People. Passion. Performance.Working together to advance treatments in oncology

Situation:

A small Biotech company was working with an oncology-specialty CRO on a Phase I, two-cohort, dose escalation and expansion study. The study was being conducted at ten study sites in the United States.

Challenges:

The first cohort of the study was less challenging to enroll patients, as it allowed the patients to have a break in-between treatments. The CRO completed enrollment in the first cohort, but behind schedule. In addition, only four out of the ten sites enrolled patients. The second cohort of the study involved much more difficult protocol requirements. The CRO became dis-engaged with the study sites and only one patient was enrolled into the study after four months of recruitment. In addition, the study experienced a turnover of three Project Managers over a period of four months. Communication with the study site and the Sponsor was poor and errors in clinical operations were occurring on a consistent basis. Finally, the Sponsor had concerns with data management quality and overall performance.

Solutions:

The Sponsor pulled the trial from the CRO and awarded it to ACT Oncology. Within 30 days, ACT took full control of all outsourced study operations, including project management, site management, clinical monitoring and biostatistics (data management at a later date).

One of the first courses of action for the ACT Team was to conduct re-engagement calls with each study site. ACT led the call with each site’s Principal Investigator and Study Coordinator; representatives from the Sponsor were also present. The primary goals of the meetings were to re-engage the study site, understand their challenges to enrolling patients into the second cohort and to establish a collaborative relationship with ACT.

ACT Oncology Rescues a Dose Escalation and Expansion

A CASE STUDY FOR: A PHASE I OVARIAN CANCER STUDY

A C T O N C O L O G Y C O N T A C T I N F O R M A T I O N

W W W . A C T O N C O L O G Y. C O M

CHRIS ELLIS Senior Director of Business Development chris.ellis@ACToncology.com 917-940-6464

PAT TEREK Senior Director of Business Development pat.terek@ACToncology.com 650-868-1788

People. Passion. Performance.Working together to

advance treatments in oncology

As a result of the information gathered from the study site, ACT recommended select changes to the protocol; the Sponsor agreed and created an amendment.

ACT developed and implemented a site support plan, focused on patient recruitment:

‣ The sites became more committed to the study through consistent communication, support and follow up to site challenges

‣ ACT motivated the sites to screen for patients with weekly meetings to discuss both barriers to patient enrollment and suggestions for patient identification and screening

‣ Study sites were provided with presentations and literature to share with referring physicians to help support recruitment efforts

Results:

‣ On-time achievement of patient enrollment for cohort two ‣ The number of actively enrolling sites doubled from four to eight (out of 10) sites ‣ The enrollment rate increased from .025% to .3% patients, per site, per month

‣ The Sponsor is highly satisfied with the study leadership and data quality

ACT increased the patient enrollment by 11xs

ACT doubled the number of study sites actively screening and enrolling

A C T O N C O L O G Y C O N T A C T I N F O R M A T I O N

W W W . A C T O N C O L O G Y. C O M

CHRIS ELLIS Senior Director of Business Development chris.ellis@ACToncology.com 917-940-6464

PAT TEREK Senior Director of Business Development pat.terek@ACToncology.com 650-868-1788

ACT

Other CRO

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