DAVA Oncology. Patient Recruitment in Cancer Clinical Trials

1 DAVA Oncology Patient Recruitment in Cancer Clinical Trials Agenda • Introductions • Background: The importance of oncology in clinical research ...
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DAVA Oncology Patient Recruitment in Cancer Clinical Trials

Agenda • Introductions • Background: The importance of oncology in clinical research • Clinical Trials: The patient’s perspective • Patient Recruitment: The trial sponsor’s perspective – Specialized patient recruitment tactics for oncology trials 2

Introductions • Mark Levonyak, President, DAVA Oncology – 20 years experience in industry, ranging from large pharma to small biotech – Founded DAVA Oncology in 2007 with mission to accelerated drug development in oncology

• Martin Lee, MD, EVP, Clinical Trial Services – Board certified medical oncologist – 20 years clinical research experience – 5 years experience in CRO industry 3

Oncology is the largest therapeutic area in clinical research Other 3%

There are 900 investigational oncology drugs

Genitourinary 3% Hematology 3% Dermatology 3% GI 4%

Oncology 31%

Musculoskeletal 4% Respiratory 5%

Endocrine 5%

Cardiovascular 6%

CNS 18%

Anti-infectives 14%

Solid Tumors Leukemia Lung Other Lymphoma Breast Prostate Unspecified Skin Colorectal Brain MM Ovarian Pancreatic Cancer-Related Kidney Liver Gastric Head/Neck Sarcoma Bladder Cervical

108 98 98 97 91 80 78 65 55 52 49 49 41 32 31 31 24 21 21 14 9

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In 2010, 31% of all compounds in clinical testing were oncology drugs Sources: Redfearn S. July 2011. Oncology, CNS therapeutic areas of opportunities. Centerwatch. PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2011/2012 PhRMA Medicines in Development for Cancer 2011

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80% of cancer trials enroll behind schedule Causes of study delays 60% 50% 49% 40%

41%

30% 20%

26%

26%

25%

Protocol Design

Legal Review

IRB Review

10% 0% Contract/ Budgeting

Patient Recruitment

Sources: Comis RL, Miller JD, Aldige CR, et al. Public attitudes toward participation in cancer clinical trials. J Clin Oncol 21:830-835, 2003 Kermani F, Bonacossa P. New Ways to Recruit Trial Subjects. Applied Clinical Trials. Feb 2003; 38-42. PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2011/2012

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• Cancer is a life-threatening illness increasing anxiety for patients and caregivers

• May not be life-threatening

• Cancer diagnoses often result in fear, uncertainty, and emotional impact

• Specialty physicians may not be involved

• Oncologists are important sources of psychological support for patients • Unique relationship between oncologist and patient • Shared decision-making

• Less emotional impact on patients

• Patients may make decisions without consulting with their physician • Information easily accessible for patients in various media outlets

Other therapeutic areas

Cancer patients

Cancer is different than other therapeutic areas

• Information is the patients’ unmet need

Source: NCI. Unique Aspects of Communication with Cancer Patients. http://www.cancer.gov/cancertopics/pdq/supportivecare/communication/healthprofessional/page2

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Engaging the whole oncology team is important for oncology clinical trial enrollment Traditional approach

Specialties involved

Multiple specialties are involved in patient identification • Pathologists ̶ ̶

Untapped potential for subject identification and referrals

• Radiation Oncologists ̶

An integral part of the care of cancer patients

• Surgeons ̶

• Focus on the oncology clinic: ‒ Oncologists and oncology staff are the drivers of subject recruitment for clinical trials

Early determination of subject eligibility for clinical trials

Highly involved in trials with a surgical component

• Radiologists ̶

Interventional radiology involved in obtaining tissue for biomarkers

• Referral Medical Oncologist ̶

Increased awareness results in more referrals 7

Cancer research is changing • Targeted therapies are evolving ̶ Biomarkers are being identified ̶ Screening for molecular targets is required before enrollment ̶ Need for biological specimen donation by patients • Targeted therapeutics are gaining FDA approval More targeted therapeutics are gaining FDA approval

