Last update: 12/10/2004

Harmonize research objectives with patients survival goals    If patients fail to sign on in adequate numbers, the assessment of the therapy will not be made, no matter how well the study is designed from the point of view of regulators and drug sponsors.

Action: Encourage sponsors to consult informed patients, such as scientists with the disease, when designing clinical trials.

Action: Visualize the study protocol from the patient’s point of view – with an appreciation that patients have one life to experiment with.

	Does the protocol compare favorably to other options in this setting?
	Does it unnecessarily include tests that patients fear, such as bone marrow biopsies?
	Do the side effects preclude the use of treatments that may be needed later?
	Does the protocol include quality of life endpoints?
	Is there genuine uncertainty about which treatment arm in a randomized trial is best?
	Can you disclose outcome data as it develops, to foster trust?
	Are predictive tests used to identify who is likely to benefit, such as gene profiling? *

“Given the number of articles that describe the correlative and predictive usefulness of array-based molecular classifications, especially in leukemias, these outcomes no longer elicit surprise. But perhaps they should — not only because of their clinical usefulness, as outlined in the editorial by Grimwade and Haferlach (pages 1676–1678), but also because of the rapid pace at which expression genomics is changing the conduct of clinical research..”
 
NEJM ~ Vol. 350:1595-1597, April 15, 2004 No 16
 
Also see Patient perspectives on clinical trial design

Provide financial support for travel, lodging, and associated tests.   When patients participate in clinical trials they provide a service to society and deserve our support, perhaps even compensation.   These individuals are heros. Action: Advocate for government assistance, especially for the uninsured, so that the financial limitations of individual patients do not impede progress or access to appropriate investigational therapies.   See Coverage of Health Care Costs for Clinical Trials - How does your state measure up? Action: Educate patients about resources that can help patient to overcome these obstacles,  such as Travel for Treatment

 

Carry out the blueprint for the National Biospecimen Network  in order to conduct more efficient and humane drug development and evaluations: Standardized collection of biospecimens;  Find novel targets using microarrays; Refine diagnosis and identify high- and low-risk disease; Find clinically useful biomarkers by identifying correlations between gene expression profiles and responders;  Select the appropriate patients for targeted-phase studies. The result is that smaller studies will be needed to achieve statistically significant results, providing relief from the competition for patients.  Fewer patients will be subjected to the toxicity of drugs that cannot help them.  The new favorable circumstances – replacing trial and error – will cause increased interest in trials and cancer research among patients, investigators, and commercial entities... See background on National Biospecimen Network

Encourage “trial talk” between the patients and treating physicians  Action: Help patients and physicians to locate appropriate studies by:  using the lymphoma-specific queries of ClinicalTrials.gov on our website;  advocating for patient-friendly descriptions of clinical trial protocols and links to related data;  encouraging sponsors to list studies in ClinicalTrials.gov as mandated by FDA.  NOTE: We consult with patients and experts to identify notable clinical trials for lymphoma,  and invite drug sponsors to inquire about adding protocols to our list.    S See Clinical Trials of Interest for Lymphoma.   Action: Provide community physicians with incentives for referring patients to clinical trials.  Action: Involve community physicians in the administration of clinical trial protocols. Action: Educate patients about the true risks of the disease, the potential of investigational treatments, and the limitations of standard therapies.  See, for example  About Lymphoma Action: Encourage patients to consult lymphoma experts to get objective opinions about investigational therapies. See Doctors page.  Action: Advise patients to have the experts they consult contact their treating physicians in order to reach a consensus on what treatment protocol is best for them. Action: Help patients to review consent forms, contact investigators, and complete applications.  Action: Inform patients on how to better evaluate medical claims and data.

Create innovative trial designs with the potential to make a positive difference in patients' lives  The time to get creative is early in the course of the disease, when the patient has better immune competence, less tumor burden, and has had fewer exposures to toxic therapies.  Action: Develop front-line protocols, combining aggressive approaches in combination and/or in sequences with biological and immune-based therapies, that provide the potential for curing or extending survival in difficult to treat lymphomas.  Action: Develop front-line protocols for indolent lymphomas that combine or sequence low toxic target biotherapies and immune-based therapies with the goal of managing the disease with minimal toxicity.    NOTE: Without publicity, a frontline idiotype vaccine study completed accrual in two weeks.   Action: Develop protocols that induce active immunity against tumor antigens, and that may overcome ways that tumors escape or suppress immunity.  Action: Reduce reliance on quick response agents when the responses are not durable and the side effects, such as myelosuppression, contribute to complications and limit future options. Action: Develop protocols for refractory end-stage disease that can extend survival while improving quality of life. Also see Recipe for Progress

	Also see our brochure on the Increasing Participation in Clinical Trials - a PDF File
	Cancer Trial Participants Rarely Told of Results - Medscape (free login req.) "That may be changing, however, as patient advocates and some clinical researchers assert that offering results recognizes patients as partners in the research process, according to Dr. Partridge."
	Clinical Trials of Interest for Lymphoma
	Coverage of Health Care Costs for Clinical Trials - How does your state measure up?
	Consult with outside experts
	Evaluating Medical Claims and Data
	Finding lymphoma clinical trials, made easy
	National Biospecimen Network
	Patient perspectives on clinical trial design
	Review the article: Experimental Therapy, End-of-Life Care Can Coexist Tue May 21, 7:12 PM ET -  HealthScoutNews
	Travel for Treatment - Lymphomation.org