Health Care Providers

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Talking With Your Patients

A participant’s decision to enroll in a clinical trial is often made from your recommendation and support. Talking with a patient about participation in a clinical trial requires an understanding of the factors that can influence the decision.

The following tips provide information on how to best support a participant’s decision to enroll in a clinical trial.

  • Clearly and effectively communicate the science and evidence-based information of the clinical trial to your patient.

  • Build trust by demonstrating competence, understanding your patient’s individual experience, expressing care, and being honest.

  • Share consistent information about clinical trials amongst your research staff so you are all working as one team.

  • Allow adequate time in your schedule to answer any questions your patient may have about the clinical trial.

  • Encourage your patients to ask about clinical trials by providing resources in waiting rooms, exam rooms, etc.

Resources

For more resources on how to talk to your patients about clinical trials:

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How to Become an Investigator​

Acceleron Pharma Inc. welcomes talented, experienced physicians to share their interest in potentially becoming Principal Investigators in Acceleron-sponsored clinical trials. Clinical trial involvement offers qualified investigators and their patients the opportunity to access new potential treatment options, as well as the opportunity to contribute to the development of novel therapies and scientific excellence.

Expanded Access​

Acceleron is dedicated to the discovery and development of innovative, life-changing medicines for patients with a wide range of serious and rare diseases. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients.

Expanded access, sometimes referred to as compassionate use, refers to the use of an investigational therapy outside of a clinical trial where the primary purpose would be to diagnose, prevent, or treat a serious condition in a patient. This is different from accessing an investigational drug under the scope of a clinical trial, where more comprehensive safety and efficacy data are monitored and collected. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.

A number of factors consistent with the US Food and Drug Administration (US FDA) and other health authorities’ guidelines should be taken into account when considering expanded access.

They include:

  • The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials)

  • Sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information

  • Ability to provide the product fairly and equitably, so that there is adequate manufacturing capacity for ongoing programs

  • Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or health authority filings designed to make the therapy available broadly

For clinical trial side effects or product inquiry reporting, please contact and talk with your study doctor or study coordinator to follow the reporting requirements and timelines specified in the applicable clinical trial protocol.

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