March

May April

2011

July June

November September January March October December February April August

2012

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Cancer clinical trials are becoming more complicated • Therapies for specific patient populations place additional demands on the inclusion/exclusion criteria of the trials • The inclusion/exclusion criteria must remain in homeostasis Changes in clinical trials 2000-03 to 2004-07 60% 50%

49%

40% 30%

58%

54%

38%

20% Enrollment rates

10% 0% -10%

Unique procedures

Total procedures

Execution burden

-20% -30% Source: PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2011/2012 PhRMA Pharmaceutical Industry 2011 Profile

1

Eligibility criteria

Retention rates

-21% -30% 9

The Patient’s Perspective Learning about cancer The clinical trial decision

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Learning about cancer • Important sources of cancer information – Physicians and healthcare professionals – Traditional media (books, magazines, TV, radio) – Web resources • General health – WebMD, MedLine Plus, Mayoclinic.com

• National organizations – NCI (www.cancer.gov), ACS (www.cancer.org)

• Disease-specific groups – Colon Cancer Alliance (www.ccalliance.org), Susan Komen Foundation (www.komen.org) 11

Why do cancer patients consider clinical trials? • Hope for a therapeutic benefit – Ability to get cutting edge care and the latest treatment discoveries

• Altruism or to advance medicine/science • Refusal to “give up”/no other medical option available • Trial provides meaningful cadence to day-to-day living • To obtain free medication 12

Learning about clinical trial options • Physician recommendation – Strong correlations with: • Whether an appropriate clinical trial exists • Whether a physician is an investigator on a clinical trial • Physician’s understanding of and belief in the trial rationale

• Other resources – Clinical trial websites • cancertrialshelp.org, clinicaltrials.gov

– Patient communities • patientslikeme.com • armyofwomen.org 13

What are the problems? • Choosing the trial with the highest potential for therapeutic benefit – Most patients are poorly positioned to judge which trials are the most likely to benefit them • Need an effective method of prioritization – Not always their physician

– The control arm for most later phase trials is “standard therapy” • When is this the best choice vs. a non-randomized study?

– What about phase I trials?

• Lack of availability of applicable trials 14

Special concerns for minorities and underserved

• Racial/ethnic minorities – Fear and mistrust of researchers – Folk medicine, myths/stigma about disease – Language barriers

• Economically disadvantaged/underserved – – – – –

Lack of access, poor quality of care More likely to be uninsured Lower levels of medical/science literacy Transportation and childcare issues Higher rate of comorbid conditions 15

The Sponsor’s Perspective Enrolling the trial quickly High quality data

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Movement of clinical trials – 1990-2012

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Why keep trials in NA and Western Europe? • Longer history of conducting clinical research – More experienced investigators – More developed research infrastructure – Better access to supportive care

• Concerns about data quality • Increased cost due to need to supply standard of care medications in emerging markets • Regulatory timelines often longer is emerging markets 18

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Multiple site selection challenges Site Selection is a critical step in the timely completion of a clinical study Poor Site Performance

Protocol Complexity

Investigator and Trial Demographics

Physician Perceptions

30% of sites enroll 70% of patients (Tufts CSDD/McKinsey)

Comparing 2000-2003 to 2004-2007 (PhRMA)

Finite pool of clinical investigators and sites

Physician knowledge of clinical trial data may be incomplete (Hoffman 2010)

50% of sites enroll 95% of patients (Tufts CSDD/McKinsey) Difficult patient recruitment accounts for 85-95% of days lost in clinical trial delays (McKinsey/Lehman) Each day a clinical trial is delayed can result in $600,000 or more in lost sales (Cutting Edge) Delays in approval of survival benefitting agents cause even higher losses for potential patients collectively as a group financially and socially (Philipson )

49% increase in total procedures 54% increase in execution burden 58% increase in total eligibility criteria

