Clinical Trials
We invite you to join our community of clinical trial volunteers, physicians, and research sites developing new treatment options
Participating in a clinical trial
For patients
Considering a clinical trial for yourself or a loved one? Here’s what to consider, and how they work.
For physicians
Have patients that would benefit from access to cutting-edge treatments? Connect them to upcoming trials.
For investigators
Interested in becoming a research site for a Formation Bio trial? Get in touch for upcoming opportunities.
Our commitment to trial participants
Patient Diversity
As drug developers, we strive to serve the unmet medical needs of all patients through the therapies we choose to develop. We believe we will be successful in achieving our mission when our treatments reach all patients, not just those that historically have been the easiest to enroll in studies. We continue to proactively integrate patient diversity efforts as core to our development planning and processes - not as an afterthought.
Data Transparency
Formation Bio recognizes the importance and responsibility we have in disclosing the clinical research associated with our products. Researchers can request access to anonymized, patient-level data sets from Formation Bio clinical trials to conduct additional research that may advance medical science and improve patient care. Upon submission of a scientifically valid research proposal (which must include a statistical analysis plan) and with a commitment to publish their findings, Formation Bio will review requests to provide access to patient-level data relevant to clinical trial data that have been published in manuscript form in a peer reviewed journal beginning 6 months and ending 2 years after publication. Since respect for patient privacy is a paramount concern, all necessary measures will be taken to ensure that privacy is safeguarded in the event such requests are granted.
The following criteria may prevent Formation Bio from fulfilling data requests:
Clinical data for which anonymization is unreasonably difficult, there is a reasonable likelihood of re-identification (e.g., small studies, single-center studies, studies terminated early for lack of enrollment, or studies for which data does not exist in a format that can be readily anonymized), or there is a reasonable likelihood of otherwise violating the privacy rights of individuals
Clinical data that have been collected subject to legal, regulatory, contractual, or consent provisions or considerations that prevent transfer to third parties
Studies in which data and results are only available in languages other than English
Substantial practical constraints to providing technical data access (e.g., older, pre-electronic data for which files cannot be located)
Any request for data associated with any ongoing development program unless made six (6) months or later following approval of the relevant product
Any request other than for non-commercial, academic purposes.
Where Formation Bio has a co-research, co-development, co-marketing/co-promotion agreement or where the product has been in-licensed or out-licensed, it is recognized that the responsibility for disclosure may be dependent of the agreement between Formation Bio and another party or parties.
Expanded Access
As drug developers we strive to serve the unmet medical needs of all patients through the therapies we choose to develop. We acknowledge, understand, and design our trials for the whole person.
Expanded Access, sometimes called “compassionate use”, is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Expanded access is different from a clinical trial in which the primary purpose is to collect extensive safety and efficacy data to support submission of an application to a regulatory authority to market a drug.
Formation Bio believes that the most appropriate way for patients to access our investigational products is by participating in our clinical trials, which are designed to determine whether the investigational products are safe and effective. Our ambition is to generate robust clinical trial data to support regulatory approvals, thereby providing the broadest possible access to individuals who might benefit from the therapy.
Currently, we do not have an expanded access program that permits access to our investigational products prior to regulatory authority authorization. Patients who are interested in participating in one of our trials are encouraged to discuss their specific needs with their physician. Information regarding our ongoing trials can be accessed at www.clinicaltrials.gov.