Key Strategies to Survive in Today\’s Changing World of Oncology Clinical Trials
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This overview highlights the most critical issues affecting oncology clinical development in the U.S. biopharmaceutical industry To view the full webcast with audio please visit http:/www.scimega.com/resources-oncology-webcasts.php
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Key Strategies to Survive in Today\’s Changing World of Oncology Clinical Trials
- 1. Key Strategies You Must Know to Survive In today ’s rapidly changing world of oncology clinical research Denise Deakin President, Scimega Research
- 3. New Cancer Cases Each Year Over 50% survive > 5 years * *American Cancer Society
- 4. Cost of Ineffective Medicine Cancer Drugs that have no effect on the patient 1 Jane Theaker, Jennifer Lewis and Marc Egelhofer (November 2010) “Personalized Healthcare: From Vision To Reality”
- 5. The Promise of Personalized Medicine
- 11. The Patient Recruitment Challenge Less than 50% of trials meet enrollment targets $40,000 for each day a site is open *Applied Clinical Trials, July 1, 2008 “Is Investigative Site Feasibility Feasible?”
- 12. Reverse Feasibility ™ Program No Sponsor or Investigator Fees
- 16. Success Story Site 1: Major teaching institution Study start-up: 2.5 months ( protocol receipt to 1st patient in ) IRB: 2 months FPI: 9 days post initiation visit Pt. enrollment: target = 3pts/12 months actual = 3 pts/5 months
- 17. Success Story Site 2: Major teaching institution Study start-up: 3.5 months ( protocol receipt to 1st patient in ) IRB: 3 months FPI: 27 days post initiation visit Pt. enrollment: target = 3 pts/12 months actual = 3 pts/4 months
- 18. Value of The Reverse Feasibility ™ Program “ It worked great for us. We’re happy to have found a couple fantastic sites that have been very helpful in meeting our aggressive enrollment timelines.” - Director of Clinical Operations
- 19. Make Better Strategic Decisions Faster To view the full webcast with audio please visit Oncology Webcast www.scimega.com
Notes de l'éditeur
- Welcome and thank you for joining us for this presentation entitled “ The Reverse Feasibility Program- A novel approach to conducting oncology clinical research” My name is Denise Deakin and I am the President of Scimega Research, a Canadian CRO with a singular focus in oncology clinical research since 1997. For the next 20 minutes, I invite you to put aside your preoccupations of the day and follow me into the ever-changing world and increasingly vital role of CLINICAL OPERATIONS. As we review the most pressing issues pertaining to oncology clinical research in the biopharmaceutical industry, I ’d like you to entertain the following thought. The most promising scientific breakthroughs in cancer research are only as good as the quality of the clinical operations that accompanies it into the clinical setting.
- In order to set the stage for the pivotal point of my discussion today, which is the introduction of the RF program, designed to enhance site selection and pt. recruitment, I ’ d first like to touch on and review three very important issues: The rising incidence and demographics of Cancer in our society The perspectives of key stakeholders such as sponsors, clinical investigator and patients as they relate to current trends in oncology drug development As well as the operational challenges associate with the development of cancer compounds There is no question that cancer research is a hot topic that has been gaining momentum over the past 30 years. In 1996, for example, 16 cancer therapies were approved by the FDA. In the 25 years preceding that, the average number was 3.
- In 2009, 10 million news cancer cases were diagnosed. By the year 2020, this number is expected to increase to 15 million. The increase in new cases is accompanied by a trend toward increased survival rates attributed largely to screening programs and early detection in breast and prostate cancer, along with the emergence of a greater number of treatment options. Today, over 50% of people diagnosed with cancer will live beyond 5 years and therefore, the increase in incidence and survival, will result in more people living with cancer. In 2008 the socio-economic burden in the U.S. was 228 billion (93.2 billion in insurance, 18.8 billion in lost productivity due to illness and 116.1 billion due to lost productivity from death)
- Targeted therapies represent close to 70% of all cancer drugs in development. Targeted therapies consist of drugs or other substances, such as monoclonal antibodies, to identify and attack specific cancer cells. These therapies may have fewer side effects, an important attribute to this type of therapy since older cancer patients often develop more severe effects to treatment.