Average trial has 2.3 protocol amendments resulting in average delay of 4 months (Getz) Pathology requirements are more prevalent, require inter-practice coordination, and can delay start of treatment

Over one third of oncology investigators are new (Clinical Trial Magnifier) Competition among sponsors for high performance sites

Primary physicians may discourage patients from clinical trial participation (Hoffman 2005) Patient interest in clinical trial participation is driven by physician

40-80% of cancer patients are unaware that clinical trials may be an option for them (NCI, Lara)

For full citation information see references 2-12

What is required of a successful site? 1 Dedication to clinical research 2 GCP, ICH, and regulatory compliance 3 History of high patient enrollment 4 Commitment to an accelerated opening timeline 5 Excited by the study rationale 6 Significant patient population 20

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Cancer trial site segmentation Academic Centers • High patient volume • Physicians frequently specialize by tumor type • Fellows also discuss treatment with patients • Most recent technology • New patients frequently return home for treatment

Large Private Practice • High patient volume • Physicians occasionally specialize by tumor type • Private hospital or multiclinic networks are common • Participation in trials by satellite sites varies • Patient population may be segmented by satellite locations

Small Private Practice • Patient volume varies • Most oncologists are generalists • Participation in clinical trial by non-investigator partners varies • Need for equipment, study staff, or other resources may be higher than average

Average site initiation 120 days (Farfel)

Average site initiation 30 days (Farfel)

32% of US oncologists (Goldstein)

58% of US oncologists (Goldstein) Farfel. Faster Study Start-Up and Reduced Costs through the Use of Clinical Document Exchange Portals. Intralinks. 2009. Online. Goldstein, Salsberg, Bajorin. Future of the Oncologist Workforce. ASCO Annual Meeting. June 2007. Online.

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Trial Design

Case 1: Academic Practice NSCLC Trial  Age ≥ 18 years  Inoperable metastatic NSCLC  1 prior platinum based regimen in the met. setting

R

1:1

Arm A: docetaxel + NEW Drug

Site Profile: Academic Center Arm B: docetaxel + placebo

General Information • 18,000 patients/yr., 25 medical oncologists • 900 New NSCLC patients/yr. • 2 institutional 2nd line metastatic NSCLC trials

Patient Consent

Investigators

Standard of Care

Demographics

900 new NSCLC pts 300 - 2nd opinions only

600 – Treatment at institution

150 – Stage I-IIIa

450 – Stage IIIb-IV

75 - 2+ prior lines of therapy

375 – 0-1 prior lines of therapy

60 – single agent 1st line

315 – platinum doublet 1st line

105 – not candidates for 2nd line

210 – candidates for 2nd line therapy

Data Coordinator • 900 NSCLC – new or existing patient, staging, and progression rates provided Principal Investigator • KOL for Lung cancer • NSCLC standard of care pem/carbo or gem/carbo 1st line, erlotinib or docetaxel 2nd line • Investigator segmentation of patient population based on patient’s presentation and clinical goals

3 investigators see 65% of NSCLC pts and put 30% on clinical trials

41 patients presented trial

15 investigators see 35% of NSCLC and put 10% on clinical trial

7 patients presented trial

48 patient presented trial information 24 patient refused any trial 18 patient went on institutional trial

6 patient went on trial

Study Coordinator • NSCLC treatment team membership • Distribution of patients between PI, Sub-I, and non-study medical oncologists Sub Investigators • Awareness of study and relationship with study coordinator and principal investigator

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Trial Design

Case 1: Academic Practice NSCLC Trial  Age ≥ 18 years  Inoperable metastatic NSCLC  1 prior platinum based regimen in the met. setting

R

1:1

Arm A: docetaxel + NEW Drug

Site Profile: Academic Center Arm B: docetaxel + placebo

Demographics

60 – single agent 1st line

Patient Consent

Investigators

300 - 2nd opinions 600 – Treatment onlyThe investigator at institution is the

Standard of Care

900 new NSCLC pts

key to enrollment

General Information • 18,000 patients/yr., 25 medical oncologists • 900 New NSCLC patients/yr. • 2 institutional 2nd line metastatic NSCLC trials

