patient access to study outcome in clinical research studies

Today I participated in a webinar titled: “A new model to meet Biopharm Transparencey Mandates and engage Participants as Partners in Clinical Research”

The focus was on Biopharma’s responsibility to communicate overview of study design and summary of results in scientifically accurate and easy to understand lay language to study participants.

Patients want to know the results of their clinical trial:
What happened since my study ended?
Why was the research needed?
What where the study results?

Although; study results of all interventional Phase II to Phase IV should be released by Biotech within one year of completion of trial, compliance to the ruling has been sketchy at best. Most often information is released in scientific journals only and due to the inability of accessing these journals, study volunteers (inadvertently) are denied the right to obtain study result information.
Objective:
Most importantly, patients should be thanked for their participation in a research study. Information should include:
Clinical trial identification
Name and contact of sponsor
General trial info (where and when, main objectives and the rationale supporting this study)
Population studied
Investigational medicinal products used
Adverse reactions and their frequency
Overall results and where additional information can be found
Comments on trial outcomes
Indication if follow up trials are foreseen

I hope for these initiatives to take hold and set a universal standard for patient participation in all clinical research studies.

Marion