- Targeted therapies represent close to 70% of all cancer drugs in development. Targeted therapies consist of drugs or other substances, such as monoclonal antibodies, to identify and attack specific cancer cells. These therapies may have fewer side effects, an important attribute to this type of therapy since older cancer patients often develop more severe effects to treatment.
- Current economic conditions, make it exceedingly difficult for biotech companies to secure the financing they need to advance their development pipelines. This is evidenced in the 50% decline of the number of clinical trials over the past two years. Compounding this unfavorable reality is the ever-increasing cost to develop cancer compounds. Oncology drugs may cost more than double the often quoted $800 Million price tag for drugs in other therapeutic areas. Attrition rates are also higher in oncology since demonstrating activity of treatment targets is more complex with novel drugs. (1 in 40 vs. 1 in 10) As we enter the era of personalized medicine, attrition rates will decline, resulting in greater efficiencies in drug development. However, personalized medicine will add an additional administrative burden to both sponsors and sites, as personalized medicine means a move away from larger clinical trials to multiple smaller ones. Gaining access to regions with a similar SOC and availability of comparator arm drugs can be also be challenging. Measuring disease response often requires sophisticated imaging equipment such as spiral CT scan and MRI, which are very expensive. Phase III, solid tumor trials, often use central imaging services. Central labs may be used for tumor marker analysis , tumor blocks etc… Again, services which add to the complexity and cost of a trial.
- Current economic conditions, make it exceedingly difficult for biotech companies to secure the financing they need to advance their development pipelines. This is evidenced in the 50% decline of the number of clinical trials over the past two years. Compounding this unfavorable reality is the ever-increasing cost to develop cancer compounds. Oncology drugs may cost more than double the often quoted $800 Million price tag for drugs in other therapeutic areas. Attrition rates are also higher in oncology since demonstrating activity of treatment targets is more complex with novel drugs. (1 in 40 vs. 1 in 10) As we enter the era of personalized medicine, attrition rates will decline, resulting in greater efficiencies in drug development. However, personalized medicine will add an additional administrative burden to both sponsors and sites, as personalized medicine means a move away from larger clinical trials to multiple smaller ones. Gaining access to regions with a similar SOC and availability of comparator arm drugs can be also be challenging. Measuring disease response often requires sophisticated imaging equipment such as spiral CT scan and MRI, which are very expensive. Phase III, solid tumor trials, often use central imaging services. Central labs may be used for tumor marker analysis , tumor blocks etc… Again, services which add to the complexity and cost of a trial.
- Current economic conditions, make it exceedingly difficult for biotech companies to secure the financing they need to advance their development pipelines. This is evidenced in the 50% decline of the number of clinical trials over the past two years. Compounding this unfavorable reality is the ever-increasing cost to develop cancer compounds. Oncology drugs may cost more than double the often quoted $800 Million price tag for drugs in other therapeutic areas. Attrition rates are also higher in oncology since demonstrating activity of treatment targets is more complex with novel drugs. (1 in 40 vs. 1 in 10) As we enter the era of personalized medicine, attrition rates will decline, resulting in greater efficiencies in drug development. However, personalized medicine will add an additional administrative burden to both sponsors and sites, as personalized medicine means a move away from larger clinical trials to multiple smaller ones. Gaining access to regions with a similar SOC and availability of comparator arm drugs can be also be challenging. Measuring disease response often requires sophisticated imaging equipment such as spiral CT scan and MRI, which are very expensive. Phase III, solid tumor trials, often use central imaging services. Central labs may be used for tumor marker analysis , tumor blocks etc… Again, services which add to the complexity and cost of a trial.
- Early phase studies, which account for XX require highly experienced cllinical investigative teams and sophisticated equipment. Since establishing MTD is an integral part of early phase research, patients have to be followed very closely and adverse events monitored with precision. Pharmacokinetic samples must be taken and managed according to strict guidelines. Good communication between the sponsor and the clinical investigative team is vital, as increasing drug dosage and adding patient cohorts must be carefully coordinated. While U.S. sites are likely to be suitable for the reasons mentioned, statistics show that they are also likely to underachieve when it comes to patient recruitment. Approximately 30% of sites on any given trial are inactive, representing $16-20,000 per site of lost sponsor investment. IRB approval times have increased as they often have more sub-committees –such as tumour boards, ethics review, pharmacy, infectious diseases, finance and legal.