Site450 potential is not the same as site performance Data Coordinator – Stage IIIb-IV • 900 NSCLC – new or existing patient, staging, and • If the investigators are motivated to enroll, this progression rates provided 75 - 2+ prior lines 375 – 0-1 prior could significantly impact enrollment of therapy lines of therapy • 150 – Stage I-IIIa

105 – not candidates for 2nd line

Principal Investigator • KOL for Lung cancer the effect of increased • NSCLC standard of care pem/carbo or gem/carbo 1st line, erlotinib or docetaxel 2nd line 210 – candidatesphysician engagement for 2nd line • Investigator segmentation of patient population based therapy on patient’s presentation and clinical goals 315 – platinum doublet 1st lineNote

3 investigators see 65% of NSCLC pts and put 30% on clinical trials

41 patients presented trial

15 investigators see 35% of NSCLC and put 10% on clinical trial

7 patients presented trial

48 patient presented trial information 24 patient refused any trial 18 patient went on institutional trial

6 patient went on trial

Study Coordinator • NSCLC treatment team membership • Distribution of patients between PI, Sub-I, and nonstudy medical oncologists Sub Investigators • Awareness of study and relationship with study coordinator and principal investigator

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Trial Design

Case 1: Academic Practice NSCLC Trial  Age ≥ 18 years  Inoperable metastatic NSCLC  1 prior platinum based regimen in the met. setting

R

Demographics

150 – Stage I-IIIa

Patient Consent

Investigators

Standard of Care

75 - 2+ prior lines of therapy 60 – single agent 1st line 105 – not candidates for 2nd line

• • • •

Site Profile: Academic Center

1:1

900 new NSCLC pts The motivation 300 - 2nd opinions only

Arm A: docetaxel + NEW Drug

Arm B: docetaxel + placebo

for investigators

600 – Treatment Publication at institution

Patient benefit 450 – Stage IIIb-IV Access to new therapies Patient referral 375 – 0-1 prior

• • Financial benefit for Data Coordinator research program

• 900 NSCLC – new or existing patient, staging, and progression rates provided

lines of therapy

315 – platinumIncreasing doublet 1st line

Principal Investigator

investigators’ interest from 30 to 50% of patients • KOL for Lung cancer of carephysicians pem/carbo or gem/carbo 1st approached and from 10 to• NSCLC 20%standard for other line, erlotinib or docetaxel 2nd line 210 – candidatesincreases patient participation 4-fold nd for 2 line therapy

• Investigator segmentation of patient population based on patient’s presentation and clinical goals

3 investigators see 65% of NSCLC pts and put 50% on clinical trials

69 patients presented trial

15 investigators see 35% of NSCLC and put 20% on clinical trial

15 patients presented trial

48 patient presented trial information 24 patient refused any trial 18 patient went on institutional trial

General Information • 18,000 patients/yr., 25 medical oncologists • 900 New NSCLC patients/yr. Scientific interest • 2 institutional 2nd line metastatic NSCLC trials

6 patient went on trial

Study Coordinator • NSCLC treatment team membership • Distribution of patients between PI, Sub-I, and nonstudy medical oncologists Sub Investigators • Awareness of study and relationship with study coordinator and principal investigator

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Trial Design

Case 2: Large Private Practice NSCLC Trial  Age ≥ 18 years  Inoperable metastatic NSCLC  1 prior platinum based regimen in the met. setting

R

1:1

Arm A: docetaxel + NEW Drug

Site Profile: Large Private Practice Arm B: docetaxel + placebo

50 – Stage I-IIIa

150 – Stage IIIb-IV 160 – 0-1 prior lines of therapy 130 – platinum doublet 1st line

40 – not candidates for 2nd line

90 – candidates for 2nd line therapy

30 – single agent 1st line

5 investigators see 20% of NSCLC pts and put 30% on clinical trials

6 patients presented trial

20 investigators see 80% of NSCLC and put 5% on clinical trial

4 patients presented trial

Patient Consent

Standard of Care

10 - 2+ prior lines of therapy

In community practices the engagement of sub investigators can have significant impact on trial accrual

