk assessment. Any particular matters such as being accompanied are also discussed.

·         The patients, many of whom have not been able to see a doctor, are informed that they can discuss any medical matter that is concerning them during their visit.

Transport and parking

·         Patients are encouraged to drive to the site whenever possible, if that is not possible Panthera will provide a taxi which is cleaned thoroughly between journeys.

·         Ample parking is available, and patients may be asked to remain in their vehicle on arrival and where possible, basic procedures can be performed without entering the site.

 

Accompanying friends or relatives

·         Patients may need or want to have someone with them. Any study partners will be admitted under the same strict safety assessments as the patients.

·         Staff members in appropriate PPE will be on hand to assist in cases where we ask other friends and family to remain in vehicles wherever possible

Inside the clinic

·         Patient waiting rooms have been adapted to ensure social distancing if there is a wait, which is avoided where possible. Patients have at least two metres between them and any other waiting patients.

·         A one way system has been incorporated where possible to reduce transmission risks

·         On arrival, patients will enter through a ‘clean room’ or reception which will be protected by screens and asked to wash hands and wear a mask while in the main circulation areas.

·         All staff are fully equipped with PPE according to the risk assessments and number of patients in the clinic.

·         Clinic rooms and any other patient contact areas are thoroughly cleaned after each usage.

 

During the examination of the patient

·         Each consultation will take place according to a minimum contact risk assessment ensuring all protocol and safety requirements are met while minimising risk of exposure.

·         PPE usage is mandatory for clinical staff during patient interactions and Full PPE is used during any higher risk procedures including any aerosol-generating procedures.

·         Patients who have other health concerns and have not been able to visit their GP are encouraged to raise any health issues.

·         Where possible, samples are collected in the same room to avoid patients moving between rooms. Samples are processed in a clean, on site laboratory before either disposal or being sterilised and shipped to an external reader.

Remote Access

·         Where the study allows for remote monitoring Panthera are encouraging Sponsors to do so. While sites remain available for critical Sponsor visits, we request that wherever possible things are managed remotely.

·         Where patient consultations or assessments can be done remotely via telephone or video, we Panthera has set up a procedure to ensure that this is available.

Stuart Young continued “The regulatory authorities have been very helpful in adapting their rules on clinical trials to meet the Covid situation. They recognise the importance that clinical trials continue and bring forward new treatments not only to treat Covid but also the many other conditions which cause suffering to patients.”

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Last Updated: 27-Oct-2020