- The information we gather on a regular basis from our network includes: Experience – Directors Clinical Research Capacity Equipment Catchment area Genotyping IRB requirements/schedule Start-up fees SOC – availability and reimbursement Recruitment openings over next 6 months
- According to the Tufts Centre for the Study of Drug Development, patient recruitment is the number 1 concern among sponsors. The majority of trials are running late by an average of 6 weeks and less than 50% are meeting or exceeding their enrollment targets. According to Ken Getz, the site feasibility process, an important pre-requisite to selecting the right sites, is to blame. He points to such issues as : Sponsors giving sites incomplete information about their study and budget Sponsors not questioning sites on enrollment projections/protocol specifics Sponsors not allowing enough time for proper assessment Sponsors requesting feasibility assessments free of charge Investigator databases not being leveraged – meaning sites are repeatedly having to answer the same questions; and finally… Site selection criteria not being properly explained to investigators. The impact of a poor site selection process is clear. Each day a site remains open costs a sponsor approximately $40,000
- When the idea was presented to sponsors, they were very excited by the prospect of having such direct access to site information. This would reduce the need for a traditional feasibility approach which can sometimes be like looking for a needle in a haystack! We had the green light from two important stakeholders. And so, we launched the Reverse Feasibility Program – with the goal being be to provide this service in conjunction with Scimega ’ s clinical trial management services, ensuring that sponsors maximize the opportunity to achieve the greatest return on investment in Canada. Beside the intended benefit of the program it also provides an important secondary benefit. Our experience and information from the reverse feasibility program could be applied to traditional feasibility studies. Because we know that opportunities will also present themselves via the traditional approach, the advantage of being able to apply our centralized information is an important one. 10 and 25% of adult Canadian cancer pts. participate in clinical trials vs. 3- 5% in the United States. So, Canada can recruit a significant number of patients when the trial is being conducted at the right site and this is what the RV program wants to accomplish.
- The information we gather on a regular basis from our network includes: Experience – Directors Clinical Research Capacity Equipment Catchment area Genotyping IRB requirements/schedule Start-up fees SOC – availability and reimbursement Recruitment openings over next 6 months
- The following success story is based on actual events but the names have been changed to protect the identity of the sponsor. A US Biotech company recently used the Reverse Feasibility program to help ensure the success of a complex dose-ranging Phase I/II study for select and rare tumor types. We initially met the sponsor at ASCO and learned that their trial had been ongoing in the US for 14 months with a total of 30 pts. recruited. And although there was no immediate concern related to recruitment delays, the Director of Clinical Operations wanted to mitigate any potential risk.
- Major teaching centres were chosen for this particular trial since the tumor types were rare. Study start-up: 2.5 months ( protocol receipt to 1st patient in ) IRB: 2 months FPI: 9 days post initiation visit Pt. enrollment: target = 3pts/12 months actual = 3 pts/5 months The Investigator having championed the trial resulted in the sponsor ’s recruitment target being met 7 months ahead of schedule. Given the fact that 80% of sites don ’t recruit on time and that even “adjusted” site feasibility assessments are accurate less than 10% of the time, this client was understandably pleased with the outcome, as were her executive management team who saw a significant return on investment in Canada, as a result of this proactive approach.
- Site 2: Major teaching institution Study start-up: 3.5 months ( protocol receipt to 1st patient in ) IRB: 3 months FPI: 27 days post initiation visit Pt. enrollment target = 3 pts/12 months actual = 3 pts/4 months Again, these performance metrics demonstrated that when the Investigator is championing a study, there is a greater sense of commitment and subsequently, timelines and recruitment can be enhanced.
- When asked to provide feedback on their experience the sponsor said that while they were impressed by Scimega ’ s oncology experience, what impressed them the most was our network of sites and the close rapport we maintain with them. In regards to the value of the RF program, they acknowledged that it was very helpful in meeting their aggressive enrolment timelines.