Investigators

Demographics

200 new NSCLC pts

General Information • 5,000 patients/yr., 25 medical oncologists • 200 New NSCLC patients/yr. • No 2nd line metastatic NSCLC trials Data Coordinator • 200 NSCLC – new or existing patient, staging, and progression rates provided Principal Investigator • In charge of the research program • NSCLC standard of care pem/carbo +/- bev or gem/carbo 1st line, erlotinib or docetaxel 2nd line • Switch maintenance in 20% of patients

Study Coordinator • Reviews all new patients to practice • Distribution of patients between PI and Sub-I’s is even

10 patient presented trial information 5 patient refused any trial 5 patient went on trial

Sub Investigators • Awareness of study and relationship with study coordinator and principal investigator

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Trial Design

Case 3: Small Private Practice NSCLC Trial  Age ≥ 18 years  Inoperable metastatic NSCLC  1 prior platinum based regimen in the met. setting

R

1:1

Arm A: docetaxel + NEW Drug

Site Profile: Small Private Practice Arm B: docetaxel + placebo

25 – Stage I-IIIa

75 – Stage IIIb-IV 70 – 0-1 prior lines of therapy 55 – platinum doublet 1st line

20 – not candidates for 2nd line

35 – candidates for 2nd line therapy

15 – single agent 1st line

4 investigators see 40% of NSCLC pts and put 35% on clinical trials

5 patients presented trial

6 investigators see 60% of NSCLC and put 5% on clinical trial

1 patients presented trial

Patient Consent

Standard of Care

5 - 2+ prior lines of therapy

Similarly in small practices, if most physicians are engaged the accrual can be as good as that of larger sites

Investigators

Demographics

100 new NSCLC pts

General Information • 2,500 patients/yr., 10 medical oncologists • 100 New NSCLC patients/yr. • No 2nd line metastatic NSCLC trials Data Coordinator • 100 NSCLC – new or existing patient, staging, and progression rates provided Principal Investigator • In charge of the research program • NSCLC standard of care pem/carbo +/- bev or gem/carbo 1st line, erlotinib or docetaxel 2nd line • Switch maintenance in 20% of patients

Study Coordinator • Reviews all new patients to practice • Distribution of patients between PI and Sub-I’s is even

6 patient presented trial information 3 patient refused any trial 3 patient went on trial

Sub Investigators • Awareness of study and relationship with study coordinator and principal investigator

Lessons in site selection Protocol designed to work within standard of care Significant patient population History of high accrual Investigator understands study rationale and challenges from discussion with study affiliated medical oncologist or other clinical expert • Investigator is excited by study • Site meets all GCP/ICH and FDA guidelines • Site has appropriate facilities, staff, equipment and technology to complete study • • • •

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Traditional recruitment techniques are minimally effective for recruitment to oncology trials • • • • •

Informed consent aids Inclusion/Exclusion cards Pocket protocols Posters Brochures/Flyers

• • • •

Internet-based recruitment Newsletters Journal advertisements Trial websites

Despite all the efforts, recruitment to oncology clinical trials still remains very low. Why do these tactics work in other areas, but not for cancer trials? 28

A new approach: focus on the physicians • Investigator and research staff education is key to enrollment Continued investigator education and engagement through peer-to-peer interactions is proven to increase enrollment ̶

• Regular interactions with investigators and research staff to: ̶

Discuss patient eligibility issues in cooperation with the medical monitor ̶

Identify barriers and discuss opportunities to accelerate enrollment at the site ̶

Share best practices and keep sites informed about enrollment status ̶

Review data presented in public forums of new and emerging trials and drug data of interest which could affect trial enrollment

• Pathologist and referral physician interactions ̶

Expand outreach, education & engagement of key stakeholders ̶

Pathologists and referral physicians are becoming key players in patient identification

