1
“Optimizing Your Involvement In Clinical Trials”
2
Investigator Landscape
Pre 1995
focus on science
close and collegial
largely academic based
safety and efficacy
few intermediaries
simple and minimal oversight
Ken Getz
Post 1995-now
focus on markets
distant and contractual
community, for profit based
speed and cost
many diverse intermediaries
complex and strict oversight
3
Investigator Landscape (continued)
78% of Americans consider their physician the most trusted source for medical and health-related information but only 17% report that they learned about clinical research from their specialty or primary care physician.
4
Challenges Recruitment
Bureaucracy
Protocol Complexity
5
Recruitment Challenges
Information provided by sponsor is not comprehensive enough for the investigator to make a good projection on their ability to recruit for the trial.
By the time the protocol is finalized it may be a completely different recruiting picture for the investigator compared to the initial information provided by the sponsor.
Protocol complexity has increased, making it more difficult to find patients that meet inclusion and exclusion criteria or be willing come to all the appointments needed for all the procedures that are required.
6
Recruitment Challenges
Budgets are often not presented until late in the process and sometimes are so far off from the investigators perspective there is no reason to even negotiate.
Investigators in large practice groups have difficulty getting referrals from other physicians in the group because the other physicians are so busy and do not think to refer patients even if they are willing to do so.
Protocols are often developed without real world input from experienced clinician investigator and coordinators.
7
Bureaucracy Challenges
Investigators, especially at academic institutions, often are caught between the institutions legal department and the sponsor’s legal department.
Repeated disputes over the same language in contracts often occurs and is resolved with virtually the same results and causes delays in study start up.
It was acknowledged that the IRB is outside of the sphere of influence of the sponsor and that investigators need to work with their institutions to streamline IRB processes.
8
Protocol Complexity Challenge
Protocol complexity is making doing the trials difficult and time consuming for patients, physicians and their staff.
In addition to increased protocol complexity, numerous amendments required impact getting the trial done.
9
CompetitionWhat is it that number one and two Pharma companies do better
than the others?
Enhance opportunity for clinical research
Listen to original research
The Ops people have authority to make decisions and make themselves accessible; e.g.: access to decision makers during study
Clinical team extremely supportive
Better data entry system
Commitment to the clinical trial process
Well organized; emphasis on rigorous science experienced
Science
10
How is Novartis an Opportunity?
Field Ops committed to engaging investigators that have patients that could benefit from novel treatments, matching your interest with our needs.
Our portfolio provides research opportunities.
Engaging you when the protocol is well defined.
Novartis partners with you to create recruitment strategies to help you be successful. “A hands on approach.”
The National CRADA simplifies the contract negotiation process with Novartis, as start up efficiency is a key success factor.
11
Novartis Clin Ops Mission
“
“To deliver quality data in a timely manner through strong relationships.”
12
Matching Interest with Need
The Novartis Portfolio offers opportunities
Development (phases 1-3)
Life cycle management (phase 4)
Therapeutic Areas
Cardiovascular Disease, Diabetes
Respiratory Disease, Dermatology
Infectious Disease (Hepatology), Immunology (i.e. lupus, Arthritis)
Transplant immunosuppressive therapies
Neuroscience (psychiatric illness, MS, seizure disorders, Parkinson's)
Ophthalmology (macular degeneration)
Oncology
13
Matching Interest with Need Planned Trials
Cardiovascular Disease
Treatment for Chronic Systolic Heart Failure
Respiratory Disease, Dermatology
LABA and LAMA alone and in Combination in COPD
LABA/Steroid in Asthma
Biologics in Psoriasis
Nicotine Vaccine (2011)
Add-on Treatment in Pulmonary Atrial Hypertension
14
Matching Interest with Need Planned Trials
Infectious Disease (Hepatology), Immunology (i.e. Arthritis, Gout)
Transplant immunosuppressive therapies
Pretreatment for Dialysis
(non-interferon) Treatment for Hepatitis B and C
Treatment for acute resistant Gout flares
Biologic in OsteoArthritis and RA
Neuroscience
Novel treatment for Multiple Sclerorsis
15
The Way Forward
Field operations colleagues are the first point of contact.
The CRA is responsible for conducting screening
Supported by an in-house clinical team
Once interests are known, local teams nominate potential investigators to match Novartis needs with your interest
Finding solutions to start up trials quickly will add to success