Clinical Trials Drug Supply in Primary Care for COVID-19

The purpose of the exercise will be to assess, and potentially award a contract(s), to Distance Selling Pharmacies (DSPs) or online pharmacies, for the distribution of medicines to patients participating in COVID-19 clinical trial(s). It is likely that more than one clinical trial may require the same service. However, the exact number of trials and the number of participants are yet to be finalised. The medicines and their quantities to be distributed are currently unknown, as we await confirmation on which drugs will be included in the clinical trials. These will be shared with suppliers as soon as is practically possible.At the moment, DHSC are working to a scenario whereby 1,000 to 5,000 patients could be recruited into national priority COVID-19 clinical trial(s) per week over a 6-month period. Only one delivery of medication will be required per patient. Manufacturers of the drugs will store and deliver the drugs to the selected DSP or online pharmacy. Notification on what medication needs to be dispatched to trial participants will be provided by the Trial Team, it is essential that the drug is received by the trial participant within 24 hours of the notification. We need to ensure rapid delivery of the drugs to the patients, therefore it would also be beneficial to explore options where the drug can be received by the participants within a 4 hour window of the notification or same day delivery. It is also vital that the trial drugs are stored and dispatched according to ICH GCP guidelines. To note, these figures are planning scenarios based on current estimates so may change as the clinical trials progress and/or expand. Actual volumes of required deliveries may be lower depending on the progression of the pandemic and the uptake of participation in a clinical trial, however, we are currently assessing the capability of suppliers to meet the upper limit of our supply requirements. Any figures shared throughout the process should not be shared with anybody who is not part of either an Expression of Interest (EOI) or a bid for this work.Therefore, we are asking suppliers to submit an EOI if they are: 1) Able to robustly meet all their prescription nominations in the first instance (i.e. able to easily handle their BAU); and2) Able to either meet the above delivery demand to distribute Covid-19 treatment courses for clinical trials or be able to ramp up their capacity to meet this demand in the timeframes set out. The expectation is that this will be in place from mid-October 2021 for a minimum period of 6 months.In order to distribute these medicines in accordance with the clinical trial protocols, these medicines may need to be re-packaged down from their manufactured packs to a size that equates to a single treatment course.Even if they don’t need to be re-packaged, with the patient information included, they will need to be labelled for individual patient use. With the new label on the pack, they will then need to be distributed throughout the UK (including the Devolved Administrations) to patients who are participating in the clinical trial. This contract is intended to be used for the UK’s response to COVID-19, to support clinical trials looking into drug efficacy. The contract will initially be for a 6 month period, with an option to extend as required.