“In the end, the final decision for a cancer patient to participate in a clinical trial rests on the recommendation of the investigator [and his/her staff] and how it is perceived and acted on by the patient.” 29 Source: Comis RL, Miller JD, Aldige CR, et al. Public attitudes toward participation in cancer clinical trials. J Clin Oncol 21:830-835, 2003

Site-specific enrollment planning •

Site profile, challenges & solutions

Clinical trial opportunities & challenges − Evaluate protocol to develop key messages and use these insights to provide an initial framework for engaging investigators



Enrollment plans & site-specific solutions − Leverage relationships and insights to develop a site-specific approach to successful enrollment



Physician-focused patient recruitmentSM − Utilize the enrollment plan to measure performance, commitment and strategies for enrollment

Performance goals & responsibilities

Patient flow & key personnel

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Engaging, educational interactions with sites MD accrual calls

MD to MD accrual visits

Conference calls/webinars

• Call and visit underperforming sites to troubleshoot enrollment challenges and raise awareness of the trial • Encourage ongoing patient enrollment at high performing sites and identify best practices • Ongoing evaluation of site-specific enrollment barriers, such as new competing trials or staffing limitations • Identify champions to visit and/or host teleconferences with regional sites Inspire, educate, & motivate!

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Accrual workshopsSM Live meetings designed to engage investigators and research personnel in interactive, case-based learning activities Successful enrollment enhancement tool to simplify the protocol, identify eligible patients, and accelerate enrollment to clinical trials Benefits •

Peer to peer interactions



Learning best practices



Site education



Potential patient identification



Discussion of enrollment challenges and solutions



Site feedback about clinical trial

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Case studies

Agenda

Case-based learning

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Accrual workshopSM testimonials “Very good discussions throughout the day” “Good to hear what problems/obstacles/questions other sites are having with study accrual” Rosemary Chandler, RN, BSN, OCN Georgia Health Sciences University Augusta, GA

“The meeting met all of my expectations. It was very informative and I enjoyed the group discussions, especially the ‘case discussions’. These are day to day events that we can run into and need to know how to handle them.” Accrual WorkshopSM Attendee

“It was a good meeting that reviewed the protocol even better than during the SIV.”

“The workshop was good. The background on NSCLC was beneficial as well as the case studies. Since the trial is not always top of mind, it helped to discuss some trickier cases.”

Accrual WorkshopSM Attendee Accrual WorkshopSM Attendee

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Impact of accrual workshopsSM 35 30

85% Cumulative enrollment increase

16% Increase 69% Increase

86% Increase

25

6 AWs in multi-center phase III trial

73% Increase

20 15

67% Increase

10 200% Increase 5 0

AW I

AW II

AW III 67%

AW IV

AW V

86%

200%

AW VI

73% 16%

AW I

(I) Dallas, TX – 15 sites (II) Boston, MA – 15 sites (III)Philadelphia, PA – 11 sites (IV) Los Angeles, CA – 21 sites (V) Chicago, IL – 6 sites (VI) New York, NY - 13 sites

o Average of 20 pts accrued after each workshop vs. 12 pts before workshop

69%

120 day enrollment pre-AW vs. post-AW

o o o o o o

AW II

AW III

AW IV

AW V

AW VI

J. Eckardt, N. Levonyak, O. Peracha, A. Nemeth, N. Ku, A. DeMaggio, M. Reese, V. Jain - ASH 2009 35

Melanoma phase III trial  Trial: double-blind, randomized, placebo-controlled phase III study of resected stage III melanoma with macroscopic lymph node involvement  Enrollment: 1300  DAVA services: physician-focused patient recruitmentSM (14 months)

0.14 p/s/m 180

80

0.10 p/s/m

160

70

140

60

DAVA Initiation

Enrollment

120

50

Sites

100

40

80

30

60

20

40

41% increase in the enrollment rate

20 0

10 0

1

2

3

4

5

6

7

8

9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Sites

Trend

Actual

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Sarcoma phase III trial  Trial: A phase III randomized study of front-line metastatic soft tissue sarcoma  Enrollment: 424  DAVA services: physician-focused patient recruitmentSM & accrual workshopsSM (10 months)

