The organisation of a clinical trial is a detailed and complex one, there are many key players involved and one of the most important elements is patient engagement and data confidentiality. As an organisation who has been working with clients in the medical, pharmaceutical and biotechnology industries and who has been managing the travel of patients involved in clinical trials for over a decade, we are faced with the challenge of managing patient confidentiality on a daily basis. Our role is to liaise with the client organisation or the “Sponsor” as they are commonly known in the industry, the hospital (site) and the patient.
A clinical trial is a research study that explores whether a medical strategy, treatment, or device is safe and effective for humans. There are strict guidelines in place which mean for the duration of the trial, the patient’s identity cannot be released to the Sponsor. A breach can lead to the integrity of the trial being compromised and in turn this could lead to the trial being terminated, at huge financial loss to all.
Confidentiality rules stipulated by the various regulatory bodies means that a Sponsor is not allowed to know any specific patient information. To fulfil this confidentiality requirement we have designed a protocol of assigning codes to the patient and study instead of using their personal information. When requested, the Sponsor would see the relevant patient ID, booking dates, type of travel on all paperwork – Itinerary, invoice and reports – but no specifics.
To ensure it’s as simple as possible for the patient or site to contact our GCP accredited team, and arrange their travel, accommodation and expense reimbursement we have developed a tailor made secure online portal. When creating this online portal we had to ensure it was compliant with GCP and HIPAA regulations, while at the same time being easily accessible and user friendly. As many of the studies take place in non-English speaking countries, we also added a translation tool to ensure it can be used anywhere in the world.
The area of patient confidentiality in a clinical trial is crucial, and the role of a clinical trial in developing treatment for new and existing diseases is ongoing, therefore managing this key area is vital for all involved. Colpitts are passionate about the work we do in this industry and we have proven, trial after trial, that we can respond to the most challenging of circumstances and situations.