almost 10 years ago
What you (still) didn’t know about clinical trials
Thanks for supporting the Clinical Trial Visualization Redesign Challenge! Are you planning to enter a submission, but not totally sure how clinical trials work?
If so, you’re in luck! We’ve put together a handy guide for you called “10 things you didn’t know about clinical trials.” If you missed last week’s email with part one, you can catch up here. Otherwise, check out part two below.
10 things you didn’t know about clinical trials — part two
Does some kind of registration system exist for clinical trials, or is the only registration at a patient’s first check-in?
A single “registration system” doesn’t exist. Patients work through their doctor and the investigation site, which is a term for the hospital or clinic where the study is being conducted. Investigation sites are responsible for educating patients on the study, obtaining Informed Consent and fully screening the patient to assure they match the eligibility criteria.
What information is shared with the study sponsor?
The sites share their enrollment status and, ultimately, the clinical study information with the sponsor so that the study results can be analyzed.
If data is clustered based on gender, age or ethnicity, is it possible to generate patient-specific data (particularly of the risks) and create a more tailored document for each patient?
Yes. Where the opportunities exist to do tailored treatment, such as with some cancers, studies can be designed to allow patients to enter specific “arms” that are tailored to them. This is more the exception than the norm at this time, but research, clinical studies and treatment regimens are clearly moving in this direction.
When do patients receive their information packages? Do patients have the information prior to signing?
Patients receive information packages from the investigational site (hospital or clinic) to consider if they want to enter the study. This information comes primarily through the Informed Consent document, which patients are encouraged to take home and review with their family, friends and others involved in the important decision of enrolling in the study. In some cases, information about the study can also be found online, such as on ClinicalTrials.gov. There are also cases in which the patient’s first interaction with the information package is at The Baseline (the first visit of the study).
If the patient's first interaction with the information package is at The Baseline, is there a medical professional present, helping explain complex wording? Are patients left to their own devices in a room by themselves?
At each investigational site there is a nurse or study coordinator available to walk through the Informed Consent and answer any questions the patient may have. Generally, patients are encouraged to take the information home with them to consult their family, friends and others.
As always, we’re here to help. If you have a question about the Clinical Trial Visualization Redesign, or about clinical trials in general, post in the Discussion Forum or shoot us an email at firstname.lastname@example.org.