DAVA Supported Sites

100 80

DAVA Initiation

Enrollment Rate

60

Period 1

0.118 (p/s/m)

40

Period 2

0.216 (p/s/m)

20

Change

+ 83%

0 1

2

3

4

5

6

7

8 Sites

9

10 Actual

11 12 Trend

13

14

15

16

17

18

13

14

15

16

17

18

Non-DAVA Supported Sites

100 80

DAVA Initiation

Enrollment Rate

60

Period 1

0.296 (p/s/m)

40

Period 2

0.200 (p/s/m)

20

Change

- 32%

0 1

2

3

4

5

6

7

8 Sites

9

10 Actual

11 12 Trend

37

NSCLC phase III trial  Trial: A phase III randomized study of non-squamous, non-small-cell lung cancer  Enrollment: 988  DAVA services: physician-focused patient recruitmentSM & accrual workshopsSM (11 months)

60

Sites

DAVA Initiation

40% increase in recruitment

50 40

242 172

Sites Trend Actual

50

10

Enrollment Rate

200 100

20

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

0

Enrollment Rates (P/S/M)

0.5

DAVA Initiation

0.4

P/S/M Before DAVA

0.3

0.35 P/S/M

0.2

1

2

3

4

5

P/S/M with DAVA

47% increase in enrollment rate

0.24 P/S/M

0.1 0.0

250 150

30

0

300

Enrollment

DAVA's Impact on Enrollment

70

6

7

8

9

10

11

12

13

14

15

Average Before DAVA Average With DAVA 16

17

18

38

Supportive Care phase III trial  Trial: A phase III supportive care trial in solid and hematological malignancies  Enrollment: 5264  DAVA service: site identification and recommendation, physician-focused patient recruitmentSM (10 months)

Enrollment forecast

1100 1000

Month of Analysis

900

Patients Enrolled

800

Trending to achieve LPE 12 months ahead of schedule

700 600 500 400 300 200 100 0 0

1

2

3

4

5 Original Goal

6

7 Actual

8 Forecast

9

10

11

12

13 39

DAVA tactic impact analysis Accrual workshopsSM

Site visits

180%

160%

160%

140%

140% 120%

67% increase in enrollment rate

120% 100%

100%

41% increase in enrollment rate

80%

80%

60%

60% 40%

40%

20%

20%

0%

0% Enrollment Rate (P/S/M) Before After

N=68

Enrollment Rate (P/S/M) Before After

N=300

A retrospective analysis was performed on 11 phase II/III randomized clinical trials to determine the impact of DAVA’s specialized tactics on the enrollment rate (P/S/M) at participating sites. This analysis focused on a time period 120 days before and after each event. 40

Our promise

To improve patient care by realizing the full potential of oncology drug development

Why DAVA Oncology o

DAVA has worked with over 43 companies, from big pharma to small biotech, on over 260 projects

o

Our team is led by four board-certified medical oncologists / hematologists with decades of clinical experience

o

Proprietary investigator database for proper study placement

o

Significant investigator relationships  Frequent educational interactions drive trial enthusiasm and enrollment

o

Peer-to-peer clinical interactions  Investigators, sub-investigators, referral physicians and pathologists

ASCO White Paper 2011: “Clinical trial site engagement and commitment through direct physician interaction with investigators.” ASCO White Paper 2011: “Impact of direct physician-to-physician contact on accelerating Oncology clinical trial accrual in multiple tumor types.” ASCO Poster 2009: “The implementation of direct physician-to-physician intervention resulted in a measureable improvement of between 50-300% in the monthly accrual of 5 cancer trials.” ASH Poster 2009: “Impact of physician-to-physician interactions utilizing case-based learning workshops to accelerate accrual.”

 Research nurses, coordinators o

Proven track record

www.davaonc.com

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